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5,150 | 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:
- Patient identified as being at an increased risk of osteoporosis by the data capture
system
Exclusion Criteria:
- Known osteoporosis.
- Patients treated with alendronate.
- Patients below 25 years of age.
- Bone metastasis.
- Terminal disease.
- Severe dementia or other disease or condition that is incompatible with participation.
- Bone mineral density scan within the past 3 years.
- Errors in their ICPC coding that leads to the patient being misclassified as having an
increased risk of osteoporosis.
- Patients not wanting to participate.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
| Screening for Osteoporosis in General Practice | NCT02220699 | Contradiction |
5,949 | 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:
- Healthy volunteers in the age between 19 and 50 years old.
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
- After fully hearing and understanding the details of this clinical trial, Subjects who
have willingness to sign of informed consent before the screening.
- Subject who are eligible from physical examination, clinical laboratory test by
investigators judgment.
Exclusion Criteria:
- Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps,
gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or
gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect
the safety and pharmacokinetic evaluation of test drug.
- Subjects who have a history of hypersensitivity or clinically significant
hypersensitivity to investigational product or the same component or other drugs
(aspirin, antibiotics, etc.).
- Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper
limit of normal range from screening laboratory results before randomization.
- Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within
a month before the screening visit or who cannot abstain during the hospital stay.
- Heavy smoker (>10 cigarettes/day).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 50 Years | Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers | NCT04324905 | Contradiction |
3,107 | 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:
- diagnosis of moderate to severe dry eye syndrome with or without Sjögren's syndrome
- receiving treatment with topical cyclosporine (Restasis)
- experience one or more moderate dry eye-related symptoms, including dryness, foreign
body sensation, burning, blurred vision, photophobia, and soreness or pain
Exclusion Criteria:
- history of ocular disorder including non-dry eye ocular inflammation, glaucoma,
contact lens use
- trauma or surgery, including punctal plug insertion within the prior 3 months
- any uncontrolled systemic disease or significant illness
- use of topical ophthalmic medications that could affect dry eye syndrome
- pregnancy, lactation, or considering a pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease | NCT01072526 | Contradiction |
5,887 | 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:
- Patients with age of 20-75 years old (inclusive) in Taiwan of both genders
- Out-patients who had been diagnosed as non-erosive gastroesophageal reflux disease
(NERD)
- Patients with heartburn or regurgitation (either one) as main symptom at least 2 days
a week and had been present for > or = 1 month before screening
- Patients with heartburn or regurgitation (either one) during the 7 days screening
period, either with frequency for > or = 4 days of mild symptom, or for > or = 2 days
of moderate to severe symptom
- Patients have signed the informed consent form
Exclusion Criteria:
- Patients with erosive gastroesophageal reflux disease (GERD), Barrett's esophagus or
esophageal stricture
- Patients with active or healing gastroduodenal ulcer (except scars)
- Patients with history of gastric, duodenal or esophageal surgery
- Patients with malignant disease of any kind
- Patients with intrahepatic stone, gallstone, gallbladder sludge, hepatic or pancreatic
carcinoma as evidenced by abdominal ultrasonography
- Patients with ischemic heart disease as evidenced by electrocardiogram
- Female patients who are pregnant or nursing mother
- Patients with a history of allergy to any of the study drugs or their related
compounds
- Patients with a history of alcohol or drug abuse
- Patients with clinically significant liver disease (aspartate aminotransferase (AST),
alanine aminotransferase (ALT)>2 upper limits of normal)
- Patients with clinically significant renal disease (serum creatinine >1.5 mg/dl)
- Patients taken a proton pump inhibitor (PPI) within 14 days before screening, or a
H2-blocker, prokinetic agent or antacid within 7 days before screening
- Patients participated any investigational drug trial within 4 weeks before screening
- Patients with any other conditions or diseases that investigator considers it is not
appropriate to enter 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 20 Years old.
Subject must be at most 75 Years | Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease | NCT01338077 | Contradiction |
408 | 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 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 diabetes) and with an intact gastrointestinal tract,
uterus, and cervix.
- Currently having regular menstrual cycles (approximately 26-35 days) by participant
report
- History of Pap smears and follow-up consistent with standard clinical practice as
outlined in the Study Manual or willing to undergo a Pap smear at Visit 1
- Protected from pregnancy by one of the following:
- Sterilization of either partner
- Abstinence from vaginal intercourse
- Consistent use of non-spermicidal condoms
- Willing to abstain from use of vaginal products (other than the study product and
condoms) including tampons (except for menses), spermicides, lubricants, and douches
for the whole study
- Willing to abstain from any vaginal and anal intercourse/activity starting 48 hours
before cervical mucus collection, as possible, and 48 hours before Visits 4 and 29,
and for 5 days after tissue collection
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- Negative urine pregnancy test
- P4 ≥3 ng/ml
- Willing to give voluntary consent and sign an informed consent form
- Willing and able to comply with protocol requirements
Exclusion Criteria:
- BMI ≥ 30 kg/m2
- 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 any hormonal contraceptive method in the last 3 months (oral, transdermal,
transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of Depo-Provera in the last 10 months
- Use of copper IUD
- 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 products, topical
anesthetic, or to both silver nitrate and Monsel's solution
- Contraindication to LNG
- In the last three 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.
- Nugent score greater than or equal to 7 or symptomatic bacterial vaginosis (BV) as
defined by Amsel's criteria
- Positive test for Trichomonas vaginalis (TV), Neisseria gonorrhea (GC), Chlamydia
trachomatis (CT), HIV-1, or Hepatitis B surface antigen (HBsAg)
- Known bleeding disorder, including deep vein thrombosis (DVT) and pulmonary embolism
(PE), or those that could lead to prolonged or continuous bleeding with biopsy
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding,
discharge, etc.)
- Known current drug or alcohol abuse which could impact study compliance
- Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS,
National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the
Severity of Adverse Events, or clinically significant laboratory abnormality as
determined by the clinician
- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, anticoagulants or other drugs known to
prolong bleeding and/or clotting, antifungals, or antivirals or antiretrovirals (e.g.
acyclovir, valacyclovir, Viread®, Atripla®, Emtriva®, or Complera®), or CYP3A4
inducers or inhibitors as detailed in the Study Manual (e.g., St. John's Wort or
erythromycin).
Note: Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) except for
treatment of dysmenorrhea during menses. Participants may use acetaminophen on an as-needed
but not daily basis during the study.
- Participation in any other investigational trial with use of a drug/device within the
last 30 days or planned participation in any other investigational trial with use of a
drug/device during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina, or cervix within the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition in the volunteer 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 | Safety, PK, and PD Study of IVRs Releasing TFV and LNG | NCT03279120 | Contradiction |
4,302 | 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. Healthy males or females aged between 18-40 years.
2. Willing and able to complete all study procedures, visits and restrictions.
3. Capable of giving written informed consent.
4. Has been determined healthy by medical history, physical and vital signs examinations.
5. Has normal results for the following screening tests: complete blood count (CBC),
sodium, potassium, blood urea nitrogen (BUN), serum creatinine, fasting blood sugar
(FBS), creatine kinase, total calcium, cholesterol, triglyceride, total protein, total
bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
phosphatase (ALP) and urinalysis.
6. Females of reproductive potential (defined as women who have not been postmenopausal
for at least 24 consecutive months [i.e., who have had menses within the preceding 24
months], or women who have not undergone surgical sterilization; specifically
hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal ligation), must have
a negative serum or urine pregnancy test with a sensitivity of at least 40 mIU/mL at
Screening and prior to drug dosing on Day 1.
7. All participants must agree not to participate in a conception process (e.g., active
attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
If participating in sexual activity that could lead to pregnancy, the participant must
agree to use two reliable methods of contraception simultaneously while receiving
study treatment and for 6 months after stopping study drug. Subjects must either be
abstinent or a combination of TWO of the following methods MUST be used appropriately:
- Condoms (male or female) with or without a spermicidal agent;
- Diaphragm or cervical cap with spermicide;
- Intrauterine device (IUD);
- Hormonal-based contraception. Participants who are not of reproductive potential
(women who have been postmenopausal for at least 24 consecutive months or have
undergone hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal
ligation or men who have documented azoospermia) are eligible without requiring
the use of contraceptives. Acceptable documentation of sterilization, menopause
or male partner's azoospermia must be provided; serum follicle stimulating
hormone (FSH) measurement can be used to document menopausal range.
Exclusion Criteria:
1. Hepatic or kidney disorders or any other disease or disorder which may in the opinion
of the Investigator interfere with the results of the study or threaten the health of
volunteers.
2. Clinically significant ECG abnormality according to ECG exam at Screening, subject's
medical history or family history judged by the Investigator that the presence of, or
an increased risk of cardiac abnormality.
3. Positive result for HIV, HCV or HBV at Screening.
4. Positive result for illicit drugs screen (opiates, amphetamines, cannabinoids or
cocaine) or alcohol screen at Screening.
5. Active alcohol or and/or drug abuse that, in the opinion of the site investigator,
would interfere with adherence to study requirements.
6. Received the excluded medications (as shown in Appendix 3) within 14 days or 28 days
prior to the first dose of study drug, or within the 5 half-lives of individual
medication, whichever is longer.
7. Participated in a clinical study and received any investigational drug or vaccine or
medical device within 90 days prior to the first dose of study drug.
8. Pregnancy or breast feeding, male partners of pregnant females. Inability to
understand the Protocol or follow its instructions.
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 40 Years | Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers | NCT03730311 | Entailment |
3,438 | 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. | Any participants over 21 years of age and under 80 who do not have an end-stage disease
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 80 Years | Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans | NCT00018486 | Entailment |
1,502 | 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:
- Men and women over 40 years of age, who meet at least one of the following criteria:
1. have established cardiovascular disease: Coronary Artery Disease, Cerebrovascular
disease (documented stroke and/or TIA), and Peripheral Vascular Disease;
2. have Diabetes Mellitus;
3. have Chronic Kidney Disease ;
4. are at high risk for CVD based on a presence of at least three of the following
established cardiovascular risk factors: age (males ≥ 45, females ≥ 55), smoker
status, hypertension, and dyslipidemia.
- No restrictions will be imposed on the recruitment process; all practices in the
region will be eligible to participate.
Exclusion Criteria:
- see above
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.
| Improved Delivery of Cardiovascular Care Through Outreach Facilitation | NCT00574808 | Entailment |
1,817 | 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. pathologically diagnosed gastric adenocarcinoma
2. Type II and III esophageal-gastric-junction malignancy
3. AJCC stage II-III
4. No contraindications for surgery, radical resection can be expected
5. KPS>60; ECOG score:0-2
6. Expactant survival period>6 months
7. Age 20~75
8. No other major health issues
9. Lab results within 7 days before inclusion must satisfy:
1. neutrophil≥1.5×109/L
2. PLT≥100×109/L
3. hemogloblin≥90g/L
4. ALT,AST<1.5 upper limit
5. Tbil≤1.0×UNL
6. serum creatinine<1.5×UNL
7. PT-INR/PTT<1.7 upper limit
10. with measurable lesion according to RECIST1.1 criteria
11. with consent
12. co-operative
Exclusion Criteria:
1. with other major health issue
2. allergic to relevant drugs
3. experienced any other drug therapy with 4 weeks before inclusion
4. experienced any drug therapy for gastric cancer at anytime
5. diagnosed with any other malignancy within the past 5 years
6. women at child-bearing age; pregnant or breast-feeding women
7. with severe heart disease
8. with upper GI digestion or disrupted absorption
9. with peripheral neural disease
10. with transplated organs or organs having been resected for transplantation
11. known DPD deficiency
12. with uncontrolled infection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer | NCT04258657 | Entailment |
4,400 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Patients eligible for inclusion in the study will have had symptoms for at least 9
months and have failed conservative management.
Exclusion Criteria:
- Significant prior elbow trauma will be excluded alternative diagnoses that better
explain their symptoms
- Patients who have had significant prior elbow trauma or surgery
- WSIB patients
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 | Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement | NCT02236689 | Contradiction |
471 | 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:
- Women undergoing frozen embryo transfer.
Exclusion Criteria:
- Women older than 40 years
- Women who have any uterine anomaly or intrauterine pathology such as:
Endometrial polyp or/ and Large fibroid with a diameter >4 cm
- Visible hydrosalpinx on transvaginal ultrasound scans
- BMI >35
Female
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in IVF-ET | NCT04079959 | Contradiction |
3,824 | 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:
- Will be included patients older than 18 years, who have moderate to strong chronic
pain in knee on most of the days days for at least 3 months, with osteoarthritis of
the knee documented by graded radiologically at 3 to 4 in Kellgren-Lawrence rating,
refractory to medical treatment (physical therapy, oral analgesics, intra-articular
injections of hyaluronic acid or corticosteroids).
Exclusion Criteria:
- The exclusion criteria are: acute knee pain, prior surgery on the knee, another
connective tissue disease affecting the knee, psychiatric or neurological disorders,
intra-articular injection of hyaluronic acid or corticosteroid for less than 3 months,
pain related to nerve sciatic, use of anticoagulants and pacemaker.
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.
| Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial | NCT02826850 | Entailment |
2,152 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Subject meets one or more criteria for the diagnosis of gout as per the American
Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary
Gout.
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45
kg/m2.
- Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
- Subject is free of any clinically significant disease or medical condition, per the
Investigator's judgment.
Exclusion Criteria:
- Subject is unable to take colchicine for gout flare prophylaxis.
- Subject has a history or suspicion of kidney stones.
