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5,563 | 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:
- Age 5-17 years, inclusive
- Either healthy lean (BMI≥ 5th percentile and <85th percentile for age/sex) or
overweight (BMI ≥ 85th percentile and <95th) or obese (BMI ≥ 95th percentile for
age/sex)
- For those with BMI≥ 85th percentile for age/sex, parental verbal confirmation that the
child had a history of BMI≥ 85th percentile for age/sex for at least six months prior
to study enrollment OR
- Age 5 years - 17 years 5 months, inclusive
- Either overweight or obese (BMI≥ 85th percentile for age/sex)
- Parental verbal confirmation that the child had a history of BMI≥ 85th percentile for
age/sex for at least six months prior to study enrollment
- Diagnosed with type 2 diabetes mellitus or insulin resistance
- Prescribed metformin (either not yet taking or began taking within 3 weeks of
enrollment)
Exclusion Criteria:
- Having an infection (viral, respiratory, gastrointestinal) in the previous 4 weeks
- Genetic or physical conditions impacting mobility over past year as determined by the
PI
- Having known chronic illnesses/disorders that may independently affect study outcome
measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental
(developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's),
hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except
well controlled asthma that does not require permanent use of inhaled/oral steroids
- Taking any of the following medications that can affect study outcome: antipsychotics,
thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs
(growth hormone replacement therapy and oxandrolone) and stimulants
- Taking metformin prescribed as part of their clinical care for longer than 3 weeks at
the time of enrollment (may begin metformin therapy prescribed as part of their
clinical care while enrolled in the study)
- BMI<5th percentile for age/sex (classified as underweight based on CDC growth charts)
- Subjects determined ineligible by the PI or delegated staff.
No condition on gender to be admitted to the trial.
Subject must be at least 5 Years old.
Subject must be at most 17 Years | Immunometabolism in Pediatric Obesity | NCT03960333 | Contradiction |
438 | 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:
Females with, unexplained infertility, 20-38 years of age. Normal menstrual cycle length of
26-35 days, male partner 20-70 years of age, Duration of infertility should have lasted
more than one year and subject should have signed informed consent.
Couples must fulfil all laboratory tests for inclusion, negative HIV-1, HCV, HBV, CMV
virology, chlamydia and syphilis. For female also negative toxoplasmosis, rubella and
hormonal screen within normal range. Furthermore patent fallopian tubes should be confirmed
by ultrasound hysterosalpingography and males should present a normal semen analysis
Exclusion Criteria:
Continuous treatment with NSAID, corticosteroids or other drugs, which can cause an
increased risk of infection, clinical signs of PID, known hypersensitivity to local
anaesthetics, non-patent fallopian tubes, abnormal uterine cavity, submucous myoma > 2 cm
in diameter, any disease or laboratory finding considered of importance by the investigator
not to include the patient, laparoscopically confirmed endometriosis of greater severity
than mild, endometriosis of any severity with adhesions. More than 2 previous inseminations
or previous unsuccessful IVF treatment.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 38 Years | A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility | NCT03386552 | Contradiction |
5,730 | 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:
- The last 100 consecutive skin biopsies performed in patients carriers of chronic leg
ulcers, hospitalized in the vascular medicine department of the Hospital Saint Joseph
Paris
Exclusion Criteria:
- No exclusion criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care? | NCT02889913 | Contradiction |
3,752 | 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. Moderate knee osteoarthritis Defined as Kellgren-Lawrence radiographic level 2 or 3
2. People who speak Spanish as a primary language
3. Age 50 or greater
4. pass a Phone screening: Reports problems with physical performance due to knee:
Answers yes to 'Are you now limited in any way in any of your usual activities because
of arthritis or joint?' Reports pain in their knee: Answers 'yes' to have you had pain
in your knee in last 30 days? Be able to walk inside home without a cane, be able to
walk ¼ of a block without a cane and be able to go up a flight of stairs without
assistance from another
Exclusion Criteria:
1. Psychiatric or behavioral comorbidity preventing participation in a group exercise
program
2. History of lower extremity joint arthroplasty
3. Morbid obesity defined as body mass index of 40 or greater
4. Presence of inflammatory arthritic condition
5. Neurologic involvement impacting functional mobility
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.
| Feasibility of Multi-modal Physical Therapy in Latino Older Adults With Moderate Knee Osteoarthritis | NCT04219423 | Contradiction |
6,439 | 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. | Inclusion Criteria:
- scheduled for a skin exam with participating dermatologists
Exclusion Criteria:
- psoriasis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 65 Years | Project Options - The ABC Method | NCT03489356 | Entailment |
3,238 | 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:
- Patients must be at least 18 years of age, must read and sign the informed consent
form (ICF), and must agree to comply with the study requirements.
- Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye,
must report having an ocular examination in the last two years and must be using
topical ocular dry eye therapy (artificial tears or Restasis) at least 4 times per
day.
- Patients must have been diagnosed with Sjogren's Syndrome (confirmed or consistent
with the American-European Consensus Criteria 2002).
Exclusion Criteria:
- Patients cannot wear contact lenses within one week prior to visit 1 and cannot wear
their contact lenses during the study.
- Patients cannot have a history of hypersensitivity to any component of FID 114657, and
cannot have diabetes (Type 1 or 2).
- Patients cannot have ocular or intraocular surgery or serious ocular trauma within the
past 6 months, and cannot have an eyelid abnormality that might affect lid function.
- Patients cannot have punctal plugs that were placed less than or equal to 30 days
prior to Visit 1, and cannot have active infections or inflammations not associated
with Sjogren's Syndrome.
- They cannot have started or changed the dose of chronic systemic medication within 7
days prior to visit 1, and must remain on a stable dosing regimen for the duration of
the study.
- Patients cannot have participated in another investigational clinical or research
study within 30 days of visit 1 and are not allowed to participate in any other drug
or device clinical trial for the duration of this study.
- Patients cannot have any findings in the vitreous, retina, macula and choroid that
show signs of active inflammation and/or any structural change that in the opinion of
the investigator is considered abnormal or unstable for that participant and/or a
score of greater than 0 for the optic nerve.
- Patients can not have had punctal cauterization within 30 days prior to Visit 1, have
a history of undergoing prior cataract surgery with complications as a result of the
cataract surgery.
- Participants who have undergone prior cataract surgery without complications must be
at least six months post-op with a stable refractive error.
- Patients cannot have received ocular prescription therapy in the last 30 days
(Restasis can be used as long as stable for at least 30 days).
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.
| Evaluation of FID 114657 in Sjogren's Syndrome Subjects | NCT01079871 | Entailment |
1,908 | 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... | Key Inclusion Criteria:
- Histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach
- Male or female aged ≥ 18 years
- Negative HER2 status obtained from the most recent available tissue sample
- Inoperable recurrent, locally advanced adenocarcinoma or progressing stage IV
adenocarcinoma of the gastro-esophageal junction or stomach, and disease progression
after either standard first- or second-line treatment (Substudy 1), or after standard
first-line treatment (Substudies 2 and 3)
- Positive test for eligible FGFR aberrations
- For Substudies 1 and 3, measurable disease as defined by the Investigator using RECIST
1.1 criteria
- ECOG PS of 0 or 1
- Men and women of childbearing potential must agree to avoid impregnating a partner or
becoming pregnant, respectively, during the study, and for at least 150 days after the
last dose of either investigational drug
Key Exclusion Criteria:
- Prior anticancer or investigational drug treatment within an interval shorter than the
following, as applicable:
1. One chemotherapy or biological (e.g., antibody) cycle interval
2. Five half-lives of any small molecule investigational or licensed medicinal
product
3. Two weeks, for any investigational medicinal product with an unknown half-life
4. Four weeks of curative radiotherapy
5. Seven days of palliative radiotherapy
6. 28 days of radiotherapy
- Prior treatment with FGFR Inhibitors (all substudies), and prior treatment with
taxanes within 6 months prior to randomization and/or anti-VEGF(R) therapeutic
antibody or pathway-targeting agents (Substudies 2 and 3), and prior treatment with
anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand-1 (PD-L1)
therapeutic antibody or pathway-targeting agents (Substudy 3)
- Concurrent evidence of clinically significant corneal or retinal disorder
- History of clinically significant cardiac disorders and/or a QT interval corrected by
Fridericia's formula (QTcF) > 450 ms for males or > 460 ms for females
- For Substudies 1 and 3, known CNS metastases
- Concurrent uncontrolled or active infection with human immunodeficiency virus (HIV;
known HIV 1/2 antibodies positive); active hepatitis B virus (HBV) and hepatitis C
virus (HCV) co-infection; active tuberculosis (for Substudies 2 and 3)
- Child-Pugh B or C liver cirrhosis, or a history of hepatic encephalopathy, hepatorenal
syndrome, or clinically-meaningful ascites related to cirrhosis (for Substudies 2 and
3)
- Administration of a live, attenuated vaccine within 30 days prior to randomization
(for Substudy 3)
- Treatment with systemic corticosteroids (except for steroidal replacement therapy) or
other systemic immunosuppressive medications within 2 weeks prior to first dose of
study drug or anticipated requirement for systemic immunosuppressive medications
during the study (for Substudy 3)
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.
| Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma | NCT04604132 | Entailment |
5,905 | 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: (all responses must be Yes)
- Between 18 and 75 years of age
- Male or non-pregnant, non-lactating female
- Willing and able to undergo endoscopy with biopsies and a blood draw
- Willing and able to discontinue use of PPIs for at least 1 month prior to the study
start date
- Endoscopy-negative heartburn of moderate severity at least 3 times-a-week for 3 months
Exclusion Criteria:(all responses must be No)
- History of:
- Barrett's Esophagus
- Erosive Esophagus
- Zollinger Ellison syndrome
- bleeding disorder
- upper gastrointestinal bleeding or malignancy
- esophageal motor disorder
- esophageal stricture
- esophageal varices
- Had the following surgeries:
- organ transplant
- gastric or esophageal surgery for the treatment of: Esophageal Cancer, Achalasia,
Gastroesophageal Reflux Disease (GERD); i.e. Nissen Fundoplication
- Have any of the following:
- Current malabsorption
- inflammatory bowel disease
- severe heart-lung-liver or renal cerebrovascular disease
- known hypersensitivity to PPIs
- Currently taking any of the following medications:
- Quinidine
- quinine
- benzodiazepines
- antineoplastic agents
- dilantin
- warfarin
- non-steroidal anti-inflammatory drugs
- narcotics
- prostaglandins
- salicylates (except baby aspirin for cardiovascular protection)
- H2-receptor antagonists
- PPIs other than study agent
- steroids
- promotability drugs
- sucralfate
- KCl
- anti-tuberculosis medication
- oral biphosphonates
- drugs requiring acid for absorption (iron, ampicillin, digoxin and ketoconazole)
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 | Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn | NCT01149395 | Contradiction |
6,420 | 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. | Inclusion Criteria:
- Male or female patients of at least 18 years of age at index date
- At least one prescription for a topical rosacea treatments: Azelaic Acid Gel, Azelaic
Acid Cream, Metronidazole Gel, Metronidazole Cream, Metronidazole Emulsion,
Metronidazole Lotion, Brimonidine Tartrate Gel
- At least one medical record with a diagnosis code for rosacea (ICD-9: 695.3)
- At least 6 months of data history prior to the index date
- Had at least one encounter at the Reliant Medical Group within 3 months prior to 01
January 2015
Exclusion Criteria:
- None
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.
| Preferences & Treatment Satisfaction Drivers in Rosacea Patients | NCT02602470 | Entailment |
3,866 | 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:
- Age greater than 30 years and less than 80 years
- Knee pain for at least 6 weeks
- Pain rate greater than or equal to 4/10 on a visual analog scale
- Morning stiffness less than 30 minutes
- Crepitus on active motion of the knee, bony tenderness, or bony enlargement of the
knee
- Willing and able to consider all medical treatment options used to manage
osteoarthritis of the knee
- No contraindications to knee radiographs or MRI
- Willing to participate in a registry
- Able to understand and sign a consent
- Able to answer registry questions independently
Exclusion Criteria:
- Diagnosis of a systemic rheumatic disease or crystalline arthritis (ie RA, SLE,
systemic sclerosis, psoriatic arthritis or psoriasis, gout, pseudogout, lyme
arthritis, reactive arthritis, viral arthritis
- pregnant or nursing
- unable to give informed consent
- contraindication to MRI such as indwelling paemaker or cochlear implant
- requirement of metal equipment (such as oxygen)
- known claustrophobia
- gadolinium allergy
- lack of fluency in English. Unfortunately, we do not have the financial resources to
offer full translation services
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years | The Knee Usual Care Evaluation Study | NCT01905358 | Entailment |
2,792 | 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:
1. Male or female aged ≥ 8 yrs of age
2. English speaking;
3. Healthy (Defined as American Society of Anesthesiologists Physical Status 1 or 2)
4. Ability to provide assent/consent/parent permission.
5. Scheduled to undergo chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus
surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee
replacement.
Exclusion Criteria:
1. History of chronic pain conditions including migraines
2. Use of opioids chronically or for major surgery within the 6 months prior to
enrollment
3. Severe obesity (BMI>35 kg/m2)
4. Taking no more than two concomitant medications known to induce or inhibit CYP2D6
activity, including paroxetine, fluoxetine, cimetidine, and duloxetine or other
medications used to treat attention deficit hyperactivity disorder (medications
containing amphetamine or methylphenidate).
5. Use of hormonal contraceptives
6. Use of medications that may alter pain sensitivity (e.g. gabapentin,/pregabalin
amitryptiline/other antidepressants, clonidine).
7. Active or history of renal/liver problems or congenital cardiac disease
8. Diagnosed developmental delay
9. Pregnant or lactating females
10. Any skin condition that prevents cuff application
11. History of seizures
12. Claustrophobia
13. Metallic implants/orthodontics/braces or other MRI exclusion (MRI safety screening
will be conducted prior to enrollment and prior to each MRI scan)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
| Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain | NCT04681183 | Entailment |
4,158 | 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:
1. Confirmed diagnosis of CF by a positive sweat test (more than or equal to 60 mEg/L by
quantitative pilocarpine iontophoresis and/ or genotype with two identifiable
mutations consistent with CF, accompanied by one or more clinical features consistent
with CF phenotype)
2. Abdominal pain during last 6 months
3. Age > 5 and <18 years
4. Either gender
4. Ability to do urea breath test which requires drinking water based solution through a
straw and breathing into a breath sample bag 5. Must be off any oral antibiotics and proton
pump inhibitors or sucralfate for 14 days.
Subject may continue their prophylactic (X 3/ week) dose of Azithromycin). Patients who are
currently on antibiotics or have been on antibiotics within 14 days will be re-screened for
inclusion criteria at their next clinic visit (i.e. no wash out).
Exclusion Criteria:
1. Females of child bearing potential with a positive urine pregnancy test The decision
not to include pregnant females is based on: 1) the quality of life screens are not
designed for pregnancy, 2) their abdominal complaints may be related to pregnancy, 3)
safety of the breath test has not been established during pregnancy.
