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4,138 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Non-smokers (<10 pack year history and no active smoking in the past year);
- Diagnosis of cystic fibrosis via standard sweat chloride/phenotypic
features/genotyping
- Able to reproducibly perform lung function testing and have an FEV1 >30% of predicted
at screening.
- No requirement for supplemental oxygen
- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the trial.
- Participants must be willing and able to comply with scheduled visits and other trial
procedures.
- Diagnosis of a pulmonary exacerbation according to Fuchs criteria (4 of the following
12 signs and symptoms) deemed to require antibiotic treatment, and must also include
the change in lung function criterion:
- Change in sputum
- New or increased hemoptysis
- Increased cough
- Increased dyspnea
- Malaise, fatigue, or lethargy
- Temperature above 38deg C
- Anorexia or weight loss
- Sinus pain or tenderness
- Change in sinus discharge
- Change in physical examination of the chest
- Decrease in pulmonary function by 10% or more from a previously recorded value
- Radiographic change indicative of pulmonary infection
Exclusion Criteria:
- Under 18 years of age
- Active or former smokers with less than 1 years since quitting, or >10 pack-year
smoking history
- Active asthma flare, as perceived by the study physician or unstable asthma
characterized by advancement of asthma therapy in the last month or two courses of
oral steroids in the past six months.
- Unable to undergo a 3.0-Tesla MRI of lungs and chest because of contraindications
including
1. Occupation (past or present) of machinist, welder, grinder
2. Injury to the eye involving a metallic object
3. Injury to the body by a metallic object (bullet, BB, shrapnel)
4. Presence of a cardiac pacemaker or defibrillator
5. Presence of aneurysm clips
6. Presence of carotid artery vascular clamp
7. Presence of neurostimulator
8. Presence of insulin or infusion pump
9. Presence of implanted drug infusion device that is not known to be MRI compatible
(i.e., was placed outside of University of North Carolina Hospitals (UNCH) or is
older than 10 years)
10. Bone growth or fusion simulator
11. Presence of cochlear, otologic or ear implant
12. Any type of prosthesis (eye, penile, etc.)
13. Artificial limb or joint
14. Non-removable electrodes (on body, head or brain)
15. Intravascular stents, filters or coils
16. Shunt (spinal or intraventricular)
17. Swan-Ganz catheter
18. Any implant held in place by a magnet
19. Transdermal delivery system (e.g. Nitro)
20. Intrauterine device (IUD) or diaphragm
21. Tattooed makeup (eyeliner, lips, etc.) or tattoos covering >25% of body surface
area
22. Body piercings (MUST BE REMOVED BEFORE MRI)
23. Any metal fragments
24. Internal pacing wires
25. Metal or wire mesh implants
26. Hearing aid (REMOVE BEFORE MRI) aa. Dentures (REMOVE BEFORE MRI) bb.
Claustrophobia
- Unable to tolerate inhalation of the gas mixture
- Unable to adequately complete other study measures, including spirometry and multiple
breath nitrogen washout
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or may
interfere with the interpretation of trial results and, in the judgment of the PI,
would make the participant inappropriate for enrollment.
- Pregnancy; women of childbearing potential must have a confirmed negative serum
pregnancy test at screening, and a negative urine test on the day of the MRI scan,
prior to the MRI scan (if serum test not performed the same day).
- Facial hair preventing a tight fit of the mask used in the study
- Allergy or intolerance due to side effects to bronchodilators
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | 19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation | NCT03497117 | Contradiction |
1,991 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma, including type II or type III
adenocarcinoma of the esophagogastric junction
- Stage III disease
- T3 or T4 and/or N2
- No stage IV disease
- Helical CT scan and laparoscopic staging required
- Potentially resectable disease
PATIENT CHARACTERISTICS:
Age
- 20 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 4,000/mm³, but < 12,000/mm³
- Granulocyte count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
Renal
- Creatinine clearance ≥ 50 mL/min
Pulmonary
- Arterial oxygen pressure (PaO_2) ≥ 70 mm Hg on room air
Other
- Able to take oral medications
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for gastric cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for gastric cancer
Surgery
- No prior surgery for gastric cancer
Other
- No other prior therapy for gastric cancer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer | NCT00182611 | Entailment |
6,516 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Subjects must have participated in the "GreenGene™ F_P3", (with Eudra CT number
2012-001445-40) or a pediatric study with GreenGene™ F
2. Have ≥50 previous exposure days to GreenGene™ F, as documented in the subject's
medical records.
3. Negative assays for FVIII inhibitor at inclusion (<0.6BU Nijmegen assay), i.e. at the
end of study "GreenGene™ F_P3" for patients entering into this extension study
immediately after finishing the previous phase III study.
4. Normal liver and kidney function
5. Platelet count ≥ 100,000㎕
6. Normal prothrombin time or International Normalized Ratio (INR) < 1.5
7. Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be
on a stable treatment regimen
8. Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each
inhibitor assay
9. Absolute CD4 lymphocyte cell count ≥ 200㎕
10. Signed the written informed consent form or informed consent was obtained from the
subject's legal guardian
11. Females must not be lactating or pregnant at screening or Baseline (as documented by a
negative beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of
25 IU/L or equivalent units of β-hCG). A test was obtained more than 72 hours before
the first dose of study drug
12. All females will be considered to be of childbearing potential unless they are
appropriate age group and without other known or suspected cause) or have been
sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy or bilateral
oophorectomy, all with surgery at least one month before dosing)
13. Willing and able to comply with all aspects of the protocol
Exclusion Criteria:
1. Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen
modification of the Bethesda assay.
2. Laboratory or clinical evidence of portal vein hypertension including, but not limited
to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata of physical
examination and/or a history of esophageal hemorrhage or documented esophageal varices
3. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
4. Hemoglobin < 10 g/dL
5. Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin
> 2x the ULN)
6. Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 3x
the ULN)
7. History of diabetes or other metabolic disease
8. History of hypersensitivity or serious adverse reaction to recombinant or
plasma-derived FVIII concentrates
9. History of pretreatment prior to the administration of FVIII products (e.g.,
antihistamines)
10. Regular use of antifibrinolytics or medications affecting platelet function
11. Hypersensitivity to hamster- or mouse derived proteins
12. Blood transfusions within 30 days of enrollment into the study
13. Current participation in another investigational drug or device study, or participated
in a clinical study involving an investigational drug or device within 30 days of
enrollment into the study
14. Unable or unwilling to cooperate with study procedures
15. Females who are pregnant (positive β-hCG test) or breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A | NCT02027779 | Contradiction |
2,022 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | - INCLUSION CRITERIA:
Initial Enrollment:
-An individual who harbors a pathogenic, or likely pathogenic, CDH1 germline variant.
Note: individuals with CDH1 variant classified as any of the following are not eligible:
- variant of uncertain significance
- benign
- likely benign.
- Age greater than or equal to 18 years.
- Physiologically able to undergo upper endoscopy.
- Ability of subject to understand and the willingness to sign a written informed
consent document.
EXCLUSION CRITERIA:
- Known bleeding disorder or thrombocytopenia that is a contraindication to endoscopic
biopsy.
- Unstable angina or recent (within 3 months) myocardial infarction.
- Any clinical contraindication to general anesthesia.
Re-Enrollment:
INCLUSION CRITERIA:
- Subject must have previously been enrolled on the study and must have undergone
endoscopy. Note: Subject may re-enroll only once after initial endoscopy performed
- Subject must have clinical need for a repeat endoscopy
- Prior on-protocol endoscopy must have occurred at least 6 months (+/- 2 weeks) and no
greater than 18 months (+/- 4 weeks)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers | NCT04535414 | Entailment |
2,908 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- A clinical diagnosis of possible, laboratory-supported probable, probable or definite
ALS, according to modified EL Escorial criteria
- FVC greater or equal to 60% at the screening visit
- Symptom onset within 5 years
- 21 to 85 years of age
- If patients are taking riluzole, they must be on a stable dose for at least the past
thirty days
- A woman of childbearing age, must be nonlactating and surgically sterile or using an
effective method of birth control (barrier method) and have a negative pregnancy test
- Able to maintain adequate hydration levels defined as 6-8 cups (8ounces/cup) of water
or a non-caffeinated beverage per day
- Willing and able to give signed informed consent that has been approved by an
Institutional Review Board (IRB)
Exclusion Criteria:
- Tracheotomy and mechanical ventilation
- Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's
disease, etc)
- Unstable medical illness (coronary artery disease, advanced cancer, active esophageal
or gastroduodenal ulcers, etc) in the last one year
- Systemic Lupus Erythematosis
- FVC < 60%
- Pregnancy or lactation
- Allergy to minocycline, tetracyclines, celecoxib, sulfonamides, NSAIDS, or creatine
- History of congestive heart failure
- Renal disease [baseline Cr > 1.5 (men) or 1.2 (women)]
- History of significant hepatic disease (baseline AST/ALT or bilirubin > 1.5x normal)
- Use of an investigational agent within thirty days of enrollment
- First degree relative with ALS or gene identified familial ALS
- Inability or unwillingness to maintain adequate daily hydration (defined above)
- Limited mental capacity such that the patient cannot provide written informed consent
or comply with evaluation procedures.
- History of recent alcohol or drug abuse or noncompliance with treatment or other
experimental protocols.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 85 Years | Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis | NCT00355576 | Entailment |
2,141 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Subject is able to understand the study procedures, the risks involved and willing to
provide written informed consent before the first study related activity.
- Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject has been taking allopurinol as the sole urate-lowering therapy indicated for
the treatment of gout for at least 8 weeks prior to the Screening Visit at a stable,
medically appropriate dose, as determined by the investigator, of at least 300 mg per
day (at least 200 mg for subjects with moderate renal impairment).
- Subject must be able to take gout flare prophylaxis with colchicine or an Nonsteroidal
anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.
- Subject has an sUA level ≥ 6.5 mg/dL at the Screening Visit and ≥ 6.0 mg/dL at Day -7
Visit.
- Subject has reported at least 2 gout flares in the prior 12 months.
- Body mass index (BMI) < 45 kg/m2
Exclusion Criteria:
- Subject with known hypersensitivity or allergy to allopurinol.
- Subject who is taking any other approved urate-lowering medication that is indicated
for the treatment of gout other than allopurinol within 8 weeks of the Screening
Visit.
- Subject who is pregnant or breastfeeding.
- Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150
mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
- Subject with a history or suspicion of drug abuse within the past 5 years.
- Subject that requires or may require systemic immunosuppressive or immunomodulatory
treatment.
- Subject with known or suspected human immunodeficiency virus (HIV) infection.
- Subject with a positive test for active hepatitis B or hepatitis C infection.
- Subject with a history of malignancy within the previous 5 years with the exception of
non-melanoma skin cancer that has been treated with no evidence of recurrence, treated
cervical dysplasia or treated in situ Grade 1 cervical cancer.
- Subject within the last 12 months with: unstable angina, New York Heart Association
class III or IV heart failure, myocardial infarction, stroke, or deep venous
thrombosis; or subjects currently receiving anticoagulants.
- Subject with uncontrolled hypertension.
- Subject with an estimated creatinine clearance < 30 mL/min.
- Subject with active peptic ulcer disease requiring treatment.
- Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
- Subject receiving chronic treatment with more than 325 mg of salicylates per day.
- Subject taking valpromide, progabide, or valproic acid.
- Subject who has received an investigational therapy within 8 weeks or 5 half-lives
(whichever is longer) prior to the Screening Visit.
- Subject with any other medical or psychological condition, which might create undue
risk to the subject or interfere with the subject's ability to comply with the
protocol requirements, or to complete the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Combining Lesinurad With Allopurinol in Inadequate Responders | NCT01510158 | Contradiction |
1,555 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion criteria:
- Age ≥ 18 years
- No significant non-invasive systolic blood pressure difference between left arm and
right arm (difference <20mmHg in systolic arterial pressure)
- Patient requires continuous monitoring of diastolic and systolic blood pressure
continuously via a radial arterial line;
- Patient information and informed consent is obtained following the procedures
described in CIP
Exclusion criteria:
- Arrythmias: tachycardia (resting heart rate > 120/min) at time of study inclusion
- Atrial fibrillation
- Psychomotor agitation
- Significant bruises or trauma on forearm
- Intravenous canula around the wrist with impossibility to place the device (Aktiia
OBPM PulseWatch) around the wrist
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements | NCT03837769 | Contradiction |
2,418 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Completion of blinded study drug treatment in the previous Phase 2b study
(PTC124-GD-007-DMD).
- Ability to provide written informed consent (parental/guardian consent if
applicable)/assent (if less than [<]18 years of age).
- In participants who are sexually active, willingness to abstain from sexual
intercourse or employ a barrier or medical method of contraception during PTC124
administration and the 6-week follow up period.
- Willingness and ability to comply with scheduled visits, drug administration plan,
study procedures, laboratory tests, and study restrictions.
Exclusion Criteria:
- Known hypersensitivity to any of the ingredients or excipients of the study drug
(Litesse® UltraTM [refined polydextrose], polyethylene glycol 3350, Lutrol® micro F127
[poloxamer 407], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla,
Cab-O-Sil® M5P [colloidal silica], magnesium stearate).
- Ongoing participation in any other therapeutic clinical trial.
- Prior or ongoing medical condition (for example, concomitant illness, psychiatric
condition, behavioral disorder, alcoholism, drug abuse), medical history, physical
findings, ECG findings, or laboratory abnormality that, in the investigator's opinion,
could adversely affect the safety of the subject, makes it unlikely that the course of
treatment or follow up would be completed, or could impair the assessment of study
results.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Phase 2B Extension Study of Ataluren (PTC124) in Duchenne/Becker Muscular Dystrophy (DMD/BMD) | NCT00847379 | Entailment |
1,977 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
patients scheduled to upper digestive endoscopy for diagnostic purposes due to complaints
of epigastric burning.
Exclusion Criteria:
American Society of Anesthesiologists (ASA) score above II, diabetes mellitus, pregnancy,
renal or hepatic failure, gastroesophageal reflux, acute cholecystitis, use of
corticosteroids up to 6 months previously, use of any prokynetic drug up to 6 weeks, and
any noncompliance or violation on the assigned protocol of preoperative fasting.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Residual Gastric Volume After the Ingestion of a Beverage Containing Carbohydrates Plus Whey Protein | NCT01828645 | Entailment |
114 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria for first group:
1. Patients with testosterone deficiency (total testosterone< 277 ng/dL [9.6 nmol/L])
measured between 7-10 am, and with one or more symptoms and signs suggestive of
androgen deficiency as mainly determined by history.
- Reduced sexual desire (libido)
- Decreased spontaneous erections
- Breast discomfort, gynecomastia
- Loss of body (axillary and pubic) hair - reduced shaving
- Very small (<5ml) or shrinking testes
- Height loss
- Low trauma fracture
- Low bone mineral density
- Hot flushes
- Sweats
- Decreased energy
- Decreased motivation
- Decreased initiative
- Decreased self confidence
- Feeling sad or blue
- Depressed mood
- Dysthymia
- Poor concentration
- Poor memory
- Sleep disturbance
- Increased sleepiness
2. Age 40 to 80 years
Inclusion Criteria for second group:
1. Patients who underwent chemical or surgical castration for prostatic cancer who are
going to receive androgen deprivation therapy.
2. Age 40 to 80 years
Exclusion Criteria (both groups):
1. Patients with history or current diagnosis of:
- Atrial fibrillation.
- Cardiac arrythmia
- Pacemaker placement.
- Myocardial infarction < 3 months
- Uncontrolled diabetes mellitus with hemoglobin A1c > 8.5% in the last 6 months.