- Subject has an estimated creatinine clearance < 60 mL/min calculated by the
Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
- Subject is on unstable doses of chronic medications. Subjects taking medications for
chronic medical conditions must be on stable doses during the course of the study,
including the Screening period. Dose adjustments are allowed if deemed medically
necessary by the investigator and following discussion with the medical monitor
- Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose
linked transporter-2 inhibitors are permitted if the dose is stable for at least 14
days prior to study medication dosing.
- Subject is unable or unwilling to comply with the study requirements or has a
situation or condition that, in the opinion of the Investigator, may interfere with
participation in the study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | RDEA3170 and Allopurinol Combination Study in Gout Subjects | NCT02279641 | Contradiction |
3,596 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- 18 years or older
Exclusion Criteria:
- history of nasal surgery, currently using topical nasal steroid spray, over the
counter decongestant, history of recurrent epistaxis or history of nosebleed within 2
weeks prior to data collection, currently pregnant
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 | Analysis of Impact on Nasal Obstruction by Commercially Available Internal Nasal Stents | NCT00683254 | Contradiction |
2,417 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion criteria (DMD):
1. Genetically or histologically established diagnosis of DMD
2. Male, age 2 - 30
Inclusion criteria (Control):
1. Male, age 2 - 30
Exclusion criteria (DMD):
1. Presence of implanted pacemaker or other electrical device
2. Presence of a superimposed neuromuscular or other medical condition that substantially
impacts the individual's health
Exclusion criteria (control):
1. Presence or past history of a neuromuscular disorder or other disease that
substantially impacts health
2. Presence of implanted pacemaker or other electrical device.
Male
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 30 Years | Electrical Impedance Myography and Ultrasound as Biomarkers of Duchenne Muscular Dystrophy | NCT01491555 | Entailment |
4,672 | 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:
- Women aged 18 or older
- Heterosexual
- Experiencing regular menstrual cycles (not more than 1 missed menstrual period in the
past 6 months).
- Currently involved in a stable, sexually active relationship.
- Fluent in the English language.
Exclusion Criteria:
- Self-report of sexual aversion or distress; or of distress related to a history of
unwanted or coercive sexual contact.
- Perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6
months; or currently pregnant, breastfeeding, or having breastfed within the past 3
months; or clinically significant untreated renal or endocrine disease.
- History of HIV infection or active, untreated pelvic, vaginal, or urinary tract
infection including sexually transmitted diseases such as chlamydia, genital herpes,
gonorrhea, or syphilis.
- Previous major pelvic surgery that may have caused nerve damage, including
hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder,
rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke,
pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis,
multiple sclerosis or spinal cord damage.
- Self-report of an untreated psychosis (e.g., bipolar disorder or schizophrenia).
- Women who do not use caffeine products regularly (i.e., on a daily basis).
- Women receiving any of the following medications will be excluded from the study, as
they have been shown to alter sexual function or arousal response:
Dehydroepiandrosterone (DHEA), testosterone and other androgens, estrogens (except
oral contraceptives), progesterone, tamoxifen, raloxifene, and other selective
estrogen receptor modulators (SERMs), Beta blockers or other drugs that affect the
autonomic nervous system and/or cardiovascular system, any approved or experimental
medications or treatments used to enhance the sexual response (e.g., sildenafil), and
antidepressants
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effects of Caffeine on Women's Sexual Arousal | NCT01242046 | Entailment |
2,076 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Man woman over 18 years old
- Certain or probable Idiopathic Pulmonary Fibrosis determined by a multi-disciplinary
discussion ("ATS / ERS / JRS / ALAT" 2018 criteria)
- Idiopathic Pulmonary Fibrosis with a diagnosis of less than 12 months
- Signed informed consent
- Patient affiliated to a social security scheme or universal health coverage or
benefiting from state medical aid
Exclusion Criteria:
- Known cause of Diffuse Interstitial Lung Disease (including connectivity,
Hypersensitivity pneumonitis or pneumoconiosis authenticated)
- Patient unable to answer questionnaires
- Pregnant or lactating woman
- Persons under guardianship
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.
| Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis | NCT04619199 | Entailment |
2,710 | 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:
- Hip and/groin pain more than 6 weeks
- Physically active
Exclusion Criteria:
- Systemic diseases
- Physically inactive
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain | NCT00716729 | Entailment |
6,453 | 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:
- Patients with moderate to severe facial telangiectasias referred to laser or
IPL-treatment. Severity and distribution of telangiectasias must be symmetrical
between left and right side of the face in the individual patient
- Telangiectasias may be observed in connection with rosacea, but rosacea must not
demonstrate clinical active inflammation or acne
- 18-65 years of age
- Fitzpatrick skin type I-III
- Fertile women must document non-reactive urine pregnancy test at the day of inclusion
- During the study, fertile women must be using effective birth control. Effective
contraception is defined as follows:
- Injectable, implantable or orally taken hormones;
- Intrauterine device;
- Trans-abdominal surgical sterilization;
- Sterilization implant device;
- Surgical sterilization of male partner;
- Complete abstinence from sexual intercourse for two weeks before exposure to
study medication and throughout the clinical study
- Verbal and written consent to participate in the study
- Documentation of medicine status
Exclusion Criteria:
- Clinical active dermatological disease in the face
- Wounds, dermatitis, tattoos or scars in treatment area
- Allergies to ingredients in Mirvaso
- Current treatment with monoamine oxidase inhibitors, tricyclic or tetracyclic
antidepressants which interacts with the noradrenergic transmission
- Current treatment with other systemic adrenergic receptor agonists or antagonists
- Patients with known liver or renal disease
- UV-exposure (solarium or sunbathing) or other treatment within the last month that
enhances skin pigmentation
- Use of other topical agents that may interact with treatment
- Local or systemic treatment with photosensitizing drugs
- Pregnancy and breastfeeding women
- Current participation in other clinical trials
- Patients that are considered incapable of complying with the protocol, i.e. patients
suffering from dementia, alcoholism or psychiatric conditions
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 | Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias | NCT02761174 | Entailment |
5,099 | 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:
Cases are admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric
femoral fracture.
Exclusion Criteria:
- Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a
higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g.
radius or shoulder) is acceptable.
- Regarded as moribund at admittance.
- Absence of a valid informed consent or assent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Nutritional Risk Factors for Hip Fracture: a Case Control Study | NCT01738776 | Contradiction |
5,837 | 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 years or older
- diagnosis of GERD established by either
- 24-h oesophageal pH monitoring (performed off medications) showing an abnormal
OAE (pH < 4 at least 4% of time) and/or
- an upper gastrointestinal (GI) endoscopy showing oesophagitis grade A or B in Los
Angeles (LA) classification
- presence of typical symptoms of GERD (heartburn and ⁄or regurgitation with at least
three episodes of typical symptoms per week in the absence of PPI therapy),
- adequate symptom relief obtained with PPIs,but needing maintenance with at least
standard dose.
Exclusion Criteria:
- presence of Barrett's oesophagus >3 cm and ⁄or with dysplasia and ⁄or previously
treated,
- presence of hiatus hernia >3 cm,
- presence of oesophagitis grade C or D in LA classification,
- presence of oesophageal stricture or achalasia,
- history of oesophageal or gastric surgery,
- presence of gastric or oesophageal varices,
- impossibility to stop an anticoagulant therapy or severe coagulopathy,
- any contraindication to general anaesthesia.
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 | Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease | NCT03223116 | Contradiction |
5,300 | 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:
- Healthy postmenopausal women age 50 years or older
- At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray
absorptiometry (DXA) for bone mineral densitometry that is, without fracture or
significant degenerative disease, as determined by the central imaging facility
- Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral
neck, or total hip, AND a T-score of at least < -1.0 at the lumbar spine; or A T-score
of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral
fracture;
Exclusion Criteria:
- Active hepatitis;
- Active pancreatitis;
- Unstable cardiac disease;
- Unstable pulmonary disease;
- Celiac disease;
- Hyper- or hypo-parathyroidism;
- Hyperthyroidism;
- Cushing's disease;
- Osteomalacia;
- Paget's disease;
- Osteogenesis imperfecta;
- Known blood disorders;
- History of kidney stones;
- Impaired renal function;
- Autoimmune diseases;
- Bone metastases or a history of skeletal malignancies;
- Cancer history that includes any cancer within the previous 5 years, with the
exception of squamous or basal cell carcinoma of the skin in which the lesions were
fully resected with clear margins described in a written report by a pathologist, and
the patient has had no recurrence of lesions for at least 1 year from the time of
original resection;
- Any condition or disease that may interfere with the ability to have or the evaluation
of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle
screws, history of vertebroplasty, or degenerative disease that results in
insufficient number of evaluable lumbar vertebrae, or >1 lumbar vertebral fracture in
L1-L4;
- More than 4 vertebral fractures in T4-L4;
- Bilateral hip replacements;
- Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time;
- Have received methotrexate or immunomodulatory agents with antiproliferative activity;
- With known dermatological disorders that would interfere with the study procedures or
assessments, or with a history of contact dermatitis;
- With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its
analogs, or components of the Macroflux® systems;
- Who, in the opinion of the investigator, should not participate in the study, or may
not be capable of following the study schedule for any reason; and
- Unwillingness or inability to abide by the requirements of the study.
- Have received any intravenous (IV) administered bisphosphonates in the past 24 months,
or >2 doses of IV administered bisphosphonates total;
- Use of oral bisphosphonates before randomization, including investigational
bisphosphonates, unless: <6 months of treatment and off for 6 months, or 6-12 months
of treatment and off for 2 years, or >12 months of treatment and off for 5 years;
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis | NCT00489918 | Entailment |
3,296 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
1. Male and female participants
2. Age 20-50
3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or
albinism.
4. Sight impairment criteria are as follows:
- Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.
- Visual acuity of up to 6 / 24 with a moderate reduction of field of vision
Exclusion Criteria:
1. Any physical impairment that would make use of the virtual reality headset difficult
or unsafe.
2. A history of vertigo or dizziness.
No condition on gender to be admitted to the trial.
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision | NCT04281732 | Contradiction |
4,309 | 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:
Men:
- in a partnered relationship with a female
- have been trying without success to conceive a pregnancy
- have been referred due to suspected or diagnosed male-factor infertility
- have the ability to read and write English
Female Partner:
- 18 to 40 years of age
- ability to read and write English
Exclusion criteria:
- living children, either biological or adoptive
- history of vasectomy
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 50 Years | Understanding Adaptive Challenges Associated With Male-factor Infertility | NCT02607098 | Entailment |
5,717 | 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:
- Children of either sex who are treated with NutropinAq® for the treatment of growth
failure
- Patients who are willing to comply with follow-up appointments throughout study
participation
- Written informed consent signed by both parents or by the liable parent or by the
legal guardian when applicable, and by the child when applicable
Exclusion Criteria:
- Patients not treated with NutropinAq®
- Patients with closed epiphyses
- Patients with active neoplasia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders | NCT00455728 | Entailment |
6,608 | 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:
- documented circulating FVIII level of ≤1%
- age 3 - 20 years
- may be on primary or secondary prophylaxis
- granting of informed consent
Exclusion Criteria:
- measurable inhibitor level at the time of enrollment
- ingestion of aspirin/supplement known to influence platelet function within 14 days of
blood sampling, or ibuprofen within 3 days
Male
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 20 Years | Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function | NCT02225483 | Contradiction |
1,795 | 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 older than 16 years with well-differentiated papillary or follicular
thyroid cancer stage I or II, according to the NTCTCS classification at time of
surgery
2. Patients younger than 45 years with any size of primary papillary or follicular
tumor
3. Patients older than 45 years with:
1. primary papillary tumor less than 4 cm or
2. primary follicular tumor less than 1 cm
- EXCLUSION CRITERIA
1. Patients with postsurgical thyroid remnant more than 5 g
2. Patients with distant metastases
3. Patients above 45 years of age having:
1. known cervical lymph nodes metastases
2. microscopic multifocal follicular cancer
3. microscopic extraglandular invasion of follicular cancer
4. gross extraglandular invasion of papillary or follicular cancer
4. Patients with confirmed histological subtypes of well-differentiated thyroid
cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary
cancer.
5. Pregnant or lactating women
6. Patients with renal impairment defined as repeat serum creatinine concentrations
above 1.5 mg/dl on thyroid hormone
7. Patients on chronic lithium therapy for psychiatric illness
8. Patients with current unstable cardiovascular conditions
9. Patients with severe chronic medical conditions (liver failure, severe
debilitation, dehydration, sodium depletion, any other cancer requiring therapy,
etc)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer | NCT00251316 | Contradiction |
1,342 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
1. Legally authorized representative is willing and able to provide written, signed
informed consent (with a written assent from the child when appropriate per local
requirements)
2. Willing and able to comply with study protocol per investigator judgement
3. Clinical diagnosis of achondroplasia (confirmed by the investigator)
4. Age between 0 to 8 years old at enrollment
5. Able to stand without assistance (if the child is 24 months or older)
Exclusion Criteria:
1. Have received chronic treatment (> 3 months) of human growth hormone (hGH) or other
medicinal products intended to affect stature or body proportionality at any time
2. Have received any dose of medicinal products intended to affect stature or body
proportionality within the previous 6 months of screening
3. Have received any investigational medicinal product or device intended to affect
stature or body proportionality at any time
4. History or presence of injury or disease of the growth plate(s), other than ACH, that
affects growth potential of long bones
5. History of any bone-related surgery that affects growth potential of long bones, such
as orthopedic reconstructive surgery and osteotomy (foramen magnum decompression, and
laminectomy with full recovery are allowed with minimum of 6 months of bone healing.
