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1,137 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- patient with newly diagnosed hypertrophic cardiomyopathy (HCM), based on conventional
echocardiographic criteria.The diagnosis of HCM will be considered definite in the
presence of left ventricle hypertrophy without cavity dilatation and without other
cardiac or systemic disease able to produce the magnitude of hypertrophy.
Exclusion Criteria:
- Associated cardiac or non cardiac disease known to cause left ventricle hypertrophy
(uncontrolled systemic Hypertension, severe aortic stenosis)
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.
| New Diagnostic Strategy in Hypertrophic Cardiomyopathy | NCT02520856 | Entailment |
2,146 | 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:
- Age ≥ 18 to < 70 years
- Baseline sUA ≥ 6.0 mg/dL after at least 2 weeks of treatment on a stable 300 mg dose
of allopurinol
- Documented diagnosis of gout according to the American Rheumatism Association
--Preliminary Criteria for the Diagnosis of Gout
- Be willing and able to take colchicine 0.6 mg per day or naproxen 220-250 mg twice
daily as prophylaxis for gout flares and, if needed, a single daily dose of a proton
pump inhibitor to prevent gastrointestinal discomfort
- Female participants must:
- Be sexually abstinent
- Be surgically sterile
- Be postmenopausal or on stable contraception
- Male participants must:
- Be sexually abstinent
- Be > 1 year post-vasectomy
- Using condoms with spermicide with partners meeting female requirements
Exclusion Criteria:
- Unable to tolerate 300 mg allopurinol
- Unable to tolerate both colchicine 0.6 mg per day and naproxen 220-250 mg twice daily
- Prior participation in a clinical study with BCX4208
- Gout flare during the Screening Period that is resolved for less than 2 weeks prior to
first treatment with BCX4208 or placebo (exclusive of chronic synovitis/ arthritis)
- Unstable angina, symptomatic arrhythmia, signs or symptoms compatible with New York
Heart Association Class III or Class IV heart failure, history of long QT syndrome, or
QTc interval < 350 msec or > 475 msec
- Poorly controlled hypertension (SBP > 160 mmHg or DBP > 100 mmHG at Screening or
Baseline)
- Moderate or severe renal impairment and/or calculated creatinine clearance of < 60
mL/min(Cockroft-Gault method)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > 2.0 x ULN
- CD4+ cell counts by flow cytometry < 500 cells/mm3
- Hemoglobin < 10 g/dL or > 18 g/dL males or < 10 g/dL or > 17 g/dL females White blood
cell count < 3.7 x 109/L or > 11 x 109/L
- Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the
next 4 months
- Positive serology for hepatitis B surface antigen or hepatitis C or HIV type 1
- Immunocompromised or on systemic immunosuppressive medications or antirheumatic drugs
(including anakinra and adrenocorticotropic hormone)from Screening to Day 92
- Azathioprine or 6-mercaptopurine within 14 days of first dose of allopurinol
Hydrochlorothiazide in doses > 50 mg per day from Screening to Day 92
- Use of herbal/dietary supplements Screening to Day 92
- Recipient of any live or attenuated vaccine within 6 weeks of Screening
- Uric acid-lowering drugs other than allopurinol from Screening to Day 92 Systemic
corticosteroids within 4 weeks prior to Day 1 (this does not include pulmonary or
nasal inhaler containing corticosteroids, ophthalmic corticosteroids, joint
injections, or low potency topical steroids)
- Investigational drug within 30 days prior to signing the ICF for this study
- Clinically significant and relevant drug allergies
- Chronic or recurrent infections (≥ 3 infections at the same site within 12 months)
- Cancer within 12 months-Except non-melanomatous localized skin cancer or completely
excised and cured carcinoma-in-situ of uterine cervix or subjects who were previously
treated for prostate or breast cancer if they currently are stable and have not been
on chemo therapy within the last year prior to screening.
- Alcohol or drug abuse within 12 months of signing the ICF, or current substance
dependence or abuse
- Other medical conditions which, in the opinion of the PI, would jeopardize the safety
of the study subject or impact the validity of the study 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.