- Diabetes mellitus with autonomic neuropathy
- Breast cancer
- Heart failure with left ventricular ejection fraction below 35%.
- Severe sleep apnea.
- Recent eye surgery (< 3 months)
- Recent ischemic stroke (< 3 months)
- History of retinal detachment.
- History of brain aneurysm.
- Severe chronic obstructive pulmonary disease (COPD) on oxygen therapy.
- Intraocular hemorrhage and lens dislocation.
- Glaucoma.
- Thyroid disease.
- Not literate in English
Exclusion Criteria for patient who will receive testosterone treatment
- Metastatic prostate cancer
- Prostate-specific antigen (PSA) concentration >4.0 mcg/L,
- Prostate-specific antigen (PSA) >3.0 mcg/L in high-risk men (African-Americans or men
with first-degree relatives with prostate cancer). (Measured at clinic visit 1)
- Polycythemia (hemoglobin level >18 g/dL, hematocrit > 52%) (measured at clinic visit
1)
- Severe acne.
- History of venous or arterial thrombosis.
- Persons not literate in English
Male
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Autonomic Manifestations of Testosterone Deficiency in Men | NCT02715713 | Contradiction |
4,432 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- males >18 yr and < 70 yr
- BMI < 38
- chronic lateral epicondylitis (symptomatic > 3 mo)
- pain on provocation >/- 4 on 11 point scale
Exclusion Criteria:
- patients on other pain medications
- bilateral elbow pain
- any humerus elbow or forearm fracture or surgery
- signs of injury other than lateral epicondylitis
- any concomitant disease or pain of the upper extremity
- orthostatic hypotension
- patients taking MAO inhibitors, phosphodiesterase inhibitors, adrenergic agents
- pregnant or nursing women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow | NCT00447928 | Contradiction |
4,497 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
Patients who are presenting for gynecologic visits or well-woman examinations who still
have an intact uterus and are between the ages of 18 and 51 years, have abnormal uterine
bleeding, and can read and write in English.
Exclusion Criteria:
- Women who are presently on a treatment for abnormal uterine bleeding.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 51 Years | HMB- Data Collection Methods | NCT02001324 | Contradiction |
5,980 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Gender:Male or female.
2. Age: from 20 y/o to 75 y/o.
3. The diagnosis is Gastroesophageal Reflux Disease.
4. With the symptoms of heartburn or acid regurgitation.
5. After explaining thoroughly the whole research purpose or process, the clients are
willing to sign the agreement.
Exclusion Criteria:
1. Exclude peptic ulcer, gall bladder stone (including intraheptaic and common hepatical
duct) and major diseased of cancer.
2. Barrett's esophagus or esophagus stricture.
3. The operation history of esophagus or gastroduodenoal regions.
4. Tarry stool suspected GI tract bleeding.
5. With the history of alcohol or drug abuse.
6. The clients with the history of study drug allergy.
7. The clients with psychologic cannot cooperate with each other.
8. The pregnant woman or the lactating women.
9. Abnormal liver function such as GOT, GPT elevated over double the normal range.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Wu-Chu-Yu Tang on Gastroesophageal Reflux Disease (GERD) | NCT01822106 | Entailment |
6,183 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Phase 2a:
Inclusion Criteria:
1. Willing and able to provide written informed consent prior to performing study
procedures
2. Male or female ≥ 18 years and ≤ 85 years
3. Hospitalized for COVID-19
4. Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx, saliva, sputum) ≤ 10
days before enrolment
5. Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or
chest-imaging [Chest X-ray or computed tomography])
6. Requiring O2 supplement ≤ 6L/min at screening
7. Requiring O2 supplementation with SpO2 ≥ 94% on O2 therapy at screening
8. First onset of COVID-19 symptoms ≤ 10 days, among fever and/or chills, headache,
myalgias, cough, shortness of breath, whichever as occurred fist
9. WOCBP must have a negative urinary pregnancy test the day of inclusion
10. All sexually active male subjects must agree to use an adequate method of
contraception throughout the study period and for 90 days after the last dose of study
drug and agree to no sperm donation until the end of the study, or for 90 days after
the last dose of XAV-19, whichever is longer
11. Patients with French social security
Exclusion Criteria:
1. Evidence of multiorgan failure (severe COVID-19)
2. Mechanically ventilated (including ECMO)
3. Receipt of immunoglobulins or any blood products in the past 30 days
4. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion
of the investigator, would affect subject safety and/or compliance
5. End-stage renal disease (eGFR < 15 ml/min/1,73 m2)
6. Child-Pugh C stage liver cirrhosis
7. Decompensated cardiac insufficiency
8. History of active drug abuse
9. Known allergy, hypersensitivity, or intolerance to the study drug, or to any of its
components
10. Females of childbearing potential without contraceptive method, or with positive
pregnancy test, breastfeeding, or planning to become pregnant during the study period
11. Current documented and uncontrolled bacterial infection.
12. Prior severe (grade 3) allergic reactions to plasma transfusion
13. Patient participating in another interventional clinical trial
14. Life expectancy estimated to be less than 6 months
15. Patient under guardianship or trusteeship
Phase 2b:
Inclusion criteria:
1. Willing and able to provide written informed consent prior to performing study
procedures
2. Male or female ≥ 18 years and ≤ 85 years
3. Hospitalized for COVID-19
4. Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx, saliva, sputum)
≤ 10 days before enrolment
5. Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or
chestimaging [Chest X-ray or computed tomography])
6. Requiring O2 supplement ≤ 6L/min at screening
7. Requiring O2 supplementation with SpO2 ≥ 92% on O2 therapy at screening (or ≥ 90
% if chronic obstructive pulmonary disease)
8. First onset of COVID-19 symptoms ≤ 10 days, among fever and/or chills, headache,
myalgias, cough, shortness of breath, whichever as occurred fist (other symptoms such
as asthenia not to be considered in this list)
9. WOCBP must have a negative urinary pregnancy test the day of inclusion
10. All sexually active male subjects must agree to use an adequate method of
contraception throughout the study period and for 90 days after the last dose of study
drug and agree to no sperm donation until the end of the study, or for 90 days after
the last dose of XAV-19, whichever is longer
11. Patients with French social security
Exclusion criteria:
1. Evidence of multiorgan failure (severe COVID-19)
2. Mechanically ventilated (including ECMO)
3. Receipt of immunoglobulins or any blood products in the past 30 days
4. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion
of the investigator, would affect subject safety and/or compliance
5. End-stage renal disease (eGFR < 15 ml/min/1,73 m2)
6. Child-Pugh C stage liver cirrhosis
7. Decompensated cardiac insufficiency
8. History of active drug abuse
9. Known allergy, hypersensitivity, or intolerance to the study drug, or to any of its
components
10. Females of childbearing potential without contraceptive method, or with positive
pregnancy test, breastfeeding, or planning to become pregnant during the study period
11. Current documented and uncontrolled bacterial infection.
12. Prior severe (grade 3) allergic reactions to plasma transfusion
13. Patient participating in another interventional clinical trial
14. Life expectancy estimated to be less than 6 months
15. Patient under guardianship or trusteeship
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia | NCT04453384 | Contradiction |
2,661 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Elective surgery
- Males and females
- Adults over 18
- All primitive inguinal hernia
Exclusion Criteria:
- Emergency surgery
- Impossibility to complete the follow-up
- Patients with acquired immunodeficiency symptoms
- Patients with relapsed inguinal hernia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia | NCT02666040 | Entailment |
676 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- patients for study are > 50 years of age,
- on chronic hemodialysis for at least one year,
- with serum ferritin levels > 2000 ng/ml and TSAT > 30%.
Exclusion Criteria:
- malignancies,
- any active infection requiring systemic antibiotic therapy, and
- hospitalization within the two weeks before screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Assessment of Iron Deposition in Major Organs of Hemodialysis Patients | NCT01169961 | Contradiction |
2,301 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- age over 10 years
- neuromuscular disease documented by genetic testing or by muscle biopsy
- not able to walk 10 meters without support
- capable of sitting upright in a wheelchair for at least 3 hours
- subject affiliated to a social security system
- subject who signed an informed consent
Exclusion Criteria:
- severe intellectual impairment limiting the comprehension of the demanded tasks
- acute neurologic, inflammatory, infectious, endocrine, orthopedic disease in the month
preceding the inclusion
- surgery scheduled within 3 weeks after enrollment
- surgery at upper limbs in the three months preceding the inclusion
- pregnant or nursing women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 80 Years | Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients | NCT01611597 | Contradiction |
1,997 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
2. Histologically proven primary gastric adenocarcinoma (Diagnostic biopsies must be
collected within 12 months prior to enrollment).
3. Written informed consent from the patient.
4. Patients planned for radical R0 gastrectomy.
Exclusion Criteria:
1. Female in pregnancy or lactation.
2. Patients with gastric cancer who can not undergo tumor resection
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney,
or liver disease, complicated by poorly controlled hypertension, diabetes, mental
disorders or diseases.
4. Patients with poor compliance or considered to be poor compliance.
5. Patients received any anticancer drugs, biotherapy, radiotherapy or immunotherapy
within 4 weeks before or after enrollment.
6. Patients after organ transplantation, long-term need to take immunosuppressants,
autoimmune diseases.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer | NCT04809025 | Entailment |
4,986 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Diagnosed with ET by a Movement Disorder Neurologist.
- Tremors that improve with alcohol.
- Ability to abstain from drinking alcohol or caffeine for at least 2 days before both
the screening and fMRI visits
- Over the age of 21.
Exclusion Criteria:
- Significant non-ET related abnormal findings during neurological exam.
- Presence of a tremor at rest.
- Pregnant or nursing.
- Unable to safely undergo MRI based on completion of a safety questionnaire.
- History of dementia, brain tumor, stroke, head trauma or a vascular malformation based
on history or MRI findings.
- Severe active medical condition, such as cardiovascular disease, that prevents subject
from lying flat for up to 120 minutes.
- Unable or unwilling to provide informed consent.
- Claustrophobia (a fear of tight spaces) or other restrictions that prevent subject
from undergoing an MRI in a confined space for up to 120 minutes.
- Unable to temporarily stop taking medications that may influence liver metabolism or
brain function.
- Tremors so severe that subject cannot safely and effectively undergo MRI
- Past/current problems with alcohol abuse or dependence.
- Unwillingness to take alcohol (ethanol), which is a potentially intoxicating drug
- History of deep brain stimulation or thalamotomy surgery.
- Sinus bradycardia, bronchial asthma, or a known allergy to propranolol (Inderal).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| Functional Imaging of Tremor Circuits and Mechanisms of Treatment Response | NCT02495883 | Entailment |
3,607 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
Routine control patients receiving and not receiving oral anticoagulant therapy
Exclusion Criteria:
Hemolytic and/or lipemic samples were excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Differences in Coagulation Test Kits | NCT01109667 | Entailment |
4,385 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
1. Subjects must conform to the diagnostic criteria for MFS;
2. Subjects must be between 12 and 25 years;
3. Subjects must have technically suitable echocardiographic windows to obtain the images
needed to calculate the biophysical properties listed as outcome measures;
4. Subjects must provide informed consent and/or assent.
Exclusion Criteria:
1. Patients with significant aortic or mitral valve regurgitation;
2. Patients with a medical condition that would preclude them from taking either of the
study medications or be taken off either medication for a brief period of time;
3. Female patients who are pregnant, planning to become pregnant, or breast-feeding.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 25 Years | Losartan Versus Atenolol for the Treatment of Marfan Syndrome | NCT00593710 | Entailment |
3,772 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Diagnosis of primary inflammatory knee osteoarthritis of the target joint defined by a
knee osteoarthritis according to the American College of Rheumatology (ACR)
classification and a score ≥ 2 according to the classification of Kellgren and
Lawrence
- Patient not eligible for surgery (or refusing surgery)
- Analog Visual Scale (VAS) pain ≥ 40 mm despite analgesic treatment for at least 3
months
- Failure or intolerance of treatment with NSAIDs and/or tramadol and/or acetaminophen,
and/or failure or intolerance or patient refusing strong opioids medication (morphine,
codeine)
- Failure or patient refusal of corticosteroid infiltration
- Patient who has signed an informed consent
Exclusion Criteria:
- Patient who is unable or unable to comply with the follow-up schedule
- Infiltration of target joint less than three months old
- Treated hyperthyroidism
- Traumatic injury, hemorrhage or bleeding less than 1 week old in the target joint
- Known arterial disease of the lower limbs stage ≥ 2 according to the classification of
Leriche and Fontaine
- Known severe allergy to Lipiodol® and/or iodized contrast product
- Known severe kidney failure (creatinine clearance < 30 ml/min)
- Pregnant or breastfeeding woman
- Patient not affiliated with a French Medicare
- Patient benefiting from legal protection
- Participation in another interventional research
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 90 Years | Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1) | NCT04733092 | Entailment |
4,266 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Male patient presenting infertility status
Exclusion Criteria:
- none
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Sperm Parameters and Sexual Quality of Life | NCT03971786 | Entailment |
1,479 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
- Patient has no medical problems or treatments that might effect their blood pressure
Exclusion Criteria:
- Pregnant or lactating females
- Patient has secondary hypertension or malignant hypertension
- Sitting systolic blood pressure > 210 mm Hg
- History of stroke
- History of myocardial infarction with in past year
- Current or prior history of heart failure
- Known hypersensitivity to losartan
- Prior exposure to losartan
- Patients known to be HIV positive
- Patient is abusing or has abused alcohol or other drugs within the past 4 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| A Study to Investigate the Antihypertensive Efficacy of MK0954 | NCT00887250 | Entailment |
1,092 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- above 35 weeks pregnancy
- diabetic mothers
- single intrauterine pregnancy
Exclusion Criteria:
- any other medical disorder
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome | NCT02136602 | Contradiction |
4,927 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Subjects who:
1. previously underwent Exablate thalamotomy for their essential tremor in a
clinical study or in a commercial procedure at least 9 months prior to enrolling
in this study for contralateral Exablate thalamotomy
2. Subjects who would benefit from a bilateral treatment for their essential tremor
and would want to undergo a staged bilateral thalamotomy
2. All subjects must have a complete baseline CRST prior from first Exablate thalamotomy
3. Men and women age 22 years to 75 years of age.
4. Minimum score of 24 on MoCA or 20 on MMSE
5. Subjects who are able and willing to give consent and able to attend all study visits
6. Postural or intention tremor severity score of greater than or equal to 2 in the both
upper extremities as measured by the CRST rating scale while on stable medication
7. Thalamus can be targeted by the Exablate device. The region must be apparent on MRI
such that targeting can be performed.
8. Able to communicate sensations during the Exablate Thalamotomy treatment
9. Original (before first Exablate procedure) CRST score of 2 or above in any one of the
items 16-23 from the Disability subsection of the CRST: speaking, feeding other than
liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social
activities.
10. Subjects on antidepressant medications must be stable for at least 3 months prior to
procedure(i.e., no change in medication drug or dosage for 3 months based on
historical medical records).
11. Remains eligible for Exablate treatment with no changes to medical history that would
affect Exablate treatment criteria, (e.g., bleeding/coagulation requirements, or new
pathology such as infarct, tumor, etc).
Exclusion Criteria:
1. Subjects with unstable cardiac status
2. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as
defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the
following occurring within a 12 month period:
3. Subjects with uncontrollable blood pressure (hypertensive with diastolic BP > 100 on
medication)
4. History of abnormal bleeding and/or coagulopathy, i.e. subjects with risk factors for
intraoperative or postoperative bleeding as indicated by: platelet count less than
100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation
studies exceeding the institution's laboratory standard
5. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within
one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
(e.g. Avastin) within one month of focused ultrasound procedure
6. Active or suspected acute or chronic uncontrolled infection
7. Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during treatment (can be up to 4 hrs of total table time.)