Limb-lengthening with full recovery is allowed with a minimum of 12 months of bone
healing.)
6. Have forms of skeletal dysplasias other than achondroplasia or medical conditions that
result in short stature or abnormal bone growth [such as severe achondroplasia with
developmental delay and acanthosis nigricans (SADDAN), hypochondroplasia, growth
hormone deficiency, Turner syndrome, pseudoachondroplasia. uncontrolled
hypothyroidism, uncontrolled diabetes mellitus, autoimmune disease requiring
corticosteroid therapy, inflammatory bowel disease, and chronic renal insufficiency]
7. History or presence of malignant disease, other than basal cell epithelioma/carcinoma
or completely resected squamous skin cancer with no recurrence for 12 months per
medical records
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 8 Years | A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia | NCT03875534 | Entailment |
4,007 | 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 (Screening Visit 1):
1. Osteoarthritis (OA) of the knee by American College of Rheumatology criteria
2. Men or women between 45-80 years of age.
3. Have documented diagnosis of primary OA of the target knee based on clinical and
radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the
tibial-femoral compartment of the target knee confirmed by standard post-anterior
weightbearing X-ray of the knee in full extension taken </= 6 months prior to Visit 1.
4. Currently taking an Nonsteroidal anti-inflammatory drug (NSAID), or acetaminophen on a
regular basis (4-7 days/ week) over last 2 weeks prior to Visit 1 and has experienced
amelioration of pain on these medications.
5. Must have a 50-foot walk test pain score of less than 40 mm on a 100 mm VAS in the
target knee at screening
6. Pain in the non-target (contralateral) knee must not be greater than 30 mm on a 100 mm
VAS on 50-foot walk test, and the target knee must be more symptomatic.
7. Willingness to stop all OA treatments.
8. Fully informed of the risks of entering the study and willing to provide written
consent to enter the study.
9. Able to understand and be willing to comply with all study requirements, particularly
the weekly injection regimen for administration of study drug.
10. Primary complaint is pain immediately following an unassisted 50-foot walk. They must
show:
1. moderate to severe pain score in the target knee as demonstrated by 40 - 90 mm
recorded on a 100 mm VAS, and
2. 20 mm increase in pain from their screening visit pain score (a "flare")
3. pain in the non-target (contralateral) knee must </= 30 mm on a 100 mm VAS
Exclusion Criteria:
1. Known hypersensitivity or allergy to any of the components of Traumeel or Zeel
2. Known hypersensitivity or allergy to acetaminophen.
3. Has body mass index (BMI) >38 kg/m2.
4. Avoidance of, or aversion to, nonprescription medications.
5. Clinical symptoms of meniscal instability or significant valgus/ varus that requires
corrective osteotomy
6. Any major injury or surgery to the target knee in the prior 12 months.
7. One or a combination of the following co-morbidities:
1. other inflammatory arthropathies, gout or pseudogout within previous 6 months
2. avascular necrosis
3. severe bone or joint deformity in target knee
4. osteonecrosis of either knee
5. fibromyalgia
6. pes anserine bursitis
7. lumbar radiculopathy with referred pain to either knee
8. neurogenic or vascular claudication
9. significant anterior knee pain due to diagnosed isolated patella-femoral syndrome
in the target knee
10. target knee joint infection or skin disorder/infection to the area surrounding
the knee within previous 6 months
11. current treatment or treatment of cancer within the previous 2 years (excluding
basal cell or squamous cell carcinoma of the skin)
8. Participated in any experimental drug or device study within the prior one (1) month
and/or IA injections six (6) months.
9. Referred pain from other joints
10. Significantly debilitating concurrent infection(s)
11. Significant ligamentous instability
12. Any prior viscosupplementation therapy (in target knee) within 6 months prior to
Screening
13. Systemic or IA injection of corticosteroids in any joint within 3 months of enrollment
14. Therapy with oral hyaluronic acid products, and/or oral pharmaceutical products
containing glucosamine and/or chondroitin sulphate and/or diacerein
15. Therapy with opioids within the last 90 days including intra-dermal delivery systems
(patches)
16. Therapy with autologous stem cells
17. Therapy with coumarins such as warfarin, Coumadin; heparin and derivative substances
including low molecular weight heparin, synthetic pentasaccharide inhibitors of factor
Xa such as fondaparinux and idraparinux; direct factor Xa inhibitors such as
rivaroxaban and apixaban; direct thrombin inhibitors such as hirudin, lepirudin,
bivalirudin, argatroban and dabigatran.
18. Concomitant inflammatory or other rheumatologic, neurological or cardiovascular
diseases which could affect the evaluation of knee pain
19. Ongoing litigation for workers compensation for musculoskeletal injuries or disorders
20. Use of alcohol of more than 4 drinks per day
21. Clinically important axial deviation (varus, valgus) greater than 15 degrees
22. Concomitant severe OA of the hip or other joints, which might interfere with the
assessments required by the study
23. Painful knee conditions other than OA (e.g., Paget's disease)
24. Hemiparesis of lower limbs
25. Significant planned surgery to lower limbs, which might interfere with the patient's
ability to comply with study requirements
26. Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular,
neurological disease that might interfere with the outcome of the study or the
patient's ability to comply with study requirements
27. Presence of infections and/or skin diseases in the area of the injection site such as
psoriasis
28. Females who are pregnant or breast-feeding or not using recognized effective
contraceptive measures. Females of childbearing potential (including those less than
one year post-menopausal) must agree to maintain reliable birth control throughout the
study.
29. Clinically significant abnormal laboratory values.
30. Patients who are likely to be non-compliant or uncooperative during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Study of Intra-articular Injections vs Placebo in Patients With Pain From Osteoarthritis of the Knee | NCT01887678 | Entailment |
6,082 | 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:
- Clinical diagnosis of Down syndrome
Exclusion Criteria:
- History of congenital cardiac defects requiring open-heart surgery
- History of gastroenterologic anomalies requiring bowel resection and/or ongoing
medical intervention
- History of leukemia or other cancer
- History of hypothyroidism requiring thyroid hormone replacement
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 24 Years | Frequency of Metabolic Syndrome in Down Syndrome Patients | NCT00864461 | Contradiction |
4,115 | 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:
- Healthy subjects:
- Normal PFT values: FEV1 > 90% predicted; and Forced vital capacity (FVC) > 90%
predicted
- Normal chest x-ray (CXR)
- Medical history: No active pulmonary symptoms (cough, shortness of breath,
sputum); Negative history of pulmonary disease; Negative smoking history (never
smoked)
- Pulmonary Disease Subjects:
- PFT values: FEV1/FVC < 70% (indicative of obstruction); and 30% < FEV1 < 50%
predicted
- CXR normal except hyperinflation
- Symptoms - chronic shortness of breath
- All test subjects, healthy and with COPD should have similar physical anthropometric
characteristics:
- Similar age with age difference less than 3 years
- Similar height (within 3-4 inches)
Exclusion Criteria:
- Any condition for which a MRI procedure is contraindicated.
- Presence of any non-MRI compatible metallic material in the body, such as pacemakers,
metallic clips, etc.
- Likelihood of claustrophobia
- Chest circumference greater than that of the helium MR coil.
- Pregnancy, by report of subject. Clinically in the Department of radiology at UVA,
self report is used when screening patients for MR scans as well as CT scans and
fluoroscopy studies. If the subject reports there is any chance of their being
pregnant a urine pregnancy test will be performed prior to any imaging.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study of Airflow in the Lungs Using Helium MRI | NCT02154568 | Contradiction |
5,690 | 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:
- Turner syndrome
- If age below 3 years, either body height below - 1 SD (standard deviation) with
average growth velocity according to chronological age or body height below 0 SD with
growth velocity below -1 SD according to chronological age
- If age above 3 years, body height below - 1 SD with average growth velocity according
to chronological age
- Measured parental height available
- Written informed consent
Female
No healthy subjects accepted to join the trial.
| Growth Response in Girls With Turner Syndrome | NCT01734486 | Entailment |
1,606 | 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:
- Adults of all races and ethnicities
- Age 21-45; BMI 20-27 kg/m2
- stable weight (+/- 10 lbs) over the previous 6 months
- Women must be pre-menopausal with regular menstrual cycles.
Exclusion Criteria:
- Regular exercise more than 3 d/wk, for 30 min measured by exercise logs and actigraphy
- normal activity levels are required throughout the study (+/-30 min/wk of baseline
level).
- Unstable, serious medical conditions
- use of medicine linked to weight gain/loss
- cancer, diabetes, or autoimmune disease
- use of illicit drugs, melatonin, diuretics or hypnotics
- current weight loss program; presence of a sleep disorder (determined by surveys and
actigraphy)
- night shift work; extreme chronotypes (extreme larks or night owls)
- habitual waking outside of 0600 h-0930h
- habitual bedtime outside of 2200h to 2400h
- sleep duration outside of 6.5 to 8.5 h/night.
- Psychiatric exclusions will be depression (Patient Health Questionnaire-9 score 9),
lifetime bipolar disorder, psychosis, or lifetime eating disorder; or any other severe
psychiatric disorder judged to interfere with study adherence as assessed by the
Structured Clinical Interview for the DSM-IV.
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 45 Years | Randomized Study of Daytime vs. Delayed Eating: Effect on Weight and Metabolism | NCT04414644 | Contradiction |
4,546 | 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:
- Women aged 20-40 years
- Women with ultrasonographic evidence of adenomyosis
- Woman complains of vaginal bleeding or pelvic pain related to adenomyosis
Exclusion Criteria:
- Women with a history of malignancy or histological evidence of endometrial hyperplasia
- any adnexal abnormality on ultrasound
- undiagnosed vaginal
- contraindication to receive Vissane or gynera .
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Dienogest for Treatment of Adenomyotic Uteri | NCT03890042 | Contradiction |
3,355 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Above 16 yrs old and less than 50 yrs old.
2. Clinically diagnosed central tympanic membrane perforations or chronic suppurative
otitis media (tubo-tympanic).
3. Dry ear: no otorrhea without medication for at least 1 month.
4. Hearing loss gap not more than 50dB
Exclusion Criteria:
1. Age less than 16 or more than 50.
2. Discharging (active) central perforations.
3. Unsafe CSOM with cholesteatoma.
4. Suspected ossicular pathology in safe CSOM if the gap > 50dB.
5. Previous ear surgery.
6. Patients unfit for surgery or having chronic medical illness.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 50 Years | Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty | NCT04687995 | Contradiction |
723 | 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:
- Ambulatory adults of either sex aged 40 to 60 years.
- Subjects with moderate OA of the knee, which can be clinically, categorized as ARA
functional Class II and III with radiological confirmation of Kellgren Lawrence Grade
II and III. (incase of bilateral OA, the knee with the more severe symptoms will be
defined as index joint)
- Subjects with OA in a flare state at the baseline defined by one of following category
of flare:
In subjects who have been receiving non steroidal anti-inflammatory drugs (NSAIDs) or
analgesic therapy for their OA, flare will be defined as having at least two of the
following three criteria while comparing screening to baseline:
1. Subject's assessment of arthritis pain VAS walking on a flat surface at baseline of ≥
40 mm;
2. Increase of ≥ 1 grade in the patients global assessment of arthritis;
3. Increase of ≥ 1 grade in the physician's global assessment of arthritis;
In subjects who are not receiving NSAID or analgesic therapy , an OA flare state will be
defined as having at least two of the following three criteria
1. Subject's assessment of arthritis pain VAS walking on a flat surface at baseline of ≥
40 mm
2. Patient's global assessment of arthritis of ''poor''; very poor
3. Physician's global assessment of arthritis of ''poor''; very poor
Exclusion Criteria:
- Subjects with any form of arthritis other than osteoarthritis.
- Administration of intra-articular or oral steroids in the past 3 month or intra
articular hyaluronic acid in the last 9 months or parenteral use of NSAIDs
- History of major chronic hepatic, cardiovascular, neurological or immunosuppressive
conditions or the presence of any infections
- Subjects with localized trauma to the lower limb
- Had received oral, intramuscular, or intra-articular corticosteroids within 8 weeks,
or intra-articular hyaluronic acid in the index joint within 6 months of study drug
administration;
- Subjects on nutritional supplement or herbal product since last one month
- Subjects otherwise judged by the investigator to be inappropriate for inclusion in 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 40 Years old.
Subject must be at most 60 Years | Study to Assess the Effect of E-OA-07 on Acute Pain Response in Subjects Suffering From Knee OA | NCT02417506 | Contradiction |
1,994 | 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. histologically proven adenocarcinoma of the stomach
2. preoperative suspicion of serosal invasion on the radiological examination
3. candidate for curative resection of the stomach with D2
4. age from 19 to 70 year old
5. Eastern Cooperative Oncology Group Performance status :0, 1, or 2
6. absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and
platelet≥100,000/microliter
7. serum Creatinine<1.5mg/dL
8. total bilirubin <2 x upper normal limit, transaminase<3 x upper normal limit
9. patients without previous administration of chemotherapeutic agent
10. patients who agreed and signed to the informed consent form
Exclusion Criteria:
1. malignancy of the stomach except for adenocarcinoma
2. history of hypersensitivity to 5-fluorouracil or mitomycin
3. concomitant infectious disease
4. active hepatitis or chronic liver disease
5. history of psychotic disorders
6. patients with disorders in the central nervous system
7. history of other malignancy within 5 years
8. history of clinically significant heart disease (congestive heart failure, symptomatic
coronary artery disease, symptomatic arrhythmia, myocardial infarction)
9. patients with increased bleeding tendency
10. pregnant or lactating female patients
11. patient who did not agreed and signed to the informed consent form
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 70 Years | Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer | NCT02205008 | Entailment |
6,605 | 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:
- Diagnosis of hemophilia A
- Age of 12 Years to 65 Years，Diagnosis of severe （defined as <1% FVIII:C documented in
medical records） or moderately severe（defined as 1%-5% FVIII:C documented in medical
records） hemophilia A .Subjects who（Age of 18 Years to 65 Years） have received or are
currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have
had >150 exposure days (EDs) with a FVIII product；The Callan (Age of 12 Years to 17)
have received FVIII products and have had>50 EDs a FVIII product.