Subject must be at most 69 Years | Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol | NCT01265264 | Contradiction |
235 | 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:
- Unexplained infertility
Exclusion Criteria:
- Known allergy to FSH
- Diabetes, hypertension, known cardiac, renal or liver disease.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Stimulated Intrauterine Insemination Cycles and Unstimulated Intrauterine Insemination Cycles in Couples With Unexplained Infertility | NCT02461173 | Contradiction |
4,465 | 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:
1. Diagnosis was refractory tennis elbow;
2. Standard extracapsular method was used for surgery.
Exclusion Criteria:
1. Patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or
the upper limb had undergone surgery within the past 6 months;
2. Diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction;
3. Case was complicated with other serious elbow joint diseases or injuries;
4. Patient did not sign the informed consent form.
No condition on gender to be admitted to the trial.
| Extracapsular Arthroscopic Treatment for Refractory Tennis Elbow--Mid-and-short Term Retrospective Study of 50 Cases | NCT04454047 | Contradiction |
1,727 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. Healthy male volunteers between 18 and <46 years of age.
2. Subjects who provide written informed consent to participate in the study.
3. BMI ranging from 18.0 to <30.0, calculated as Weight (Kg)/Height (m2).
4. Non-smoking (by declaration) for a period of at least 6 months.
5. No known history of significant neurological, renal, cardiovascular (including known
structural cardiac abnormalities or hypertension), respiratory (asthma), endocrine,
gastrointestinal, hepatic or hematopoietic disease, neoplasm, psychiatric or any other
clinically significant medical disorder, which in the investigator's judgment
contraindicate administration of the study medications.
6. No history of drug or alcohol abuse.
7. No known allergy or hypersensitivity to any drug or food.
8. No clinically significant abnormalities in screening physical exam.
9. No clinically significant abnormalities in clinical laboratory parameters (hematology,
biochemistry and urinalysis) at Screening, as determined by the study physicians.
10. Negative HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody tests at
Screening.
11. No significant abnormalities in electrocardiogram.at Screening.
12. Subjects with negative urinary drugs of abuse screen determined at Screening and on
admission to the clinical research center prior to dosing day.
13. Subjects must be able to adhere to the visit schedule and protocol requirements and be
available to complete the study.
14. Subjects must satisfy a medical examiner about their fitness to participate in the
study.
Exclusion Criteria:
1. Subjects with any clinically significant abnormality upon physical examination or in
the clinical laboratory test values.
2. Subjects with a history of clinically defined peptic ulcer or any gastrointestinal
surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder
likely to influence supplement absorption, or with any history of severe
gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
3. Subjects with significant allergic response to any drug or history of food allergies
deemed clinically significant or exclusionary for the study.
4. Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the
study, or subjects with recent significant change in body weight.
5. Treatment with prescription or over-the-counter drugs, nutraceuticals including
vitamins, herbal medications, food supplements and other prescription drugs not
mentioned above, within 7 days prior to first dosing day.
6. Use of paracetamol (acetaminophen) less than 24 hours before the first dosing day.
7. Subjects who donated blood or received blood or plasma derivatives in the three months
preceding the first study dosing.
8. Participation in another clinical trial with drugs within 3 months prior to first
study dosing day (calculated from the previous study's last dosing date).
9. Subjects with an inability to communicate well with the investigators and Clinical
research Center staff (i.e., language problem, poor mental development or impaired
cerebral function).
10. Subjects that have difficulty fasting or consuming the standard meals that will be
provided.
11. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of
study start, which is considered of significance by the Principal Investigator.
12. Subjects who are non-cooperative or unwilling to sign the consent form.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 46 Years | Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin | NCT03807050 | Entailment |
534 | 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 women ages 18 - 45 years.
- Regular menstrual cycles (24-35 days).
- Pelvic pain ≥ 3 months with cyclical component.
- Negative pregnancy test and must use nonhormonal contraception.
- Non-lactating.
- No history of liver disease.
- Consent to participate in the study.
- Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin
staining and histological evaluation within the past 4 years.
Exclusion Criteria:
- Major psychiatric conditions or the abuse of alcohol or drugs which would make it
difficult for the subject to complete study procedures.
- Active or prior infection with hepatitis, human immunodeficiency virus (HIV)
infection, or history of high-risk activities (e.g., IV drug abuse) which would
increase risk to laboratory personnel. Of note, no testing for hepatitis or HIV will
be performed as part of this study and all tissues will be handled and discarded as if
they were potentially infected.
- Patients with liver dysfunction (elevated liver enzymes > 2 times the upper limit of
normal).