8. Subjects with life-threatening systemic disease that include but not limited to the
following will be excluded from the study participation: HIV, Liver Failure, blood
dyscrasias, etc...
9. Any clinically significant moderate to severe sensory deficit lasting greater than 30
days after the first Exablate thalamotomy NOTE: Subjects with clinically significant
moderate to severe sensory deficit following first Exablate thalamatomy should be
excluded even if event resolves within a few months of treatment. This may cause new
first thalamotomy subjects to be ineligible for the bilaterally staged treatment.
10. Moderate to severe cerebellar disturbance (imbalance or ataxia) or presence of
moderate or severe hemiparesis NOTE: Subjects with moderate to severe cerebellar
disturbance (imbalance or ataxia) or presence of moderate or severe hemiparesis
following first Exablate thalamatomy should be excluded even if event resolves within
a few months of treatment. This may cause new first thalamotomy subjects to be
ineligible for the bilaterally staged treatment.
11. Any persistent dysphasia/dysarthria, language impairment following first Exablate
thalamotomy.
NOTE: Subjects with significant impairment following first Exablate thalamotomy should
be excluded even if event resolves within a few months of treatment. This may cause
new first thalamotomy subjects to be ineligible for the bilaterally staged treatment.
12. Significant reduction in cognitive function since the first thalamotomy. NOTE:
Subjects with significant reduction in cognitive function following first Exablate
thalamatomy should also be excluded even if event resolves within a few months of
treatment. This may cause new first thalamotomy subjects to be not eligible for the
bilaterally staged treatment.
13. Subject is pregnant or breastfeeding.
14. Subjects who have an overall Skull Density Ratio of less than 0.40 as calculated at
screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 75 Years | Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor | NCT03465761 | Entailment |
477 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- singleton intrauterine pregnancy.
- gestational age less than 10 weeks
- history of previous cesarean section(one or more)
Exclusion Criteria:
- negative fetal pole pulsation.
- any condition distorting uterine cavity i.e uterine myoma,uterine cavity anomalies
- multifetal pregnancy.
- any condition necessitate termination of early pregnancy i.e maternal medical disorder
,molar pregnancy.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar | NCT03208842 | Contradiction |
2,412 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Ambulant children age 5-10 years with an established diagnosis of Duchenne Muscular
Dystrophy
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 10 Years | A Multicenter Randomized Placebo-Controlled Double-Blind Study to Assess Efficacy and Safety of Glutamine and Creatine Monohydrate in Duchenne Muscular Dystrophy (DMD) | NCT00018109 | Entailment |
1,636 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. Parental Informed Consent for enrollment in the CHAMPS! CAMP and accompanying research
sessions,
2. Personal assent for participation in the workshop and research sessions.
3. Age 14 to 19 years old ;
4. Affiliation with youth serving organizations, or part of a current foster youth or
former foster youth alumni group.
Exclusion Criteria:
1. Age 13 or younger, 20 or older;
2. Married
3. Inability to participate verbally in English;
4. Cognitive impairment that precludes the subject from giving assent or informed consent
for any reason;
5. Refusal of consent to participate in the study by their parent.
6. Already pregnant or a parent, because we are attempting primary prevention.
7. Prior participation in a comparable local program, such as Love U2.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 14 Years old.
Subject must be at most 19 Years | Louisville Teen Pregnancy Prevention Project | NCT01411878 | Entailment |
4,532 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Healthy women, aged 18-<40 years who wish to use a combined hormonal contraceptive.
- Women not intending to become pregnant for 13 months.
- Intact uterus and both ovaries.
- Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal
contraception; if postpartum or postabortal, history of regular menstrual cycles of
21-35 days in length and at least one cycle (2 menses) with a cycle length consistent
with her past cycles.
- Sexually active (currently) and willing to discontinue current contraceptive method to
participate in the study.
- In the opinion of the investigator, able to comply with the protocol, e.g. live within
the study site catchment area or within a reasonable distance from the site.
- Do not meet any of the exclusion criteria.
- Signed informed consent prior to entry into the trial.
Exclusion Criteria:
- Known hypersensitivity to estrogens or progestins.
- Known hypersensitivity to silicone rubber.
- Known or suspected pregnancy.
- History of infertility of >1.0 year in woman or her male partner.
- History of vasectomy or sterility in male partner; tubal ligation (sterilization) in
women
- Undiagnosed abnormal genital bleeding.
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed
at screening with Chlamydia or gonorrhea may be included in the trial following
treatment; partner treatment is also recommended. Investigators should make a
determination if subjects are at high risk for reinfection, e.g. multiple sex
partners, untreated partner, and whether such subjects can be included.)
- History of pelvic inflammatory disease since last pregnancy episode.
- History of toxic shock syndrome.
- Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative
may participate provided there is follow up for this finding per standard of care).
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a
vaginal ring.
- Women planning to undergo major surgery.
- Smoking in women who are 35 years and over or will be 35 years during the course of
the trial; Women < 35 years who smoke 15 cigarettes or more must be evaluated by the
PI for inclusion based on risk factors that would increase their risk for CVD, e.g.
lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
- Breastfeeding.
- Current or past thrombophlebitis or thromboembolic disorders.
- History of venous thrombosis or embolism in a first-degree relative <55 years of age
suggesting familial defect in blood coagulation system, which in the opinion of the
principal investigator, suggests use of a hormonal contraceptive could pose a
significant risk.
- Cerebrovascular or cardiovascular disease.
- History of retinal vascular lesions, unexplained partial or complete loss of vision.
- Known or suspected carcinoma of the breast.
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
- Past history of any other carcinoma unless in remission for more than 5 years.
- Current or past medically diagnosed severe depression, which, in the opinion of the
investigator, could be exacerbated by use of a hormonal contraceptive.
- Headaches with focal neurological symptoms.
- Severe constipation.
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
- Benign or malignant liver tumors; active liver disease.
- Diastolic blood pressure (BP) ³85 mm Hg and/or systolic BP ³135 mm Hg after 5-10
minutes rest.
- Known or suspected alcoholism or drug abuse.
- Abnormal serum chemistry values according to the physician's judgment.
- Participation in another clinical trial within last 30 days.
- Weight >95 kg or >209 lbs.
- Use of liver enzyme inducers on a regular basis.
- Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months
before initiation of treatment. Use of Depo-Proveraâ [depo-medroxyprogesterone (DMPA)]
unless suspended 6 months before treatment.
- Current use of implanted hormonal contraceptives, including Mirenaâ [progestin
containing intrauterine system (IUS)], Jadelleâ, Norplantâ or Implanonâ (subjects
using any of these methods who request removal for reasons unrelated to the purpose of
enrollment in this study may be considered for participation).
- Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons
unrelated to the purpose of enrollment in this study may be considered for
participation.
- Known HIV infection.
- Women at high risk of contracting HIV, e.g. women with multiple sex partners who need
to use condoms consistently, injection drug users. If women enrolled in the study do
use condoms to protect against STIs, they should be instructed that this occasional
use should be with non-N-9 containing condoms and they should record condom use in
their diaries. Women found to have an STI at screening will be treated prior to
inclusion in the study (with the exception of those infected with HIV).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring | NCT00455156 | Contradiction |
2,944 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | PATIENTS:
Inclusion Criteria:
1. ALS diagnosis (possible, probable, or definite) in the past year
2. Expresses distress (4+) on Distress Thermometer, or symptoms of anxiety or depression
(VAS scales)
3. Speaks English
4. Able and willing to give informed consent
5. Speaks clearly enough for telephone communication
Exclusion Criteria:
1. Untreated or under-treated Major Depressive Disorder
CARE PARTNERS:
Inclusion Criteria:
1. Has a family member or close friend diagnosed with ALS (possible, probable, or
definite) in the past year
2. Expresses distress (4+) on Distress Thermometer, or symptoms of anxiety or depression
(VAS scales)
3. Speaks English
4. Able and willing to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Coping Effectiveness Training for ALS | NCT01583205 | Entailment |
216 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Voluntarily sign and date the study consent form(s), which have been approved by an
Institutional Review Board (IRB). Written consent must be obtained prior to the
initiation of any study procedures.
- Male between 18 and 75 years of age.
- Documented diagnosis of primary hypogonadism (congenital or acquired) or
hypogonadotropic hypogonadism (congenital or acquired).
- Serum total testosterone < 300 ng/dL on 2 measurements
- Naïve to androgen replacement or has discontinued current treatment and completed a
washout of 4 weeks following androgen treatment.
- Judged to be in good general health as determined by the principal investigator based
upon the results of a medical history, physical examination, vital signs, laboratory
profile and a 12-lead electrocardiogram (ECG).
Exclusion Criteria:
- History of significant sensitivity or allergy to androgens, or product excipients.
- Clinically significant findings in the pre-study examinations including abnormal
breast examination requiring follow-up, abnormal ECG.
- Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or
International Prostate Symptom Score (I-PSS) score > 19 points.
- Body mass index (BMI) ≥ 40 kg/m2.
- Clinically significant abnormal laboratory value, in the opinion of the investigator,
in serum chemistry, hematology, or urinalysis including but not limited to:
1. Baseline hemoglobin > 16 g/dL
2. Hematocrit < 35% or > 50%
3. PSA > 4 ng/mL
- History of seizures or convulsions, including febrile, alcohol or drug withdrawal
seizures.
- History of any clinically significant illness, infection, or surgical procedure within
4 weeks prior to study drug administration.
- History of stroke or myocardial infarction within the past 5 years.
- History of, or current or suspected, prostate or breast cancer.
- History of diagnosed, severe, untreated, obstructive sleep apnea.
- History of abuse of alcohol or any drug substance in the opinion of the investigator
within the previous 2 years.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt
of a transfusion of any blood product within 12 weeks prior to the start of treatment.
- Inadequate venous access for collection of serial blood samples required for
pharmacokinetic profiles.
- Receipt of any investigational product within 4 weeks or within 5 half-lives prior to
the start of treatment.
- Inability to understand and provide written informed consent for the study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Testopel ® vs. Generic Testosterone Pellets. | NCT04523480 | Entailment |
4,762 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria per protocol and informed consent:
- Diagnosis of tinnitus established through a history and physical exam or review of
records.
- Subjects 19-89 years of age
- Tinnitus present for at least 6 months and severe enough to seek medical attention
- Subjects taking SSRI's (a class of anti-depressant medications)and benzodiazepines (a
class of anti-anxiety medications) for depression or anxiety related to tinnitus must
be stable on their current dose for at least 3 months and must not alter their dose or
medication during their involvement with this study
- Subjects must agree to avoid consuming alcohol within 72 hours of each rTMS session
- Female subjects of childbearing potential must demonstrate a negative pregnancy test
during their initial clinic visit and must agree to use effective contraception during
their participation in this study
- Subjects must sign an informed consent and agree to comply with study and follow-up
procedures, including completion of all necessary questionnaires and testing, as well
as, being video-recorded for safety purposes during rTMS sessions
- Subjects must speak and comprehend English adequately to understand and complete any
study-related instructions and questionnaires
Exclusion Criteria per protocol and informed consent:
For rTMS
- Subjects or any of their 1st-degree relatives must not have been diagnosed with
epilepsy
- Subjects must not have a history of seizure disorder or migraines
- Subjects must not have any history of a brain aneurysm, stroke, previous cranial
neurosurgery, acoustic neuroma, glomus tumor, active Menniere's Disease, profound
hearing loss (greater than 90 dB at 4000 Hz), or any major neurological or psychiatric
disorders (excluding depression or anxiety related to tinnitus)
- Medications that lower seizure threshold or reduce cortical excitation (i.e.,
tricyclic antidepressants, bupropion or anticonvulsants)
- Subjects must not have any history of a head injury that resulted in a loss of
consciousness for more than 10 minutes
- Subjects must not be pregnant or refuse to utilize effective contraception during
their participation in this study For MRI
- Subjects must not have any metal implants or devices in the head or neck or a
pacemaker.
- Subjects must not have severe claustrophobia if they are to have an MRI.
- Significant abnormalities must not be present on acquired or existing CT or MRI image
of the head.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 89 Years | Effect of rTMS on Resting State Brain Activity in Tinnitus | NCT00926237 | Entailment |
6,364 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- • Male or female over 18 years of age at the time of enrollment
- Current symptoms of COVID-19 ; fever alone or fever and at least one of the
following symptoms need to be present
- Dry cough
- Sore throat
- Shortness of breath
- Chills
- Muscle pain
- Headache
- New loss of taste or smell
- Chills with repeated shaking
Exclusion Criteria:
- • Unwilling to provide informed consent
- Unwilling to undergo bi-weekly serological test during the 1-month enrollment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19) | NCT04372004 | Entailment |
1,259 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
TRAINING SET INCLUSION CRITERIA
- Subjects able to understand and sign Informed Consent;
- Males or females >18 years of age;
- Have a pleural effusion of known or unknown origin;
- Scheduled for a diagnostic and/or therapeutic procedure to remove pleural fluid.
VALIDATION SET INCLUSION CRITERIA
- Subjects able to understand and sign Informed Consent;
- Males or females >18 years of age;
- Have a pleural effusion of unknown origin;
- Scheduled for a diagnostic procedure to remove pleural fluid.
Exclusion Criteria:
TRAINING SET EXCLUSION CRITERIA
- For Subjects currently receiving chemotherapy and/or radiation therapy- Subjects who
have received chemotherapy and/or radiation therapy must have completed these
modalities one month before entering the study.
- Females known to be pregnant;
- Already entered into the study;
- Unable or unwilling to provide informed consent or is there a high risk that the
subject may not comply with the protocol requirements
VALIDATION SET EXCLUSION CRITERIA
- For Subjects currently receiving chemotherapy and/or radiation therapy- Subjects who
have received chemotherapy and/or radiation therapy must have completed these
modalities one month before entering the study.
- Females known to be pregnant;
- Already entered into the study;
- Unable or unwilling to provide informed consent or is there a high risk that the
subject may not comply with the protocol requirements
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Multiple Biomarkers in Undiagnosed Pleural Effusion | NCT00316134 | Entailment |
2,629 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- inguinal hernia
Exclusion Criteria:
- emergency surgery for incarcerated hernia
- femoral hernia
- recurrent inguinal hernia after laparoscopic inguinal hernia repair
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 89 Years | Prone-position CT for Diagnosing Inguinal Hernia | NCT02939443 | Entailment |
5,273 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- older than 18 years old
- having an osteoporosis treatment
- following a Therapeutical Education for Patient
Exclusion Criteria:
- opposition for anonymised data gathering
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up | NCT02892188 | Entailment |
3,350 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Subject states that he/she has type 2 diabetes (as evidenced by use of oral
hypoglycemic medication for at least two months).
2. Subject is between 18 and 75 years of age, inclusive.
3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
prior to screening visit.
4. If female is of childbearing potential, is practicing a method of birth control.
5. Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.
6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid
medication or hormone therapy, subject has been on constant dosage for at least two
months prior to screening visit.
Exclusion Criteria:
1. Subject uses exogenous insulin for glucose control.
2. Subject states that he/she has type 1 diabetes.
3. Subject states that he/she has a history of diabetic ketoacidosis.
4. Subject takes an alpha-glucosidase inhibitor.
5. Subject states that he/she has a current infection ; has had inpatient surgery, or
corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior
to screening visit.
6. Subject states that he/she has an active malignancy (excluding the following dermal
malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the
cervix).
7. Subject states that he/she has had a significant cardiovascular event ≤ six months
prior to screening visit; or stated history of congestive heart failure.
8. Subject states that he/she has end stage organ failure or is status post organ
transplant.