- Subjects without a past history of, or current no factor VIII inhibitor. For
laboratory-based assessments, any Bethesda inhibitor titer Lower than the laboratory's
normal range or <0.6 BU/mL (BU:Bethesda Units ).
- Liver and kidney function in accordance with the standard
- Subjects of childbearing potential should agree to use and utilize an adequate method
of contraception throughout treatment and for at least 28 days after study is stopped
- Evidence of a personally or legally acceptable representative (legally acceptable
representative is only applicable to Callan subjects) signed and dated informed
consent document indicating that the subject has been informed of all pertinent
aspects of the study
- The part one of subjects subjects who are willing and able to comply with scheduled
visits, treatment plan, laboratory tests, and other study procedures; Subjects must be
in a non bleeding state before the administration of rFVIII on Day 1; Subjects should
not have received an infusion of any FVIII products for at least 3 days (at least 72
hours) before the administration of rFVIII on Day 1
Exclusion Criteria:
- Current FVIII inhibitor or history of FVIII inhibitor (>0.6 BU/mL )
- Diagnosed with any bleeding disorder in addition to hemophilia
- Documented Human Immunodeficiency Virus (HIV)
- Subjects anticipating elective surgery or other invasive procedure within 1 month
following study entry
- Treatment with an immunomodulatory within 30 days or 5 half lives preceding Day 1,
whichever is longer
- Subjects with known hypersensitivity to the active substance or to any of the
excipients of rFVIII. Subjects with a known hypersensitivity to Chinese Human
embryonic kidney cell proteins
- Subjects with severe anemia requiring blood transfusion
- Subjects with significant hepatic or renal impairment (alanine aminotransferase (ALT)
or aspartate aminotransferase (AST) >5 x ULN, or total bilirubin >2 x ULN or serum
creatinine >2 x ULN), prothrombin time >1.5 x ULN, platelet count <80,000 μL. History
of sensitivity to heparin or heparin induced thrombocytopenia or others
thrombocytopenia
- Patients with heart surgery history requires anticoagulation therapy; Subjects with
severe heart disease, including myocardial infarction or heart failure Grade 3 or
higher(NYHA Classification)
- Blood pressure unable to be controlled ideally(systolic pressure>150 mmHg，diastolic
pressure>90 mmHg)
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Evaluate Efficacy and Safety of Recombinant Factor VIII （rFVIII）Treatment of Severe or Moderately Severe Hemophilia A | NCT02930317 | Contradiction |
6,848 | 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:
- Skin rash typical of dermatomyositis: "lilac" rash (+/- oedemata) of upper eyelids,
periungual sign, erythematous-scaly eruption occurring over the MCP and IPP, elbow,
knees (Gottron's signs ands papules), erythema of light-sensitive areas OR
- Muscle weakness which is proximal, bilateral and objectifiable by clinical examination
≤ 4/5, and CPK≥2N (N<170).
- Increase CPK and presence of acquired myositis specific antibody
AND
-Onset of troubles ≤3 years
Exclusion Criteria:
- Pregnant female
- Proximal motive neuropathy
- Refusing participation
- Patient under 18 years old
- Adult patient under legal protection
- Patient with contraindication for MRI, pacemaker
- For all other magnetic or ironic implanted equipments, metal workers, must contact PI
to ensure their eligibility
- Ocular muscles weakness, isolated dysarthria,
- Patients suffering from toxic myopathy, amyloidosis, inherited muscular dystrophy
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.
| Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies | NCT01432613 | Entailment |
1,704 | 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:
- Women with age comprised between 18 and 45 years
- Normal uterus (evaluated trough ultrasound 2D/3D and/or hysteroscopy)
- Presence of at least one ovary
- Body mass index:
- Normoweight: 18.0-24.9 kg/m2 and non smokers
- Obese ≥30.0 kg/m2 and non smokers
- Smokers: Normoweight and smoke at least 10 cigarettes per day
Exclusion Criteria:
- Overweight=25.0-29.9 kg/m2
- Patients with Intrauterine device in the last 3 months
- Patients who had had hormonal contraceptives in the 2 previous months.
- Adnexal or uterine pathologies
- Polycystic ovary
- Existence of serious or uncontrolled bacterial, fungal or viral infections that could
interfere with the involvement of the patient in the study or in the evaluation of the
study results.
- Any disease or medical condition that could be unstable or could endanger the security
of the patient and her compliance in the study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Maternal Transcriptomic Regulation of the Preimplantation Embryo | NCT02813746 | Entailment |
3,260 | 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:
- autoimmune or infectious disease
Exclusion Criteria:
- No
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Lymphocyte Sub-populations and Auto Immune Diseases | NCT03901664 | Entailment |
470 | 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 between 20 and 35 years old.
- Body mass index between 20 - 30.
- Unexplained infertility .
- Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).
- Normal hysteroscopy ( healthy uterus with no fibroids or other growths)
- Fresh embryo transfer of 2 or more blastocysts stage.
- Embryo transfer on day 5 after fertilization
Exclusion Criteria:
- Women younger than 20 years old or older than 35 years old.
- Previous one or more failed IVF.
- Uncorrected congenital or acquired uterine anomalies.
- Other causes of infertility rather than unexplained infertility.
- Less than 2 embryo transfer, cleavage stager frozen embryo transfer.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection | NCT02987478 | Contradiction |
6,310 | 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:
- Fluent in English
- Tested positive for COVID-19
Exclusion Criteria:
- Prisoners
- Unable to provide own informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Symptom-Based Markers for COVID-19 Transmission | NCT04665245 | Entailment |
3,988 | 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:
- Symptoms of osteoarthritis of the hip or knee for a minimum of six months
- History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs,
acetaminophen or another analgesic agent on a regular basis (>= three days/week) for
at least three months before the screening visit
- History of positive benefit with acetaminophen use for osteoarthritis pain
- History (ie, at any time in the past since diagnosis) of osteoarthritis pain of the
hip or knee when not taking osteoarthritis analgesic medication
- Subjects must report a history of a pain level of moderate, moderately severe, or
severe, a WOMAC pain score >= 65 at baseline, and a 20% or greater increase in their
pain score relative to their score at screening
Exclusion Criteria:
- History of surgery, including arthroscopy, or major trauma to the study joint in the
previous six months before the screening visit
- Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence
radiographic criteria
- Signs of clinically important active inflammation of the study knee joint including
redness, warmth, and/or a large, bulging effusion with the loss of normal contour at
the screening and/or baseline visits
- Secondary osteoarthritis of the study joint including, but not limited to, septic
arthritis, inflammatory joint disease, gout, Paget's disease of bone, articular
fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly,
hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis
- History of acute inflammatory arthritis or pseudogout of the study joint.
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.
| An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee. | NCT00240799 | Entailment |
5,237 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
- Participant who has low bone mineral density
- Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the
lumber spine and hip
- Participant is ambulatory (can walk)
Exclusion Criteria:
- Participant has secondary osteoporosis or has a metabolic bone disorder other than
osteoporosis or osteopenia
- Participant has received osteoporosis medications or other medications that affect
bone
- Participant is already participating in another drug study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022) | NCT00620113 | Entailment |
5,586 | 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:
- Pre pubertal children
- Study group: BMI precentiles over 85 (overweight and obese children)
- Control group: BMI precentiles between 5-85 (normal weight children)
Exclusion Criteria:
- Children with organic Disease
- Competitive athlete
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Years old.
Subject must be at most 13 Years | The Effect of Information on Physical Fitness Measures and Training in Overweight Children | NCT03165604 | Contradiction |
3,894 | 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:
- Had unilateral or bilateral knee OA
- Knee OA K&L grade ≥ 2
- VAS = 3 cm over the previous 24 hours
- Able to walk ≥ 6-meter distances with or without an aid
Exclusion Criteria:
- Had knee or lower limb surgery
- Oral corticosteroid use (current\ 4 weeks)
- Altered sensation around knee and shoulder
- Exhibited cognitive difficulties
- Intra-articular corticosteroid or hyaluronic acid injection within 6 months
- Had leg sciatica
- Contraindication to manual therapy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis | NCT02865252 | Entailment |
4,973 | 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:
- Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms
clearly present in at least 1 upper limb; patient has had tremor present for at least
2 years prior to Screening
- Off medication, or on a stable dose of medication for their tremor for at least 28
days prior to Screening
Exclusion Criteria:
- Recent history or active clinically significant manifestations of metabolic, hepatic,
renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal,
dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological
(other than essential tremor) disorders
- Medical history of seizures
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 Years | Evaluate SAGE-547 in Patients With Essential Tremor | NCT02277106 | Entailment |
4,102 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
Group "Narcoleptic Patients":
- Type 1 or Type 2 narcolepsy
- > 18 years
- Usually followed at the Lyon Sleep Medicine Center
Group "Control":
- At least one member of each family of cases (siblings, cousins ...)
- > 18 years and of the same age as the case if possible (+/- 5 years)
- No narcolepsy
Exclusion Criteria:
- uncertain diagnosis (for the "Narcoleptic Patients" Group)
- poor knowledge of the French language
- Refusal to participate
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of Academic and Professional Trajectories of Narcoleptic Patients | NCT03173378 | Entailment |
4,686 | 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:
- Subjects in good health as confirmed by medical history, physical exam, and PAP smear
within the preceding six months
- Non-smokers, if between 35 and 45 years of age
- Patients who are not pregnant or lactating
- Had at least one normal menstrual period within 35 days prior to screening
- Completed their last term pregnancy at least 42 days prior to screening and had at
least one normal menstrual period since the last pregnancy
- Must be post-menarcheal (have had at least one normal menstrual period) and
pre-menopausal (having regular menstrual periods)
Exclusion Criteria:
- History or presence of disorders commonly accepted as contraindications to steroid
hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis,
thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary
artery disease, uncontrolled hypertension, or migraines with focal aura, benign or
malignant liver tumor that developed during the use of oral contraceptives or
estrogen-containing products
- carcinoma of any body system, diabetes mellitus with vascular involvement, known or
suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal
vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of
liver function, liver disease or renal disease
- absence of cyclic bleeding for at least three months, recent history of alcohol or
other substance abuse
- significant depression or psychiatric disease that would result in an unreliable
patients
- any subject deemed by the investigator to have questionable reliability in her ability
to comply with the protocol and provide accurate information.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen | NCT00344383 | Entailment |
3,802 | 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:
- Signed informed consent.
- 18 years of age, or older.
- Capable of completing the diary card.
- Ability to complete the HRQL questionnaires.
- A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid
arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily
NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in
any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose
aspirin (>325 mg/day).
- Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior
to baseline endoscopy and; Are expected to remain stable for the duration of the
study. and; Must be administered orally for the duration of the study. If more than
one type of NSAID treatment is used, at least one type must be given orally.)
- Hp negative by UBT, serology or biopsy based test, at visit 1.
Exclusion Criteria:
- Current, or history of, gastric or duodenal ulcer
- Current, or history of, esophageal, gastric or duodenal surgery.
- History of GERD, not associated with NSAID use.
- Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved
by defecation.
- Pain, discomfort or burning in the upper abdomen not associated with the use of
NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
- Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the
esophagus.
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.
| Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs | NCT00241527 | Entailment |
824 | 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:
- Knee pain most of the days the last month
- Over 38 years old
- Crepitus on active motion
- Morning stiffness less than 30 minutes
Exclusion Criteria:
- Not been diagnosed for current knee pain
- Non-traumatic cause due to current knee pain
- No other rheumatic, severe somatic or psychological diseases that can affect the
outcome measures.
- Not pregnant
- Does not know enough Swedish to answer questionnaires.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 38 Years old.
| A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care | NCT03822533 | Entailment |
4,416 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- aged between 18-70 years
- pain on the lateral side of the elbow for less than six months
- tenderness over the lateral epicondyle
- pain during extension of wrist and fingers
Exclusion Criteria:
- upper extremity and neck disorders
- other elbow pathologies
- presence of tendon rupture
- usage of non-steroidal anti inflammatory drugs
- joint limitations due to a previous radius/ulna fracture
- previous elbow surgery
- osteoporosis, malignancy, hemophilia, neurologic deficit(s) in the ipsilateral upper
limb
- cognitive disfunction
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 | Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Lateral Epicondylitis | NCT03944122 | Contradiction |
722 | 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:
- Age ≥ 18 years old
- Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
- Pain involving the base-of-thumb
- X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following
items involving the trapeziometacarpal joint : osteophytes, joint space narrowing,
subchondral bone sclerosis or subchondral cysts
- 1990 American College of Rheumatology classification criteria for hand osteoarthritis
adapted to base-of-thumb osteoarthritis
- Medical examination
- Written consent
- Health insurance
- For women of childbearing age, a negative urinary pregnancy test
Exclusion Criteria:
- History of thumb surgery
- History of inflammatory or crystal-associated rheumatic disease
- Neurological disorders involving the hands
- Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
- Osteoarthritis involving the scaphotrapezial joint
- Hand or wrist trauma ≤ 2 months
- Hand or wrist intra-articular injections ≤ 2 months
- Contra-indication to botulinum toxin A injection or to splinting
- Cognitive or behavioral disorders making the assessment impossible
- Participant unable to speak, read and write french
- Bilateral BTOA without predominant symptomatic side
- Pregnancy and breast feeding
- Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected
minors or adults, guardianship or trusteeship, etc.)