2. Inability to do urea breath test which requires drinking water based solution through
a straw and breathing into a breath sample bag.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 18 Years | An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients | NCT00765401 | Contradiction |
2,154 | 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. Has negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for
detection of SARS-CoV-2 RNA from a respiratory specimen;
2. History of symptomatic gout defined as:
1. ≥ 3 gout flares within 18 months of Screening or
2. Presence of ≥ 1 gout tophus or
3. Current diagnosis of gouty arthritis
3. At the Screening Visit: male age 21 - 80 years, inclusive, or female of
non-childbearing potential age 21-80 years, inclusive, where nonchildbearing potential
is defined as:
a. > 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony
or b. Post-menopausal (> 24 months of natural amenorrhea or in the absence of >24
months of amenorrhea, one documented confirmatory FSH measurement)
4. Has chronic refractory gout defined as having failed to normalize sUA and whose signs
and symptoms are inadequately controlled with any of the xanthine oxidase inhibitors,
or for whom these drugs are contraindicated for the patient;
5. Has at the Screening Visit SUA ≥ 7 mg/dL
6. Negative serology for HIV-1/-2 and negative antigen to hepatitis B and negative
antibodies to hepatitis C;
Exclusion Criteria:
1. Has a history of anaphylaxis, severe allergic reactions, or severe atopy;
2. Has a history of any allergy to pegylated products, including, but not limited to
pegloticase (Krystexxa®), peginterferon alfa-2a (Pegasys®), peginterferon alfa-2b
(PegIntron®), pegfilgrastim (Neulasta®), pegaptanib (Macugen®), pegaspargase
(Oncaspar®), pegademase (Adagen®), peg-epoetin beta (Mircera®), pegvisomant
(Somavert®) certolizumab pegol (Cimzia®), naloxegol (Movantik®), peginesatide
(Omontys®), and doxorubicin liposome (Doxil®);
3. Is taking and cannot discontinue known major CYP3A4/P-gp inhibitors or major
CYP3A4/P-gp inducers at least 14 days before dosing. Patients must remain off these
medications for the duration of the study, including natural products such as St.
John's Wort or grapefruit juice.
4. Is taking drugs known to interact with rapamycin (sirolimus - Rapamune®) such as
cyclosporine, diltiazem, erythromycin, ketoconazole, posaconazole, voriconazole,
itraconazole, rifampin, verapamil unless they are stopped 14 days prior to dosing and
will not be used/prescribed during the trial.
5. Is a post-menopausal woman that has initiated or had a change in dose of hormone
replacement therapy (HRT) less than 1 month prior to the Screening Visit or during the
Screening Phase.
6. Had a gout flare during Screening that was resolved for less than 1 week prior to
first treatment with study drug (exclusive of chronic synovitis/arthritis) unless the
patient has a history of inter-flare intervals of < 1 week.
7. Has uncontrolled diabetes at Screening with HbA1c ≥ 8.5%;
8. Has fasting Screening glucose > 240 mg/dL;
9. Has fasting Screening triglyceride > 500 mg/dL;
10. Has fasting Screening low-density lipoprotein (LDL) > 200 mg/dL;
11. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency;
12. Has uncontrolled hypertension defined as blood pressure > 170/100 mmHg at Screening
and 1 week prior to dosing
13. Individual laboratory values which are exclusionary
- White blood cell count (WBC) < 3.0 x109/L
- Serum aspartate aminotransferase (AST) or alanine amino transferase (ALT) > 3x
upper limit of normal (ULN) in the absence of known active liver disease
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- Urine albumin creatinine ratio (UACR) > 3.0
- Hemoglobin (Hgb) < 9 g/dL
- Serum phosphate < 2.0 mg/dL
14. Is receiving ongoing treatment for arrhythmia, including placement of an implantable
defibrillator, unless considered stable and on active treatment;
15. Has evidence of unstable cardiovascular disease or unstable cerebrovascular vascular
disease. This includes patients who have had a cardiac/vascular event(s) in the last 3
months including heart attack, stroke or vascular bypass surgery or patients who are
deemed, by their physician or PI, to have active cardiovascular, cerebrovascular or
peripheral vascular symptoms/disease inadequately controlled by medication;
16. Has congestive heart failure, New York Heart Association Class III or IV;
17. Unless clinically stable and/or appropriately treated, electrocardiogram (ECG) with
evidence of clinically significant arrhythmia or other abnormalities that, in the
opinion of the investigator, are consistent with significant underlying cardiac
disease;
18. History of significant hematological disorders within 5 years or autoimmune disorders,
and/or patient is currently immunosuppressed or immunocompromised;
19. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek,
Fasturtec), pegloticase (Krystexxa®®), pegadricase (SEL 037))
20. Patient has received a live vaccine in the previous 6 months.
21. Patient is planning to receive any live vaccine during the study.
22. History of malignancy within the last 5 years other than basal skin cancer;
23. Patients with a documented history of moderate or severe alcohol or substance use
disorder within the 12 months prior to randomization.
24. History of or evidence of clinically severe interstitial lung disease
25. Immunocompromised state, regardless of etiology
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 80 Years | A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy | NCT04513366 | Contradiction |
1,550 | 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:
- right handed adults
- no known physical or neurological abnormalities
Exclusion Criteria:
- patients with:
- cardiac pacemaker
- surgical clips or values on the heart
- implants
- metal or metallic fragments in any part of the body
- pregnancy
- claustrophobia
- a personal or family history of epilepsy
- currently taking antipsychotic drugs
- currently taking antidepressant drugs
- currently taking antianxiety drugs
- history of concussion.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years | Sensory Basis of Speech Motor Learning | NCT04497428 | Contradiction |
1,324 | 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:
- Parent(s) or guardian(s) are willing and able to provide written, signed informed
consent
- 5 to 14 years old at end of study
- ACH, documented by clinical grounds, confirmed by genetic testing
- At least 6-month of pretreatment growth assessment in Study 111-901 before study
entry, and one standing height at least 6 months prior to screening for 111-202
- Negative pregnancy test at the Screening Visit for females ≥ 10 years old or who have
begun menses
- If sexually active, willing to use a highly effective method of contraception while
participating in the study
- Ambulatory, able to stand without assistance
- Willing and able to perform all study procedures as physically possible
- Parents/caregivers willing to administer daily injections to the subjects
Additional inclusion Criteria Optional, Open-label Extension Phase:
- Appropriate written informed consent
Exclusion Criteria:
- Hypochondroplasia or short stature condition other than ACH
- Have any of the following:
- Hypothyroidism or hyperthyroidism
- Insulin-requiring diabetes mellitus
- Autoimmune inflammatory disease
- Inflammatory bowel disease
- Autonomic neuropathy
- Recent acute illness associated with volume dehydration not completely resolved
prior to the first dose of study drug
- Unstable condition requiring surgical intervention during the study
- Growth plates have fused
- Have a history of any of the following:
- Renal insufficiency, defined as creatinine > 2 mg/dl
- Anemia
- Baseline systolic BP < 75 mm Hg or recurrent symptomatic hypotension or recurrent
symptomatic hypotension, recurrent symptomatic orthostatic hypotension
- Cardiac or vascular disease, including the following:
- Cardiac dysfunction (abnormal echocardiogram [ECHO] including left ventricle
[LV] mass) at Screening Visit
- Hypertrophic cardiomyopathy
- Pulmonary Hypertension
- Congenital heart disease with ongoing cardiac dysfunction
- Cerebrovascular disease
- Aortic insufficiency
- Clinically significant atrial or ventricular arrhythmias
- Have an ECG showing any of the following:
- Right or left atrial enlargement or ventricular hypertrophy
- PR (period of time from the beginning of atrial depolarization until the
beginning of ventricular depolarization) interval > 200 msec
- QRS (The Q, R, and S heart waves that are measured on an electrocardiogram)
interval > 110 msec
- Corrected QTc-F (Measure of the corrected time between the start of the Q wave
and end of the T wave in the heart's electrical cycle) > 450 msec
- Second- or third-degree atrioventricular block
- Documented Vitamin D deficiency
- Require any investigational agent prior to completion of study period
- Have received another investigational product or investigational medical device within
30 days before the Screening visit
- Use of any other investigational product or investigational medical device for the
treatment of ACH or short stature
- Current chronic therapy with antihypertensive medications, angiotensin-converting
enzyme (ACE) inhibitors, angiotensin II receptor blockers, diuretics, beta-blockers,
calcium-channel blockers, cardiac glycosides, systemic anticholinergic agents, any
medication that may impair or enhance compensatory tachycardia, diuretics, or other
drugs known to alter renal or tubular function
- Treatment with growth hormone, IGF-1 (Insulin-like growth factor), or anabolic
steroids in the previous 6 months or long-term treatment (> 3 months) at any time
- Long-term treatment (> 1 month) with oral corticosteroids
- Concomitant medication that prolongs the QT/QTc-F interval within 14 days or 5
half-lives, whichever is longer, before the Screening visit
- Pregnant or breastfeeding at the Screening Visit or planning to become pregnant (self
or partner) at any time during the study
- Limb-lengthening or bone-related surgery < 18 months prior to study enrollment
- Had a fracture of the long bones or spine within 6 months prior to screening (except
for fracture of digits or toes)
- AST (Aspartate Transaminase) or ALT (Alanine Transaminase) at least 3x upper limit of
normal (ULN) or total bilirubin at least 2x ULN
- Evidence of severe sleep apnea requiring surgery or new initiation of CPAP (Continuous
positive airway pressure).
- History of malignancy and chemotherapy/radiation or currently under work-up for
suspected malignancy
- Known hypersensitivity to BMN 111 or its excipients
- Have a condition or circumstance that, in the view of the Investigator, places the
subject at high risk for poor treatment compliance or for not completing the study
- Concurrent disease or condition that would interfere with study participation or
safety
- Have abnormal findings on baseline clinical hip exam or imaging assessments that are
determined to be clinically significant as determined by the PI.
- Have a history of hip surgery or severe hip dysplasia
- Have a history of clinically significant hip injury in the 30 days prior to screening.
- History of slipped capital femoral epiphysis or avascular necrosis of the femoral
head.
- Are unable to lie flat when in prone position
Additional Exclusion Criteria for Optional, Open-label Extension Phase:
- Use of restricted therapies during the initial 6 months of the study
- Permanently discontinued BMN 111 during the initial 6 months 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 5 Years old.
Subject must be at most 14 Years | A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia | NCT02055157 | Contradiction |
2,776 | 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 disease
Exclusion Criteria:
- Cardio-respiratory disease
- Anti-inflammatory treatment
- Cognitive disorders
- Written consent form haven't get
- history of relevant drug allergy
- infection of the skin at the site of needle puncture area
- coagulopathy
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 | Analgesic Efficacy of Erector Spinae Plane Block for Laparoscopic Inguinal Hernia Repair | NCT04131985 | Entailment |
6,080 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Diagnosis of Down syndrome
Exclusion Criteria:
- Nystagmus (Involuntary beating movement of the eyes)
- Visually significant media opacities (e.g. cataracts or corneal scars)
- Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)
- Anisometropic amblyopia (reduced vision in one eye related to a long-standing
uncompensated difference in prescription between the two eyes)
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.
| Spectacles for Patients With Down Syndrome | NCT03367793 | Contradiction |
3,240 | 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:
- Patients with a diagnosis of PSS - according to the criteria of the American-European
Society for the classification of Primary Sjögren's Syndrome (Vitali et al., 2002);
- Female gender
- Aged above 18 years
Exclusion Criteria:
- Patients who had cognitive difficulties, with diagnosis of Secondary Sjögren's
Syndrome,
- A regular physical exercise practitioner or who were practicing physical exercise
regularly up to 2 months before the interview.
- Patients in clinical conditions that prevented the practice of physical exercise
according to previous medical evaluation, such as decompensated diabetes mellitus,
decompensated thyroid disease, severe cardiorespiratory diseases, etc. - Use of
medications that interfere with physical aspects, especially in response to the
sensation of fatigue.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Resistance Exercise in Woman With Primary Sjörgen Syndrome. | NCT03130062 | Entailment |
6,624 | 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:
- Male patients
- Age from 0 years
- With the diagnosis of severe congenital haemophilia A (FVIII≤1%)
- History of exposure days (ED) to any FVIII products fulfilling the criteria of
previously treated patients:
- Patients of 12 years or above: 100 exposures days (ED) or more
- Patients below 12 years: 50 exposure days (ED) or more
Exclusion Criteria:
- Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory
- Known history of FVIII inhibitors
Male
No healthy subjects accepted to join the trial.
| Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A | NCT02938585 | Contradiction |
4,865 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Cushing's disease diagnosed by complementary explorations according to the National
Program of Diagnosis and Care of the Cushing 's disease
Exclusion Criteria:
- other cause of Cushing's syndrome
- known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1,
complexe of carney, McCuneAlbright syndrome)
- patient does not understand french
- life expectancy of less than 6 months
- pregnant women
- dependent patient
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.
| Cushing's Disease Complications | NCT02568982 | Entailment |
2,800 | 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:
- Subjects undergoing laparoscopic repair for the treatment of either single or
bilateral inguinal hernias
- All surgical residents at New Hanover Regional Medical Center
Exclusion Criteria:
- Subjects requiring emergency surgery
- Pregnant subjects
- Subjects under the age of 18 years of age
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias | NCT01825187 | Entailment |
5,332 | 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:
1. Subjects diagnosed with severe hereditary VWD (VWF:RCo<15-20 IU/dL) of any type
2. Subjects less than 6 years of age
3. Subjects that do not adequately respond to treatment with desmopressin (DDAVP) or had
a previous treatment failure with DDAVP. Note: Inadequate response to DDAVP treatment
or a previous treatment failure with DDAVP is not required for subjects with VWD type
2b and 3. A confirmed diagnosis in medical history is sufficient for this criterion,
since treatment with DDAVP is not indicated in or contraindicated for these VWD
patients.
4. Signed informed consent form provided by an authorized representative on behalf of the
subject in accordance with local law and institutional policy.
Exclusion Criteria:
1. Subject has been diagnosed of acquired VWD
2. Subjects bleeding at the time of the first infusion or the 10 days prior to the
infusion
3. Subjects treated with DDAVP or another FVIII containing VWF concentrate during the 5
days prior to the infusion of the Fanhdi. This may be reduced to 3 days for subjects
with type 3 VWD.
4. Subject is known or suspected to have present or past inhibitor activity (antibodies)
directed against FVIII or VWF
5. Subject is known to have history of intolerance to any Fanhdi® containing substance
6. Subject is known to have history of anaphylactic reaction(s) to blood or blood
components
7. Subjects presenting with severe platelet dysfunctions due to drugs (aspirin, other
NSAIDs, etc.) or other pathologies (uremic thrombopathy, hematological diseases)
8. Subjects with known previous infection with Hepatitis A Virus (HAV), Hepatitis B Virus
(HBV), Hepatitic C Virus (HCV), or HIV or clinical signs and symptoms consistent with
current HAV, HBV, HCV or HIV infection.
9. Subjects presenting with anemia (hemoglobulin <11 g/dL)
10. Subjects diagnosed with metabolic diseases that are not clinically controlled, such as
diabetes mellitus, that could potentially interfere with the interpretations of the
study
11. Subjects participating in another clinical study within 30 days prior to screening or
has received any investigational treatment within 3 months prior to screening
12. If it is anticipated that the subject will be treated with other products containing
FVIII or VWF different from Fanhdi® during a period of one year
13. The subject is unlikely to adhere to the protocol requirements 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 2 Months old.
Subject must be at most 6 Years | Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease | NCT02472665 | Contradiction |
5,225 | 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:
- Ambulatory postmenopausal women.
- Age 55 years or older
- Subject has provided informed consent prior to any study specific procedures
- Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to
screening visit
- Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of
equal to or less than those listed in the protocol.
- At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray
absorptiometry (DXA) at the screening visit
Exclusion Criteria:
- Received other osteoporosis treatment or bone active treatment
- Evidence of history of any of the following:
- hyperthyroidism (stable on antithyroid therapy is allowed)
- hypothyroidism (stable on thyroid replacement therapy is allowed)
- hypo- or hyperparathyroidism
- hypo- or hypercalcemia based on the central laboratory reference ranges
- Recent tooth extraction (within 6 months of screening visit)
- Paget disease of bone (subject report or chart review)
- other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis
imperfecta) (chart review)
- Abnormalities of the following per central laboratory reference ranges:
- vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be
allowed and subjects may be re-screened
- hypercalcemia
- elevated transaminases ≥ 2.0 x upper limits of normal (ULN)
- History of any solid organ or bone marrow transplant
- Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in
situ) within the last 5 years
- Known intolerance to calcium or vitamin D supplements
- Self-reported alcohol or drug abuse within 12 months prior to screening
- Currently receiving treatment in another investigational device or drug study, or less
than 30 days since ending treatment on another investigational device or drug study(s)
- History or evidence of any other clinically significant disorder, condition or disease
that in the opinion of the Investigator or Amgen physician, if consulted, would pose a
risk to subject safety or interfere with the study evaluation, procedures or
completion
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis | NCT01732770 | Entailment |
5,673 | 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:
- All the patients who have benefit during one year of a treatment by Genotonorm during
the study 94-8123-014
- All patients who have stopped during one year will be included if a signed written
informed consent
Exclusion Criteria:
- Endocrine disease, except well substituted hypothyroidism
- Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary | NCT00174278 | Contradiction |
6,864 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Age greater than 60;
- Memory complaints as defined by two questions:
1. "Do The subject think your have memory problems?"; and,
2. "Has there been a decline in your memory over the last 10 years?"