9. Subject states that he/she has a history of renal disease.
10. Subject states that he/she has current hepatic disease.
11. Subject states that he/she has a history of severe gastroparesis.
12. Subject states that he/she has a chronic, contagious, infectious disease, such as
active tuberculosis, Hepatitis B or C, or HIV.
13. Subject has taken/is currently taking any herbals, dietary supplements, or
medications, other than oral hypoglycemic medications, during the past four weeks
prior to screening visit that could profoundly affect blood glucose.
14. Subject states that he/she has clotting or bleeding disorders.
15. Subject is known to be allergic or intolerant to any ingredient found in the study
products.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Comparison of Nutritional Products for People With Type 2 Diabetes | NCT00797069 | Contradiction |
188 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- All boys identified in the period from January 1990 to February 2013
Exclusion Criteria:
- Misclassified (other diagnoses)
- Insufficient data
- Lost to follow up
Male
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 20 Years | Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment | NCT02034487 | Entailment |
181 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria: Serum testosterone concentration < 300ng/dL Absence of a pituitary or
hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -
Exclusion Criteria: Previous androgen treatment, diabetes mellitus, arterial hypertension
other hormone deficiencies
-
Male
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 45 Years | The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism | NCT02042638 | Entailment |
5,666 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Bone age of at least 15 years for girls or at least 16 years for boys within 6 months
of obtaining the DXA scan
- Previous enrollment in the NCGS core study, 85-036
- Tanner Stage 4 or greater
- Either spontaneous or induced puberty
- Subjects who plan on terminating GH treatment for statural purposes for one or more of
the following reasons: epiphyseal fusion, slowing growth rate indicates that near
adult height has been reached, or satisfied with current height
Exclusion Criteria:
- Current therapy with a non Genentech GH product
- Pregnancy (to avoid exposure to low levels of radiation from DXA scanners)
- Bilateral hip replacement
- Weight >130 kg (286 lb.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | Bone Mineral Density (BMD) in Adolescents With Growth Hormone Deficiency (GHD) | NCT00097526 | Contradiction |
4,639 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Age 21 through 45 years (inclusive) at Screening
2. Able and willing to provide written informed consent
3. Able and willing to comply with all study procedure requirements, including, clinical
and laboratory assessments, vaginal and rectal examinations, urine and blood testing,
as well as attendance at all scheduled study visits
4. In general good health at Screening and Enrollment as determined by the Investigator
of Record (IoR)/ or designee
5. Negative pregnancy test at Screening and Enrollment
6. HIV-negative at Screening and Enrollment
7. Able and willing to provide adequate locator information
8. Willingness to use study-provided male condoms for the duration of study participation
for penetrative intercourse
9. Per participant report at Screening, regular menstrual cycles with at least 21 days
between menses (does not apply to participants who report using a progestin-only
method of contraception at screening, e.g., Depo-Provera, progesterone-containing IUDs
or extended use of oral contraceptives)
10. Per participant report at Enrollment, using an effective method of contraception and
intending to use an effective method for the duration of study participation;
effective methods include:
- Hormonal methods, excluding vaginal rings
- Intrauterine device (IUD) inserted at least 42 days prior to Enrollment (but not
past the maximum length of recommended usage according to package instructions)
- Sterilization of participant or partner at least 42 days prior to Enrollment
- Self-identifies as a woman who has sex with women exclusively
- Sexually abstinent for the at least 90 days prior to enrollment and the intention
to remain sexually abstinent for the duration of study participation
11. Per participant report at Screening, states a willingness to refrain from inserting
any non-study vaginal or rectal products or objects into the vagina or rectum,
including but not limited to, spermicides, female condoms, diaphragms, contraceptive
vaginal rings, vaginal medications, menstrual cups, cervical caps (or any other
vaginal barrier method), vaginal/rectal douches, enemas, non-study approved
lubricants, sex toys (vibrators, dildos, etc.), and tampons for the duration of the
study product use periods and for 24 hours prior to each scheduled study clinic visit.
12. Pap result consistent with Grade 0 according to the Female Genital Grading Table for
Use in Microbicide Studies Addendum 1 to the Division of AIDS (DAIDS) Table for
Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004
(Clarification dated August 2009) or satisfactory evaluation of non-Grade 0 Pap result
with no treatment required per clinical judgment of IoR or designee in the 12 calendar
months prior to the Enrollment Visit
13. At Screening, participant agrees not to take part in other research studies involving
drugs, medical devices, or vaginal/rectal products for the duration of study
participation (including the time between the Screening and Enrollment visits)
Participants in the biopsy subset must also meet the following criteria at Screening
to be eligible for inclusion:
14. Willing to abstain from inserting anything into the vagina or rectum for 72 hours
prior to and following the collection of these samples, including vaginal and rectal
intercourse
15. Willing to restrict the use of non-steroidal anti-inflammatory drugs (NSAIDs), aspirin
and/or other drugs that are associated with the increased likelihood of bleeding
following mucosal biopsy collection for 72 hours prior to and following the collection
biopsies
Exclusion Criteria:
1. Participant report of any of the following:
1. Known adverse reaction to the study product (ever)
2. Known adverse reaction to latex (ever)
3. Current male sex partner with known history of adverse reaction to latex (ever)
4. History of serum HBsAg positivity (ever)
5. Non-therapeutic injection drug use in the 12 calendar months prior to Enrollment
6. STI or reproductive tract infection (RTI) requiring treatment in the 6 calendar
months prior to Enrollment
7. Post-exposure prophylaxis (PEP) for possible HIV-1 infection within the 6
calendar months prior to Enrollment
8. Last pregnancy outcome within 90 days or less prior to Enrollment
9. Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage)
within the 42 days prior to Enrollment Note: This does not include biopsy for the
evaluation of an abnormal pap result or endometrial biopsy that occurred more
than 7 days prior to Enrollment, provided that all other inclusion/exclusion
criteria are met.
10. Participation in any other research study involving drugs, medical devices or
vaginal products 42 days or less prior to Enrollment
11. Anticipated IUD replacement within the next 3 months or an IUD inserted 42 days
or less prior to Enrollment
12. Participant report at Screening and/or Enrollment intention of becoming pregnant
in the next 3 months
13. Currently breastfeeding at the time of Screening and/or Enrollment
14. History of bleeding problems (Participants in the biopsy subset only)
2. Laboratory abnormalities at Screening greater than or equal to a Grade 2*:
1. Aspartate aminotransferase (AST) or alanine transaminase (ALT)
2. Hemoglobin
3. Platelet count
4. Serum creatinine Otherwise eligible participants with an exclusionary test
result(s) listed above may be re-tested during the screening process. If a
participant is re-tested and a non-exclusionary result is documented within the
42 days of providing informed consent, the participant may be enrolled.
3. Urinary tract infection (UTI) at Screening and/or Enrollment Note: Otherwise eligible
participants diagnosed with UTI during Screening will be offered treatment and may be
enrolled after completing treatment and all symptoms have resolved. If treatment is
completed and symptoms have resolved within 42 days of obtaining informed consent, the
participant may be enrolled.
4. Pelvic inflammatory disease or an STI or RTI requiring treatment per current WHO
guidelines at Screening and/or Enrollment
5. Clinically apparent Grade 2 or higher pelvic** and/or rectal*** examination finding
(observed by study staff) at Screening and/or Enrollment Note: Cervical bleeding
associated with speculum insertion and/or specimen collection judged to be within the
range of normal according to the clinical judgment of the IoR/designee is considered
expected non-menstrual bleeding and is not exclusionary.
Note: Otherwise eligible participants with exclusionary pelvic and/or rectal
examination findings may be enrolled/randomized after the findings have improved to a
non-exclusionary severity grading or resolved. If improvement to a non-exclusionary
grade or resolution is documented within 42 days of providing informed consent, the
participant may be enrolled.
6. Any other condition that, in the opinion of the IoR/designee, would preclude informed
consent, make study participation unsafe, complicate interpretation of study outcome
data, or otherwise interfere with achieving the study objectives
- per the Division of AIDS Table for Grading the Severity of Adult and Pediatric
Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009) **
per the Division of AIDS Table for Grading the Severity of Adult and Pediatric
Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009),
Addendum 1 Female Genital Grading Table for Use in Microbicide Studies *** per
the Division of AIDS Table for Grading the Severity of Adult and Pediatric
Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009),
Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification
dated May 2012).
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel | NCT01768962 | Entailment |
3,334 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- 18 years of age or older
- Undergo any type of surgeries under general anesthesia in UCI Medical Center
- Mechanically ventilated during surgery
- Arterial line placement is preferred but not required
- Agree to sign the consent and HIPAA forms
Exclusion Criteria:
- Less than 18 years of age
- Pregnant women
- Refused to sign the consent and HIPAA forms
- Receive vasoactive medication prior to surgery
- Has these conditions: hypotension, hypothyroidism, moderate or poorly controlled
hypertension, chronic poorly-controlled diabetes, heart failure patients, and patients
with active airway flow obstruction, left ventricular dysfunction, intra-cardiac
shunts, right ventricular dysfunction, atrial fibrillation, arrhythmias
- patients with surgeries at or around site of sensor placement
- Subject has skin abnormalities affecting the digits such as psoriasis, eczema,
angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish
or acrylic nails that would prevent monitoring of SpO2 levels during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Comparing Pleth Variability Index (PVI) Measurements at Different Sensing Locations | NCT02124551 | Contradiction |
6,038 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patient is an ambulatory, community-dwelling male or nonpregnant female and is at
least 18 years old at the Screening Visit. Lactating females must agree not to
breastfeed.
- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit
while taking standard QD PPI therapy.
Exclusion Criteria:
- Patient may not meet any of the excluded conditions specified in the protocol
- Patient has any alarm symptoms including but not limited to GI bleeding, anemia,
vomiting, dysphagia, or unexpected weight loss any time during the Screening or
Pretreatment Periods
- Patient has a history of clinically significant hypersensitivity or allergies to any
of the excipients contained in the study medication (active or placebo).
NOTE: Additional inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD) | NCT02637557 | Entailment |
3,785 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Knee pain attributed to osteoarthritis for at least 1 year.
- Meet American College of Rheumatology clinical or clinical plus x-ray criteria for
knee osteoarthritis
- Have at least a moderate pain rating on at least one of the five Western
Ontario-McMaster University Osteoarthritis Index (WOMAC) scales
Exclusion Criteria:
- Significant conditions of the spine, hips, or feet that affect the ability to walk
- Significant medical conditions that affect the ability to walk and function
- Inflammatory arthritis, such as rheumatoid arthritis or gout
- Degenerative arthritis secondary to other conditions, such as hemochromatosis,
Wilson's disease, or ochronosis
- Current significant soft tissue rheumatism such as fibromyalgia, anserine bursitis, or
trochanteric bursitis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Tidal Lavage in Knee Osteoarthritis | NCT00000424 | Entailment |
1,367 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- out-patients children with diagnosis of functional constipation or have faecal
impaction on medical history and physical examination
Exclusion Criteria:
- children with organic causes for defecation disorders, such as Hirschsprung disease,
spina bifid, hypothyroidism, or other metabolic or renal abnormalities;
- Children receiving medication influencing gastrointestinal motility;
- Children with suspected gastrointestinal obstruction or stenosis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 16 Years | Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children | NCT01592734 | Contradiction |
5,436 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Referred to study by gynecologist or internist/family practitioner with diagnosis of
menorrhagia or referred by self through community advertising or networking
- Prospective pictorial chart scores of menses >100
- Negative pelvic exam and Pap smear within the past year. *Ultrasound if manual exam
indicates abnormal uterine size; *Endometrial biopsy if >35 and non-cyclic bleeding;
*Rule out acute pelvic diseases - gonorrhea, chlamydia
- Age 18-50
- Willing to go off oral contraceptives and selected drugs (including some nutritional
supplements and drugs that affect coagulation such as aspirin and ibuprofen) for
initial laboratory testing and throughout the cross-over drug portion of the study
- Periods at least every 39 days
Exclusion Criteria:
- Patient is not proficient in English
- Patient is pregnant
- Patient on hormone replacement, Depo-Provera, or Norplant in last three months
- Patient has intrauterine device (IUD) present
- Patient is taking warfarin sodium (Coumadin) or other anti-coagulation therapy
- History of documented vascular disease (coronary artery disease, cerebrovascular
disease or stroke, transient ischemic attack, peripheral vascular disease)
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Chronic renal or liver disease
- History of seizure disorder
- History of cancer (other than non-invasive skin cancer)
- History of venous or arterial thromboembolism
- Patient with a previously diagnosed bleeding disorder has taken or is taking
desmopressin acetate or antifibrinolytic drugs for treatment of heavy menstrual
bleeding
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Treatment and Management of Women With Bleeding Disorders | NCT00111215 | Entailment |
1,349 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
1. Written informed consent is obtained from the children's parent(s) / legal guardian(s)
before any study-related activity is carried out
2. The child is able to provide written informed assent, where this is required according
to national legislation, before any study related activity is carried out
3. The child has been diagnosed as having achondroplasia documented by clinical diagnosis
4. The child is between 0 years and 10 years of age, inclusive, on the date of consent /
assent
5. The investigator has considered the family and prospective participating child being
able to comply with the study procedures
Exclusion Criteria:
1. The child has a diagnosis of hypochondroplasia or any short stature condition other
than achondroplasia (eg, spondyloepiphyseal dysplasia congenital [SEDC],
pseudoachondroplasia, trisomy 21)
2. The child has any medical condition that may impact growth or where the treatment is
known to impact growth, such as but not limited to hypothyroidism or hyperthyroidism,
insulin-requiring diabetes mellitus, autoimmune inflammatory disease (including celiac
disease, systemic lupus erythematosus [SLE], juvenile dermatomyositis, scleroderma,
and others), autonomic neuropathy, or inflammatory bowel disease
3. Treatment in the previous 12 months prior to consent and assent with growth hormone,
insulin-like growth factor 1 (IGF-1), anabolic steroids, or any other drug expected to
affect growth velocity
4. Any surgery that affects the growth plate of the long bones that is planned, or has
occurred in the past 18 months
5. Participation in any interventional study (investigational product or device) for
treatment of achondroplasia or short stature
6. Has had bone-related surgery impacting assessment of anthropometric measurements or is
expected to have it during the study period. Children with previous limb-lengthening
surgery may enroll if surgery occurred at least 18 months prior to the date of
consent/assent and healing is complete without sequelae as determined by the
investigator
7. Has any condition that in the view of the investigator places the child at high risk
of poor compliance with the visit schedule or of not completing the study.
8. Any concurrent disease or condition that in the view of the investigator would
interfere with study participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 10 Years | Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia. | NCT03794609 | Entailment |
4,008 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Subject has been diagnosed, according to American College of Rheumatology guidelines,
with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory
drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone
telephone.
Exclusion Criteria:
- Subject has had surgery on index joint.
- Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
- Subject has active gastrointestinal or cardiovascular disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" | NCT00139776 | Entailment |
341 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Be in good general overall health with no chronic medical conditions that result in
periodic exacerbations that require significant medical care.
2. Between 18 and 40 years inclusive at the enrollment visit.
3. Weight ≥ 80 kg.
4. Have regular menstrual cycles that typically occur every 21-35 days when not using
hormonal contraception.