- Patient with epilepsy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis | NCT03187626 | Contradiction |
6,421 | 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. Subject is male or female aged 18 years or older.
2. Subject has a clinical diagnosis of facial rosacea.
3. Subject has a clinician's assessment score of moderate to severe erythema prior to
enrollment.
4. Subject has a self assessment score of moderate to severe redness prior to enrollment.
5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.
Exclusion Criteria:
1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.
2. Subjects with a condition or who are in a situation, which in the Investigator's
opinion may put a subject at risk, may confound study results, or may interfere with a
subject's participation in the study.
3. Subjects with conditions causing facial erythema which would confound the assessment
of treatment.
4. Subjects who are taking or have recently taken medications known to have interactions
with α2-adrenergic agonists.
5. Subjects with known allergies or sensitivities to one of the components of the
investigational products.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea | NCT01659853 | Entailment |
2,380 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Male
- Age 8 years to 17 years
- Non-Ambulatory (unable to complete 10m run/walk under 10s)
- Weight </=100Kg
- Diagnosis of DMD confirmed by at least one the following:
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
deficiency, and clinical picture consistent with typical DMD, or
- Gene deletions test positive (missing one or more exons) of the dystrophin gene,
where reading frame can be predicted as 'out-of-frame', and clinical picture
consistent with typical DMD, or
- Complete dystrophin gene sequencing showing an alteration (point mutation,
duplication, or other mutation resulting in a stop codon mutation) that can be
definitely associated with DMD, with a typical clinical picture of DMD, or
- Positive family history of DMD confirmed by one of the criteria listed above in a
sibling or maternal uncle, and clinical picture typical of DMD.
- Cardiac ejection fraction >55% on echocardiogram
- Use of nutritional, herbal and antioxidant supplements taken with the intent of
maintaining or improving skeletal muscle strength or functional mobility has been
discontinued at least 4 weeks prior to screening (daily multivitamin use is
acceptable).
- Glucocorticoid therapy, if used, must have a stable weight-based dose for at least 3
months prior to enrollment
- Cardiac therapy, if used, includes prophylactic ACE inhibitors, aldosterone receptor
antagonists (e.g.
spironolactone, eplerenone, etc.), and/or beta-blocker therapy, and must be stable for 3
months prior to enrollment.
- Hematology profile within normal range.
- Baseline laboratory safety chemistry profile within typical range for DMD (elevated
ALT / AST acceptable in the absence of elevated GGT, elevated CK acceptable).
Exclusion Criteria:
- Inability to complete cardiac or strength, range of motion and mobility assessments
per protocol
- Current enrollment in another treatment clinical trial.
- History of significant concomitant illness or significant impairment of renal or
hepatic function.
- Use of regular daily aspirin or other medication with antiplatelet effects within 3
weeks of first dose of study medication.
- Cardiac symptoms that, in the opinion of the investigator, may be suggestive of
imminent moderate to severe cardiac events, irrespective of LVEF.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 17 Years | Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents | NCT02964377 | Entailment |
5,992 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Patients over the age of 18 who have proven GERD (with nighttime heartburn at least 3
days a week).
2. Agree to undergo sleep positioning therapy.
3. Able to read, understand, and complete study questionnaires.
4. Have mobile phones with an operating system (Android or iOS) that supports the LEFT
device.
Exclusion Criteria:
1. Patients who are under the age of 18.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Effect of Positional Therapy on Symptoms of Gastroesophageal Reflux Disease: A Prospective Pilot Study | NCT04500288 | Entailment |
5,990 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Male or Female aged ≥18 years
2. Subjects with refractory reflux symptoms to PPIs standard treatment as follows:
2.1 Ongoing heartburn symptom with or without these GERD-related symptoms :
Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety,
Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia,
Weight loss.
2.2 Ongoing heartburn symptom with or without erosion ≥ grade A according to LA
Classification.
3. Decided to participate and signed on an informed consent form willingly.
Exclusion Criteria:
1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at
screening.
2. History of operation in esophagus, stomach or duodenum.
3. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/ pyloric
stricture, Primary esophageal spasm, Barrett's esophagus ≥ 3 cm, Zollinger-Ellison
syndrome.
4. Infectious or inflammatory bowel disease, Severe malabsorption, Severe chronic heart
failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis.
5. History of cancer within 5 years, except completely recovered skin cancer ALT or AST ≥
Upper limit of normal range X 3.
6. Need antibiotics due to severe infection.
7. Pregnant or breast-feeding women.
8. Conversation impairment because of alcohol, drug addiction or mental illness, etc.
9. Inability to record diary card
10. In 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 least 18 Years old.
Subject must be at most 90 Years | A New System for GERD Diagnosis and Treatment | NCT03600974 | Entailment |
5,573 | 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:
- Eligible for the TIGER Kids primary study
- BMI >/= 85th percentile
- Height >/= 4 feet 6 inches
- Weight < 350 pounds
Exclusion Criteria:
- Anemia
- American College of Sports Medicine (ACSM) contraindications to exercise testing
(i.e., medical history of cardiovascular or pulmonary conditions, physical conditions
that affect the ability to exercise)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 16 Years | Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary | NCT03611296 | Contradiction |
3,817 | 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:
- Patients suffering from symptomatic knee OA (uni/bi lateral) for at least six months,
fulfilling the ACR clinical criteria for OA of the knee, and having radiographically
assessed OA of the knee according to the Kellgren and Lawrence scale.
- Patients with VAS pain score of ≥3cm (measured at baseline).
- Males and females between the ages of 40-75.
- 17<BMI<40
- Ambulatory and active patients that can participate in a rehabilitation program that
includes daily walking
- Stable medical regimen (no recent changes to the pain medication within a month)
- Able to walk at least 50 meters and scored positive on the STEADI test
- Able to understand, read and sign the informed consent form
- English or Spanish speaking
Exclusion Criteria:
- Patients suffering from acute septic arthritis.
- Patients suffering from inflammatory joint disease such as rheumatoid arthritis.
- Patients with diagnosis of avascular necrosis of the knee.
- Patients with diagnosis of neuromuscular disease.
- Patients with more than 3 falls in the last 12 months, OR any fall with an injury in
the last 12 months.
- Patients exhibiting a lack of physical or mental ability to perform or comply with the
study procedure.
- Patients with a history of pathological osteoporotic fracture
- Patients with referred pain in the knees from back or hip joint symptoms.
- Patients with severe back pain, ≥ 4 cm in visual analogue scale (0-10) [1] or
radiating leg pain
- Patients with generalized body pain (both upper and lower extremities, such as
fibromyalgia
- No major surgery to the affected limb and contralateral limb (e.g. no joint
replacements or surgical fracture repair)
- No major cardiovascular comorbidities (able to enroll in an active exercise program)
- Patient started on lipid lowering medication in last 3 months
- Any change in blood pressure medications
- No recent physical therapy (no more recent than 6 months) on the affected limb
- No active heart disease (ischemia or heart failure admissions within 6 months) and no
active COPD (exacerbation within 6 months)
- No active malignancies on ongoing treatment
- Patient with neurological gait pattern
- Patient requiring assistive device during gait analysis.
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 | The Effect of AposTherapy on Knee Pain | NCT03171168 | Entailment |
813 | 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:
- Patients seeking treatment at the primary health care for problems with their joints
(pain, stiffness).
Exclusion Criteria:
- Patients diagnosed with RA
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Survivin as Predictive Biomarker for RA | NCT03444623 | Entailment |
2,053 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Any patient with malignant pleural effusion who will undergo palliative treatment with
insertion of intercostal tube.
Exclusion Criteria:
1. Patients <18 years old, unable to provide informed consent.
2. Had an allergy or other contraindication to intrapleural pleurodesis.
3. Had evidence of unexpandable lung believed by the responsible clinician to represent
insufficient.
4. pleural apposition that would preclude pleurodesis, and/or had an expected survival
of<1 month.
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 90 Years | Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion | NCT04074902 | Contradiction |
662 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
1. Male or female of 18-80 year old.
2. With blood transfusion history or RBC-transfusion-dependence.
3. BM smear and biopsy plus chromosome analysis within 3 months before signing ICF,
otherwise done during screening.
4. Excluding other diseases which might cause hematological abnormalities.
5. Serum ferritin level≥500ng/ml with no sign of active infection or malignant disease.
6. Treatment with underlying disease is permitted for non-hematological and hematological
conditions.
7. Previous iron chelation therapy like deferasirox or deferoxamine is permitted.
8. ECOG performance score ≤2
9. All subjects must: agree not to donate blood or be counseled about pregnancy
precautions and risks of fetal exposure.
10. Written informed consent.
Exclusion Criteria:
1. Patients who are under 18-year-old or over 80-year-old.
2. Prior history of other cancer unless cancer-free for ≥5 years.
Subjects with the following history/concurrent conditions may enroll at any time:
Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Prostate cancer
stage-1
3. Proved HIV-1 infection
4. Active HBV or active HCV infection.
5. Pregnant or lactating
6. Patients unwilling to or unable to comply with the protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Study of MRI Monitoring in Patients With Aplastic Anemia and Low or Int-1 Risk of MDS Complicated With Iron Overload | NCT02833493 | Contradiction |
3,030 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Intellectual disability
- Age 15-60 years
- Low physical activity
- Sedentary lifestyle
Exclusion Criteria:
- Medical contradictions for participation
- High levels of physical activity
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 60 Years | Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability | NCT04079439 | Entailment |
4,581 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | - INCLUSION CRITERIA:
1. Female
2. Between 18 and 28 years of age (inclusive)
3. Reported menarche between the ages of 11 and 14 years
4. Gynecological age of less than or equal to 14 years
5. A history of self-reported regular menstrual cycles when not on contraceptive
medication of between 25 and 35 days (inclusive) at prescreen and knowledge of
date of onset of menses before the screening visit
6. A BMI of 18.5 to 27 kg (Summation)m(2) and a weight >= 93 lbs.
7. Agrees to use barrier contraception method for the duration of the study
8. Agrees to abstain from alcohol consumption during both 5-day diet/exercise study
interventions
9. Agrees to abstain from donating blood during the study and within 30 days of
completing the study
10. Is willing and able to fulfill the requirements of the protocol and to provide
informed consent
11. Able to speak and read English
12. Lives within 50 miles of the Clinical Research Unit
EXCLUSION CRITERIA:
1. Currently lactating or pregnant or planning on becoming pregnant for the duration of
the study
2. Has ever given birth
3. History in the past 3 months of dieting or weight loss amounting to greater than 2 kg
(4.4 lbs)
4. > 4 hours per week of aerobic exercise for the past 3 months
5. Has initiated training for an athletic sport or event in the past 3 months that, in
the opinion of the investigator, may interfere with the results of the study
6. Currently using hormone-based contraception, including those administered orally,
vaginally, via injection, sub-dermally, or transdermally
7. Current use of medications or supplements that may interfere with the results of the
study, including:
i.Steroids
ii.Hormone-based contraception
iii.Sleeping pills
iv.Homeopathic substances (e.g. Chinese herbs, protein or other powders, and
other-the-counter extracts)
v.Stimulants (e.g. Ritalin)
vi.Antidepressants or anti-epileptic medications or centrally acting anti-hypertensive
medications
8. Current use of recreational drugs (alcohol intake will be monitored and excluded
during the two intervention periods)
9. Unable to consume food containing dairy or nuts
10. Has currently or has a history of any of the following: autoimmune, heart, liver,
renal disease, diabetes, or another health condition deemed by the PI to be a
contraindication to study participation. History of thyroid disorder is permissible if
the patient is biochemically euthyroid on replacement.
Additional Eligibility Criteria to be Met Prior to Start of Intervention(s):
Criteria 1 Habitual energy intake between 35-55 kcal/kg LBM*day
Criteria 2 VO2max less than or equal to 40 ml/kg/min with the option to increase this at
the discretion of the PI, depending on the current and past exercise level of the
participant
Criteria 3 Hemoglobin, prolactin and TSH within normal female range for testing laboratory.
Criteria 4 Ovulation confirmed in the cycle before each study intervention by self-reported
positive urine test, ultrasound and/or progesterone blood-levels
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 28 Years | CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study) | NCT02858336 | Contradiction |
4,766 | 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:
- Clients 18 years and older with complaint of dizziness, vertigo, and/or imbalance who
are willing to proceed with procedures of study.
- Inclusion for control group: no history of dizziness, vertigo, and/or imbalance.
Exclusion Criteria:
- Conditions that warrant immediate referral to the Emergency Department or Primary Care
Physician (undiagnosed and unstable disorders relating to cardiac, neurologic,
metabolic, etc, dysfunction); no history of dizziness, vertigo, and/or balance
problems.
- Clients with conditions that therapists believe may be aggravated by testing
including, but not limited to: variants of head injuries, migraines, seizure
disorders, panic/anxiety, claustrophobia, severe headache and/or nausea, and
hypersensitivity to sensory stimuli
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Helpfulness of the Vibration Test Performed in Room Light on Clients With Inner Ear Problems | NCT02626052 | Entailment |
3,508 | 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. Male and female children less than 6 years of age.