- Fluency in English;
- Ability to ingest oral medications; and,
- Willing to replace current vitamin intake with a standardized multivitamin provided
for the study.
Exclusion Criteria:
- Clinical stroke or Parkinson's disease;
- Taking FDA approved drug for symptomatic treatment of Alzheimer's disease (Aricept,
Razadyne, Exelon, and/or Namenda);
- History of significant renal insufficiency (creatinine ≥1.5);
- History of renal stones or peptic ulcer disease;
- Use of vitamin supplements containing more than 400mcg of folic acid per day within 2
months of Screen Visit;
- As determined by the study physician, clinically significant serum folate and vitamin
B12 deficiency on screening blood tests that would require further clinical evaluation
and treatment
- As determined by the study physician, clinically significant medical conditions,
physical exam findings or abnormal blood tests at screening that would require further
clinical evaluation and treatment
- B12 injections 6 months prior to the Screen Visit;
- Confirmed clinical diagnosis of Mild Cognitive Impairment (MCI), vascular dementia or
Alzheimer's Disease (AD); and,
- Known hypersensitivity to L-methylfolate, methyl-cobalamin or N-acetylcysteine.
- Use of any other investigational agent used during the 30 days prior to Screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Study of the Effects of Cerefolin NAC on Inflammation Blood Markers in Older Individuals With Memory Complaints | NCT00597376 | Contradiction |
3,209 | 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:
- Individuals with dry eye, Ocular pain for more than 3 months, Contact lens users,
Individuals using topical treatment and/or systemic medication for dry eye syndrome,
Individuals with history of photo-ablative ocular surgery (Laser-assisted in situ
keratomileusis (LASIK) , Photorefractive keratectomy (PRK), Small incision lenticule
extraction(SMILE), Individuals with history of autoimmune disease (Lupus, Rheumatoid
Arthritis, Sjögrens),
Exclusion Criteria:
- Individuals with pacemakers or implantable defibrillators, Individuals with diagnosis
of epilepsy, History of facial trauma one month prior to recruitment, Acute facial
pain with unknown etiology, History of ocular surgery one month prior to recruitment,
Trigeminal neuralgia, Active Herpes Zoster Ophthalmicus,
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effect of Transcutaneous Electric Stimulation on Corneal Nerves and Chronic Ocular Pain | NCT04648085 | Entailment |
3,470 | 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:
- Have a diagnosis of Type 2 diabetes mellitus according to the World Health
Organization (WHO) diagnostic criteria
- Are women not of child-bearing potential due to surgical sterilization (hysterectomy
or bilateral oophorectomy or tubal ligation) or menopause.
- Are male patients using a reliable method of birth control during the study and until
3 months after the last dose of study medication.
- Are being treated with either diet and exercise alone, or with diet and exercise in
combination with metformin. Metformin therapy must have been stable and unchanged for
at least 3 months prior to screening and at a dose of at least 1000 milligram per day
(mg/day).
- Have a hemoglobin A1c (HbA1c) value of 7.0% to 10.5%, inclusive.
- Have a body mass index (BMI) between 25 to 45 kilogram per meter squared (kg/m^2),
inclusive.
In the opinion of the investigator, are capable and willing to:
- Perform self-monitoring of blood glucose
- Complete a study diary as required for this protocol
- Maintain consistent dietary, physical activity, and sleeping patterns throughout the
duration of the study
- Comply with treatment regimens
- Have given written informed consent to participate in this study in accordance with
local regulations and the Ethical Review Board (ERB) governing the study site.
Exclusion Criteria:
- Have more than 1 episode of severe hypoglycemia (defined as an event during which the
patient requires the assistance of another person to actively administer carbohydrate,
glucagon, or other resuscitative actions) within 6 months prior to screening, or have
a current diagnosis of hypoglycemia unawareness.
- Have had two or more emergency room visits or hospitalizations due to poor glucose
control in the 6 months prior to screening.
- Have gastrointestinal disease that may significantly impact gastric emptying or
motility or have undergone gastric bypass or gastric banding surgery.
- Have had a previous diagnosis of pancreatitis.
- Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
- Have a history of myocardial infarction, unstable angina, or a coronary
revascularization procedure within 6 months of screening.
- Have a history of supraventricular tachycardia, ventricular tachycardia, or other
cardiac arrhythmia.
- Have a history of transient ischemic attack (TIA) or stroke within 6 months of
screening.
- Have poorly controlled hypertension (systolic blood pressure greater than or equal to
150 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg) as determined
by the mean of three separate measurements.
- Show evidence of labile blood pressure, including symptomatic postural hypotension.
- Have any abnormality of the ECG that would impact patient safety or data
interpretation.
- Show clinical signs or symptoms of liver disease, or liver function tests (LFTs;
aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than 2.5
times upper limit of normal (ULN) as determined by the central laboratory at
screening.
- Have a current or previous diagnosis of Gilbert's disease.
- Have previous or current diagnosis of Hepatitis B or C
- Have a serum creatinine >2 milligrams per deciliter (mg/dL) or, in patients being
treated with metformin, a serum creatinine above (or creatinine clearance below) what
is approved in the metformin product labeling in the respective country.
- Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical
evaluation and/or an abnormal thyroid stimulating hormone result as determined by the
central laboratory at screening; patients receiving dose-stable thyroid replacement
therapy for at least 3 months prior to screening will be allowed to participate in the
study.
- Have any other abnormal laboratory value that, in the opinion of the investigator,
precludes the patient from participation in the study. Laboratory abnormalities
consistent with type 2 diabetes mellitus and all other eligibility criteria are
acceptable: for example, abnormalities of blood glucose, hemoglobin A1c (HbA1c),
urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
- Have a currently suspected or treated malignancy, or are in remission from a
clinically significant malignancy (other than basal or squamous cell skin cancer, in
situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have a personal or family history of pancreatic neoplasia.
- Have non-fasting triglycerides >600 mg/dL.
- Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month
period prior to screening), or any oral antihyperglycemic medication (OAM) other than
metformin within the 3-month period prior to screening.
- Currently use or intend to use prescription or over-the-counter medications, including
herbal supplements, to promote weight loss or to regulate blood glucose.
- Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular
topical, other topical, inhaled preparations) or have received such therapy within 8
weeks prior to screening.
- Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than
metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal
motility, central nervous system stimulants (with the exception of caffeinated
beverages), fibrates, and niacin greater than or equal to 1 grams per day (gm/day).
- Have an average weekly alcohol intake that exceeds 2 units per day for males and 1
unit per day for females (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150
milliliters (mL) of wine; 1.5 oz or 45 milliliter (mL) of distilled spirits).
- Currently use drugs with a narrow therapeutic index (for example, digoxin, lithium,
phenytoin, theophylline, and warfarin).
- Currently use drugs that are known to prolong the QT interval.
- Currently use or intend to use potent inhibitors of CYP3A, which include but are not
limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole,
ketoconazole, nefazodone, saquinavir, and telithromycin.
- Have previously completed or withdrawn from this study or any other study
investigating LY2409021.
- Have known allergies to LY2409021 or related compounds.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical
trial involving an investigational product or unapproved 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
- Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder
that may affect the ability to participate in the trial.
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 | A Study of LY2409021 in Patients With Type 2 Diabetes | NCT01241448 | Entailment |
3,975 | 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. Age 20-80
2. diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for
knee OA
3. symptomatic OA that lastede for at least 3 months before screening
4. Baseline Pain VAS ≥50 mm
5. treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due
to OA pain
6. X-ray Kellgren-Lawrence grade 1~4
7. volauntarily enrolled with informed consent
8. no improvement with medical treatment for at least 3 months
Exclusion Criteria:
1. disease in spine or lower extremities that can affect the outcome of index knee
2. surgery on lower extremities within 6month before injection or planned
3. joint symptoms that can affect the interpretation of the trial data or prevent the
subject from enrollement including but not limited to symptomatic fracture,
fibromyalgia, rheumatoid arthritis, reactive arthritis
4. steroid injection to the index knee within preivious 3months
5. hyaluronic acid injection to the index knee within preivious 6months
6. underwent cell therapy or gene therapy in the past
7. more than 3 times upper normal limit in one or more of the followings: serum
creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) or more than 3 times upper normal limit in two or more of the followings:
bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
8. participation in a different clinical trial other than this within 4 weeks after
initiation of the current study
9. use (reccuent use or addiction) of substances that can affect pain sensation such as
narcotics
10. females of childbearing age who do not consent to effective contraceptive methods
during the study period
11. pregnant or lactating woman
12. malignancy
13. considered to be inappropriate for the trial 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 20 Years old.
Subject must be at most 80 Years | Clinical Study of Intra Articular Injection of Catholic MASTER Cell (Bone Marrow Derived Mesenchymal Stem Cell) in Knee Osteoarthritis | NCT04240873 | Entailment |
122 | 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:
- Testosterone deficiency
- Completed study ARD-0403-004
Exclusion Criteria:
- Previous treatment with testosterone replacement therapy within 4 weeks
- Moderate-severe benign prostatic hypertrophy or prostatic cancer
- Haematocrit >50%
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Open-Label Study of ARD-0403 in Testosterone Deficient Men | NCT00562731 | Contradiction |
1,496 | 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:
- Male or female older than 18 years
- Patient with unexplained dysphagia
- Patient without cause of dysphagia on eso-gastro-duodenal endoscopy
- Patient referred for esophageal manometry
- Patient with health insurance
- Informed consent signed
Exclusion Criteria:
- Patient younger than 18 years
- Allergy to one component of manometry catheter
- Drug intake which can modify the esophageal motricity within 12 hours preceding the
realization of the manometry
- Patient unable to give his consent or legally incompetent
- Patient non qualified according to the investigator
- Patient refusal or absence of informed consent signed
- Concomitant participation to another 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.
| Esophageal High Resolution Manometry and Dysphagia | NCT01284894 | Entailment |
3,363 | 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:
- Tympanic membrane perforation without chronic secretion or cholesteatoma
- Suspected otosclerosis
Exclusion Criteria:
- Below 12 years of age
- Patient not consenting to study
- Perioperative findings suggesting chronic otitis or cholesteatoma
- Patients not fluent in Norwegian or unable to cooperate in audiometry
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.
| Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease | NCT00222417 | Contradiction |
6,725 | 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, 5-70 years, inclusive
- Plasma FVIII activity <1% documented (Laboratory result or MD documentation of Severe
Hemophilia A diagnosis)
- Currently prescribed prophylaxis treatment regimen infusing ≥3 times a week
- Willing to alter their prophylaxis treatment regimen per study protocol
Exclusion Criteria:
- Bleeding disorder(s) other than Hemophilia A
- Current inhibitor (>0.6BU)
- Thrombocytopenia (platelet count <100,000K/µL since it can alter TEG®/ROTEM® results)
- Creatinine >2x the upper limit of normal (indicating potential platelet dysfunction)
- Prothrombin time >3 seconds above the upper limit of normal (indicating potential
liver dysfunction)
- Any concurrent clinically significant major disease, frequent bleeding pattern or
history of non-compliance that, in the opinion of the investigator, would make the
subject unsuitable for enrollment
- Participation within the past 30 days in any other clinical study involving
investigational drugs
- Planned major surgery within 30 days prior to screening or during the study period
- Current use of any medication known to have effects on the coagulation system
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 70 Years | Individualizing Hemophilia Prophylaxis Using Thromboelastography | NCT02582060 | Contradiction |
1,163 | 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:
- Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural
effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because
of trapped lung (patients with only partial expansion however receiving talc poudrage,
but needing permanent pleural cathetes, are also eligible)
Exclusion Criteria:
- - Age younger than 18 years
- Expected survival of less than 3 months
- Chylothorax
- Total white blood cell count less than 1000/microL
- Pregnancy or lactating mothers
- Irreversible bleeding diathesis
- Irreversible visual impairment
- Contraindications to general anesthesia
- Poor general clinical conditions ( ECOG PS >=2)
- Patients unable to provide 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.
| Indwelling Pleural Catheter for Trapped Lung | NCT03550027 | Contradiction |
6,147 | 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:
1. Age: Male or female patients 18 -65 years old
2. Respiratory samples tested positive for the novel coronavirus.
3. Initial symptoms will within 7 days
4. Nonpregnant women (confirmed by urine human chorionic gonadotropin (HCG) test prior to
enrollment)
Exclusion Criteria:
1. Severe clinical condition (meeting one of the following criteria: a resting
respiratory rate greater than 30 per minute, oxygen saturation below 93%, oxygenation
index (OI) < 300 mmHg (1 mmHg = 133.3 Pa), respiratory failure, shock, and/or combined
failure of other organs that required ICU monitoring and treatment).
2. Chronic liver and kidney disease and reaching end stage. (Serum aspartate
aminotransferase (AST) and Serum alanine aminotransferase (ALT) will be elevated over
5 times of normal upper range will excluded).
(Normal upper limit of Serum AST = 40 units /L, ALT = 56 units /L)
3. Serum uric acid >7.0 mg/dL in Male and Serum uric acid >6.0 mg/dL in Female will
excluded
4. ICU patient
5. Previous history of allergic reactions to Favipiravir.
6. Pregnant or lactating women
7. Women of a childbearing age with a positive pregnancy test.
8. Miscarriage, or within 2 weeks after delivery
9. Hypertensive patients, who are taking Calcium Channel Blockers
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 65 Years | Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh | NCT04402203 | Contradiction |
4,776 | 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:
- Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
- Voluntarily consent to participate in the study;
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding;
- Participants presenting uncontroled systolic hipertension (>140/90 mmHg);
- Participants presenting uncontroled diabetes (blood glucose >200 mg/dL).
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 65 Years | Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease | NCT04674735 | Entailment |
3,389 | 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:
A - Vascular cognitive impairment:
1. Presence of diabetes
2. The International Society of Vascular Behavioral and Cognitive Disorders (VASCOG)
criteria for vascular cognitive impairment
3. Age between 55 and 90 (inclusive)
4. Score on the Montreal Cognitive Assessment (MOCA) 15 to 23
5. Presence of a responsible caregiver who will accompany mild cognitive impaired (MCI)
subjects to all procedures.
6. Evidence of vascular disease
7. The patient should have a capacity to consent.
8. English speakers
B- Cognitively normal elderly Subjects:
1. Presence of diabetes
2. Absence of National Institute on Aging (NIA) - Alzheimer's Association core clinical
criteria for probable Alzheimer's Disease (AD) and VASCOG criteria for vascular
cognitive impairment.
3. Objective memory scores within normal range for age (do not meet MCI Subjects
criterion 2)
4. Age between 55 and 90 (inclusive)
5. English speakers
Exclusion Criteria:
1. Any significant neurologic disease (other than vascular cognitive disease and stroke),
such as Parkinson's disease, brain tumor, seizure disorder, multiple sclerosis, or
history of significant head trauma followed by persistent neurologic deficits.
2. Any significant systemic disease including hepatic failure, heart failure, renal
failure, Chronic obstructive pulmonary disease (COPD), active infection and autoimmune
disease.
3. Any significant systemic illness or unstable medical condition, including:
uncontrolled or insulin-dependent diabetes mellitus, uncorrected hypothyroidism or
hyperthyroidism, or systemic cancer.
4. Investigational agents are prohibited 4 weeks prior to entry and for the duration of
the study. Previous treatment with an investigational small molecule with anti-amyloid
properties or passive immunization against amyloid within 1 year of study entry.