5. If subject is postpartum or post-abortal, she must have experienced a menstrual bleed
since the pregnancy ended
6. If a subject recently used non-injectable hormonal contraception, one bleeding episode
consistent with menses must have occurred since last use;
7. Willing to avoid use of any hormonal or intrauterine contraception until the end of
the study;
8. For women with a recent history of Depo Provera use, the most recent injection must
have been at least 6 months before study entry, and the subject must have had at least
one normal menstrual cycle (2 consecutive menses);
9. Request emergency contraception within 72 hours (3 days) after unprotected coitus, as
defined by lack of contraceptive use, condom breakage (including condoms lubricated
with spermicide), or other barrier contraceptive method failure;
10. Have a negative urine pregnancy test at time of screening
11. Reports all acts of unprotected coitus since her prior menses are within 72 hours
prior to enrollment;
12. Willing to abstain from further acts of unprotected intercourse until the end of the
study;
13. Give voluntary, written informed consent, and agree to observe all study requirements
including being available for follow up for at least the next 4 weeks;
14. Accepts that the risk of pregnancy with oral EC is greater than that following
placement of a copper IUD for EC.
Exclusion Criteria:
1. Be currently pregnant (positive high-sensitivity urine pregnancy test);
2. Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless
the subject has already had a menses following discontinuation of breastfeeding;
3. Desire to use hormonal systemic contraception within 5 days of study drug use
4. Have had a female sterilization procedure;
5. Have a partner with a history of vasectomy;
6. Current inability to tolerate oral medication;
7. Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid
replacement therapy in the last year.
8. Have known liver disease;
9. Have known liver abnormalities with elevated enzymes at least twice the upper limit of
normal requiring use of liver enzyme inducers.
10. Have known hypersensitivity to the active substance UPA or LNG, or any of the
excipients of the study treatment.
11. Have a current need for exogenous hormones.
12. Have concomitant use of strong CYP3A4 inhibitors (as identified by the FDA) or
inducers at the time of or planned use within 3 days of dosing;
13. Use any medications that can interfere with the metabolism of hormonal contraceptives;
take antibiotics that can interfere with metabolism of hormonal contraceptives at the
time of or planned use within 3 days of dosing of the study drug; or use any drugs
designated by the FDA as falling in the Pregnancy and Lactation narrative subsections
(formerly Category D or X medications).
14. Current or recent (within one month) participation in any other trial of an
investigational medicine or device or planning to participate in another clinical
trial during this study.
15. Have a history of a bariatric surgery procedure associated with malabsorption.
16. Live outside of the catchment area of the study site.
17. Have used UPA or LNG EC within 30 days prior to enrollment and not had a menses since
using the drug.
18. Be a site staff member with delegated study responsibilities or a family member of a
site staff member with delegated study responsibilities. -
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg | NCT03537768 | Contradiction |
2,393 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Beyond 2 years old
- Diagnosis with Duchenne Muscular Dystrophy, and female carriers, genotypically
confirmed
- Diagnosis should be supported by muscle biopsy, if no genetic confirmation.
Exclusion Criteria:
- Presence of other clinically significant illness
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
| A Registered Cohort Study on Duchenne Muscular Dystrophy | NCT04012671 | Entailment |
2,361 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Patient hospitalized in one of the ICU departments or Continuing Medical or Surgical
Care Units of the Rennes University Hospital for less than 3 months, and presenting
muscle weakness of the lower limbs with a MRC motor test on the main muscle segments
giving a score less than or equal to 48/60 (diagnostic criterion of ICU Weakness)
- Person of full age;
- Affiliation to a social security scheme;
- Free, informed and signed written consent.
Exclusion Criteria:
- History of a central neurological event with clinical repercussions
- Gait disorders pre-existing to hospitalization in intensive care and limiting the
walking perimeter (declaration by the patient) or requiring the use of technical
assistance;
- Uncontrolled epilepsy (seizure less than 6 months old);
- Adults who are the subject of legal protection (safeguard of justice, curatorship,
guardianship), persons deprived of their liberty;
- Non-French speaking person;
- Pregnant or breastfeeding woman.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU-weakness | NCT04713345 | Entailment |
4,012 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Males or females 18 years of age or older
2. Diagnosis of OA of the knee by a combination of clinical and radiographic findings
3. OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4
inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography
with 10° caudal beam angulation. A specially designed positioning frame will be used
to standardize the positioning for image acquisition.
4. Patients who have failed to adequately respond for at least 6 months to at least 2 OA
therapies that include conservative, non-pharmacological therapy and simple analgesics
(e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of
activities that cause joint pain; exercise; weight loss; physical therapy; and removal
of excess fluid from the knee
5. Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale.
6. Body mass index (BMI) < 40 kg/m²
7. If female, must be postmenopausal (for at least 2 years), surgically sterilized
(bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually
abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12
months after treatment
8. Males who are not surgically sterile (vasectomy) for at least 6 months prior to
screening must confirm their willingness to use adequate methods of contraception from
Day 1 through 12 months after treatment
9. Willing to agree not to use illicit drugs during the study, and to have illicit drug
testing at screening and at later time points, if illicit drug use is suspected during
the study
10. Able to comply with study requirements and complete the full sequence of
protocol-related procedures and evaluations, including post-hospitalization,
out-patient, and follow-up visits
11. Able to understand and provide written informed consent
Exclusion Criteria:
1. Use of pain medication (including NSAIDs and cannabidiol [CBD] oil) less than 15 days
before treatment (acetaminophen allowed)
2. Regular use of anticoagulants
3. Symptoms of locking, intermittent block to range of motion, or loose body sensation
that could indicate meniscal displacement or an IA loose body
4. Corticosteroid injection into the index knee within 3 months prior to screening
5. Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasma
injection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC),
placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic
product into the index knee within 6 months prior to screening
6. Patients with known hypersensitivity reactions to ASA or any of its constituents
(e.g., HA, dimethyl sulfoxide [DMSO])
7. Knee surgery on the index knee within 12 months prior to screening and/or planned knee
surgery during the study
8. Knee surgery on the contralateral knee within 6 months prior to screening and/or
planned knee surgery during the study
9. Acute index knee trauma within 3 months prior to screening
10. Knee effusion requiring aspiration of the index or contralateral knee within 3 months
prior to screening
11. Contralateral knee pain ≥ 4 on the WOMAC Pain scale on most days during the past week.
12. Current therapy with any immunosuppressive therapy, including corticosteroids (> 5
mg/day of prednisone)
13. Clinically significant findings on the screening laboratory tests or physical
examination that are not specific to OA of the knee and may interfere with study
conduct or interpretation of data or increase patient risk
14. Clinically significant intercurrent illness, medical condition, non-knee pain, or
medical history (including neurological or mental illness, human immunodeficiency
virus, fibromyalgia, complex regional pain syndrome, or any active infection,
including hepatitis B or C) that could jeopardize the patient safety, limit
participation, or compromise interpretation of data derived from the patient
15. Active alcohol or substance use disorder, or any other reason that would make it
unlikely for the patient to comply with study procedures
16. Females who are pregnant (positive pregnancy test at screening or prior to treatment)
or lactating
17. Participation in another clinical trial within the 30 days (or 5 half-lives of the
investigational compound, whichever is longer) before screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee | NCT04636229 | Entailment |
2,185 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Male, aged 18 ~45 years old;
2. In accordance with the gout classification criteria of the American Rheumatic Society
in 1977 or ACR/EULAR (European Alliance against Rheumatism) in 2015 ;
3. Willing to receive uric acid-lowering drugs regularly for at least 3 months;
4. No drugs affecting sperm quality were taken within 3 months before screening.
5. Sign the informed consent form.
Exclusion Criteria:
1. Patients who have a pregnancy plan during the trial;
2. Patients with severe heart, liver, kidney and other important organs, blood and
endocrine system diseases, the evaluation criteria are as follows:
1. Heart disease: patients with a history of heart disease such as decompensated
cardiac insufficiency, refractory hypertension or coronary heart disease;
2. Liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase
(AST) ≥ 2 times the upper limit of normal reference value (ULN);
3. Renal function: complicated with renal tubule and/or renal interstitial lesions,
or renal insufficiency: serum creatinine≥ULN or glomerular filtration rate (eGFR)
<60ml/min/1.73m2;
3. leukocyte (WBC) count <3 × 109/L and/or hemoglobin (Hb) <100g/L and/or platelet (PLT)
count <80 × 109/L;
4. Other serious diseases, such as tumors, etc;
5. Those who are unable to cooperate with the treatment of mental illness or other
reasons;
6. Allergic constitution or multi-drug allergy;
7. Those who are known to be allergic or intolerant to uric acid-lowering drugs in the
trial;
8. Chromosome abnormality or deletion of AZF region of Y chromosome;
9. Previous history of orchitis, epididymitis, mumps or varicocele affecting sperm
quality;
10. Positive semen bacterial culture, or Chlamydia trachomatis, Ureaplasma Urealyticum and
Mycoplasma hominis;
11. Those who have a history of exposure to high temperature, chemistry, physics or
toxicants in the past year;
12. Those who undergo X-ray or CT examination in the past 3 months and during the period
of enrollment;
13. When entering the group, the semen routine did not reach the standard stipulated in
the WHO Manual for Laboratory examination of Human semen and sperm-Cervical mucus
interaction (Fifth Edition), that is, semen volume>1.5ml, pH>7.2, sperm
density>15x106/ ml, sperm motility (percentage of forward motile sperm, PR)>32%,
normal sperm morphology>4%;
14. Patients with other systemic diseases who are being treated with other drugs that may
affect semen quality.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | The Influence of Urate-lowering Therapy on Sperm Quality of Male Gouty Patients：A Prospective Cohort Study | NCT04213534 | Contradiction |
4,727 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Age group (35-70 years old).
2. Women consenting to have a total laparoscopic hysterectomy.
Exclusion Criteria:
1. Patients with relative contraindication to general anesthesia (e.g. chronic liver cell
failure)(All laparoscopic procedures are done under GA).
2. Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary
dysfunction).
3. Bleeding tendency (e.g. anticoagulants, platelets disorders)(will affect the blood
loss measurement)
4. Body mass index more than 35 Kg/m2(not suitable for laparoscopic surgeries as obesity
affects airway pressure )
5. Uncorrected anemic patients (Hemoglobin < 10 gm. /dl).(will affect the outcomes eg :
Blood transfusion , hospital stay … etc )
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 70 Years | Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy | NCT04808583 | Entailment |
5,480 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Confirmed diagnosis of GCA and having a diagnosis of LV-GCA confirmed by imaging
(PET/CT)
- Informed consent to the local GCA cohort BARK
- Followed for GCA treatment in the outpatient department.
Exclusion Criteria:
- Known hypersensitivity or allergy to Gadolinium (Gd)-based MRI contrast agents.
- Patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies or
other not MR-compatible implants (e.g. pumps etc.).
- Renal failure or severely impaired kidney function (eGFR < 30 ml/min /1,73 m2)
- Epilepsy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Longitudinal Imaging in Patients With Large Vessel Vasculitis to Predict Further Disease Course | NCT04204876 | Contradiction |
1,102 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | INCLUSION CRITERIA:
Patients of either gender, aged 18-85 years.
Symptomatic patients receiving clinically indicated evaluation for cardiomyopathy and found
to have obstructive HCM.
LV outflow tract gradient greater than 30 mm Hg at rest by echocardiography or cardiac
catheterization.
EXCLUSION CRITERIA:
Positive pregnancy test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy: A Pilot Study | NCT00035386 | Entailment |
5,938 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Adults, 18-59 years old
- moderate heartburn at least 3 days/week
- males and non-pregnant/non-lactating females
- Complete relief while using a PPI or only some relief of symptoms while on a PPI
Exclusion Criteria:
- erosive esophagitis
- unable or unwilling to undergo endoscopy and biopsy or Bernstein testing
- eosinophilic esophagitis
- negative Bernstein test
- known hypersensitivity to amiloride
- renal disease
- diabetes
- hypotension
- electrolyte imbalance
- contraindication to diuretics, including taking lithium or ACE inhibitors. -history of
gastric or esophageal surgery
- history of ZE syndrome
- bleeding disorder
- UGI bleeding
- esophageal motor disorder
- esophageal stricture
- Barrett's esophagus
- UGI malignancy
- esophageal varices
- subjects with current malabsorption
- inflammatory bowel disease
- severe heart-lung-liver-renal-cerebrovascular disease
- subjects post-transplant
- diabetes
- actively taking the following medications: tricyclic antidepressants, quinidine,
quinine, dilantin, warfarin, narcotic analgesics, antineoplastic agents, salicylates
(except a baby aspirin for cardiovascular protection); steroids, NSAIDs (including
COX-2 inhibitors), KCl, anti-tuberculosis medication, bisphosphonates, and
triamterene, cyclosporine, tacrolimus, and other potassium sparing drugs like
spironolactone
- serum potassium of 5.5 mEq/L or higher
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 59 Years | Do Acid Sensing Ion Channels Contribute to Heartburn? | NCT01095133 | Contradiction |
4,946 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Must be ≥22 years of age
- Competent and willing to provide written, informed consent to participate in the study
- A diagnosis of essential tremor as confirmed from clinical history and examination by
a movement disorder neurologist
- A tremor severity score of 2 or above in the dominant hand/arm as measured by any one
of the TETRAS upper limb items and a minimum subset score of 6 across all upper limb
items
- Significant disability due to essential tremor (Bain & Findley score of 3 or above in
any one of the upper limb items and a minimum subset score of 8 across all upper limb
items)
- Stable dose of tremor medications, if applicable, for 30 days prior to study entry
- Stable dose of antidepressant medications, if applicable, for 90 days prior to study
entry
- Willing to comply with study protocol requirements including:
- remaining on a stable dosage of tremor and antidepressant medications, if
applicable, during the duration of the study
- no significant alcohol or caffeine consumption within 8 hours prior to study
visits
- no usage of the Cala TWO device within 8 hours prior to study visits
Exclusion Criteria:
- Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5
(score of 4 or higher)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain
stimulator, or implanted metal in the wrist to be stimulated
- Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife
radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor
- Suspected or diagnosed epilepsy or other seizure disorder
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous
lesions of skin at stimulation site
- Peripheral neuropathy affecting the tested upper extremity
- Presence of any other neurodegenerative disease like Parkinson-plus syndromes
suspected on neurological examination. These include: multisystem atrophy, progressive
supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This
includes excluding anyone with the presence of parkinsonian features including
bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting
tremor but no other symptoms or signs of PD may be included.
- Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
- Are participating or have participated in another interventional clinical trial in the
last 30 days which may confound the results of this study, unless approved by the
Sponsor
- Significant alcohol or caffeine consumption within 8 hours prior to study enrollment,
which may confound the results of the study, where significant caffeine is considered
more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered
more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled
spirits).
- Subjects unable to communicate with the investigator and staff
- Any health condition that in the investigator's opinion should preclude participation
in this study
- Pregnancy or anticipated pregnancy during the course of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
| Prospective Study for Symptomatic Relief of ET With Cala Therapy | NCT03597100 | Entailment |
2,435 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Patients with suspected pulmonary sarcoidosis stage I/ II
- Age > 18 years
- Both males and females
- Written informed consent is obtained.
Exclusion Criteria:
- Patients with obvious other organ involvement of sarcoidosis where a simple diagnostic
biopsy to assess granulomas can be performed.
- Löfgren's syndrome
- Inability to undergo fiberbronchoscopy, EBUS or EUS (e.g. respiratory insufficiency,
esophageal stenosis
- Contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia)
- Pregnancy
- Inability to obtain informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Trial for the Diagnosis of Sarcoidosis | NCT00872612 | Contradiction |
3,643 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- all adult patients visiting the emergency department or urgent care clinic at any one
of the six participating sites during the allocated one month time period
Exclusion Criteria:
- those who do not meet inclusion criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | ED Overcrowding Validation Study | NCT02754245 | Entailment |
5,263 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Informed consent obtained before any trial-related activities
- Postmenopausal women and male aged 50 years or old
- Osteoporosis by DXA or fragility fracture history
- Osteopenia with more than one osteoporotic risk factors
Exclusion Criteria:
- Secondary osteoporosis
- Renal insufficiency (Ccr< 35ml/min)
- New fractures < 3 months, prior bilateral hip fractures or surgical replacement.