2. A diagnosis of adrenal insufficiency as confirmed by an inappropriately low cortisol
usually with other supporting tests.
3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without
fludrocortisone).
4. Adequately hydrated and nourished.
5. Ability of parents/carers to understand and give written Informed Consent
Exclusion Criteria:
1. Clinically evident acute adrenal insufficiency (adrenal crisis).
2. Inability of the child to take oral therapy.
3. Concomitant therapy (other than that required to treat adrenal insufficiency, Vitamin
D, Fluoride, Thyroxine and growth hormone).
4. Subjects with clinical signs of acute infection or fever on Day 1.
5. Any surgical or medical condition which in the opinion of the investigator may place
the subject at higher risk from his/her participation in the study.
6. Parents/carers of subjects unwilling to consent to saving and propagation of
pseudonymised medical data for study reasons.
7. Subjects who are dependent on the investigator or the sponsor.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 6 Years | Treatment of Adrenal Insufficiency in Children | NCT02720952 | Contradiction |
648 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Undergoing liver biopsy for suspected or known hemochromatosis
- Undergoing liver biopsy for living-related liver donation evaluation
Exclusion Criteria:
- Contraindication to MRI
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration | NCT00587535 | Contradiction |
5,249 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women aged between 45 up to 75;
- Bone mineral density T score at the lumbar spine (L1-L4), femoral neck or total hip
should be equal or less than -2.5 and equal or more than -4. (-4 ≤ T score ≤-2.5); or
patients with high risk of fracture on the basis of FRAX criteria which according to
osteoporosis treatment guidelines, need medicinal treatment.
- Ability to comprehend and willingness to sign the Informed Consent Form for this
study;
- Signed informed consent with full knowledge and mental health.
Exclusion Criteria:
- Lack of consent for being in the trial and not complying with an 18-months follow-up;
- Having hypersensitivity to denosumab or any component in the formulation (excipients
include acetic acid, sorbitol, polysorbate 20, sodium hydroxide, water for
injections);
- Malabsorption syndrome;
- History of thyroid surgery, parathyroid surgery or intestinal resection which has been
caused malabsorption.
- Patient with CKD stage 4 and 5 should be exclude (GFR <30cc/min)
- Level of serum 25-(OH) vitamin D less than 20 ng/ml; (If vitamin deficiency has been
corrected, and two tests show the level above 20 ng/ml within a month, the patient can
be enrolled.)
- Pre-existing hypocalcemia (Albumin-adjusted serum calcium level less than 8 mg/dl in
fasting specimens) which is uncorrectable;
- Untreated hypercalciuria (>250 mg/24h) and hypocalciuria (<100 mg/24h). If urine
calcium level of patient is less than 100 mg per 24 hours and by vitamin D treatment
the problem has been solved or if urine calcium level of patient is greater than 250
mg per 24 hours, but PTH is normal, the patient can be enrolled.
- Presence of osteonecrosis of jaw (ONJ) risk factors including a diagnosis of cancer,
poor oral hygiene, periodontal and/or dental diseases, having dentures; and comorbid
disorders (anemia (hemoglobin level less than 11 g/dl, if it is corrected, patient can
enter the study), history of diseases with coagulopathy, oral and dental infection);
- Malignancy;
- Having severe and active infections; (Severe infection is a difficult treated
infection, like diabetic foot infection, but if the infection is treatable, after
treatment, the patient can be enrolled.)
- Being bed rest (for 2 weeks during the past 3 months)
- A case in which the patient cannot take 1000 mg oral elemental calcium per day; (as
supplement)
- A case in which bone mineral density could not be accurately measured;
- Conditions that influence bone metabolism, including hyperparathyroidism or
hypoparathyroidism, hyperthyroidism or hypothyroidism, hypocalcemia, inflammatory
rheumatologic diseases such as rheumatoid arthritis, Paget's disease of bone,
osteomalacia that is resistant to therapy (definition of resistant to therapy: not
being responder to 1-month administration of vitamin D).
- Patients will be excluded if they have one severe or more than 2 moderate vertebral
fractures. (Severe fracture is defined as more than 50 percent vertebral height loss
and moderate fracture is defined as 25-50 percent vertebral height loss).
- Use of injectable bisphosphonates within the previous 12 months;
- Use of oral bisphosphonates within the previous 3 months;
- History of severe skeletal pain with bisphosphonates;
- Use of parathyroid hormone or its derivatives, systemic hormone-replacement therapy,
selective estrogen-receptor modulator, calcitonin, or calcitriol within 6 weeks before
study enrollment.
- Use of corticosteroids (>5 mg/prednisone daily or equivalent for ≥ 3months), in the
past 3 months and more.
- Use of heparin (more than 20,000 international units/day for 6 months and longer), in
the past 6 months and more.
- Patient that is possible to be administrated corticosteroids (>5 mg/prednisone daily
or equivalent for ≥ 3months) or heparin (more than 20,000 international units/day for
6 months and longer) in the 18 month of the study, because of her chronic disease(s)
such as allergy, asthma, coagulation disorders, should be excluded.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 75 Years | Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women | NCT03293108 | Entailment |
4,712 | 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 30-60, female
- Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom,
Increasing size, Menorrhagia) myomas or adenomyosis
- Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)
- At least a 6-month thorough follow-up record available
- Informed consent
Exclusion Criteria:
- Endometrial hyperplasia without myoma or adenomyosis
- Body Mass Index more than 30
- Huge uterus defined by longitudinal uterine diameter larger than 10cm and
anteroposterior diameter larger than 8cm in USG
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 60 Years | Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy | NCT01064128 | Entailment |
2,802 | 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:
- Subjects with definite, probable, or laboratory supported probable ALS will be
eligible.
1. ALS diagnosed as probable, laboratory supported probable or definite according to
the World Federation of Neurology El Escorial criteria [Brooks et al. 2000]
2. Age 18 or older
3. Capable of providing informed consent and complying with trial procedures
4. SOD1 mutation confirmation by study team
5. Not taking Riluzole (Rilutek) or on a stable dose for 30 days
6. Not taking Coenzyme QR10R or on a stable dose and brand for 30 days
7. Absence of exclusion criteria
Exclusion Criteria:
1. History or evidence of malabsorption syndromes
2. Exposure to any experimental agent within 30 days of onset of this protocol
3. Women who are pregnant or planning to become pregnant
4. Women of childbearing potential not practicing contraception
5. Women who are breastfeeding
6. Enrollment in another research study within 30 days of or during this trial
7. Alcoholism
8. Patients taking phenytoin (Dilantin) or other therapy affecting folate levels
9. Dementia (MMSE <22)
10. Seizure disorder
11. Folate deficiency
12. Megaloblastic anemia
13. Cardiovascular disorder/arrhythmia
14. Impaired kidney function, defined as creatinine levels of 2.5 x ULN
15. Impaired liver function, defined as AST or ALT of 3 X ULN
16. Advanced ALS patients, defined as those with any of the following: forced vital
capacity <60% (use of BIPAP is allowed); tracheostomy; or mechanical ventilation
17. Use of any of the following medications: cytosine, arabinoside, methotrexate,
daunorubicin, sulfonamides, zidovudine, lorazepam, coumadin, sulfamethoxazole, and
trimethoprim
18. Patients taking Lithium within 30 days of or during this trial
19. Incapable of providing informed consent and complying with trial procedures
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.
| SOD1 Inhibition by Pyrimethamine in Familial Amyotrophic Lateral Sclerosis (ALS) | NCT01083667 | Contradiction |
561 | 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:
- Patients who have had hydatidiform mole treated by evacuation and/or curettage and now
meet the criteria of low risk GTN, as defined by the International Federation of
Gynecology and Obstetrics (F.I.G.O.)/World Health Organization (W.H.O.) 2002 staging
and risk scoring criteria:
- A plateau in the beta-hCG assay for 4 consecutive weekly levels over a period of
3 weeks or longer; that is, days 1, 7, 14, 21; for this study, a plateau will be
defined as less than a 10% decline using as a reference the initial value in the
series of values taken over a period of 3 weeks; OR
- A rise in the beta-hCG assay of 3 consecutive measurements, or longer, over at
least a period of 2 weeks or more; days, 1, 7, 14; for this study, a rise will be
defined as an increase of greater than 20% taking as a reference the initial
value in the series of values taken over the 2-week period; OR
- When the beta-hCG level remains elevated above normal for 6 months or longer
- Patients must have a clinically significant elevated beta-hCG level of greater than 20
mIU/ml
- Patients must have non-metastatic low risk GTN with a W.H.O. 2002 risk score of no
greater than 6
- Patients must have no metastatic disease as determined by the pelvic examination,
pelvic ultrasound, and chest x-ray
- Patients must have signed an approved informed consent and Health Insurance
Portability and Accountability Act (HIPAA) authorization
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 or 1
- Patients must have histologically confirmed complete or partial mole
- Patients must agree to use an accepted method of contraception (oral contraceptives,
birth control patches, Depo-Provera, diaphragm, contraceptive foam and condom, or
male/female sterilization)
- Patients must meet pre-entry requirements
Exclusion Criteria:
- Patients who do not have persistent low-risk GTN
- Patients with any evidence of metastatic disease beyond the uterus
- Patients with persistent or recurrent GTN (same gestation) that have already been
treated with chemotherapy
- Patients with other invasive malignancies, with the exception of non-melanoma skin
cancer, patients who have had any evidence of the other cancer present within the last
5 years or patients whose previous cancer treatment contraindicates this protocol
therapy
- Patients with histologically confirmed choriocarcinoma, placental site trophoblastic
tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage
- Patients who refuse to use an accepted method of contraception
- Patients who have had more than one curettage for the management of the current
disease or who have undergone hysterectomy
Female
No healthy subjects accepted to join the trial.
| Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors | NCT00521118 | Contradiction |
2,540 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Clinical diagnosis of Atopic Dermatitis
- Children over 6 months.
- Teens lower than 19 years
No inclusion / Exclusion Criteria:
- Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as
well as pertinent to the study, which may affect the outcome of the research.
- Being in use of drugs that can affect systemically in the course of the disease, such
as systemic corticosteroids and immunosuppressants, for at least 30 days.
- Allergy or severe adverse reactions attributable to the administration of the
probiotic.
- Non adherence to treatment (ie not present regular use, as prescribed) for at least
one continuous month.
- Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held
during the search.
- Patient's request (or responsible's request)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 19 Years | Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children | NCT02519556 | Entailment |
6,580 | 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:
- As per investigator's judgement, a willingness and ability to comply with scheduled
visits, treatment plans, laboratory tests, and other study procedures, including the
patient-reported outcome (PRO) questionnaires and bleed diaries through the use of an
electronic device or paper
- Aged 12 years or older at the time of informed consent
- Diagnosis of congenital hemophilia A with persistent inhibitors against FVIII
- Documented treatment with bypassing agents or FVIII concentrates in the last 6 months
(on-demand or prophylaxis). Prophylaxis needs to be discontinued the latest by a day
before starting emicizumab
- Adequate hematologic, hepatic, and renal function
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use a highly effective contraceptive method with a
failure rate of <1% per year during the treatment period and for at least five
elimination half-lives (24 weeks) after the last dose of emicizumab
Exclusion Criteria:
- Inherited or acquired bleeding disorder other than hemophilia A
- Ongoing (or plan to receive during the study) immune tolerance induction (ITI) therapy
(prophylaxis regimens with FVIII and/or bypassing agents must be discontinued prior to
enrollment). Patients receiving ITI therapy will be eligible following the completion
of a 72-hour washout period prior to the first emicizumab administration
- History of illicit drug or alcohol abuse within 12 months prior to screening, as per
the investigator's judgment
- High risk for thrombotic microangiopathy (TMA) (e.g., have a previous medical or
family history of TMA), as per the investigator's judgment
- Previous (in the past 12 months) or current treatment for thromboembolic disease (with
the exception of previous catheter-associated thrombosis for which antithrombotic
treatment is not currently ongoing) or current signs of thromboembolic disease
- Other conditions (e.g., certain autoimmune diseases) that may increase the risk of
bleeding or thrombosis
- History of clinically significant hypersensitivity reaction associated with monoclonal
antibody therapies or components of the emicizumab injection
- Known human immunodeficiency virus (HIV) infection with CD4 count <200 cells/μL within
6 months prior to screening
- Use of systemic immunomodulators (e.g., interferon or rituximab) at enrollment or
planned use during the study, with the exception of antiretroviral therapy
- Concurrent disease, treatment, or abnormality in clinical laboratory tests that could
interfere with the conduct of the study or that would, in the opinion of the
investigator or Sponsor, preclude the patient's safe participation in and completion
of the study or interpretation of the study results
- Receipt of: Emicizumab in a prior investigational study; An investigational drug to
treat or reduce the risk of hemophilic bleeds within five half-lives of last drug
administration; A non-hemophilia-related investigational drug within last 30 days or
five half-lives, whichever is shorter; or, Any concurrent investigational drug.
- Pregnancy or lactation, or intent to become pregnant during the study
- Positive serum pregnancy test result within 7 days prior to initiation of emicizumab
(females only)
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.
| A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors | NCT03191799 | Contradiction |
5,288 | 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:
- Osteoporotic patients who meet any of the following condition:
1. with at least one fragility fracture,
2. above 70 year-old with bone mineral density below 70% young adult mean,
3. with bone mineral density below 60% young adult mean
- Women three years or more after menopause or men
Exclusion Criteria:
- Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal
insufficiency, poorly controlled diabetes mellitus or other causes of secondary
osteoporosis
- A history or suspicion of active urolithiasis at any time
- Use of bisphosphonates in the past 12 months
- Use of medications known to affect bone in the past 2 months
- Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A New Active Vitamin D, ED-71 for Osteoporosis | NCT00144456 | Entailment |
1,489 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Patient is at least 40 years of age
- Clinical diagnosis of osteoarthritis of the knee for greater than 6 months based on
clinical and radiographic criteria
- Female patients of childbearing potential must have a negative pregnancy test prior to
study enrollment and must agree to remain abstinent, and use barrier, intramuscular,
or implanted contraceptives from Visit 1 until 28 days after the last dose of study
medication.