Previous treatment with an active immunization against amyloid.
5. History of schizophrenia or other major psychiatric disorder (DSM IV criteria).
6. History of alcohol or substance abuse or dependence (DSM IV criteria) within the past
2 years.
7. Pregnancy, as determined by screening pregnancy tests for pre-menopausal females
8. Impairment of visual or auditory acuity sufficient to interfere with study procedures.
9. Education level < 6 years.
10. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal
fragments or foreign objects in the eyes, skin or body. The presence of
claustrophobia, precluding MRI.
11. Drink more than 5 alcoholic drinks per week or any heavy drinking days in the last 30
days
12. Women who are pregnant or nursing, or fail to use one of the following methods of
birth control unless she or partner is surgically sterile or she is postmenopausal
(hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive
sponge, double barrier [diaphragm or condom plus spermicide], or intrauterine device
(IUD)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 90 Years | Validating Imaging Biomarkers of Small Vessel Disease in Diabetic Individuals Using Advanced MRI Techniques. | NCT03754608 | Contradiction |
3 | 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:
- Total testosterone level <240 ng/dL
- Serum LH and FSH levels within normal limits
Exclusion Criteria:
- Elevated prolactin
- Evidence of Benign Prostatic Hypertrophy
- History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or
any other malignancy
- Clinically significant endocrine/metabolic or cardiovascular disease
- Significant polycythemia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo | NCT00290134 | Contradiction |
2,032 | 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. Patients volunteered to participate in this study and signed informed consent.
2. Endoscopic biopsy or metastatic biopsy was confirmed to be the adenocarcinoma of the
stomach / gastroesophageal.
3. Her - 2 negative(Including: Her protein detection -/1+, and Her protein 2+ but FISH
negative).
4. Without any antitumor therapy;
5. According to the 7th edition of AJCC, imaging (CT/MRI) confirmed that the
adenocarcinoma of the stomach / gastroesophageal with the initial single site
metastasis had a detectable lesion (according to the RECIST 1.1 standard); Single site
metastasis includes: liver, spleen, pancreas, ovary, retroperitoneal lymph node
(16a1/b2), adrenal gland, kidney;
6. Age from 18 to 70 years.
7. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
8. Life expectancy more than 12 weeks.
9. Histological specimens were provided for biological target detection of her-2;
10. Surgical patients agree to undergo surgery and sign an informed consent to perform the
risk of surgery；
11. The main organ function meet the following criteria within 7 days before treatment:
- blood routine examination( No blood transfusion within 14 days)
1. HB≥90g/L，
2. ANC≥1.5×109/L，
3. PLT≥80×109/L；
- blood biochemical examination
1. TBIL <1.5 Upper Limit Of Normal（ULN）;
2. ALT and AST<2.5ULN(or ≤ 5×ULN in patients with liver metastases).
3. Cr≤1.5ULN or creatinine clearance>60ml/min.
- Doppler ultrasonography: left ventricular ejection fraction (LVEF) was lower than
normal (50%).
12. Female subjects of child-bearing potential should agree to use contraceptive measures
(such as intrauterine contraceptives, contraceptives or condoms) within six months of
the study period and the end of the study. The serum or urine pregnancy test was
negative within 7 days prior to the study and must be non-lactation. Men subjects
should agree to use contraceptives in the study period and within six months at the
end of the study period.
Exclusion Criteria:
1. 5 years or at the same time have other malignant tumors；
2. docetaxel or oxaliplatin and other research with chemotherapy drugs are serious
allergy;
3. patients with severe cachexia can not eat and can not tolerate chemotherapy and
surgery;
4. During the screening period, there was an unknown cause of fever before the first
administration and the body temperature was> 38.5 ° C (as judged by the investigators,
cancer-related fever subjects could be enrolled);
5. Patients with any severe and / or uncontrollable disease, including:
1. Patients with hypertension who are not well controlled by antihypertensive
medication (systolic BP ≥150 mmHg, diastolic BP ≥100 mmHg);
2. Myocardial ischemia or myocardial infarction with grade I or above, arrhythmia
(including QTc≥480 ms) and ≥2 grade congestive heart failure (New York Heart
Association (NYHA) classification);
3. Severe infection that is active or uncontrollable (≥CTCAE grade 2 infection);
4. Renal failure requires hemodialysis or peritoneal dialysis;
5. Have a history of immunodeficiency, including HIV-positive or other acquired,
congenital immunodeficiency disease, or history of organ transplants;
6. Poor glycemic control in diabetic patients (fasting blood glucose (FBG)> 10 mmol
/ L);
7. Patients with seizures who require treatment;
6. Currently there are gastrointestinal diseases such as intestinal obstruction
(including incomplete intestinal obstruction) or the researchers determine the
patients may cause gastrointestinal bleeding, perforation or obstruction;
7. Within 4 weeks prior to enrollment, there were non-healing wounds, ulcers or
fractures;
8. CNS metastasis;
9. Persons with psychiatric abuse who can not be abdicated or have mental disorders;
10. patients who have participated in other anti-cancer drug clinical trials within 4
weeks;
11. According to the judgment of the researcher, there is a concomitant disease which
seriously endangers the safety of the patient or affects the patient in completing 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 70 Years | The FLOT Regimen Conversion Therapy of Adenocarcinoma of the Stomach / Gastroesophageal | NCT03451942 | Entailment |
6,129 | 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:
- Adult patient with documented SARS-CoV-2 infection requiring hospitalization.
Exclusion Criteria:
- Lack of consent
- Patients hospitalized in an intensive care unit
- Patient under guardianship or curatorship
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.
| Role of the Microbiota in the Evolution of the SARS-CoV-2 Disease,COVID-19, in Hospitalized Patients | NCT04669938 | Contradiction |
3,927 | 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, or taking NSAIDs/ analgesia for knee pain on most days past month
- Knee pain 4-10 on 10cm VAS
- Medial tibio-femoral compartment joint space narrowing in symptomatic knee
Exclusion Criteria:
- Unstable diabetes
- <2mm medial tibio-femoral compartment joint space width
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 75 Years | The Long-term Evaluation of Glucosamine Sulphate Study | NCT00513422 | Entailment |
6,429 | 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. | Inclusion Criteria:
- Subject has moderate to severe papulopustular rosacea and at least mild erythema and
mild telangiectasia.
- Subject is willing and able to apply the test article(s) as directed, comply with
study instructions and commit to all follow-up visits for the duration of the study.
- If subject is a woman of childbearing potential, she must have a negative urine
pregnancy test and agree to use an effective form of birth control for the duration of
the study.
Exclusion Criteria:
- Subject is pregnant, lactating or is planning to become pregnant during the study.
- Subject has any other active dermatological condition on the face that may interfere
with the conduct of the study.
- Subject has used systemic immunosuppressants within 30 days prior to study start.
- Subject has used systemic retinoids within 6 months prior to study start.
- Subject has used any topical rosacea therapy within 14 days prior to study start.
- Subject has had laser or light therapy on the face within 3 months of study start.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30
days prior to first application of the test article.
- Subject has used vasodilators or adrenergic blocking agents within 6 weeks of study
start (except subjects on stable dose for greater than 3 months).
- Subject has active ocular rosacea and/or blepharitis/meibomianitis requiring treatment
by an ophthalmologist.
- Subject has previously failed to have improvement of rosacea with appropriate use of
systemic tetracycline family of antibiotics or use of the components of PDI-320.
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.
| An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea | NCT01828177 | Entailment |
3,189 | 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:
Healthy females
- 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active women requesting birth control
- In good general health, confirmed by medical history, physical (including gynecologic)
examination and screening laboratory values
Exclusion Criteria:
- Known or suspected pregnancy;
- Lactating women
- Significant skin reaction to transdermal preparations or sensitivity to surgical /
medical tape
- Any disease that may worsen under hormonal treatment (cardiovascular, liver,
metabolic)
- Use of other contraceptive methods than study medication
Female
Accepts Healthy Volunteers
Subject must be at least 17 Years old.
Subject must be at most 40 Years | Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System | NCT01181479 | Entailment |
210 | 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:
1. Male patients aged 18 years and older.
2. Diagnosis of hypogonadism including Klinefelter's or late onset HG. Patients may have
been diagnosed at any point in their lives. Documentation of the diagnosis of HG
(including symptomatology and laboratory values including testosterone levels
confirmed on two separate occasions) is required.
3. Written informed consent.
Exclusion Criteria:
1. Any previous treatment with testosterone therapy.
2. History of breast cancer, prostate cancer, or high-grade prostatic intraepithelial
neoplasia.
3. Prior radical prostatectomy.
4. Life expectancy shorter than 24 months as judged by the Clinical Site investigator.
5. Current major psychiatric disorders or drug or alcohol abuse, which will likely affect
participation or compliance in the Registry, in the opinion of the Clinical Site
Investigator.
6. Gender dysphoria or sexual reassignment (e.g., transexualism).
7. Patients actively enrolled in any interventional clinical trial.
8. Planned relocation outside Clinical Site region within 24 months.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Registry of Hypogonadism in Men | NCT00858650 | Entailment |
5,017 | 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 with task-dependent essential tremor in upper limb. Tremor is present during
at least one of the study functional tasks i. pointing task (touch between nose and a
pen held 2 ft. in front. ii. pouring task (cup: pouring water out/in). iii. feeding
task (weighted fork from plate on table to mouth). iv. string instrument bowing or
holding instrument in static position. v. computer mouse (simple vertical or
horizontal movements).
- Patients must be capable of performing informed consent.
- Patients on stable medications for treatment of task-dependent essential tremor for 1
month prior to study entry and maintain them throughout the study.
- Patients previously treated with BoNT of any type must have occurred no sooner than 12
weeks prior to study entry.
Exclusion Criteria:
- Patients with no presence of tremor during study functional tasks.
- Presence of tremor during the functional task is below minimum amplitude required to
be considered for injection based upon investigator's clinical judgment.
- Patients with unstable medical conditions or psychiatric conditions.
- Patients with a medical condition that precludes them from receiving BoNT injections.
- Pregnant women, or premenopausal women not willing to use contraceptive measures
throughout the duration of the study.
- Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure to
other than the listed tremorogenic or potentially tremorogenic drugs is allowed only
if, in the opinion of the investigator, this will not interfere with the study drug
evaluations.
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 | A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor | NCT03136341 | Entailment |
1,567 | 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:
- Boys aged 9-15 and Girls aged 8-13
- Fracture to distal radius after low to moderate energy trauma
- No other health concerns
- Healthy (non fracture) subjects for comparison
Exclusion Criteria:
- Fracture is a result of severe trauma
- Children with ontological medical conditions
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 15 Years | Risk Taking and Fracture Study | NCT01768598 | Contradiction |
6,010 | 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:
- GERD responsive to and requiring daily PPI therapy
Exclusion Criteria:
- Esophageal varices, particularly related to portal hypertension • Patients whom the
physician determines to be a poor candidate for endoscopic procedures and/or
anesthesia.
Patients must also be willing to allow their data to be shared with the Sponsor and FDA.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Endoscopic Implantation of Enteryx for the Treatment of GERD | NCT00346905 | Entailment |
84 | 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:
- Have legal representative who understands the study procedures, alternative treatments
available and risks involved with the study, and voluntarily agrees to the
individual's participation by giving written informed consent, and the individual has
an age-appropriate understanding of the same to give informed written assent if
applicable.
- Diagnosed with hypogonadotropic hypogonadism (either isolated or associated with
panhypopituitarism), either congenital or acquired with onset prior to puberty.
- Have bilateral pre-gonadarche testes as defined by testicular volume <4.0 mL for each
testicle, as determined by ultrasound and assessed by the investigator (if qualified)
or local radiologist with appropriate training and expertise in reading testicular
ultrasound. Note: participants with a volume of <4.0 mL in one testicle and a volume
of 4-8 mL in the other testicle are considered to be pre-gonadarche and may
participate, if there is no history or evidence of a primary testicular disorder (see
Exclusion Criteria 1 and 2).
- Have circulating levels of total testosterone (Total T) less than the lower limit of
normal (LLN) of 8.3 nmol/L as specified by the central lab for a young healthy adult
male.
- Have follicle stimulating hormone (FSH) ≤2 IU/L and luteinizing hormone (LH) ≤2 IU/L.
- Have inhibin-B levels ≤35 pg/mL. (Note: if individual has inhibin-B levels >35 pg/mL,
but meets all of the other inclusion/exclusion criteria, either a GnRH agonist (GnRHa)
stimulation test or GnRH IV infusion test may be performed.
- In good general physical and mental health, in the opinion of the
investigator/sponsor, as assessed by physical examination and routine clinical
laboratory tests.
- Have a parent/guardian able and willing to support the individual's participation by
supporting adherence to study drug dosing and visit schedules.
Exclusion Criteria:
- Have a history of bilateral cryptorchidism (maldescended testes) or unilateral
cryptorchidism treated after the age of 2 years.
- Have a history or presence of clinically significant testicular problems (e.g.,
epididymitis, orchitis, testicular torsion, varicocele Grade III, testicular atrophy,
occlusive azoospermia, etc.) that would impair participants response to treatment or
has had known damage or injury to the vas deferens.
- Had any previous treatment with GnRH, gonadotropins (e.g., hCG, FSH) or androgens
(e.g., testosterone, etc.). Note: Use of GnRH and gonadotropins for diagnostic testing
purposes only is allowed. Participants with use of hCG and androgen therapy prior to
the age of 2 years old can be included in the trial. Participants with transient use
of androgens (i.e., for less than 2 weeks) that was stopped at least 6 months prior to
signing informed consent can also be included in the trial.
- Has an untreated or inadequately treated pituitary or hypothalamic tumor.
- Have uncontrolled endocrinopathies, including thyroid, adrenal, and pituitary
disorders not on stable replacement therapies.
- Has a history of active pituitary hypersecretion as evidenced by hyperprolactinemia or
Cushing's disease, acromegaly, or any other active pituitary hypersecretion syndrome.
(Note: Individuals who have been treated and are clinically stable, with no evidence
of hypersecretion for at least 12 months prior to screening, may participate.
- Has had hypophysectomy within 12 months to the start of screening.
- Has history of oncologic chemotherapy treatment.
- Has had brain radiotherapy within 12 months of start of treatment for a primary tumor,
or any history of brain radiotherapy for metastatic disease.
- Has diabetes mellitus.
- Has history of Human Immunodeficiency Virus (HIV).
- Has renal insufficiency, as determined by investigator, based on serum creatinine,
blood urea nitrogen, and estimated glomerular filtration rate.
- Has clinically significant liver disease, including active viral hepatitis or
cirrhosis. Individuals with a prior history of liver disease which is now inactive or
successfully treated may be enrolled if all liver function values performed within the
past year have been normal and within the normal range at Visit 1.
- Has had a recent history of recreational or illicit drug use, including marijuana; or
routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or
engages in binge drinking.
- Has an allergy/sensitivity to gonadotropins or its/their excipients.
- Has used an investigational drug and/or participated in any other clinical trial
within the past 8 weeks (prior to Visit 2), or will participate in any other clinical
trials (excluding surveys) during the course of this trial.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 17 Years | Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043) | NCT03019575 | Contradiction |
935 | 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:
- Both sexes
- Painful Knee Osteoarthritis with presence of osteophytes on radiography
- At least 1 of the following 3 criteria's: adult >50 years old, morning stiffness <30
minutes, or in the pre-stage surgical (programmed knee prosthesis replacement).
- Acceptance to participate in the study
- Patients affiliated to a social security scheme (beneficiary entitled)
Exclusion Criteria:
- Patient under guardianship, or protection of justice.
- Cognitive impairment
- Contraindications to Physical Activities
- Patient in the incapacity to answer the questionnaire
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.
| Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients (GONEARS) | NCT04465331 | Entailment |
487 | 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. women after 5 failures in IVF cycles with cause unknown.
2. women after 5 failures in IVF due to thin endometrium (<6 mm) and unresponsive to
estrogen supplements.