- Other medication contraindications
- Malignant tumors
- Mobility-impaired individuals
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Intervention Study of Drugs in Patients Osteopenia and Osteoporosis | NCT04719572 | Entailment |
3,874 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Painful, or predominantly unilateral painful, knee osteoarthritis of any etiology
- Knee without clinical signs of intra-articular effusion
- Kellgren score ≥ II on X-ray
- WOMAC pain sub-score ≥ 5 in the month preceding the inclusion visit
Exclusion Criteria:
Clinical:
- Inflammatory arthropathy,infectious, neoplastic within the past year
- Neuromuscular pathology
- Cardiorespiratory pathology or any other severe disease that interferes with the
functional capacities
- Any decompensated or unstable chronic pathology
- Glomerular filtration rate (GFR)<15 mL/min/1.73m²) within the past 6 months
- HBA1c in diabetic people > 12% within the past 6 months
- BMI ≥ 35kg/m2
- Infection: joint, general, distant, cutaneous
- Foreign material in the knee to be treated: prosthesis, osteosynthesis material
- Severe coagulation problem: platelets <100000/mm3 within the past 6 months
- Allergy to BoNT-A
- Allergy to HA
- Pregnant or breast-feeding women
- Treatment with aminoglycosides or direct oral anticoagulants
- Treatment with VKA (antihemorrhagic vitamin) if INR (International Normalized Ratio)
higher than 3 within the past month
- Change of anti-pain treatment less than 2 weeks before enrolment
- Treatment with III pain killers or corticosteroids because of intense pain that does
not respond to schedule I and II pain-killers
- Intra-articular injection of corticosteroids in the previous two months
- Viscosupplementation and/or injection of BoNT-A in the knee to be treated within the
past 6 months
- Injection of BoNT-A (except the knee to be treated) within the past 3 months
- Swallowing troubles
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis | NCT02832713 | Entailment |
5,761 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
1. Biopsy-proven diagnosis of OLP as per WHO histological criteria* with no evidence of
epithelial dysplasia or malignancy.
2. Presence of painful oral symptoms associated to OLP, with minimum severity of pain
being 3 or more, on a 0-10 numeric pain rating scale at screening and confirmed at
recruitment/start of the intervention.
3. Age >18 years and willing to participate into the study.
4. Receiving no therapy or receiving best standard topical therapy (typically topical
corticosteroids or immunosuppressant) with the exclusion of systemic corticosteroids
or systemic immunosuppressant
Exclusion Criteria:
1. Use of systemic antibiotics, retinoid, corticosteroids or immunosuppressant.
2. Pregnancy or receiving IVF treatment.
3. Individuals with systemic disorders affecting the immune system (e.g., HIV, connective
tissue disorders, cancer, etc.)
4. Evidence of oral dysplasia or malignancy on previous biopsy. -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Clinical and Biological Effects Of The Use Of Probiotic VSL#3 In Patients With Oral Lichen Planus | NCT03052179 | Contradiction |
2,231 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
Patients (> 18 years old) with gout flare defined by following items :
- Identification of sodium urate crystals in synovial fluid analysis
- Or gout flare diagnosis according to Nijmegen criteria (score > 8/13)
- Man (2 pts)
- History of flare (2 pts)
- Flare involving first metatarsophalangeal joint (2.5 pts)
- Maximum of flare within 24h (0.5pt),
- Redness (1 pt),
- History of hypertension or cardiovascular diseases (1.5 pts),
- Serum urate level > 360 µmol/l during flare (3.5 pts)
- Duration of flare < 48 h
- Monoarticular involvement
Exclusion Criteria:
- Hypersensitivity to colchicine, fexofenadine, benzodiazepine or the excipients of
these drugs
- Contra-indication to colchicine : chronic kidney disease stage 4-5, severe hepatic
impairment, treatment by macrolide antibiotics
- Used of pain-killers other than acetaminophen
- Involvement in another clinical trial with drug administration
- Illiteracy
- Pregnant woman or breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Relation Between Blood Concentration of Colchicine and Response to Colchicine Treatment in Gout Flare | NCT03933007 | Entailment |
1,862 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients with gastric intestinal metaplasia and/or gastric cancer
- Healthy controls
Exclusion Criteria:
- Metabolic syndrome and its components
- IBD
- Autoimmune diseases
- Otherwise tumours
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Microbiome Analysis in Gastric Intestinal Metaplasia and in Gastric Cancer and Subtypes Correlation | NCT04365946 | Entailment |
1,354 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Molecular or clinical diagnosis of achondroplasia (as confirmed by physical exam
and/or radiograph review by the PI, one of the co-PIs or other qualified clinical
geneticists)
- Subjects must have been seen for a clinical genetics visit at Johns Hopkins, Alfred I.
DuPont Hospital for Children, University of Wisconsin-Madison or University of Texas
- Subjects may be active clinical patients at the above sites or no longer treated at a
given site but with sufficient retrospective clinical data for extraction as
determined by the PI or co-PIs
Exclusion Criteria:
- Skeletal dysplasia diagnosis other than heterozygous
- Achondroplasia
- There is no medical complication or condition which excludes a patient with
achondroplasia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Achondroplasia Natural History Multicenter Clinical Study | NCT02597881 | Entailment |
612 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Correctly diagnosed with recurrent miscarriages
Exclusion Criteria:
- Known course of the condition
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Description of the Uterine Cavity in Patients With Recurrent Miscarriages | NCT02746588 | Entailment |
1,378 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Children with Idiopathic constipation
Exclusion Criteria:
- Hirschsprung's disease or Anorectal malformations
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 12 Years | Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation | NCT02361749 | Contradiction |
5,677 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
The study was conducted in children attending 5th and 6th grade in all 20 public schools of
the Municipality of Puente Alto, Santiago, Chile. All students were invited to participate
in the study. Parents or their representatives signed an informed consent form and
boys/girls an informed acceptance form.
Exclusion Criteria:
Subjects not signing the informed consent or acceptance forms were excluded from the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 15 Years | Metabolic Syndrome in Children and Adolescents | NCT03203863 | Contradiction |
5,489 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
1. Diagnosis of Giant Cell Arteritis (GCA) defined by the following Revised GCA Diagnosis
Criteria:
- Age ≥50 years.
- History of Erythrocyte Sedimentation Rate (ESR) ≥ 50 mm/hour or C-Reactive
Protein (CRP) ≥ 10 mg/L.
- Presence of at least one of the following:
- Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or
temporal artery tenderness, otherwise unexplained mouth or jaw pain upon
mastication).
- Unequivocal symptoms of Polymyalgia Rheumatica (PMR), defined as shoulder
and/or hip girdle pain associated with inflammatory stiffness.
- Systemic inflammatory disease in which the presence of the fever (>38
degrees Celsius for ≥ 7 days), weight loss (> 5 pounds or 10% premorbid
weight), and/or night sweats were attributable to GCA and no other cause was
identified.
- Presence of at least one of the following:
- Temporal artery biopsy revealing features of GCA.
- Evidence of large-vessel vasculitis by angiography or cross-sectional
imaging, including but not limited to magnetic resonance angiography (MRA),
computed tomography angiography (CTA), positron emission tomography-computed
tomography (PET-CT) or evidence of large-vessel or temporal artery
vasculitis by ultrasound (US).
2. Relapse with active GCA within 6 weeks of study entry where active disease is defined
by an ESR ≥30 mm/hr or CRP ≥10 mg/L AND the presence of at least one of the following:
- Unequivocal cranial symptoms of GCA (new onset or recurrent localized headache,
scalp or temporal artery tenderness, otherwise unexplained mouth or jaw pain upon
mastication [i.e., jaw claudication]).
- Unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain
associated with inflammatory stiffness.
- Other feature(s) judged by the clinician investigator to be consistent with GCA
or PMR flares (e.g. fever of unknown origin, weight loss, fatigue/malaise, etc.)
3. Clinically stable at baseline visit (study drug initiation) such that the subject is
able to safely participate in the standardized taper regimen in the opinion of the
investigator.
Exclusion Criteria
1. Presence of any other autoimmune disease (such as systemic lupus erythematosus,
rheumatoid arthritis, inflammatory arthritis, other vasculitides, scleroderma,
polymyositis, dermatomyositis, or other similar systemic connective tissue diseases).
2. Subjects demonstrating symptoms of visual loss (transient or permanent blindness) or
diplopia attributable to GCA.
3. Subjects with history of aortic dissection, myocardial infarction, or cerebrovascular
attack attributable to GCA.
4. Has received, or is expected to receive, any live virus vaccinations (with the
exception of herpes zoster vaccination) within 3 months before the first dose of study
drug, during the study, or within 3 months after the last administration of the study
drug. All patients who have not received the herpes zoster vaccine at screening will
be encouraged (per local guidelines) to do so prior to randomization; vaccination must
occur >4 weeks prior to randomization and start of investigational product. Patients
will be excluded if they were exposed to herpes zoster vaccination within 4 weeks of
planned randomization.
5. Organ transplant recipients.
6. Have had a major surgery within 8 weeks prior to screening or will require major
surgery during the study that, in the opinion of the investigator would pose an
unacceptable risk to the patient.
7. Have experienced any of the following within 12 weeks of screening: myocardial
infarction (MI), unstable ischemic heart disease, stroke, or New York Heart
Association Stage IV heart failure
8. Have a history or presence of cardiovascular (including but not limited to
uncontrolled hypertension), respiratory, hepatic, gastrointestinal, endocrine,
hematological, neurological, or neuropsychiatric disorders, or any other serious
and/or unstable illness that, in the opinion of the investigator, could constitute an
unacceptable risk when taking investigational product or interfere with the
interpretation of data.
9. Are largely or wholly incapacitated permitting little or no self-care, such as being
bedridden or confined to a wheelchair.
10. Have an estimated glomerular filtration rate (eGFR) of <50 mL/min/1.73 m^².
11. Have a history of chronic liver disease with the most recent available aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of
normal (ULN) or the most recent available total bilirubin ≥1.5 times ULN (if
available).
12. Have a history of lymphoproliferative disease; or have signs or symptoms suggestive of
possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or
have active primary or recurrent malignant disease; or have been in remission from
clinically significant malignancy for < 5 years.
1. Subjects with uterine cervical carcinoma in situ that has been resected with no
evidence of recurrence or metastatic disease for at least 3 years may participate
in the study
2. Subjects with basal cell or squamous epithelial skin cancers which have been
completely resected with no evidence of recurrence for at least 3 years may
participate in the study.
13. Active infections, or history of recurrent infections or have required management of
acute or chronic infections as evidenced by any of the following:
1. Currently on any suppressive therapy for a chronic infection (such as
tuberculosis, cytomegalovirus, herpes simplex, herpes zoster, or atypical
mycobacteria).
2. History or suspicion of chronic infection (e.g. prosthetic joint infection)
3. Hospitalization for treatment of infection within 60 days of baseline visit
4. Use of parenteral (IV or IM) antimicrobials (antibacterial, antifungals,
antivirals, or antiparasitic agents) within 60 days of baseline or oral
antimicrobials within 30 days of baseline visit for treatment of an active
infection. This does not include the use of antibiotics for prophylaxis against
pneumocystis pneumonia since this is considered standard of care for patients on
prednisone ≥ 20 mg/day for longer than 3 consecutive months.
14. Have had symptomatic herpes zoster infection within 12 weeks prior to screening.
15. Have a history of disseminated/complicated herpes zoster [for example, multidermatomal
involvement, ophthalmic zoster or Central Nervous System (CNS) involvement]
16. In the opinion of the investigator, are at an unacceptable risk for participating in
the study.
17. Have known or documented diagnosis of human immunodeficiency virus (HIV).
18. Have known or documented primary immunodeficiency.
19. Have had household contact with a person with active tuberculosis (TB) and did not
receive appropriate and documented prophylaxis for TB.
20. Have had evidence of active TB or have previously had evidence of active TB and did
not receive appropriate and documented treatment.
21. Have evidence of latent TB as documented by a local lab positive QuantiFERON®-TB Gold
test and a normal chest x-ray, unless a patient completes at least 4 weeks of
appropriate treatment prior to study entry and agrees to complete the remainder of
treatment while in the trial.
1. If the QuantiFERON®-TB Gold test results are positive, the patient will be
considered to have latent TB and will be excluded. If the test is indeterminate,
the test may be repeated once within 2 weeks of the initial value. If the repeat
test results are again not negative, the subject will be considered to have
latent TB (for purposes of this study) and will be excluded.
2. Exceptions include subjects with a history of active or latent TB who have
documented evidence of appropriate treatment and with no history of re-exposure
since their treatment was completed. (Such subjects would not be required to
undergo the protocol specific TB testing, but would require a baseline chest
x-ray).
22. Have a positive test for Hepatitis B Virus (HBV) defined as:
1. Positive for hepatitis B surface antigen (HBsAg), or
2. Positive for anti-hepatitis B core antibody (HBcAb) If any of the Hepatitis B
tests have an indeterminate result, confirmatory testing will be performed by an
alternate method.
23. Have Hepatitis C Virus (HCV) (positive for anti-hepatitis C antibody with confirmed
presence of HCV).
24. Have any of the following specific abnormalities on screening tests:
1. ALT or AST > 2 x ULN
2. Total bilirubin ≥1.5 x ULN
3. Hemoglobin < 10 grams/deciliter
4. Total white blood cell count (WBC) < 2500 cells/μL)
5. Neutropenia (absolute neutrophil count [ANC] < 1200 cells/μL
6. Lymphopenia (lymphocyte count < 750 cells/μL)
7. Thrombocytopenia (platelets < 100,000 cells/μL)
8. eGFR < 50 mL/min/1.73m²
In the case of any of the aforementioned laboratory abnormalities, the tests may be
repeated once within approximately 2 weeks from the initial values, and values
resulting from repeat testing may be accepted for enrollment eligibility if they meet
the eligibility criterion.
25. Are pregnant or breast feeding at the time of screening or enrollment.
26. Are females of childbearing potential who do not agree to use 2 forms of highly
effective birth control when engaging in sexual intercourse with a male partner while
enrolled in the study and for at least 4 weeks following the last dose of the study
drug
1. Females of non-childbearing potential are defined as women ≥60 years of age,
women
≥40 but <60 years of age what had had cessation of menses for at least 12 months,
or whom who are congenitally or surgically sterile (that is have had a
hysterectomy, or bilateral oophorectomy or tubal ligation)
2. The following birth control methods are considered highly effective (the subject
should choose 2 to be used with their male partner
i. Oral, injectable, or implanted hormonal contraceptives ii. Condom with spermicidal
foam, gel film, cream or suppository iii. Occlusive cap (diaphragm or cervical/vault
caps) with a spermicidal foam, gel, film, cream or suppository iv. . Intrauterine
device v. Intrauterine system (for example progestin-releasing coil) vi. Vasectomies
male (with appropriate post-vasectomy documentation of the absence of sperm in the
ejaculate)
27. Are males who do not agree to use 2 forms of highly effective birth control (see
above) while engaging in sexual intercourse with females partners of childbearing
potential while enrolled in the study and for 4 weeks after the last dose of the study
drug.
28. Have donated more than a single unit of blood within 4 weeks prior to screening or
intend to donate blood during the course of the study.
29. Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug above
within the 2 years prior to screening.