- Patient is of American Rheumatism Association (ARA) functional Class I, II, or III
- Patient is willing to limit alcohol intake to 2 or less drinks per day during study
and the follow-up period
- Patient is willing to avoid unaccustomed physical activity for the duration of the
study and follow-up period
- With the exception of osteoarthritis, the patient is judged to be in good general
health based on medical history, physical exam, and routine laboratory tests
- Patient is able to read, understand and complete study questionnaires, including
questions requiring a visual analog scale (VAS) response
- Patient provides written informed consent for the trial
- For prior non-steroidal anti-inflammatory drug (NSAID) users only, the patient has a
history of positive therapeutic benefit with NSAIDs and has taken an NSAID prior to
study enrollment and at a therapeutic dose level prior to study enrollment (Visit 1)
- For prior NSAID users only, the patient assessment of Pain Walking on a Flat Surface
(WOMAC Section A, Question1) at Visit 1 (prestudy) is less than 80 mm (100 mm VAS)
- For prior NSAID users only, prior to randomization, and following discontinuation of
NSAIDs during the washout period specified patients must satisfy the following 3 flare
criteria: Minimum of 40 mm on patient reported Pain Walking on a Flat Surface (WOMAC
Section A, Question 1); Increase of 15 mm on patient reported Pain Walking on a Flat
Surface (WOMAC Section A, Question 1) compared to prestudy baseline recorded at Visit
1; and A worsening in Investigator Global Assessment of Disease Status of at least 1
category on a 5 category scale compared to Visit 1 recording
- For prior acetaminophen/paracetamol users only, patient has taken
acetaminophen/paracetamol on a regular basis prior to study enrollment (Visit 1) and
does not use NSAIDs for the treatment of osteoarthritis of the knee
- For prior acetominophen/paracetamol users only, at both Visits 1 and 2, patients must
satisfy all of the following 3 criteria: Minimum of 40 mm on patient reported Pain
Walking on a Flat Surface (WOMAC Section A, Question 1); Investigator Global
Assessment of Disease Status as fair, poor, or very poor; and Minimum of 40 mm on
Patient Global Assessment of Disease Status (100 mm
VAS)
Exclusion Criteria:
- Patient has a concurrent medical/arthritic disease that could confound or interfere
with evaluation of efficacy
- Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has
active psychosis, or significant emotional problems at the time of the study which in
the view of the investigator are sufficient to interfere with the conduct of the study
- Patient has a history of gastric or biliary surgery (including gastric bypass
surgery), or small intestine surgery that causes clinical malabsorption
- Patient is allergic to, or has a history of a significant clinical or laboratory
adverse experience associated with etoricoxib or celecoxib or any of their
constituents
- Patient is allergic to acetaminophen/paracetamol, or has hypersensitivity (e.g.,
bronchoconstriction in association with nasal polyps) to aspirin or NSAIDs
- Patient has an estimated glomerular filtration rate is less than or equal to 30 ml/min
- Patient has Class II-IV congestive heart failure
- Patient has established ischemic heart disease, cerebrovascular disease, or peripheral
vascular disease
- Patient has uncontrolled hypertension with an diastolic exclusionary limit of > 90 mm
Hg and a systolic exclusionary limit of > 140 mm Hg
- Patient has moderate or severe hepatic insufficiency defined as Child Pugh score > 6
- Patient has a history of neoplastic disease
- Patient has a history of any illness, which in the opinion of the investigator, might
confound the results of the study or pose additional risk to the patient
- Patient is, at the time of signing informed consent, a user of recreational or illicit
drugs or has had a recent history (within the last 5 years) of drug or alcohol abuse
or dependence
- Patients considered morbidly obese with a body mass index (BMI) ≥ 35 kg/m^2
- Patient has new use (within 2 weeks of Visit 1 and during the entire duration of the
study and follow-up period) of physical medicine modalities involving the study joint,
including but not limited to: physical therapy, chiropractic interventions,
acupuncture, Transcutaneous Electrical Nerve Stimulator (TENS), and ultrasound
- Patient is expected to undergo surgery involving the study joint during the course of
the study
- Patients taking oral contraceptives
- Patients using intra-articular steroids or hyaluronic acid injections to the study
knee or other immunosuppressant medication within 3 months of Visit 1
- Patients using intravenous, intramuscular, or oral corticosteroids, intra-articular
steroids or hyaluronic acid injections to any joint other than the study joint within
1 month of Visit 1
- Patients using topical or systemic analgesic medications within 3 days of Visit 1 and
throughout the duration of the study
- Patients using non-study NSAID or cyclooxygenase 2 (COX-2) specific inhibitor during
the study treatment period, with the exception of low-dose aspirin (≤ 325 mg/day)
- Patients receiving a Chinese traditional arthritis treatment within 1 week of Visit 1
- Patients with clinically significant abnormalities on Visit 1 clinical examination or
laboratory safety tests. Serum transaminases should be ≤ 150% of the upper limit of
normal
- Patients currently participating in or has participated in a study with an
investigational drug or device within 4 weeks of signing informed consent
- Patients with an active peptic ulcer or a history of inflammatory bowel disease
- Patients with a personal or family history of an inherited or acquired bleeding
- Patients that are pregnant or breast-feeding, or expecting to conceive within the
projected duration 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 40 Years old.
| Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis | NCT01554163 | Entailment |
4,635 | 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:
- Women scheduled for robotic assisted laparoscopic hysterectomy
Exclusion Criteria:
- Patients who will not consent.
- Hysterectomy due to malignant conditions.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Vaginal Cuff Closure in Robotic Hysterectomy | NCT02696239 | Entailment |
4,009 | 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. Adult patients with an American Society of Anesthesiologists (ASA) physiological
status I-III
2. Patients presenting for unilateral primary total knee replacement.
3. No focal neurologic deficit of the surgical lower extremity.
4. Cognitively intact with the ability to sign informed consent
Exclusion Criteria:
1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
2. History of long term use of daily opioids (>1 months) with oral morphine equivalent
(OME) >5mg/day.
3. Body mass index (BMI) > 40 kg/m2
4. Allergies to medications used in this study such as: fentanyl, hydromorphone,
ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin,
tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
5. Major systemic medical problems such as:
- Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
- Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart
Association (NYHA) class III-IV
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute
necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary
biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver
abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
6. Impaired cognitive function or inability to understand the study protocol
7. Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in
the operative extremity, coagulopathy [platelets < 100,000, International Normalized
Ratio (INR) >1.5], refusal, etc.).
8. Previous contralateral knee replacement managed with regional or periarticular
injection
9. Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
10. Pregnancy or breast feeding (women of child-bearing potential, must have a negative
pregnancy test)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA) | NCT02223364 | Entailment |
5,417 | 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:
- von Willebrand Disease (VWD) patients defined prepartum as Type 1 per National Heart,
Lung, and Blood Institute (NHLBI) criterion of von Willebrand Factor (VWF) level less
than 30 percent, or Type 2, or Type 3
- VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 will determine
enrollment in the non-corrector or corrector group:
- Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:Act less
than 100 percent will be enrolled in the non-corrector group. In patients with an
isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as
a non-corrector
- Patients with VWF parameter levels greater than or equal to 100 percent self-corrected
at gestational weeks 34-38 will be enrolled in the corrector group
- Written informed consent from the patient prepartum, before gestational week 39
Exclusion Criteria:
- Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen
disorders
- Presence of liver disease or renal disease, clinical suspicion or diagnosis of
preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or
coagulopathy
- Age less than 18 years
- Inability of the local laboratory to monitor the VWF laboratory tests needed during
the course of treatment to determine Wilate dosing adjustments
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Von Willebrand Factor in Pregnancy (VIP) Study | NCT04146376 | Entailment |
1,171 | 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:
1. Age of 18 - 60 years.
2. patients of both genders.
3. patients diagnosed as pleural effusion by the physician.
4. patients with asymmetrical chest expansion.
Exclusion Criteria:
1. Orthopedic conditions.
2. Pleural effusion due to transudate conditions like: liver cirrhosis, …. etc.
3. Malignant conditions.
4. Cognitive impairments.
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 60 Years | the Effect of Chest Expansion Exercises on Pleural Effusion | NCT04553315 | Contradiction |
3,615 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Healthy volunteers over the age of eighteen that have been recently dismissed from the
Emergency Department at Mayo Clinic Hospital, Saint Marys Campus.
- We will recruit a convenience sample of 100 patients from the Emergency Department who
have completed their Emergency Department evaluation and treatment and are being
discharged to home with non-painful conditions.
Exclusion Criteria:
- We will exclude persons under the age of eighteen
- Vulnerable populations (pregnant patients and prisoners)
- Those with an allergy to any of the study agents
- Those with acute pain
- Those using antihypertensive or antiarrhythmic agents
- Those with significant cardiopulmonary comorbidities (namely history of arrhythmia,
coronary artery disease, hypertension, and heart failure)
- Those with concomitant use of Monoamine oxidase A (MAO) Inhibitors
- Those with a diagnosis of angle closure glaucoma or benign prostatic hyperplasia (BPH)
- Those with a history of cerebrovascular disease
- As well as those with a history of previous nasal surgery or known nasal anatomic
abnormalities.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial. | NCT02285634 | Entailment |
1,438 | 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:
- Age 60-85 years' old
- Both male and female patients
- ASA I-II
- Body mass index (BMI) ≤ 30 kg/m2
- Elective surgery under general anaesthesia with the use of laryngeal mask airway (LMA)
/ LMA Proseal / LMA Supreme
- Type of surgery: Urogynecological, General Surgery, Orthopedics, Eye, Vascular,
Plastic
- Surgery/anaesthesia lasting for 0.5-3 hours
Exclusion Criteria:
- Patients with difficulty in swallowing, preexisting neuromuscular or central nervous
system disorder
- Patients undergoing intra abdominal, thoracic, face, nasal or throat surgery
- Known condition interfering with gastric emptying
- Patients with cognitive or hearing impairment and inability to provide informed
consent
- ASA III-IV patients
- Use of muscle relaxant during the course of general anesthesia
- Contraindication or previous adverse response to any of the study drugs
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.
Subject must be at most 85 Years | To Compare Effect of Sevoflurane Versus Desflurane on the Return of Swallowing Reflexes in the Elderly | NCT01833676 | Contradiction |
2,273 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Diagnosis of Duchenne muscular dystrophy confirmed by at least genetic testing,
theoretically treatable by exon 53 skipping.
- Age between ≥ 12 and <20 years old.
- Non ambulant patients (i;e; inability to walk more than 10 meters without any of
assistance).
- Patients covered by a national health insurance scheme.
- Signed informed consent.
Exclusion Criteria:
- Patient incapable of sitting upright in a wheelchair for at least one hour.
- Patients with severe intellectual impairment preventing them from fully understanding
the exercises to be performed.
- Recent (less than 6 months ago) upper limb surgery or trauma This criteria is however
no definitive. Patients who have undergone upper limb surgery or trauma may
nonetheless be enrolled once the 6 month period is over.
- Known immune deficiency.
- Contraindications to NMR exams
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 20 Years | Observational Study of Patients With Duchenne Muscular Dystrophy Theoretically Treatable With Exon 53 Skipping | NCT01385917 | Contradiction |
6,417 | 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, who is at least 18 years of age or older at screening visit.
- Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
- A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0)
on Baseline/Day 1.
- A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on
Baseline/Day 1.
Exclusion Criteria:
- More than 2 facial inflammatory lesions (papules, pustules, and nodules).
- Presence of areas of significant scaling or crusting on the face.
- Presence of psoriatic lesions on the face.
- Presence of any other dermatological condition of the face that, in the opinion of the
Investigator, may significantly interfere with the interpretation of the clinical
trial results.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema | NCT01882712 | Contradiction |
5,363 | 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:
- Male subjects between 0 and <12 years of age.
- Diagnosed with severe haemophilia A (FVIII:C <1%), and pre-treated for a minimum of 20
to 50 exposure days.
- Have evidence of vaccination against hepatitis A and B (or presence of antibodies
against hepatitis A and B due to either a previous infection or prior immunisation),
as documented in the medical notes at enrolment.
- The subject and/or legal guardian understand(s) the nature of the study and has/have
given written informed consent to participate in the study and is/are willing to
comply with the protocol.
Exclusion Criteria:
- For all subjects at Day 1: Are actively bleeding.
- Have received an infusion of any FVIII product, cryoprecipitate, whole blood, plasma
or desmopressin acetate in the 4 days prior to their dosing within the PK component.
- Have a known history of, or who are suspected of having FVIII inhibitors.
- Have received aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) within 7
days of administration of the IMP.
- Have an impaired liver function ie, bilirubin >1.5 x upper limit of normal (ULN)
and/or aspartate/alanine aminotransferase (AST/ALT) >2.5 x ULN (referring to limits of
the laboratory that performs the determination) at Screening.
- Are human immunodeficiency virus [HIV]-1/-2 antibody positive with a viral load of
>200/µL.