Exclusion Criteria:
1. history of hematology disease
2. allergy to GCSF
3. neutrophilia
4. severe lower back pain
5. liver dysfunction
6. hyperuricemia
7. a recent febrile disease or pneumonia
8. rheumatoid arthritis 9. sickle cell disease-
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients | NCT01315470 | Contradiction |
2,624 | 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:
- adult patients presenting with a bilateral inguinal hernia planned for a minimal
invasive laparoscopic repair
Exclusion Criteria:
- Age below 18 years
- unilateral groin hernia repair
- incarcerated hernias
- open hernia repair
- no informed consent
- pregnant women
- ASA score 4 or more
- patient included in another 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.
| Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair | NCT03904888 | Contradiction |
3,992 | 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:
- primary knee osteoarthritis
Exclusion Criteria:
- inflammatory conditions
- autoimmune disorders
- psychiatric illness
- morbid obesity
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA) | NCT01425827 | Entailment |
3,398 | 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:
- Clean and healthy ear canal, eardrum and pinna
- Ability to keep current position (of head and body) during a period of about 5 minutes
while seated.
Exclusion Criteria:
- Ear infections
- Ear wax in the ear
- Hyperacusis
- Pacemaker
- Tremor
- Disability to keep position.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
Subject must be at most 67 Years | Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software | NCT02555462 | Contradiction |
5,000 | 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 FOR TREMOR PATIENTS:
- Patients diagnosed with a tremor syndrome, including, but not limited to
- Essential tremor (per definition of the Tremor Research Group)
- Parkinson disease (per UK Brain Bank criteria)
- Focal tremor such as isolated head tremor, voice tremor
- Task-specific tremor such as primary writing tremor
- Orthostatic tremor
- Patients with other tremor syndromes such as dystonic tremor, intention tremor,
etc.
- Age 18 or older
- Able to give informed consent
- Agree to not drink caffeine or alcohol for 12 hours before phenotyping and selected
sub-study visits because both agents can modify brain activity and may confound
outcome measures.
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- Age 18 or older.
- Able to give informed consent.
- Agree to not consume caffeine or alcohol for 12 hours before selected sub-study visits
because both agents may modify the activity of the brain during the study.
EXCLUSION CRITERIA FOR TREMOR PATIENTS:
- Problematic alcohol use, as defined by a score of 8 or higher on the WHO Alcohol Use
Disorders Identification Test (AUDIT).
- History of a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of
seizures.
- History of psychotic disorder, Bipolar Disorder or a current depressive episode.
- History or clinical evidence of another neurologic disorder than a tremor syndrome as
defined above, which may interfere with the ability to comply with protocol
requirements or interpret the obtained results.
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- Have abnormal findings of clinical significance on the neurological examination that
may affect the scientific integrity of the study
- Problematic alcohol use, as defined by a score of 8 or higher on the WHO Alcohol Use
Disorders Identification Test (AUDIT)
- History of a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of
seizures.
- History of psychotic disorder, Bipolar Disorder or a current depressive episode.
ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS
SPECIFICALLY FOR MRI:
We will follow the NMR Center guidelines for MR safety.
Some of the exclusions are:
- Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain
stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear
implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity
as these make having an MRI unsafe.
- Unable to lie flat on the back for the expected length of the experiment.
- Have uncontrolled movements of the head.
- Have an abnormality on the brain imaging or neurologic examination not related to the
diagnosis.
- Uncomfortable being in a small space for the expected length of the experiment.
- Non-removable body piercing or tattoo posing MRI risk
- Pregnancy.
ADDITIONAL EXCLUSION CRITERIA FOR TREMOR PATIENTS AND HEALTHY VOLUNTEERS FOR TMS AND MRI:
- Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip or ocular foreign
body.
- Implanted electronic device including deep brain stimulation systems.
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 99 Years | Clinical and Physiological Studies of Tremor Syndromes | NCT03027310 | Entailment |
1,609 | 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 for a Waterpipe Tobacco Smoker
- Adult male or female exclusive waterpipe tobacco smoker
- Smokes at least 1 waterpipe tobacco head per month
- Smokes waterpipe tobacco at home
- Age 21 years or older
Inclusion Criteria for a Non-Smoker
- Adult male or female non-smoker
- Lived in a 'non-smoker home' at least in the last month
- Age 21 years or older
Inclusion Criteria for a Non-Smoker Home
- No smokers have lived in in the past month
- No visitors had smoked indoors/outdoors in the past month
Exclusion Criteria
- Major physical/psychiatric illnesses
- Daily waterpipe smokers
- Pregnant women
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| Assessing Toxicity of Waterpipe Tobacco Smoking | NCT03253653 | Contradiction |
3,357 | 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:
- tympanic membrane,
- dry middle ear cavity,
- absence of exclusion criteria.
Exclusion Criteria:
- signs of cholesteatoma,
- anemia,
- thrombocytopenia,
- chronic use of immunomodulatory agents and / or antimicrobials,
- malignancy in the ear area,
- systemic infectious disease,
- autoimmune disease,
- inability and / or refusal of the patient to participate in the research,
- pregnancy and / or breast-feeding.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear Infections | NCT04761562 | Contradiction |
5,830 | 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:
- Age 18-80 years
- Dependent upon daily PPIs for > 6 months
- Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of
omeprazole or equivalent.
Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days
a week and are at least moderate in severity.
- Abnormal ambulatory pH study off PPI therapy for 7 days.
- Normal or near normal esophageal motility (by manometry)
- Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should
not exceed 2.5 cm
- Patient willing to cooperate with post-operative dietary recommendations and
assessment tests
- Signed informed consent
Exclusion Criteria:
- BMI > 35
- Hiatal hernia > 2 cm
- Esophagitis Los Angeles grade C or D
- Esophageal ulcer
- Esophageal stricture
- Esophageal motility disorder
- Pregnancy or plans for pregnancy in the next 12 months (in females)
- Immunosuppression
- ASA > 2
- Portal hypertension and/or varices
- History of previous resective gastric or esophageal surgery, cervical spine fusion,
Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or
dermatomyositis, eosinophilic esophagitis, or cirrhosis
- Active gastro-duodenal ulcer disease
- Gastric outlet obstruction or stenosis
- Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric
emptying study if patient complains of postprandial satiety during assessment
- Coagulation disorders
- Interprocedural determination of anatomical presentation which in the opinion of the
surgeon does not allow safe device introduction.
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 | Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study | NCT01136980 | Contradiction |
6,442 | 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. | Inclusion Criteria:
1. Patients with clinical diagnosis of moderate to severe facial rosacea as determined
by:
- At least 8 but no more than 50 total papules and/or pustules (inflammatory
lesions)
- Presence of moderate to severe erythema
- Presence of telangiectasia.
- An Overall Rosacea Severity score ≥2.5
2. Patient is male or female over 18 years of age.
3. No known medical conditions that, in the Investigator's opinion could interfere with
study participation
4. Patient is willing and able to comply with all requirement of the protocol
5. Patient is willing and able to give written informed consent prior to participation in
the study
Exclusion Criteria:
1. Presence of skin diseases at or near the investigational area
2. Immunosuppressed state or other serious systemic disease
3. Signs and/or symptoms of systemic infection
4. Concomitant medication:
- Use of oral and/or topical antibiotic treatment within 14 days prior to study
entry.
- Use of any topical anti-rosacea agent except antibiotics within 14 days prior to
study entry.
- Use of cyproterone acetate, CPA-containing contraceptives (e.g. Diane) or other
corticosteroids (during the last 3 months);
- Use of retinoids (during the last 4 weeks)
5. Use of artificial sun bath or having a sun holiday during the last 2 weeks
6. Alcohol or drug abuse, according to assessment by the investigator
7. Known or suspected hypersensitivity to Minocycline or any of the excipients in the
Study Medication
8. Use of another investigational drug within 30 days prior to entry into this study
9. Pregnant or lactating 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.
| Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients | NCT01134991 | Entailment |
2,901 | 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:
- possible, probable (clinically or laboratory) or definite ALS according to the revised
version of the El Escorial World Federation of Neurology criteria
- disease duration more than 6 months and less than 3 years
- best-sitting FVC between 50% and 95% of predicted normal
- continuously treated with 100 mg riluzole daily, for at least one month
- onset of progression weakness within 36 months prior to study
- women of childbearing age be non-lactating and surgically sterile or using a highly
effective method of birth control and have a negative pregnancy test
- capable of thoroughly understanding all information given and giving full informed
consent according to GCP
Exclusion Criteria:
- previous participation in another clinical study within the preceding three months
- tracheotomy or assisted ventilation of any type during the preceding three months
- gastrostomy
- any medical condition known to have an association with motor neuron dysfunction which
might confound or obscure the diagnosis of ALS
- presence of any concomitant life-threatening disease or impairment likely to interfere
with functional assessment
- confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT more than
1.5 upper limit of normal)
- renal insufficiency (serum creatinine more than 2.26 mg/dl)
- evidence of major psychiatric disorder or clinically evident dementia precluding
evaluation of symptoms
- known hypersensitivity to any component of the study drugs
- likely to be not cooperative or comply with the trial requirements (as assessed by the
investigator), or unable to be reached in the case of an emergency
- other antidiabetics
- heart failure or heart failure in the patients history (NYHA I to IV)
- history of macular oedema
- treatment with thiazolidinediones within 3 months prior to screening
- known or suspected history of alcohol and/or drug abuse
- treatment with gemfibrozil within 3 months prior to 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.
| Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis | NCT00690118 | Entailment |
20 | 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:
- Men between 45 and 80 years age
- Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at
least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV)
disease or are at an increased risk for CV disease.
Exclusion Criteria:
- Participants with congenital or acquired hypogonadism for whom long-term therapy with
placebo would not be medically appropriate
- Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha
reductase inhibitors)
- Participants who have been treated with testosterone in the past 6 months and for whom
testosterone therapy is contraindicated
- Confirmed testosterone < 100 ng/dL
- Body Mass Index (BMI) > 50
- Hemoglobin A1c (HbA1C) > 11%
- Hematocrit (Hct) > 50%
- Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
- History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart
failure (Class III and IV).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study | NCT03518034 | Contradiction |
6,843 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Inclusion Criteria:
- Patient's informed consent
- Age: 18-59 years old
- No serious somatic diseases.
- Patients with complaints of sore throat, coughing, burning sensation in the throat,
coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign
body feeling in the throat, voice changes, heartburn and belching.
- Diagnosis: Chronic pharyngitis
- Chronic laryngitis
Exclusion Criteria:
- Disagreement to participate in scientific research
- Age: under 18 and over 60
- Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs
- Patients with pulmonary pathologies
- Patients with allergic manifestations (seasonal hay fever, asthma, etc.)
- With diagnoses: Acute respiratory diseases
- Patients with general neuralgic disorders
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 59 Years | Method of Early Diagnosis of Laryngopharyngeal Reflux | NCT04771221 | Entailment |
6,559 | 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:
- Children less than (<) 12 years of age, with allowance for participants 12 to 17 years
of age who weigh <40 kilograms (kg) (Cohort A only); and participants <2 years of age
will be allowed to participate only after the protocol-defined interim data review
criteria are met (Cohort A only)
- Diagnosis of congenital hemophilia A of any severity and documented history of
high-titer inhibitor (that is [i.e.], greater than or equal to [>/=] 5 bethesda units
[BU])
- Requires treatment with bypassing agents
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria:
- Inherited or acquired bleeding disorder other than hemophilia A
- Ongoing (or planning to receive during the study) immune tolerance induction (ITI)
therapy or prophylaxis treatment with FVIII
- Previous (in the past 12 months) or current treatment for thromboembolic disease or
signs of thromboembolic disease
- Other disease that may increase risk of bleeding or thrombosis
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapy or components of the emicizumab injection
- Known infection with human immunodeficiency virus (HIV) or hepatitis B or C virus
- Use of systemic immunomodulators at enrollment or planned use during the study period
- Planned surgery (excluding minor procedures such as tooth extraction or incision and
drainage) during the study
- Inability (or unwillingness by caregiver) to receive (allow receipt of) blood or blood
products (or any standard-of-care treatment for a life-threatening condition)
- Participants who are at high risk for thrombotic microangiopathy (TMA) (e.g., have a
previous medical or family history of TMA), in the investigator's judgement
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 | A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors | NCT02795767 | Contradiction |
3,787 | 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:
- Individuals with knee osteoarthritis severity II, III, or IV according to the
Kellgren-Lawrence Classification,
- Individuals with positive active knee extension test,
- Individuals with a body mass index of 30 or less,
- Individuals with a pain severity of at least 3/10 according to the visual pain scale.
Exclusion Criteria:
- Individuals with health problems that prevent them from doing the evaluations and
exercises to be used in the study,
- Individuals who exercise regularly for the last six months,
- Individuals with a diagnosis of neurological disease affecting the lower extremity.
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.
Subject must be at most 75 Years | Comparison of the Effects of Static and PNF Hamstring Stretching Exercises in Patients With Knee Osteoarthritis | NCT04645238 | Entailment |
371 | 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 >18yrs, able to read and write English
- Intrauterine gestations with anembryonic sac between 10 and 45mm or
- 10-15mm sac with no growth in three days or other radiologic signs of abnormal
pregnancy such as irregular sac or debris within the gestational sac
- An embryonic pole <30mm with no cardiac activity
Exclusion Criteria:
- Intrauterine gestations with CRL <5mm or >30mm without cardiac activity
- Incomplete abortion as defined as open cervix and large amount of cramping/bleeding
- Hemodynamic instability and/or heavy vaginal bleeding
- Hemoglobin less than or equal to 8
- Inability to follow-up (ie, lack of transportation or access to telephone)
- Bleeding disorder or taking anticoagulants
- Prior medical or surgical treatment of the current pregnancy
- Obvious Infection
- Active Lactation
- Allergy to mifepristone or misoprostol
- Chronic corticosteroid use
- Severe gastrointestinal disease (e.g inflammatory bowel disease, severe gastritis)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 64 Years | MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure | NCT00468299 | Contradiction |
365 | 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:
- Pregnant women 10th to 16th Week of gestation
Exclusion Criteria:
- Vaginal Bleeding, Twins, vaginal infections, Antibiotics up to 4 weeks to
randomisation
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Treatment of the Intermediate Vaginal Microbiota With Vaginal Lactobacillus Casei Rhamnosus to Improve Pregnancy Outcome | NCT02979288 | Contradiction |
3,676 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- All consecutive patients during the study period
- age > 18 y/o
Exclusion Criteria:
- Patients seen during the washout period
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.
| Scribes in the Emergency Department | NCT01599910 | Entailment |
3,904 | 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. Subject is 40-75 years old.
2. Body Mass Index (BMI) ≤ 40 kg/m2.
3. Subject has Kellgren-Lawrence (K-L) severity grade II or III in the Index knee as
determined by X-Ray. Contralateral knee: K-L severity grade 0, I or II.
4. Subject has had at least two signs and at least two symptoms of OA disease (based on
the European League Against Rheumatism (EULAR) recommendations for diagnosing knee OA)
in the Index knee for at least 6 months despite conservative treatment (weight
reduction, physical therapy, pain medications, etc.). The EULAR signs and symptoms are
as follows:
- Signs: crepitus, restricted movement and bony enlargement
- Symptoms: persistent knee pain, limited morning stiffness and reduced function
5. Subject must be willing to abstain from other IA treatments of the knee for the
duration of the study.
6. Subject is willing to discontinue all analgesics including nonsteroidal
anti-inflammatory drugs (NSAIDs), except acetaminophen before the treatment injection
and through the completion of the study. NSAIDs should be discontinued through the
Screening period.
7. Subject is willing to use only acetaminophen (up to a maximum of 3.0 grams per day)
for the treatment of joint pain for the duration of the study. At least forty-eight
hours prior to the Baseline Visit and each follow-up visit, the Subject is willing to
discontinue use of acetaminophen
8. Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin
sulfate products throughout the study, if taken prior to signing ICF.
9. Subject is able to understand and comply with the requirements of the study and
voluntarily provides consent.