30. Have previously received baricitinib for other investigational study.
31. Are unable or unwilling to make themselves available for the duration of the study
and/or are unwilling to follow study restrictions/procedures
32. Are currently enrolled in, or discontinued within 4 weeks prior to screening from any
other clinical trial involving an investigational product or nonapproved use of a drug
or device or concurrently enrolled in any other type of medical research judged not to
be scientifically or medically compatible with this study.
33. Are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or sibling
whether biological or legally adopted.
34. Have a chronic medical illness requiring the use of oral of IV glucocorticoid
treatment (e.g. asthma or emphysema) during the trial or requiring long term
glucocorticoid treatment such that they would not be able to safely undergone a
standardized glucocorticoid taper.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Baricitinib in Relapsing Giant Cell Arteritis | NCT03026504 | Contradiction |
6,462 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Key Inclusion Criteria:
1. Male or female who is at least 18 years of age or older.
2. A clinical diagnosis of facial rosacea.
3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
and at Baseline/Day 1 (prior to the study drug application).
4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and
at Baseline/Day 1 (prior to the study drug application).
Key Exclusion Criteria:
1. More than 20 facial inflammatory lesions of rosacea
2. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
telangiectasia.
3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
sedatives, systemic anesthetics, or alpha agonists.
4. Less than 3 months stable dose treatment with tricyclic anti depressants, cardiac
glycosides, beta blockers or other antihypertensive agents.
5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea | NCT01789775 | Entailment |
5,083 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women 45 years or older. No period for at least two years.
- History of back pain that started at least 2 months prior to the initial visit (likely
due to spinal bone fracture determined by investigator).
- Minimum of one moderate spinal bone fracture.
- Beginning pain level of at least four on an eleven point scale.
- Bone Mineral Density (BMD) must meet criteria
- Able to read, understand, and administer self-questionnaires.
- Be willing and able to use a pen-injector to deliver the medication.
Exclusion Criteria:
- Are at increased risk for osteosarcoma.
- Have an active or suspected diseases that affects bone metabolism other than
osteoporosis.
- Participants that already know that they will require procedures to repair their
spinal bone fractures.
- Abnormal values of certain lab tests.
- Anything that would make it difficult to determine if the back pain was due to the
fracture.
- Poor medical or psychiatric condition.
- Alcohol or drug abuse within a year of the study start.
- Certain malignant neoplasms in the 5 years prior to enrollment.
- Active liver disease or clinical jaundice.
- Significantly impaired renal function.
- History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
- Known contraindication or intolerance to risedronate and/or teriparatide therapy.
- Treatment with oral strontium or certain therapeutic doses of fluoride.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis | NCT00343252 | Contradiction |
3,273 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Suspected or confirmed Sjogren's syndrome
- 18+ years of age
Exclusion Criteria:
- Any condition that in the opinion of the investigator may confound study results or
cause concerns for safety
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Corneal Nerve Structure in Sjogren's | NCT03203382 | Entailment |
2,376 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
- Informed consent
Exclusion Criteria:
- Other clinically significant concomitant disease states (e.g., renal failure)
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant or his/her parents or legal
caregivers,
- Inability to lie still for the duration of the imaging procedures (approximately 45
minutes each for echocardiography and CMR)
- MR-incompatible implanted or accidentally incorporated metal device or claustrophobia
that prohibits use of magnetic resonance imaging
Male
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 18 Years | Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy | NCT02470962 | Entailment |
6,590 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males, age 18 to 65 years
- Subjects with Severe hemophilia A with a documented plasma FVIII level of <1%
- ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
Exclusion Criteria:
- Evidence of current or past inhibitor antibody
- History of any congenital or acquired coagulation disorders other than hemophilia
A
- Platelet count <75,000/mm3
- Abnormal renal function (serum creatinine >2 times the upper limit of the normal
[ULN] range)
- Active liver disease verified by medical history or persistently elevated alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or
severe liver disease as evidenced by, but not limited to any of the following:
International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein
hypertension including presence of otherwise unexplained splenomegaly and history
of esophageal varices.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate | NCT02483208 | Contradiction |
4,751 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
1. Adults aged between 18 to 70 years old;
2. Diagnosed with unilateral ISSNHL according to the National Institute for Deafness and
Communication Disorders (NICDC) criteria30: a decrease in hearing of ≥30 decibels
(dB), affecting at least 3 consecutive frequencies occurring within a 72-hour period.
Since premorbid audiometry is generally unavailable, premorbid hearing level will be
defined as the opposite ear's thresholds in this condition;
3. Reported vertigo/dizziness/imbalance/lateropulsion and abnormal results in at least
one of the vestibular function tests (including SOT, caloric test, vHIT, cVEMP, and
oVEMP);
4. Onset of audio-vestibular symptoms occurred within 7 days;
5. Be willing to sign the informed consent of the study.
Exclusion Criteria:
1. Definite etiologies are found or highly suspected after clinical evaluations, such as
vestibular schwannoma, stroke, trauma or demyelinating disease;
2. Diagnosed with a present or previous hearing or balance disorders which might be
confused with ISSNHL (history of Meniere's disease, benign paroxysmal positional
vertigo, vestibular neuronitis or vestibular migraine; history of otosclerosis;
history of luetic, congenital or genetic hearing loss, etc.);
3. Hearing level (evaluated with PTA) in the unaffected ear is abnormal, so that a
premorbid hearing level of the affected ear may not be estimated;
4. Suspected as central vestibular dysfunction, evaluated by present and previous medical
history, physical examination and VNG;
5. Present with conditions contraindicated systemic glucocorticoids use, such as
tuberculosis, hepatitis C or B infection, active herpes zoster infection or other
known human immunodeficiency virus, pancreatitis, insulin-dependent diabetes mellitus,
severe osteoporosis, chronic renal insufficiency or gastrointestinal ulcer;
6. A history of more than 3 days sufficient systemic glucocorticoids uses (≥1 mg/kg/d)
within 3 months which may increase the risk of adverse effects. Considering that the
glucocorticoids is a well-acknowledged standard treatment and that the patients might
have probably received initial systemic glucocorticoids in emergency before outpatient
appointment, we only excluded those who have received sufficient glucocorticoids
(≥1mg/kg/d prednisone) for more than 3 days in previous 3 months;
7. Having received other systemic etiological treatments for ISSNHL (including hyperbaric
oxcygen therapy (HBOT), thrombolytic drugs and antiviral drugs) which may confound the
effects of study drugs. Patients who received only emergency or symptomatic treatments
will not be excluded (i.e., betahistine, promethazine, diazepam, mecobalamin or ginkgo
biloba leaves extracts);
8. Not appropriate for receiving vestibular function tests due to combination of
fracture, inflammatory or suppurative ear disease, severe cervical spondylosis or
severe psychotic disorders;
9. Multiple organ dysfunction or unstable vital signs;
10. Pregnancy or lactation;
11. Evaluated as unsuitable for the trial for any other reasons by investigators.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids | NCT03974867 | Entailment |
3,316 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- Confirmed diagnosis of ONH (Diagnosis will be confirmed by ocular fundus
photography.Disc-macula distance 0.35 or below. In eyes without ONH, the DD/DM ratio
is greater than 0.3581.)
- Ages 2-10 years
- Ability to ambulate independently
- Under care of endocrinologist if on pituitary hormone replacement therapy.
Exclusion Criteria:
- Non-ambulatory
- Active malignancy
- Cardio-respiratory disorder
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 10 Years | Biological Clock Dysfunction in Optic Nerve Hypoplasia | NCT00825591 | Entailment |
882 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
Subjects with a clinical definition of knee OA using NICE guidelines:
- Age ≥ 45
- Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric
rating scale, where 0 = no pain and 10 = worst pain possible
- History of knee pain for at least 3 months
- Morning stiffness in the morning lasting less than 30 minutes
Exclusion Criteria:
- Walk with an assistive device
- Current use of oral opiates or centrally acting pain medications
- History of lower extremity surgery
- Underwent an intra-articular knee joint injection in the past 3 months
- Suffer from inflammatory arthritis or other conditions that affect lower extremity
functions
- Currently receiving treatment for their knee and unwilling to stop this treatment for
the duration of the study
- Currently pregnant
- Skin allergies to adhesives
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Effectiveness of a Walking Intervention on Impact Loading and Pain | NCT04148807 | Entailment |
5,004 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Patients in good general health
- Definite ET based on the TRIG diagnostic criteria
- Patients must have tremor affecting both upper extremities and at least 1 upper
extremity must have a postural or action/intention tremor that is rated from 2
(moderate) to 4 (severe) as defined in Part A (Tremor location/severity rating) of the
TRS at the Visit 2 evaluation
- Patients must have a negative urine drug screen at screening with exceptions for
legally prescribed benzodiazepines or opioid analgesics. Patients must have a negative
blood alcohol test at screening and be willing to abstain from alcohol for at least 24
hours prior to each study visit.
Exclusion Criteria:
- Abnormal neurologic signs or progressive neurological disorders, such as Parkinson's
Disease, brain tumor, demyelinating disease, CNS trauma, active CNS infection, stroke,
or any CNS disease, other than ET, that could interfere with the evaluation of tremor
- Patients with dystonia or dystonic tremors, enhanced physiologic tremor, task specific
tremor (e.g., writing tremor), or historical or clinical evidence of psychogenic or
fictitious movement disorders
- Patients currently taking or recently exposed to prohibited medications unless, in the
opinion of the study investigator, the patient is able to follow the washout procedure
and restrictions described in the protocol prior to randomization
- Patients taking more than one tremor-reducing agent who are unable to discontinue all
or all but one of these medications
- Patients who have achieved no discernable tremor reduction after treatment with at
least 2 of 3 following tremor-reducing medications specifically prescribed for the
treatment of ET: propranolol, primidone, or topiramate
- Prior exposure to carisbamate (RWJ-333369)
- Surgical procedures for treatment of ET such as deep brain stimulation or thalamic
ablation
- Current or past (within 1 year) major psychotic disorder, such as schizophrenia or
other psychotic conditions, major depressive disorder with psychotic features or other
psychiatric disorders
- Exacerbation of major depression within the past 6 months
- History of suicide attempts or suicidal ideation in the past year
- History of drug or alcohol abuse within the past year
- Patients who are not able to abstain from alcohol consumption for 24 hours prior to
each evaluation
- Patients with abnormal screening laboratory values or ECG (electrical heart tracing)
- Patients with a history, diagnosis or clinical signs for a significant major medical
disorder that might disqualify.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor | NCT00524056 | Entailment |
2,547 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Patient with AD, defined according to the criteria of the United Kingdom Working Party
: AD should be diagnosed when a child has an itchy skin condition plus three or more
of the following: Protocol EDU DA RC15_0035 Version n°4 du 15/09/16 Page 28 sur 44
CONFIDENTIAL Visible flexural dermatitis involving the skin creases, such as the bends
of the elbows or behind the knees (or visible dermatitis on the cheeks and/or extensor
areas in children aged under 10 years) Personal history of flexural dermatitis (or
dermatitis on the cheeks and/or extensor areas in children under 10 years) Personal
history of dry skin in the last 12 months Personal history of asthma or allergic
rhinitis (or history of atopic disease in a firstdegree relative of children aged
under 4 years)
- Onset of signs and symptoms under the age of 2 years (this criterion should not be
used in children aged less than 4 years). Patient aged at least 3 months and less than
18 years.
- SCORAD 20 (moderate to severe AD)
- Patient who received treatment an anti-inflammatory topical treatment (topical
corticosteroid or topical tacrolimus)
- Informed consent of parents
- Agreement of the child when appropriate
- Patient affiliated to French social security system
Exclusion Criteria:
- Patient does not meet the criteria of AD
- SCORAD < 20
- Patient aged 18 years or more
- Patient treated with oral corticosteroids currently or systemic immunosuppressant 2
months prior to the eligibility assessment
- Patients with primary immunodeficiency diseases.
- Consent not given
- Patient not affiliated to French social security system
- Patient with intercurrent disease, may be excluded if the investigator believes
participation in the trial is not in the best interest of the patient
- Personal decision of the child or their parents not to be included
- Child and / or parents lack the mental capacity to give informed consent
- Child / Parents do not have a sufficient command of the French language for
understanding TPE program.
- Patient or parent who has already received structured TPE for AD.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 18 Years | A Multicenter Randomized Control Trial in Children With Moderate to Severe Atopic Dermatitis to Assess the Benefit of a Nurse-led One-to-one Education Program in Addition to Standard Care Compared to Standard Care Alone on the Long Term Control of Disease Severity at 6 Months | NCT02634905 | Entailment |
2,851 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Patients with a diagnosis of probable, laboratory-supported probable, or definite
amyotrophic lateral sclerosis according to the El Escorial revised criteria
- Disease duration ≤ 24 months
- Disease progression in the past 3 months
- Score ≥ 2 at the item "swallowing" of the ALS Functional Rating Scale Revised
- Score ≥ 2 at the item "walking" of the ALS Functional Rating Scale Revised
- Treatment with steady regimen of riluzole for a minimum of 1 month before study entry,
and desiring its continuation
- Able to give informed consent
- Written informed consent
Exclusion Criteria:
- Motor neuron diseases other than ALS
- Severe head trauma in the past
- History of seizures
- History of ischemic stroke or hemorrhage
- Pacemaker
- Metal implants in the head/neck region
- Severe comorbidity
- Intake of illegal drugs
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis | NCT03293394 | Entailment |
4,064 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Both males and females
- Patients with age 45-65 years
- Patients with knee OA of grade II or III according to Kellgren-Lawrence grade.
- Pain intensity ranging between> 5 measured by Numeric Pain Rating Scale.
- Patients who had minimum score of 25 on the Western Ontario McMaster Universities
Osteoarthritis Index (WOMAC) total score.
- Patients having knee pain for at least 3 months.
Exclusion Criteria:
- Patients with pain in other lower limb joints.
- Patients with symptomatic hip osteoarthritis.
- Patients with knee surgery in last 6 months.
- Patients with complaint of cancer, diabetes, neurological deficit or uncontrolled
hypertension
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 65 Years | Low Level Laser Therapy in Knee Osteoarthritis | NCT04682171 | Entailment |
3,626 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- All patients that visit the ED during one of the two periods of recruitment, monday to
friday between 8:30am and 4:30pm, will be screened for inclusion. We chose this time
interval as they correspond to period that can be exposed to a cross checking, which
will occur at 11:30 am, 2:00 pm and 4:30 pm.