- Suffer from an acute or chronic medical condition, other than haemophilia A, which
may, in the opinion of the Investigator, affect the conduct of the study.
- Suffering from von Willebrand disease (VWD) with von Willebrand factor: ristocetin
cofactor (VWF:RCo) level <50 IU/dL at Screening.
- Have a known or suspected hypersensitivity or previous evidence of severe side effects
to a plasma-derived FVIII product or to human albumin.
- Have participated in a clinical study or used an investigational compound in another
study (eg, a new chemical entity not registered for clinical use) in the 3 months
preceding the first day of IMP administration, or are planning to enter such a study
during the study period.
- Unwillingness and/or inability to comply with the study requirements.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 12 Years | Study of Biostate® in Children With Hemophilia A | NCT01229007 | Contradiction |
545 | 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:Healthy females: 1) 18 years of age or older, 2) requesting an elective
termination of pregnancy by medical abortion, 3) with an intrauterine pregnancy no more
than 63 days gestation on the day of mifepristone administration as documented by
endovaginal ultrasound, 4) willing and able to sign informed consent, 5) willing to comply
with the study protocol and visit schedule, 6) willing to have a surgical abortion/D&C if
indicated, and 7) with easy and ready access to a telephone.
-
Exclusion Criteria:1) ultrasound evidence at the evaluation(s) prior to mifepristone
treatment of an early pregnancy failure, 2) contraindication to mifepristone (known allergy
to mifepristone, chronic corticosteroid administration, adrenal disease), 3)
contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, poorly
controlled seizure disorder, or known allergy to prostaglandin), 4) known or suspected
extrauterine pregnancy, 5) known or suspected pelvic infection, 6) hemoglobin <10 mg/dL, 7)
known clotting defect or receiving anticoagulants, 8) cardiovascular disease (angina,
valvular disease, arrhythmia, or cardiac failure), 9) current breastfeeding, 10) pregnancy
with an IUD in situ, 11) current use of any experimental drug, 12) suspected or confirmed
endometrial arteriovenous malformation, 13) active oral herpes lesions per subject report,
14) prior participation in this research study, or 15) current participation in another
research study that, in the opinion of the investigator, would interfere with the conduct
of this study.
-
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation | NCT00330993 | Contradiction |
5,285 | 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 with a diagnosis of osteoporosis of at-Risk
- Have a medical indication to receive Ibandronate+Vitamine D+Calcium
Exclusion Criteria:
- Osteoporosis due to secondary causes
Female
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America | NCT02635997 | Entailment |
4,683 | 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:
- Women in the fertile age (between 20-45 years), not assuming oral contraceptives from
at least three months
- Referred normal menses .Use of the same brand of sanitary protection wear for the
whole of the period.
- BMI between 18 and 30
Exclusion Criteria:
- Abnormal Bleeding Score
- Positive gynecological history of fibroids, polyps or malignancy
- Treatment with anti-coagulants, antifibrinolytics, non steroidal anti-inflammatory
agents
- Use of oral contraceptives in past three months
- Use of intrauterine devices (IUDs) in past three months .Hgb levels <12 g/dl and
Ferritin <25 ng/ml.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles | NCT01276964 | Entailment |
2,674 | 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:
- primitive inguinal hernia
- age > 18 years old
- compliancy to the study
Exclusion Criteria:
- reccurent inguinal hernia
- age < 18 years old
- refusal 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 18 Years old.
| Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial | NCT02011698 | Entailment |
4,285 | 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:
- Is either:
1. A healthy volunteer (i.e.: someone not diagnosed with a lung disorder written
below; this may include smokers who have not been diagnosed with a lung disorder)
or
2. Has been diagnosed with one of the following respiratory disorders: lung
transplants, lung resection, lung cancer, asthma, cystic fibrosis, chronic
obstructive pulmonary disease, emphysema, mesothelioma, asbestosis, pulmonary
embolism, interstitial lung disease, pulmonary fibrosis, bronchiectasis, seasonal
allergies, pneumonia, cold virus, lung infection, pulmonary hypertension,
pulmonary dysplasia, obstructive sleep apnea
- Able to provide informed consent
- Able to hold their breath for imaging:
1. Healthy volunteers enrolled in this study must be able to hold their breath for
25 seconds
2. Lung disorder participants must be able to hold their breath for 15 seconds
Exclusion Criteria:
- Have contraindication to MR imaging (i.e. ferrous implants, cardiac pacemakers) -
determined by MR screening prior to scans.
- Have a history of claustrophobia.
- Female exclusion only: are or may be pregnant.
- Requires an oxygen mask and cannot use a nasal cannula.
- Blood oxygen saturation is below 92% (measured at rest in a sitting position, and with
an O2 nasal cannula if the participant normally uses one).
- Has had an acute respiratory infection in the past 10 days.
- Is a student currently enrolled in a course at Lakehead University where the Principal
Investigator (PI) is the instructor.
- Is a student currently enrolled in a degree program at Lakehead University where the
PI is their direct thesis supervisor.
- Is currently an employee of the PI at the Thunder Bay Regional Research Institute
(TBRRI) and/or Lakehead University.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders | NCT02748798 | Entailment |
2,503 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- The entire population of Manitoba is considered for inclusion.
Exclusion Criteria:
- Individuals less than or equal to 6 months of age;
- Having less than one year of insurance coverage before the enrolment period;
- Not registered with MH during the enrolment period;
- Physician or hospitalization records indicating a diagnosis of any demyelinating
condition between 1971 (earliest year for which information is available) and the
index date.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
| A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada | NCT02367222 | Entailment |
3,064 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1. Adolescents with confirmed clinical and previous molecular diagnosis of FXS or AS, age
between 13 to 17 years, inclusive.
2. Subjects must assent to participation in the study (if appropriate), have a parent or
legal guardian/representative capable of providing informed consent on behalf of the
subject, and commit to participate in all assessments described in the protocol.
3. Subjects must be receiving a stable dose of concomitant medications
4. Subjects should be able to complete study assessments.
5. Subjects who are non-sterile must agree to either remain completely abstinent or to
use two effective contraceptive methods from screening until 7 days after the last
dose of study treatment.
6. Subjects must have a parent or other reliable caregiver who agrees to accompany the
subject at all study visits and provide information about the subject as required by
the study protocol, and ensure compliance with the protocol.
Exclusion Criteria:
1. Inability to swallow a capsule.
2. Poorly controlled seizures
3. Clinically significant abnormal ECG at the time of screening.
4. Positive result on serum or urine pregnancy test for women of child-bearing potential
(have experienced menarche) who are not using a dual method of contraception (e.g.,
condoms plus oral contraceptives), with abstinence being an accepted method.
5. Allergy to gaboxadol or any excipients
6. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a
degree that would limit participation in the study
7. History of suicidal behavior or considered a high suicidal risk by the investigator.
8. Any medical, psychological, social disorder(s), or other conditions - including
seizure disorder
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 17 Years | Single Dose Pharmacokinetic (PK) Study | NCT03109756 | Entailment |
5,396 | 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:
- Participants older than 18 years
- Participants presenting at the outpatient clinic for Mirena IUD insertion.
- Participants able to provide informed consent as documented by signature with at least
24 hours of reflection time
- Good understanding of written and oral speaking used at the centre where the study
will be carried out.
Exclusion Criteria:
- Participants who are contraindicated for the insertion of the IUD Mirena
- Participants under use of excessive alcohol, narcotics or benzodiazepines prior to
procedure
- Participants who do not wish to be informed of a chance discovery
- Participant receiving anaesthetics prior to IUD insertion procedure
- Participants on anticoagulant medication
- Participants under use of an analgesic
- Previous cervical operation
- Severe vaginal bleeding
- Participant previously enrolled in this study
- Cervix diameter smaller than 26 mm
- Mullerian anomalies with two cervices
- Nabothian cyst
- Cervical myomas
- Cervical condylomas
- Squamous intraepithelial lesion (Cervical dysplasia)
- Cervical endometriosis
- Cervical tears
- A well exposed cervix and / or well aligned vaginal and cervical canals where no
traction is required for IUD insertion
- Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which
may contraindicate or complicate IUD insertion
- Large ectopy, for which it is not possible to find a suitable location near the ectopy
where native tissue is present
- Large scar tissue, for which it is not possible to find a suitable location near the
scar where native tissue is present
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Usability, Safety and Efficacy of AspivixTM (Comparative Study) | NCT04441281 | Entailment |
3,289 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- Patient over 18 years old
- Patient with suspected NOIA, evoked after clinical examination by a specialized
ophthalmologist
- For which a brain and visual MRI is planned
- Express consent to participate in the study
- Affiliate or beneficiary of a Social Security scheme
Exclusion Criteria:
- Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy | NCT04451265 | Contradiction |
4,414 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Age 18-70 years
- Pain from the lateral part of the elbow
- The pain increases on resisted dorsiflexion of the wrist with the elbow extended and
the fingers flexed or the pain increases on resisted radial deviation of the wrist or
the pain increases on resisted extension of the 3. finger
Exclusion Criteria:
- Duration of complaints less than 2 weeks or more than 3 months
- The tenderness is located within the muscle body itself in the proximal part of the
short radial extensors muscle of the wrist (Cyriax type IV)9.
- Treatment within the last 12 months for the same condition with corticosteroid
injection or physiotherapy
- Bilateral complaints
- Previous surgical treatment for lateral epicondylitis
- Deformities of the elbow (congenital or acquired)
- Cervical radiculopathy or referred pain from neck or shoulder
- Previous fractures or tendon ruptures in the elbow
- Systemic musculoskeletal disease
- Previous allergic reactions to corticosteroids or lidocaine
- Contraindications to corticosteroids or NSAIDs:
- On-going or previous gastro-intestinal bleeding
- previous ulcer or dyspepsia, severe asthma
- on-going systemic infection
- local skin-infection
- recently vaccinated with live virus
- coagulopathies
- SLE
- severe liver- or kidney-disease
- heart failure
- diabetes
- use of warfarin or NSAIDS
- Pregnancy or breast-feeding
- Fertile females not on effective birth control
- Psycho-social or other reasons for not being able to participate throughout 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 | Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis | NCT00826462 | Contradiction |
5,844 | 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:
- 18 to 80 yrs of age
- 2 to 3 episodes of GERD/week
- erosive esophagitis or abnormal 24 hr pH
- able to read and understand, complete questionnaires
Exclusion Criteria:
- barrett's esophagus or peptic stricture on endoscopy
- normal EGD and normal 24 hour pH
- previous upper GI surgery
- comorbidity (cardiovascular, respiratory, renal, hepatic)
- use of narcotics or pain medication on regular basis
- insomnia, shift work sleep disorder, sleep apnea, restless leg syndrome
- diabetes, scleroderma or neuromuscular 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 80 Years | Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD. | NCT00674245 | Contradiction |
4,851 | 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:
- Diagnosed with ACTH independent endogenous Cushing's Syndrome
- Available adrenal imaging prior to being treated with Korlym®
- Treated with Korlym® and followed for at least 3 months (follow-up data should be
available)
Exclusion Criteria:
- Diagnosed with adrenocortical carcinoma
- Participant in any clinical trial(s) during the observational 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.
| Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome | NCT02663609 | Contradiction |
871 | 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:
- Male and female
- Age group 50-75 years
- Knee osteoarthritis GI, GII and G III (Kellgren & Lawrence system).
Exclusion Criteria:
- Traumatic arthritis
- Unstable cardiovascular state
- Neuro-muscular disorders involving the lower extremity
- History of surgery of lower limb
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 75 Years | Effects of Anti-gravity Treadmill Training on Knee Osteoarthritis in Geriatric Population. | NCT04299568 | Entailment |
3,722 | 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 osteoarthritis aged 50 to 75 years knee pain lasting for than three months knee pain
intensity over 20 mm on Visual Analog Scale-VAS
Exclusion Criteria:
knee operation, Malignant diseases Systemic infectious diseases inflammatory diseases
Fibromyalgia syndrome physical therapy and/or a knee injection within the last three months
antidepressants, pregabalin or duloxetine usage
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 75 Years | Knee Osteoarthritis, Kinesiophobia and Physical Activity | NCT03875040 | Contradiction |
6,012 | 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:
- Cases:
- male or female patients aged between 21 and 65 years with typical clinical
manifestations of gastroesophageal reflux but endoscopy-negative for esophageal
mucosal breaks
- by typical clinical manifestations of gastroesophageal reflux, we refer to the
occurrence of heartburn and/or regurgitation more than twice a week, with a
minimum duration of 8 consecutive weeks, and with symptoms severe enough to
affect daily activities
- Controls:
- healthy male or female aged between 21 and 65 years who are asymptomatic for GERD
and other digestive diseases
Exclusion Criteria:
- Endoscopic confirmed erosive esophagitis
- Complications such as Barrett's esophagus, gastric and/or duodenal peptic ulcer,
stenosis
- Esophageal, gastric or duodenal cancer or other malignancy
- History of esophagus, stomach, or duodenum surgery
- Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices,
and patients on warfarin and antiplatelets)
- Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy or any
underlying disease or medication that might affect the lower esophageal sphincter
pressure or increase the acid clearance time
- A history of bronchial asthma, or known allergy to fluorescein
- Pregnant or breast-feeding (for females)
- Below 21 or above 65 years of age
- Severe co-morbidities (e.g., such as end-stage renal failure, congestive cardiac
failure, liver cirrhosis, severe arthritis requiring long term non-steroidal
anti-inflammatory drug therapy)
- Unable or unwilling to give informed consent
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 | Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy | NCT00954070 | Entailment |
Subsets and Splits