Baseline Inclusion Criteria 24 Subject has a Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) pain-sub-score ≥ 50 mm and ≤ 90 mm in the affected knee and ≤
30 mm in the contralateral knee on a 100 mm Visual Analog Scale (VAS) scale.
Exclusion Criteria:
1. Subject received an IA injection of Hyaluronic Acid (HA) and/or steroid in either knee
within 6 months of signing the ICF. A Subject will be excluded if they are planning to
receive an HA or steroid injection (other than the study injection) in either knee
during the course of this study.
2. Subject had an arthroscopy of either knee within 3 months of signing the ICF.
3. Subject had an open surgical procedure of either knee or hip or any surgery of the
spine within 12 months of signing ICF. Subject plans to have knee, hip or spine
surgery within the study period.
4. Subject has intra-articular trauma to the Index knee. Subject has concurrent
multi-system or multi-limb trauma.
5. Subject has evidence or medical history of the following diseases in the Index knee:
septic arthritis; inflammatory joint disease; history of Reiter's syndrome; gout;
chondrocalcinosis associated with recurrent episodes of acute synovitis of the knee
consistent with pseudogout; osteochondritis dissecans, Paget disease of the bone;
ochronosis; acromegaly; hemochromatosis; primary osteochondromatosis; known history of
Wilson disease; heritable disorders or collagen gene mutations.
6. Subject has a history of cartilage repair surgery in the Index knee within 3 years of
signing the ICF.
7. Subject has a history of Anterior cruciate ligament (ACL) repair, reconstruction or
injury in the Index knee within 3 years of signing the ICF.
8. Subject has X-Ray findings of acute fractures, severe bone loss, avascular necrosis,
severe bone or joint deformity in the Index knee.
9. Subject has significant varus or valgus deformity greater than 8 degrees in either
knee.
10. Subject has a clinically apparent tense effusion of the Index knee.
11. Subject has knee instability in either knee per the Investigator's assessment.
12. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.)
Occasional use of a cane is acceptable.
13. Subject has medical condition(s) which could affect study assessments or may adversely
affect the safety and/or success of the study treatment. This includes but is not
limited to the following: a. Peripheral neuropathy severe enough to interfere with
evaluation of the subject, b. Vascular insufficiency severe enough to interfere with
evaluation of the subject, c. Active fibromyalgia, d. Hemiparesis involving either
lower extremity, e. Immunocompromised or immunosuppressive disorder or receiving
medications to treat immunosuppressive disorders, f. Systemic bleeding disorder(s), g.
Current malignancy or treatment within the last 5 years, except for non-melanoma skin
cancer, h. Significant psychiatric disorder, i. Active drug and/or alcohol abuse
within the past year, j. Uncontrolled diabetes with a Screening Hemoglobin A1C (HbA1c)
of >7% k. contraindication to Triamcinolone Hexacetonide (TH) including active
tuberculosis, herpes simplex keratitis, acute psychoses and systemic mycoses and
paracitoses.
14. Subject is taking medications at the time the subjects signs the ICF which could
interfere with the treatment procedure, healing and/or assessments. This includes but
is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet
treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular
protection is allowed if a stable regimen is maintained for the duration of the study.
15. Subject is receiving treatment using electromagnetic stimulation and/or low intensity
ultrasound in the Index knee at the time of signing the ICF, within 3 months of
signing the ICF or plans to receive treatment any time during the study period.
16. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical
(excluded in Index knee only) corticosteroid within 30 days of signing the ICF are
excluded. Topical corticosteroid use at any site other than the Index knee is allowed.
17. Subject has a pre-treatment contraindication to IA injections or aspiration of the
Index knee, including cutaneous infection in the injection site area, active IA
infection (as suggested by moderate or marked effusion), knee deformity or condition
which, in the opinion of the Investigator could jeopardize the sterility or delivery
of the IA injection.
18. Subjects with a history of hypersensitivity to any of the ingredients in the
hyaluronan or previous hypersensitivity to the administration of corticosteroids or an
inability to tolerate acetaminophen.
19. Subject has any contraindication to the receipt of a corticosteroid.
20. Subject is receiving or in litigation for worker's compensation.
21. Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman
of child bearing potential who refuses to use effective contraception during the
course of the study.
22. Subject was involved in any other research study involving an investigational product,
or a new application of an approved product, within 60 days of signing the ICF.
23. Subject previously treated with Cingal for knee osteoarthritis.
Baseline Exclusion Criteria 25. Subject has a decrease of ≥ 20 mm in the WOMAC
pain-sub-score (average of 5 pain scales) from Screening to Baseline in the Index knee on a
100 mm Visual Analog Scale (VAS) scale.
26. Subject has a synovial fluid aspirate volume > 10 mL in the Index knee. 27. Subject has
a contraindication to continue with the study treatment injection based on the visual
appearance of the synovial fluid aspirate unless the fluid is examined microscopically
prior to injection with no clinically significant findings (e.g. bacteria, crystals or
blood).
28. Subject has range of motion of less than 100° flexion in either knee.
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.
Subject must be at most 75 Years | Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain | NCT04231318 | Entailment |
5,477 | 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:
- Males or females >= 18 years of age.
- A diagnosis of hemophilia A, moderate (FVIII:C 0.01-0.04 U/ml) or mild (FVIII:C >=
0.05 U/ml); or a diagnosis of VWD, defined by a low VWF:RCo and past bleeding history.
- For those with VWD, an inability to use DDAVP due to i) unresponsiveness defined as
VWF:RCo or FVIII:C level lower than 50 IU/dl or less than a 3-fold increase after 0.3
microgram/kg DDAVP; ii) allergic reactions or seizures; or iii) a contraindication to
DDAVP.
- Willingness to have blood drawn.
- Willingness to sign informed consent.
Exclusion Criteria:
- Presence of other bleeding disorders, acquired Von Willebrand disease, primary
thrombocytopenia.
- Use of immunomodulatory or experimental drugs, or diuretics.
- Pregnant or lactating women.
- Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation,
atrial flutter), hypertension, MI, stroke, or thrombosis.
- Past allergic reaction to Neumega.
- Surgery within the past 8 weeks.
- Inability to comply with study protocol requirements.
- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
containing substantial quantities of FVIII and/or VWF within five days of study.
- Baseline safety and/or hematology lab values outside the normal limits and/or an EKG
indicating an arrhythmia.
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 and Safety of IL-11 in DDAVP Unresponsive | NCT00994929 | Entailment |
948 | 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:
1. Hand Osteoarthritis (OA) patients:
- Subjects with hand osteoarthritis according to the American College of
Rheumatology (ACR) classification criteria for clinical OA; hand pain, aching or
stiffness and 3 of the following points;
1. Hard tissue enlargement of 2 or more of 10 hand joints.
2. Hard tissue enlargement of 2 or more interphalangeal joints.
3. Fewer than 3 swollen Metacarpal joints.
4. Deformity of 1 or more of 10 hand joints.
- Pain and dysfunction in the joints of the hands and/or wrists
- Possession of a smartphone with internet.
2. Rheumatoid Arthritis (RA) Hand patients:
- Subjects with hand arthritis according to the American College of Rheumatology
(ACR) clinical and immunological criteria for clinical RA. Patients must meet 4
of the following seven criteria:
1. Morning stiffness in and around joints lasting at least 1 hour.
2. Swelling in three or more joints.
3. Swelling in hand or wrist joints,
4. Symmetrical joint swelling.
5. erosions or decalcification on radiographs of hand and/or wrist.
6. Rheumatoid nodules.
7. Abnormal serum rheumatoid factor.
- Pain and dysfunction in the joints of the hands and/or wrists.
- Possession of a smartphone with internet
Exclusion Criteria:
1. Hand Osteoarthritis Patients:
- Age under 18 years
- People with cognitive impairment
- Surgery on any upper limb joint or fracture in the upper limb within the previous
6 months
- People on the waiting list for upper limb surgery.
- Persons who have received steroid injections into the joints of their hands in
the two months prior to recruitment.
- People with inflammatory rheumatic disease (arthritis, spondylitis or cancer)
2. Rheumatoid Arthritis Hand Patients
- Age under 18 years
- People with cognitive impairment
- Surgery on any upper limb joint or fracture in the upper limb within the previous
6 months
- People on the waiting list for upper limb surgery.
- 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.
| Effectiveness of an Exercise Program and Education Through a Mobile Application for the Management of Patients With Hand Osteoarthritis and Rheumatoid Arthritis | NCT04263974 | Entailment |
1,015 | 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:
- 50 years of age or older
- Knee pain on most days of the week
- Less than 30 minutes of morning stiffness
- Bony enlargement
- Bony tenderness to palpation
- Signs of inflammation
- Able to safely climb 2 flights of stairs without aid
Exclusion Criteria:
- Any other forms of arthritis
- Osteoporosis
- History of patellofemoral symptoms
- Active non-arthritic knee disease
- Knee surgery
- Use of cane or walking aid
- Unstable heart condition
- Neurological conditions
- Skin allergy to medical tape
- Hip or ankle injuries in past 3 months
- Any injuries that would prohibit participation in yoga
- Ipsilateral hip or ankle conditions
- Currently receiving cancer treatment
- Currently pregnant
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| A Biomechanical Exercise Program for Knee OA | NCT02370667 | Entailment |
3,548 | 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:
1. Males and females at ages 20-65 years
2. Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency
due to autoimmune adrenalitis, i.e. Addison´s disease
3. A stable daily glucocorticoid replacement dose for at least 3 months prior to study
entry
4. An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
5. If needed, a stable fludrocortisone replacement dose for at least 3 months prior to
study entry
6. Body mass index (BMI) of 20-35 kg/m2
7. Ability to comply to the protocol procedures and having signed informed consent to
participate in the study
Exclusion Criteria:
1. Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,
hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere
with the study assessment of completion of the study
2. Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
3. Pregnant or lactating women
4. Diabetes Mellitus
5. Systemic infections
6. Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
7. Any medication with agents which in the investigators judgement might interfere with
the study drugs kinetics, including therapies affecting gastro intestinal emptying or
motility
8. Alcohol/drug abuse or any other condition associated with poor patient compliance,
including expected non-cooperation, as judged by the investigator
9. Hypersensitivity to the active substance or any excipients used in the study drug of
choice
10. Any additional underlying disease that may need regular or periodic pharmacological
treatment with glucocorticoids during the trail, such as asthma, skin- or eye
conditions treated with inhaled or topical glucocorticoids
11. Any additional underlying condition that needs treatment with intramuscular or
intra-articular steroid injections during the trial
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 65 Years | A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT) | NCT03210545 | Entailment |
5,697 | 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:
- Boys and girls ages 5-6 yrs and 12-14 yrs and their mothers
- Children must have a BMI greater than or equal to 15th percentile for their age
- Children and their mothers must have at least a moderate liking of the study foods
used
Exclusion Criteria:
- Participants should not have any food allergies
- Participants should have no dietary restraints
- Participants should have no psychopathology that can limit food choice and alter
eating
- Participants should have no developmental disabilities that can limit food choice and
alter eating
- Participants cannot have a cold or upper respiratory distress that could influence
taste, appetite or olfactory sensory responsiveness
- Participants cannot be on any medications that could influence taste, appetite or
olfactory sensory responsiveness
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 14 Years | Influence of Parents and Friends on Children and Adolescents | NCT00875576 | Entailment |
1,569 | 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. Healthy sexually active women who have ever used an FC and using condoms (male or
female) as their current method of contraception.
2. Be 18 to 40 years at enrolment (inclusive).
3. Have a negative urine pregnancy test at enrolment visit.
4. Is HIV negative
5. Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using
hormonal contraception.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that
ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks
gestation.
8. Be willing to accept a risk of pregnancy.
9. Reporting to have at least four acts of heterosexual vaginal intercourse per month for
a period of 6 months.
10. Be willing to only use the study product (Cupid or FC2 female condom) as the primary
method of contraception over the course of the study.
11. Be capable of using the study product properly and agree to observe all study
directions and requirements.
12. Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and
details of condom use and any condom failures.
13. Be willing to state that, to her best knowledge, her sexual partner:
- Has not had a vasectomy or been previously diagnosed as infertile.
- Is HIV negative
- Has no known history of allergy or sensitivity to natural rubber latex,
water-based or silicone lubricants
- Does not want her to become pregnant in the next 7 months
14. Agree to have fingerprint identity check
15. Be willing to give written informed consent to participate in the trial.
16. Intend to stay in the area for the next 6-7 months
17. Be willing to be randomized
Exclusion Criteria:
1. Have a history of allergy or sensitivity to rubber latex or water-based /silicone
lubricants
2. Have evidence of sexually transmitted infections on syndromic assessment and / or
vaginal examination
3. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study.
4. Have a history of infertility or pelvic inflammatory disease without a subsequent
spontaneous intrauterine pregnancy.
5. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy.
6. Be in a monogamous relationship of less than 4 months with their partner.
7. Have any contraindications to pregnancy (medical condition) or regularly use
medications that are unsafe to use in pregnancy
8. Have shared injection drug needles in the past unless has a negative HIV test at least
6 weeks since last use.
9. HIV positive.
10. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within 3 months prior to screening or have clinical evidence of HSV
on exam.
11. Be lactating or breastfeeding.
12. Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
13. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
screening.
14. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
screening or enrollment.
15. Have received a Depo-Provera® injection in the 6 months prior to enrolment or
Nur-Isterate in the last 4 months prior to enrolment
16. Have a past (within 12 months) or current history of alcohol or drug [recreational,
prescription or over-the-counter (OTC)] abuse.
17. Have taken an investigational drug or used an investigational device within the past
30 days.
18. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom | NCT04233632 | Contradiction |
1,964 | 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 in the Familial Gastric Cancer Registry held in Cambridge fulfilling clinical
criteria for HDGC.
- Patients willing to undergo at least one upper GI endoscopy with random biopsies
according to Cambridge biopsy protocol.
Exclusion criteria:
- Patients who decline evaluation with endoscopy either as a screening or surveillance
tool
- Patients on clopidogrel, and/or warfarin for high risk condition and unable to
withhold temporarily the medication.
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.
| Biopsy Technique for Endoscopic Surveillance of Hereditary Diffuse Gastric Cancer | NCT03950908 | Entailment |
6,748 | 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:
- Male subjects, younger than 12 years old.
- Severe hemophilia B (Factor IX [FIX] activity of ≤ 2%).
- Body weight ≥ 10 kg.
- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years).
- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
family history of inhibitors against FIX.
- Written informed consent for study participation.
Exclusion Criteria:
- Known hypersensitivity to any FIX product or hamster protein.
- Known congenital or acquired coagulation disorder other than congenital FIX
deficiency.
- Kidney or liver disease.
- Recent life-threatening bleeding episode.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 11 Years | A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B | NCT01662531 | Contradiction |
2,848 | 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:
Arm 1 (newly diagnosed ALS patients)
- Have a clinical diagnosis of probable ALS according to the revised El Escorial
criteria.
- MR of the brain and cervical spine cannot explain symptoms.
- Diagnosed with likely ALS within 6 months from enrolment and treated with Riluzole
50mg x 2
- Symptom onset no longer than 2 year prior to inclusion.
- ALS-FRC-R of 36 or more (not any item below 2).
- Age equal to or greater than 35 years at time of enrollment
Arm 2 (earlier diagnosed ALS patients)
- Have a clinical diagnosis of probable ALS according to the revised El Escorial
criteria.
- MR of the brain and cervical spine cannot explain symptoms.
- Treated with Riluzole 50mg x 2.
Exclusion Criteria:
- Dementia, FTD or other neurodegenerative disorder at baseline visit
- Any psychiatric disorder that would interfere with compliance in the study.
- Use of high dose vitamin B3 supplementation within 30 days of enrollment
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at
baseline visit.
- Genetically confirmed mitochondrial disease
- Patients who become tracheostomized as part of the treatment of ALS
- Patients with short expected survival at the discretion of the investigator. Such
cases cannot be expected to follow protocol procedures.