Exclusion Criteria:
- Patients whose care is not provided by an EP (for example psychiatrist or
maxillo-facial surgeon)
- Scheduled return attendance to the ED
- Low severity, defined by
1. Triage level 5 on a 1 to 5 scale 13,14
2. Patients referred to a "minor" or "fast track" unit
3. Patients discharged home less than 1 hours after first contact with an EP
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Cross Checking to Reduce Adverse Events in the Emergency Department | NCT02356926 | Entailment |
1,209 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Age greater than or equal to 18 years old
- Diagnosis of a paramalignant pleural effusion (defined as a recurrent pleural effusion
directly caused by malignancy with known thoracic involvement)
- Estimated life expectancy greater than 3 months
- Full lung re-expansion on chest x-ray after thoracentesis
Exclusion Criteria:
- Age less than 18 years old
- Pregnant or lactating subject
- Any history of prior pleural talc administration
- History of an indwelling pleural catheter placed on the side of the active
paramalignant pleural effusion
- Estimated life expectancy less than 3 months
- Active clinical heart failure
- Inability to return for frequent follow up appointments
- Current incarceration
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Talc Outpatient Pleurodesis With Indwelling Catheter | NCT03973957 | Entailment |
760 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- were 18 years of age or older, reported unilateral ankle pain for at least 6 months
and had either reported no significant benefit from conservative treatment (rest,
physical therapy, orthoses or pain medications etc.) or were unable to tolerate side
effects of medications
- ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to
the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible
narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing
of joint space, some sclerosis and possible deformity of bone contour)22
- had a current total AOS score (described below) of > 3 and < 9 (possible range, 0-10)
- were normally active, not bedridden or confined to a wheelchair, and were able to walk
30 meters without the aid of a walker, crutches or cane
- were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other
analgesic medication (except for rescue medication) for the duration of the study
- did not receive physical therapy or trial of shoe modifications or orthotics during
the study period
Exclusion Criteria:
- pregnant and lactating women
- bilateral ankle OA requiring treatment of both ankles
- chronic ankle instability
- lower leg trauma other than within the ankle
- previous orthopedic surgery on the spine, hip or knee
- presence of active joint infections of foot or ankle
- previous surgery or arthroscopy on the ankle within 12 months
- intraarticular steroid or HA injection in the treated ankle within the past 6 months
- treatment with anticoagulants or immunosuppressives
- history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
- history of avian protein allergy
- presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma,
etc) or poor health status that would interfere with the clinical assessments during
the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis | NCT00918736 | Contradiction |
1,045 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Male or Female over 75 years-old
- Emergency consult resulting on an hospitalization in the geriatric service or in the
internal medicine service
- Hospitalised in the Centre Hospitalier Intercommunal de Toulon for syncope, presenting
these symptoms:
- Loss of consciousness with quick return to normal (less than one minute)
- Spontaneous resolution
Exclusion Criteria:
- history of syncope
- other loss of consciousness (epilepsy, stroke, head trauma)
- anticoagulated treatment
- patient's objection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 75 Years old.
| Prevalence Rate of Pulmonary Embolism Among Not Anticoagulated Patients | NCT03525535 | Contradiction |
6,358 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
- Age >18 years
- Able to express informed consent to participate in the study
Exclusion Criteria:
- patients unable to express consent,
- patients aged <18 yr,
- with signs and symptoms compatible with Covid-19 but without certified diagnosis by
swab/BAL or serological examination of presence of COVID IgG antibodies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE | NCT04788433 | Entailment |
4,265 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Have no clinically relevant abnormalities
- Non smoker
Exclusion Criteria:
- Have or had a history of clinically significant, severe, progressive, or uncontrolled
renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,
neurologic, cerebral, or psychiatric disease
- Have any underlying physical or psychological medical condition
- Be unable or unwilling to undergo multiple venipunctures because of poor tolerability
or lack of easy access to veins
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects | NCT01081704 | Entailment |
6,602 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males with severe congenital hemophilia A or B defined as <1% FVIII or <2% FIX
concentration by measurement at the time of screening or from reliable prior
documentation (e.g., measurement in other clinical Bayer trials, or diagnostic genetic
testing)
- Male with any inhibitor titer at screening or prior to screening at any time from
medical records. Subjects may be receiving a bypassing agent (rFVIIa; NovoSeven and/or
aPCC; FEIBA) for treatment.
- Age: 18 to 65 years at screening
- BMI: 18 to 29.9 kg/m2
Exclusion Criteria:
- Subjects with known bleeding disorders (such as von Willebrand factor [vWF]
deficiency, FXI deficiency, platelet disorders, or known acquired or inherited
thrombophilia etc.) other than congenital Hemophilia A or B with or without inhibitors
- History of angina pectoris or treatment for angina pectoris
- History of coronary and/or peripheral atherosclerotic disease, congestive heart
failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as
systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg
even if controlled
- History of thrombophlebitis, venous/arterial thromboembolic diseases (particularly
deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction,
cerebrovascular accident, ischemic heart disease, transient ischemic attack)
- Known or suspected hypersensitivity of the immune system, history of anaphylactic
reaction, known severe allergies, non-allergic drug reactions, or multiple drug
allergies
- Subjects with inhibitors treated with FEIBA, who are not willing to accept rFVIIa
(NovoSeven) for the treatment of any bleeds occurring either between screening and
dosing or after study drug administration, and until the end of the study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia | NCT03481946 | Contradiction |
5,982 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Experiencing heartburn at least 2 days per week over the past month.
2. Having heartburn that responds to heartburn medication.
3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion
in the study.
Exclusion Criteria:
1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by
a physician and confirmed by testing (endoscopy).
2. Be unwilling to take only the study medication, and antacid provided as a rescue
medication for relief of acute heartburn during the study.
Other protocol-defined inclusion or exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn | NCT00389948 | Entailment |
3,069 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria for Individuals with Intellectual Disabilities:
- Participants will have an age range between 2 and 17.11 years of age inclusive
- Male or female
- Diagnosis of an intellectual disability based on the fourth edition of the Diagnostic
and Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the
International Statistical Classification of Diseases and Related Health Problems
(ICD-10), and an expert clinical evaluation
- have historical evidence of significant abnormal developmental milestones as
determined by neurological history
- care provider that will reliably bring subject to study visits, and is trustworthy to
provide accurate accounts of services provided to the subject
Inclusion Criteria for Individuals with Speech Delay/Language Disorder:
- Participants will have an age range between 2 and 17.11 years of age inclusive
- Male or female
- Diagnosis of a speech delay based on the fourth edition of the Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the
International Statistical Classification of Diseases and Related Health Problems
(ICD-10), and an expert clinical evaluation
- Preschool Language scale (PLS) score of at least 1 standard deviations below age level
(for children in the age range of 2-6.11)
- care provider that will reliably bring subject to study visits, and is trustworthy to
provide accurate accounts of services provided to the subject
Exclusion Criteria:
- medically unstable (such as having unstable seizures)
- primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by
the investigators
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 17 Years | Pivotal Response Treatment for Individuals With Intellectual Disabilities | NCT01988623 | Entailment |
2,195 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Subjects must present with confirmed diagnosis of gout, meeting the American College
of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute
arthritis of primary gout
- Subjects must have experienced at least one (1) acute gouty arthritic attack in the 12
months prior to randomization
- Presence of acute gout flare for no longer than 3 days at Visit 2
- Pain intensity at inclusion (Visit 2) of 7-10 on 11-point PI-NRS (defined as severe
gout flare for this study)
- All patients should not have contraindications for Colchicine use
- Subjects with a history of intolerance to NSAIDs (Checklists Checklist 1)
- Subjects with significant medical contraindication to NSAIDs (Checklist 2)
- Subjects with past failure of NSAIDs to control acute gouty arthritis attacks in the
previous 12 months (Checklist 3)
- Regarding significant medical contraindication to NSAIDs or past failure of NSAIDs to
control acute gouty arthritis attacks in the previous 12 months (i.e. refractoriness
to NSAIDs) the patient must meet one of below criteria:
1. At least one historical episode within the previous 12 months of being refractory
or intolerant to NSAIDs that makes the physician concerned to use NSAIDs for a
subsequent acute gout attack
2. The current (referring) physician judgment is that NSAIDs are not appropriate for
treating the patient's gouty arthritis flare which may be due to changes in
patient status such as worsening co-morbid conditions or co-medications (e.g., GI
tract disease, renal insufficiency, hypertension, fluid retention, concurrent use
of diuretics and/or an angiotensin converting enzyme inhibitor or angiotensin
receptor blocker, especially in CKD)
- Subjects must be willing and able to give written informed consent. A HIPAA and/or
state privacy consent must also be signed
- Subjects must be able to swallow tablets
- Use of permitted concomitant medications must be unchanged in dose and or frequency,
30 days prior to screening
- Adequate organ function, evidenced by the following laboratory results within 90 days
prior to randomization (historical lab results are acceptable).
- Creatine clearance > 45 mL/min based on Cockroft-Gault glomerular filtration rate
(GFR) estimation
- For women of childbearing potential and men with partners of childbearing potential,
agreement to use a highly effective, non-hormonal form of conception.
Exclusion Criteria:
- Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of
infectious/septic arthritis, acute polyarticular gout (4 or more joints), with
arthritis due to any cause other than gout that may confound any study assessments per
Investigator discretion
- Subjects who have experienced >2 acute gouty arthritic attacks per month, or >12
attacks overall, in the 6 months prior to randomization
- Subjects with a history of myocardial infarction, unstable angina, cerebrovascular
events, or coronary artery bypass grafting within the previous 6 months prior to
screening
- Subjects with a Body Mass Index >45 kg/m2; calculated as body weight (kg)/height (m)2
at Screening Visit
- Subjects with acute or chronic infections including known HIV and/or Hepatitis B or C
- Uncontrolled hypertension (>160/90 mmHg seated) (if the first set of BP assessment
meets the definition of uncontrolled hypertension, a second set of BP assessments may
be performed after the patient has rested for at least 30 min. If the second set of BP
assessments does not meet the definition of uncontrolled hypertension the patient will
be eligible for participation)
- Subjects with proteinuria ≥1+ or ≥30 mg on dipstick urinalysis that is confirmed on
repeat assessment within 24 hours
- Subjects with significant heart failure and activity impairment (Class III-IV of the
New York Heart Association (NYHA)
- Subjects with any history of malignancy, 5 years prior to randomization
- Subjects with CKD NKF stages 3B -5 chronic renal dysfunction (eGFR <45 mL/min/1.73m2
acc. to Cockcroft Gault formula)
- Subjects with serious hepatic disorder (Child-Pugh scores B or C)
- Subjects who have not washed out of dopamine antagonists or depleting drugs excluding
anticholinergics and/or antihistamines with anticholinergic effects at least 14 days
prior to Day 1 (Visit 2)
- Subjects with a documented history of alcohol or substance abuse within the 12 months
prior to randomization(consumption of >21 units of alcohol per week is considered
alcohol abuse)
- Subjects with significant CNS effects including vertigo and dizziness
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Bucillamine for the Treatment of Acute Gout Flare in Subjects With Moderate to Severe Gout | NCT02330796 | Contradiction |
6,106 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- adults with COVID19 (proven by polymerase chain reaction, or with strong clinical
suspicion based on clinical features and/or radiodiagnostics)
Exclusion Criteria:
- minors
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| COVID-19 Resuscitation Plans and Decisions on Escalation and Limitation of Treatment | NCT04743232 | Contradiction |
4,079 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
---
Exclusion Criteria:
Participants with a history of neurological disorders or of sleep disorders will be
excluded.
Participants who do not believe they would be able to fall asleep in the lab will be
excluded.
Participants with severe asthma requiring hospitalization for treatment, history of
significant food or non-food allergy, presence of known smell, taste or ear-nose-throat
disorder, or a history of sinusitis or allergic rhinitis will be excluded.
Participants who are certain they breathe through their mouths during sleep and those who
snore (and therefore likely breathe through their mouths as well) will be excluded.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Reactivating Specific Memories During Sleep in Conjunction With a Suppression Context | NCT04702750 | Contradiction |
2,474 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- 18 years old or older
- Diagnosis of cutaneous sarcoidosis or granuloma annulare with supportive skin biopsies
in which other causes of granulomas (infectious, foreign body) have been ruled out
- Patients with either: Cutaneous Sarcoidosis Activity and Morphology (CSAMI) activity
score greater than or equal to 10 (patients with a CSAMI greater than or equal to 10
have active cutaneous sarcoidosis involving several distinct cutaneous sites and would
otherwise be considered candidates for systemic therapy), or any CSAMI score and
sarcoidosis involvement causing functional impairment (i.e. nasal or visual field
obstruction).
- For patients with granuloma annulare, patients with 5% or greater Body Surface Area
(BSA) will be enrolled.
- If patients are on other systemic therapies for their sarcoidosis or granuloma
annulare, they must be taking a stable dose of the other medication(s) for at least 3
months with no plans to change the regimen in the next 6 months. With the exception of
methotrexate and/or low dose prednisone, use of concomitant immunosuppressants, e.g.
infliximab, azathioprine, etc., will not be permitted.
- Females of childbearing potential must agree to use birth control during the study and
there must be a negative pregnancy test documented prior to starting the medication.
- Patients must be willing to undergo skin biopsies, blood collection, and total body
photography and comply with clinic visits
Exclusion Criteria:
- Age <18 years old
- Patients with a history of malignancy (except history of successfully treated basal
cell or squamous cell carcinoma of the skin)
- Patients known to be HIV or hepatitis B (HBV) or C (HCV) positive (prior exposure to
but clearance of HBV and HCV is acceptable for study entry as long as patient is being
monitored by hepatology)
- Patients with active tuberculosis or untreated latent tuberculosis as determined by
positive tuberculin skin test or positive QuantiFERON® Tuberculosis (TB) test and, as
necessary, chest X-ray
- Patients with significant hepatic impairment
- Patients with untreated peptic ulcer disease
- Patients taking immunosuppressive medications, with the exception of methotrexate
and/or low- dose prednisone, including but not limited to mycophenolate mofetil,
azathioprine, tacrolimus, cyclosporine, or Tumor Necrosis Factor (TNF-α) inhibitors
- Women of childbearing potential who are unable or unwilling to use birth control while
taking the medication
- Women who are pregnant or nursing. If a woman becomes pregnant during the study, she
will stop study medication and be removed from the study. She will be urged to follow
up with her Primary Care Physician or OB/GYN. The study doctors will ask to follow the
pregnancy to its outcome.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare | NCT03910543 | Entailment |
6,324 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patient with COVID-19 confirmed by positive RT-PCR or considered as probable by the
in-charge physician,
- ≥18 years old,
- Not requiring respiratory assistance and/or other intensive care
- Not subject to a limitation of active therapeutics
Exclusion Criteria:
- History of pneumonectomy
- Any reason making chest ultrasonography impossible
- Any reason making 14-day follow-up impossible
- Patient opposition to research participation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Point Of Care UltraSonography for Risk-stratification of COVID-19 Patients | NCT04338100 | Entailment |
3,544 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Male or female patients ≥ 18years of age with Primary Adrenal Insufficiency (Addison's
disease) confirmed on biochemical testing.
- Male or female patients ≥ 18years of age with ACTH deficiency defined by a stimulated
peak cortisol in response to insulin-induced hypoglycaemia or short synacthen testing
<400 nmol/l, with known organic pituitary disease, and no adjustment in hormone
replacement for at least 3 months prior to study entry.
- Signed informed consent to participate in the study
Exclusion Criteria:
- Age < 18 years
- Patients with acute medical or surgical illness
- Patients with advanced cardiac/pulmonary disease
- Patients with a terminal illness
- Patients on glucocorticoids for purposes other than ACTH deficiency
- Patients on agents that interfere with corticosteroid metabolism
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Optimising Steroid Replacement in Patients With Adrenal Insufficiency | NCT03282487 | Entailment |
325 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion criteria
- age<40 years,
- first ICSI cycle,
- third day FSH< 10 mIU/mL,
- serum E2 level on day of hCG administration <4,000 pg/mL,
- number of ova obtained >15
Exclusion Criteria:
- age 40 years or more,
- basal FSH 10 mIU/mL or more ,
- eggs retrieved 15 or less ,
- E2 level on day of hCG administration 4000 or more pg/ mL or more,
- repeat ICSI , need for PGD, presence of myoma , hydrosalpinx (unless disconnected)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Is Adding E2 to P4 Luteal Support In High Responder Long Gn-RH Agonist ICSI Cycles Detrimental to Outcome? RCT | NCT01790282 | Contradiction |
5,381 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- New subjects undergoing evaluation for the diagnosis of VWD determined to have a
VWF:Ag or VWF: RCo < 50 IU/dl and or a VWF:RCo/VWF:Ag of <0.7. Also subjects will be
included if Type 2 N VWD is clinically suspected
Exclusion Criteria:
- Those subjects whose lab results do not meet the inclusion criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
| Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD) | NCT02466789 | Entailment |
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