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.
| The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS. | NCT04562831 | Entailment |
4,609 | 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:
- Age 18-80
- Candidate for conventional laparoscopic-assisted hysterectomies procedures
- patient has a cervix and a uterus
Exclusion criteria
- Difficulty understanding the English language
- Anatomy that precludes the use of a uterine manipulator
- Current inclusion in another research study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | New Use of the ViKY Device for Uterus Positioning | NCT01531504 | Entailment |
4,051 | 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) the American Society of Rheumatology established the diagnostic criteria for knee
OA in 2001;
- 2) Kellgren/Lawrence score of knee joint grade as I,II and early III.
- 3) According to "Principles of clinical guidance for new drugs of traditional Chinese
Medicine ",diagnosed as "Xi Bi Disease".
- 4) Patients with informed consent.
- 5)Blood and urine routine tests, liver and kidney functions, electrocardiogram were
normal before recruitment.
- 6) Patients were not treated with NSAIDS drugs or hormone drugs, and no patients were
treated with drugs related to this disease at least 2 weeks.
Exclusion Criteria:
- 1)Patients suffer from other rheumatic and metabolic diseases such as gout, rheumatoid
arthritis, diabetes and so on.
- 2) Patients with knee joint inflammatory infection, such as suppurative and
nonspecific.
- 3)Patients accompanied by traumatic synovitis, Villonodular pigmented synovitis,
synovial membrane of the knee is the main lesion.
- 4) Patients with informed consent.
- 5)The color of joint fluid of patients' knees is pink or other color or cloudy; the
white blood cell counts > 1000 /mm3 or with crystal in the joint fluid.
- 6)Patients blood RF > 30IU/ml, ESR > 20mm/h, CRP > 10mg/L.
- 7)Patients combined with severe cardiovascular, cerebrovascular, liver, kidney and
other primary diseases and mental diseases.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid | NCT03586700 | Entailment |
4,570 | 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:
- Pre- and Peri-menopausal woman patient age 35-50 years
- Women with fibroids and indication for laparoscopic hysterectomy at which a
morcellators for cutting and extraction of tissue is required.
- Normal Pap test result in the last year
- Hemoglobin level of 10.0 g/dL or more at the time of treatment
- Subject able to comprehend and give informed consent for participation in this study
- Signed informed consent form
Exclusion Criteria:
- Patient is not considered suitable for a laparoscopic hysterectomy procedure
- Women with:
- Known or suspected gynecologic malignancy
- Known cervical dysplasia
- Postmenopausal women
- Undiagnosed vaginal bleeding
- Abdominal wall thickness is larger than 10 cm
- Atypical hyperplasia or malignancy in preoperative endometrial biopsy.
- Known cognitive disorder
- HIV or any other immunosuppressive disorder
- Liver disease
- Renal failure (Serum creatinine above 2.5 dL/ml)
- Cardiopulmonary disease contraindicating laparoscopic surgery
- History or evidence of gynecologic malignancy within the past five years
- Pace maker, internal defibrillator/cardio converter
- Impaired coagulation parameters
- Previous extensive pelvic surgery
- Psychological/psychiatric disease
- Contraindications to anesthesia or abdominal surgery.
- Concurrent participation in any other clinical study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy | NCT03216772 | Contradiction |
559 | 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. Age between 20 to 40 years.
2. Baseline FSH > 10 IU/L.
3. Fresh stimulated cycles
4. Antagonist cycles
Exclusion Criteria:
1. Uterine fibroid if encroaching uterine cavity.
2. Mullerian anomalies.
3. Ovarian endometrioma.
4. Adnexal hydrosalpinx "except after disconnection".
5. Ovarian hyper stimulation syndrome (OHSS) an exaggerated systemic response to ovarian
stimulation characterized by a wide spectrum of clinical and laboratory
manifestations. It is classified as mild, moderate, or severe according to the degree
of abdominal distention, ovarian enlargement, and respiratory, hemodynamic and
metabolic complications.
6. Poor responders according to bologna criteria.
7. Women refused to participate in an RCT.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Effect of Adding Gonadotropins Releasing Hormone Agonist to Progesterone for Luteal Phase Support in Assisted Reproductive Technique (Antagonist Cycles). | NCT04087408 | Contradiction |
5,210 | 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:
- Women who are capable of understanding and giving written, voluntary informed consent
before the clinical study screening visit
- Women with the ability to self-administer a daily injection or having a designee who
will give the injections
- Women who are postmenopausal with at least one year since their last menstruation. If
a subject's menopausal status at screening is in question, because of history or
because the subject had a hysterectomy without oophorectomy, a follicle-stimulating
hormone (FSH) level >40 mIU/mL will satisfy the definition of postmenopausal status.
- Women 45-54 years of age with the following T-score and/or vertebral fracture
- T-score >=3.0 standard deviations (SD) below mean peak bone mass of young women
at the lumbar spine, femoral neck, or total hip Or
- T-score >=2.5 SD below mean peak bone mass of young women at the lumbar spine,
femoral neck, or total hip with a prevalent vertebral fracture verified by the
central imaging organization before the subject is enrolled into the study
- Women >=55 years of age with the following T-score and/or vertebral fracture:
o T-score >=2.5 SD below mean peak bone mass of young women at the lumbar spine,
femoral neck, or total hip Or
- T-score >=2.0 SD below mean peak bone mass of young women at the lumbar spine, femoral
neck, or total hip with a vertebral fracture verified by the central imaging
organization before the subject is enrolled into the study
The following types of vertebral fractures should not be considered for subject enrollment
into this study:
- Pathological fractures due to malignant disease or infection
- Fractures due to excessive trauma sufficient to cause a fracture in young individuals
with normal bone mass
Exclusion Criteria:
A. Vertebral Deformity (assessed as described in Appendix 2 of the protocol, are sufficient
for exclusion):
· Vertebral deformities
- Patient has 5 or more vertebral (thoracic and lumbar) fractures
- Patient has 2 or more lumbar vertebral deformities (L1 to L4)
B. DXA Imaging:
· Inability to have a DXA scan performed, e.g.:
- A history of a lumbar laminectomy which interferes with the DXA measurement of the
lumbar vertebrae
- The presence of pedicle screws
- The patient cannot lay flat on her back for the required time to provide accurate
imaging
- Patient is not able to have an A/P lumbar vertebral DXA performed
- Patient has a history of vertebroplasty
- Any other excessive degenerative disease which interferes with the DXA measurement of
the lumbar vertebrae or hip
C. History of or Concurrent Illness:
- Disorders of Immunity
- HIV
- Significant* immunological disorders
- Endocrine system
- Any history of hyper- or hypoparathyroidism
- Cushing's disease
- Hyperthyroidism (within 12 months)
- Significant* endocrine disorders
- Gastrointestinal system
- Significant* gastrointestinal disorders
- Kidney and collecting system
- Clinically significant* history of nephrolithiasis or urolithiasis
- Current impaired renal function and/or verified kidney calcification*
- Significant* renal disorders
- Liver, biliary tract and pancreatic systems
- Active hepatitis or pancreatitis
- Significant* hepatic or pancreatic disorders
- Musculoskeletal system
- Any history of other metabolic bone diseases within the past 5 years, (e.g.,
Paget´s disease, osteogenesis imperfecta, osteomalacia)
- Subjects with chronic, active joint disease and/or joint infection
- Neoplasia - Any history of bone cancer or any cancer within the previous 5 years, with
the exception of squamous or basal cell carcinoma**
(**)Patients who have had either squamous or basal cell carcinoma of the skin can enroll
if:
1. The lesion(s) were fully resected with clear margins described in a written report by
a pathologist, and
2. The patient has had no recurrence of lesions for at least one year from the time of
the original resection.
· Nervous system
- Significant* neurological or psychiatric disease
· Vascular, respiratory and cardiac system
- Significant* unstable cardiac or pulmonary disease
(*) Significance will be determined by the investigator on the basis of history,
physical exam, and/or laboratory screens. Significant disorders necessitate ongoing
changes in therapeutic medication or frequent monitoring.
D. Concurrent Medication:
Patients cannot be enrolled into this clinical trial if they have received any of the
following therapies at any time:
- Any PTH or PTH analogs [e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs]
- Fluoride
- Strontium
Patients must have been off the following agents for the specified times before
entering the screening phase of this clinical trial:
- Any investigational drug (>30 days)
- Anabolic steroids or androgens (>6 consecutive months)
- Active Vitamin D3 metabolites and analogs, e.g., calcitriol (>90 days)
- Provera (medroxyprogesterone) (According to label instructions)
- Systemic corticosteroids, more than 5mg/day formulation equivalent to 5mg/day
prednisone (>12 consecutive month or as acute bolus for nonrecurring condition).
A patient who has been enrolled in the study and needs to receive an acute bolus
of steroids (oral or injectable) for a self-limited illness may continue
treatment in the study if the following requirements are met:
- The maximal dose of steroid (prednisone equivalent) is limited to no more
than 225 mg (7.5 mg each day for 30 days)
- The illness is acute in nature and is not expected to recur during the
remaining treatment period of the study
- Inhaled corticosteroids equivalent to <1200 μg of beclomethasone
- Bisphosphonates, including investigational bisphosphonates
- If the patient has received bisphosphonates for >90 days during 12 months
immediately before screening, the patient is excluded from this study.
- If the patient has received bisphosphonates for more than 12 months at any
time.
*The patient may be enrolled if she:
Has taken bisphosphonates for >=30 days but <=90 days, and has completed washout of
equivalent time.
No washout is necessary if the patient has taken bisphosphonates <30 days.
- Intravenous (IV) pamidronate
- Patient can have received 1 dose of pamidronate in >3 to 12 months
immediately preceding the screening visit. Patient should not have received
this 1 dose within the three months immediately prior to the screening visit
- Patient must not have received >2 doses at any time before screening.
- Cyclical Etidronate
- Patient should not have an exposure equal to 9 months on a standard dose
(e.g., 400 mg).
- Exposure to cyclical etidronate must be <=6 months on a standard dose (e.g.,
400 mg/day) prior to the screening visit.
- Phenytoin for seizure control:
- If the patient has received phenytoin <5 years before, the patient is
excluded from this study
- The patient may continue in the screening process if:
>=15 years have passed since the last dose of phenytoin or if use was between 5-15
years before the screening visit and the patient received phenytoin for <2 months
Patients may be enrolled if they have been stabilized on the following therapy for the
specified amount of time:
- Thyroid Hormone (<0.1 mg/day thyroxine) therapy for >=6 months
- If taking >= 0.1 mg/day but <= 0.2 mg/day, must have serum TSH level >= 0.1
mU/L. Patients will be excluded if they are taking doses of >0.2 mg/day.
- If a patient has had a minimal change in L-thyroxine dose of <=0.025 mg/day
within 6 months of enrollment, and has been on this new dose for >=2 months,
she may continue. The patient must have the history documented with
L-thyroxine in the CRF.
- If a patient requires an increase or decrease in her thyroid replacement
dose, after she has been enrolled in this clinical study, each increment or
decrement should be <=0.025 mg/day, and increments should not occur more
frequently than once per month, as recommended by a physician who is caring
for the patient. The patient must have a TSH and thyroxine level within 3
months of the dose change to ensure that the patient does not become
hyperthyroid, or hypothyroid.
- Thiazide (Stable dosage of thiazide for >=3 consecutive months)
All patients must stop the following therapies at least 4 weeks before starting the
stabilization period and will remain off these therapies for the remainder of the
clinical study. The informed consent must be signed prior to the washout of any
therapy. Screening laboratories must be performed only after the washout is complete.
However, imaging studies (BMD, X-rays) may be performed prior to starting the
calcitonin, estrogen, or Selective Estrogen Receptor Modulation (SERM) washout.
· Calcitonin
- Estrogen replacement therapy by oral, transdermal, or intramuscular
administration
- Vaginal application of estrogen-containing creams (If conjugated estrogen or
estradiol: <=0.5 g twice each week [total of 1.0 g weekly] this medication is
allowed)
- SERM drugs, e.g., tamoxifen, raloxifene, Evista
- Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc)
protein, monoclonal antibody against tumor necrosis factor (e.g., remicade
[infliximab]
- Medication known to affect the metabolism of bone (the Principal Investigator
should discuss this with the PMO before the patient is excluded from enrollment).
E. Miscellaneous Concurrent Medications
· Methotrexate,which interferes with DNA synthesis, repair and cellular replication.
· Immunomodulatory agents with antiproliferative activity.
· Intra-articular injections
- Patients may receive a maximum of 1 intra-articular injection (ONE JOINT ONLY) every
6 months while participating in this study. The dose of corticosteroid injected should
not exceed the anti-inflammatory equivalent dose of Prednisone 40-mg suspension. The
dose and volume should be adjusted downward as appropriate to the size of the joint.
F. Laboratory Values and Physical Examination Findings:
-For laboratory values, the levels shown below are the upper limits for exclusions
based on specific test results. For weight, the limit is the lower limit.
· Serum calcium >10.7 mg/dL (>2.67 mmol/L)
· Serum creatinine > 1.5 mg/dL (132.6 µmol/L)
· Urinary calcium to creatinine ratio >=1.0 (mmol/mmol)
- Total serum alkaline phosphatase >130 U/L (Serum total alkaline phosphatase value
given is for the U.S.; >311 U/L (Argentina), >159 U/L (Mexico).
- Body weight <40 kg
G. Substance Abuse:
· Subjects are excluded for a history of alcohol and/or drug abuse as determined by
the investigator
H. Compliance:
Subjects are excluded if they exhibit suspected or confirmed poor compliance in
completing clinical study evaluations and/or clinical study required questionnaires.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Calcium Supplementation in Postmenopausal Women | NCT00172172 | Entailment |
4,855 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Patients with pituitary Cushing's disease within the two months prior to study entry
- Patients for whom written informed consent to participate in the study has been
obtained
- Female patients of child bearing potential who have not undergone clinically
documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use
barrier contraception throughout the course of the study, and for one month after the
study has ended
Exclusion Criteria:
- Female patients who are pregnant or lactating
- Patients who have been previously treated with certain medications may be required to
be without certain medications prior to entering the study
- Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or
HgbA1C > 10
- Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or
history of acute MI less than one year prior to the study entry or clinically
significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg
or greater)
- Patients with chronic liver disease
- Patients with clotting disorders or abnormal blood counts
- History of immuno-compromise, including a positive HIV test result
- Patients with active gall bladder disease
- Patients who have participated in any clinical investigation with an investigational
drug within 1 month prior to dosing
- Patients with active malignant disease (with the exception of basal cell carcinoma or
carcinoma in situ of the cervix)
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 | A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease | NCT00088608 | Entailment |
4,319 | 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:
- Age 18-90 years
- Dyspnea or/and peripheral edema
- Informed consent
Exclusion Criteria:
- Renal insufficiency with creatinine > 2.8mg/dl
- Anemia (hemoglobin < 8.0mg/dl)
- 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 90 Years | NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema | NCT00143793 | Entailment |
278 | 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 18-50 years, inclusive;
- General good health (by volunteer history and per investigator discretion) without any
clinically significant systemic disease (including, but not limited to, significant
liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease,
osteoporosis or bone disease, and type 2 diabetes);
- Currently having regular menstrual cycles, if not on hormonal (including continuous)
contraception, by volunteer report and per investigator discretion;
- History of Pap smears and follow-up consistent with American Congress of Obstetricians
and Gynecologist (ACOG) practice guideline #109 (see study manual) or willing to
undergo a Pap smear at Visit 1. (Note: See study manual for clarification of
eligibility criteria specific to Pap smear results.)
- Willing to abstain from the use of any vaginal product other than the study gel
including spermicides, lubricants, vaginal hygiene products, contraceptive
intravaginal ring, diaphragms, and cervical caps (non-hormonal IUC if used as her
method of contraception, is allowed) for the duration of the study;
- In a monogamous relationship for at least the last four months with a male partner, at
least 18 years old with no known risks for STIs, and not known to be HIV positive, who
is willing and able to comply with the study requirements, and with whom condoms are
not typically used;
- Protected from pregnancy by sterilization of either partner, use of combination oral
contraceptives or patch for at least two cycles, or non-hormonal intrauterine
contraception throughout the study. Continuous oral contraceptives are allowable if
the patient is at low risk for breakthrough bleeding;
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection;
- Negative urine pregnancy test; and
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol.
Exclusion Criteria:
- History of hysterectomy;
- Currently pregnant or within two calendar months from the last pregnancy outcome.
Note: If recently pregnant must have had at least two spontaneous menses since
pregnancy outcome;
- Use of Depo-Provera in the last 120 days;
- Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study;
- History of sensitivity/allergy to any component of the study product, topical
anesthetic, or allergy to both silver nitrate and Monsel's solution;
- In the last six months, diagnosed with or treated for any STI or pelvic inflammatory
disease. Note: Women with a history of genital herpes or condylomata who have been
asymptomatic for at least six months may be considered for eligibility;
- Symptomatic vulvovaginal candidiasis, Nugent score greater than equal to 7 at
screening or symptomatic bacterial vaginosis (BV) at Visit 2, or symptomatic urinary
tract infection (UTI);
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis;
- Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
vesicles suspicious for a sexually transmitted infection;
- Positive test for HIV;
- Positive test for Hepatitis B surface antigen (HBsAg);
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy;
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.);
- Known current drug or alcohol abuse which could impact study compliance;
- Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS
Table for Grading the Severity of Adverse Events;
- Systemic use in the last two weeks or anticipated use during the study of drugs on a
daily basis that may reduce renal function (e.g., ibuprofen) or liver function (e.g.,
Tylenol®), or that may affect anti-HSV activity (e.g., acyclovir or valacyclovir) of
any of the following: corticosteroids, antibiotics, antifungals, antivirals (e.g.
acyclovir or valacylovir) or antiretrovirals (e.g. Viread®). Note: Participants should
avoid nonsteroidal anti-inflammatory drugs (NSAIDs) except for treatment of
dysmenorrhea during menses. Participants may use Tylenol® on an as-needed but not
daily basis during the study
- Participation in any other investigational trial (device, drug, or vaginal
trial)within the last 30 days for this study or planned participation in any other
investigational trial during the study;
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days; and
- Abnormal finding on laboratory or physical examination or a social or medical
condition which, in the opinion of the investigator, would make participation in the
study unsafe or would complicate interpretation of data.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel | NCT01369303 | Contradiction |
4,332 | 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:
- Normal volunteers without a cancer diagnosis.
- No contraindications to the use of CPAP
- Facial injury or deformity preventing wearing facial mask
- Recurrent vomiting
- Chronic cough with phlegm
- Previous pneumothorax
- Facial lacerations or fractures
- Recent tracheal or esophageal anastomosis
- Recent GI surgery (last 90 days).
- 18-90 years of age
- Ability to sign informed consent
- Hebrew or English speakers
Exclusion Criteria:
- Contraindications to CPAP
- Facial injury or deformity preventing wearing facial mask
- Recurrent vomiting
- Chronic cough with phlegm
- Previous pneumothorax
- Facial lacerations or fractures
- Recent tracheal or esophageal anastomosis
- Recent GI surgery (last 90 days).
- Under age 18 or above age 90 years
- Inability to sign informed consent
- Members of special populations (mental illness, pregnant women, prisoners, not legally
competent).
- History of severe active restrictive or obstructive lung disease (as defined as at
least one hospitalization over previous two years)
- Any medical condition requiring an inpatient hospitalization for more than 72 hours
over the previous 2 years, aside from elective surgery.
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 90 Years | Effect of CPAP on Breath Hold and Chest Movement in Normal Volunteers | NCT02545686 | Contradiction |
6,688 | 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:
- Healthy
- Require a simple tooth extraction
Exclusion Criteria:
- Use of previous aspirin or NSAID
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 80 Years | Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population | NCT00405613 | Contradiction |
6,544 | 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. Age ≤12 years at the time of signing the informed consent
2. Male patients with severe (<1%) or moderate (<2%) hemophilia A
3. History of a high titer (>5 BU) inhibitor
4. Within 1 year of successful ITI, according to ISTH definitions (inhibitor titer <0.6
BU, recovery more than 60% of expected, and half-life of >6 hours). Successful ITI has
been achieved with any FVIII concentrate.
5. Currently on emicizumab or willing to alter their prophylaxis treatment to emicizumab
per study protocol.
Exclusion Criteria:
1. Age >12 years at the time of signing the informed consent
2. Partial tolerance (not meeting criteria for complete tolerance per ISTH)
3. History of anti-drug antibodies to emicizumab
4. Unwilling to receive exposure to intravenous FVIII concentrates.
5. History per the investigator's discretion of non-compliance to prior therapy.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 12 Years | Preventing Inhibitor Recurrence Indefinitely | NCT04621916 | Contradiction |
1,534 | 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. Orthopedic specialist diagnoses tearing of the triangular fibrocartilage complex and
undergoes arthroscopic surgery
2. Age between 19 and 60 years old
Exclusion Criteria:
1. serious heart rhythm
2. epilepsy
3. Severe pulmonary heart disease
4. History of mental illness
5. received acupuncture treatment 1 month ago
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 60 Years | Electroacupuncture Improves Pain and Wrist Functionality | NCT04178265 | Contradiction |
537 | 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:
- Female age ≤ 37 years
- BMI 18-29 kg/m2
- Regular cycle (25-35 days)
- Standard indication for IVF
- No major uterine abnormalities
- Written informed consent
Exclusion Criteria:
- Indication for IVF male factor with a total motile sperm count < 20x106
- ICSI or andrological indication
- Known abnormal (male or female) karyotype
- Oocyte donation
- One previous IVF treatment not resulting in embryo transfer
- History of recurrent abortion
- Medical contra indication for pregnancy or IVF treatment
- Relevant systemic disease
- Active substance abuse
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 37 Years | A Study of the Effects of a Novel Ovarian Stimulation Regimen on Embryo Aneuploidy Rates in In Vitro Fertilization (IVF) | NCT00866008 | Contradiction |
3,427 | 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:
- Risk factors and diagnosis of dyslipidemia according to the AGLA-recommendations (see
appendix B) at screening
- LDL-C < 6.0 mmol/l
- Triglyceride level < 5.0 mmol/l.
Exclusion Criteria:
- Subjects receiving higher than "usual maintenance" doses of Lipid Lowering Therapy
(LLT) 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 18 Years old.
Subject must be at most 80 Years | A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol | NCT00136942 | Entailment |
6,974 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Age 50 and older
- Diagnosis of dementia
- Rating 15<MMSE<24
- The patient has reliable caregivers
- Signed consent form to participate in the study after informed by reliable caregivers
of the patient or another witness
- The patient is on treatment with donepezil for at least one month prior to joining the
clinical trial
Exclusion Criteria:
- Severe gastrointestinal, kidney, hepatic, endocrine, pulmonary, or hematologic
disease.
- Other primary psychiatric or neurological disorder.
- Clinically significant laboratory and ECG abnormalities.
- Participation in another clinical study than this
- Refusal to sign the consent form to participate in the study after informed by
reliable caregivers of the patient or another witness
- The patient is on treatment with donepezil for less than a month before its
integration in the clinical study
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.
Subject must be at most 95 Years | ADVANCE Study: Alzheimer Disease eVAluation iN Clinical PracticE | NCT01772095 | Entailment |
5,562 | 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 less than or equal to (</=) 8 years (females) or </= 10 years (males) as
determined by x-ray of the left hand and wrist obtained within six months before
enrollment
- Prepubertal males and females by physical exam
- Naive to rhGH therapy
- Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable
etiology for short stature
- Height standard deviation score (Ht SDS) </= -1.5 (</= 5th percentile) for IGHD
participants; Ht SDS </= -2.25 (</= 1.2 percentile) for ISS participants
Exclusion Criteria:
- Short stature etiologies other than IGHD or ISS
- Participants receiving chronic corticosteroid therapy (greater than [>] 3 months) for
other medical conditions
- Participants with active malignancy or any other condition that the investigator
believes would pose a significant hazard to the participant if rhGH were initiated
- Females with turner syndrome
- Any previous rhGH treatment
- Participation in another simultaneous medical investigation or trial
- Pediatric participants with closed epiphyses
- Participants prescribed rhGH doses outside the variance of NCGS control participant
dosing
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 14 Years | A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device | NCT01243892 | Contradiction |
1,133 | 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:
- Each patient that comes from the Emergency room and/or in office doctors visit
(Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience
(T-LOC)
Exclusion Criteria:
- Patients younger than 15 years old
- Pregnant women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
| Applicability of Syncope Guidelines in Cataluña | NCT01721369 | Entailment |
1,074 | 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:
1. POTS patients referred for day to day orthostatic intolerance with greater than 3
symptoms for greater than 3 months and will have the diagnosis of symptomatic postural
tachycardia made during a screening tilt table test :
- dizziness
- nausea and vomiting
- palpitations
- fatigue
- headache
- exercise intolerance
- blurred vision
- abnormal sweating heat.
2. Vasovagal Syncope patients will have at least 3 episodes of fainting episodes in the
past year.
3. Healthy control subjects
Cases will be between the ages of 14 and 29 years old Cases will have normal physical
examination, and normal electrocardiographic and echocardiographic evaluations.
Only those free from heart disease, and from systemic illness will be eligible to
participate.
This excludes patients with illnesses and disease states known to be associated with
endothelial cell dysfunction such as diabetes, renal disease, congestive heart failure,
systemic hypertension, acute and chronic inflammatory diseases, neoplasm, immune mediated
disease, trauma, morbid obesity and peripheral vascular disease.
At the time of testing all patients and control subjects must refrain from vasoactive drugs
for two weeks. Please check with us about any medication that you are taking.
Exclusion Criteria:
- Cardiovascular causes of syncope
- An active medical condition that may explain the diagnosis
- A previous medical condition with undocumented resolution that may explain the
diagnosis
- Past or present major psychiatric disorder
- Substance abuse within 2 years before onset of symptoms.
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 29 Years | Mechanisms of Vasovagal Syncope | NCT01791816 | Contradiction |
2,583 | 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:
- adult male
- symptomatic and palpable inguinal hernia
- open, elective, primary unilateral inguinal hernia repair
Exclusion Criteria:
- bilateral inguinal hernia repair
- BMI >35
- chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes,
severe liver disease or COPD
- chronic prostatitis, orchitis, testicular pain
- local or systemic infection at time of repair
- known collagen disorder
- chronic pain syndrome or under active pain management
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Strattice in Repair of Inguinal Hernias | NCT00681291 | Contradiction |
1,384 | 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:
1. Infants and Children With Constipation
2. Postoperative infants and children with Hirschsprung's disease
3. Good compliance
Exclusion Criteria:
1. Infants and Children With Constipation
2. Poor compliance
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Month old.
Subject must be at most 14 Years | Anal Dilatation for Infants and Children With Constipation | NCT02255747 | Entailment |
3,698 | 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:
- Males and females 60 to 100 years of age
Exclusion Criteria:
- Knee joint replacement surgery
- Diabetes mellitus
- Uncontrollable hypertension
- Neuropathies of the lower extremity
- Poor mental cognition (i.e., inability to follow instructions)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
| Effects of Strength Training on Knee Osteoarthritis | NCT00000406 | Contradiction |
449 | 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. Gestational age more than 28 weeks the gestational age was determined based upon the
date of the first day of last normal menstrual period and confirmed by ultrasound scan
during the 1st trimester
2. Women at high risk for primary atonic postpartum hemorrhage
- Over distended uterus
- Large fetus
- Multiple fetuses
- Hydramnios
- Distension with clots accidental hemorrhage
- Exhausted myometrium
- Prolonged labor
- Oxytocin or prostaglandin stimulation
- Chorioamnionitis
- Previous uterine atony
- Placenta previa
- Marked anemia
Exclusion Criteria:
1. Cervical tear
2. extensive birth canal tear
3. Postpartum hemorrhage
4. Retained placenta
5. Coagulopathy
6. Chronic medical illness hepatic renal
7. Pregnancy induced hypertension PIH
8. Refusal to participate in the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 49 Years | Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery | NCT02136719 | Contradiction |
43 | 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:
- Documented hypothalamic or pituitary hormone deficiency
- Testosterone deficiency, defined as total serum testosterone less than 250 ng/dL at
two 8 AM readings
- Growth hormone deficiency, defined by either of the following:
- For subjects who have thyroxine and cortisol deficiencies, either a subnormal
age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL
- For subjects who do not have thyroxine and cortisol deficiencies, either a subnormal
age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL
- Duration of testosterone and growth hormone deficiencies of two years or more
- Replacement of cortisol and/or thyroxine deficiencies
- Able to give informed consent
Exclusion Criteria:
- Current testosterone treatment or treatment during the two years prior to study entry
- Current growth hormone treatment or treatment during the three years prior to study
entry
- Use of other prescription or over-the-counter androgens (androstenedione, DHEA),
estrogens, or antiandrogens (spironolactone, ketoconazole)
- Diseases that could influence bone, such as hyperparathyroidism
- Medications that could influence bone, such as anticonvulsants or glucocorticoids
(prednisone greater than 20 mg/day for longer than 2 weeks/year). Calcium and
over-the-counter vitamin D supplements are allowed.
- Cancer that could limit life expectancy to fewer than 5 years
- Neuromuscular disease or history of stroke with residual neurological defect
- Severe or uncontrolled psychiatric illness or dementia
- Noncancerous enlargement of the prostate gland (American Urological Association
symptom score greater than 21)
- Prostate cancer by history, prostate nodule on digital rectal exam (DRE), or prostate
specific antigen (PSA) greater than 4
- Current alcohol or drug dependence
- Heart failure (New York class III or IV)
- Unstable angina
- Myocardial infarction within 3 months of study entry
- Liver disease (ALT greater than 3 x normal)
- Renal disease (serum creatinine greater than 2.5 mg/dl)
- Diabetes mellitus (glycosolated hemoglobin greater than 8.0%)
- Hypertension (systolic BP greater than 160 or diastolic BP greater than 100 mm Hg)
- Hematocrit greater than 48%
- Weight greater than 300 pounds
- Poor quality scan at baseline even when repeated
- Untreated, severe, obstructive sleep apnea (Epworth sleepiness score greater than 10)
- Unable to undergo an MRI because of a cardiac pacemaker or ferrometallic objects in
the body
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Testosterone and Growth Hormone for Bone Loss in Men | NCT00080483 | Contradiction |
3,451 | 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:
- Filled and poorly adherent (defined as a PDC < 80%) to medication for hyperlipidemia,
hypertension, or diabetes
- Suboptimal average adherence to all of the qualifying medications that a patient has
filled (defined as combined (average of averages) PDC < 80%)
- For patients with hypertension or diabetes, poor or worsening disease control
(according to relevant clinical targets)
Exclusion Criteria:
- Patients with <6 months of continuous enrolment in the health plan
- Patients with no available contact information
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 | Tele-Pharmacy Intervention to Improve Treatment Adherence | NCT02512276 | Entailment |
4,893 | 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. Subject is informed and has been given ample time and opportunity to think about
his/her participation and has given his/her written informed consent
2. Subject is ≥18 years of age
3. Subject's health status: individual is considered to be healthy (hypertension and
hypotension is permissible. Other stable diseases at the time of testing are also
permissible)
4. Subject is capable of undergoing controlled hypoxaemia to the levels called for the in
the protocol with minimal medical risk (unless only participating in the blood
pressure study).
Exclusion Criteria:
1. Subject cannot expose their face fully for a reading to be taken
2. Subject is unable to give informed consent
3. Subject is outside of the specified age range
4. Subject has already taken part in the study (all 4 sub studies)
5. Subject with significant irregular heart rhythm or any disease that might affect the
results of the study
6. Subject is not capable of undergoing controlled hypoxia and would be placed at undue
medical risk if this occurred
7. Subject has any contraindications identified that would deem them unsuitable to take
part
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application | NCT03998098 | Contradiction |
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