- Presence of pre-existing malignancy, including carcinoma of the breast or uterus.
- Women with other causes of chronic pelvic pain including infectious, gastrointestinal,
musculoskeletal, neurologic or psychiatric.
- Elevated WBC.
- NYHA functional class I-IV heart failure.
- Diabetics.
- Known pregnancy or positive pregnancy test.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Use of Rosiglitazone in the Treatment of Endometriosis | NCT00115661 | Contradiction |
453 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Diagnosis of infertility who are candidate for IVF
2. Surgical diagnosis of endometriosis within 10 years of study entry
3. Willing to sign/give informed consent and adhere to parameters of study
4. Normal endometrial cavity as diagnosed by 3D ultrasound and office hysteroscopy
examinations at baseline or after correction of underlying clinically relevant cavity
abnormalities
5. Day 2-4 serum FSH level ≤ 12 mIu/mL and/or random serum AMH level ≥ 0.9 ng/mL and/or
antral follicular phase follicle count obtained by trans-vaginal ultrasound
examination ≥ 5
6. No contraindication to GnRH agonist or GnRH antagonist use
7. No prolonged use of GnRH agonist or antagonist (> 30 consecutive days) or other
treatment for endometriosis within 4 months of study entry
8. Have at least one euploid embryo available for transfer
9. Agrees to transfer best quality embryo as determined by CCRM physician and embryology
team
10. Regular menses ranging from 22-36 days
11. Agrees to use barrier contraception throughout GnRH agonist or antagonist
administration
12. No evidence of untreated hydrosalpinx
Exclusion Criteria:
1. Age <21 or > 42 years at time of initiation of IVF cycle
2. Day 2-4 FSH level >12 mIu/mL or random serum AMH level <1.0 ng/mL and antral follicle
count obtained by trans-vaginal ultrasound examination < 5
3. Planned use of donor oocytes or embryos
4. Planned use of gestational carrier
5. Use of GnRH agonist, GnRH antagonist or other approved medical therapy for
endometriosis (with the exception of combination contraceptives) for > 30 consecutive
days prior to study entry
6. Unwilling to abide by study parameters or sign informed consent
7. No documentation of surgical diagnosis of endometriosis with study timeline (10 years
of study entry)
8. Absence of embryos predicted to be euploid available for transfer (embryos with no
results may not be included in transfer)
9. Prior adverse reaction to any GnRH agonist or antagonist
10. Uncorrected or uncorrectable clinically relevant uterine cavity abnormalities or
hydrosalpinx
11. Acute or chronic renal, pulmonary, hepatic, or cardiac disease
12. Prior diagnosis of pituitary adenoma or any other intracranial lesion
13. Menstrual cycles outside the range of inclusion criteria
14. Diagnosis of polycystic ovary syndrome (PCOS)
15. Pregnancy prior to study initiation or initiation of endometrial preparation for
embryo transfer.
16. Undiagnosed vaginal bleeding
17. Clinically relevant adenomyosis as diagnosed by baseline 3D ultrasound exam (and/or
MRI if felt to be appropriate)
18. Bipolar disorder, history of suicidal ideation, any other psychiatric disorder
requiring lithium or anti-psychotic medications
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 42 Years | Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis | NCT04445025 | Contradiction |
5,177 | 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:
- Post-menopausal women aged 50-80 years
- T score < -2.5 at lumbar spine, total hip or femoral neck on dual x-ray absorptiometry
(DXA) OR T score < -1.5 with a personal or family history of fracture
Exclusion Criteria:
- Previous use of bisphosphonates or Teriparatide; current estrogen therapy; any other
osteoporosis therapy in the past 6 months
- Metabolic bone disease other than osteoporosis
- Body mass index (BMI) < 18
- Weight > 325 lbs
- Current smoking or current alcohol use that exceeds 3 units of alcohol daily
- Use of medications known to affect bone metabolism
- Renal disease, history of kidney stones or hypercalciuria
- Hypo- or hyperparathyroidism; hypo- or hypercalcemia
- Serum vitamin D level < 20 ng/dL
- Refusal to adjust their dietary calcium to <750mg (i.e. two servings per day of
calcium rich food)
- History of bone marrow or organ transplant
- History of malignancy or radiation to the bone
- History of esophageal stricture, dysmotility or severe reflux disease
- Gastrointestinal malabsorption
- Use of digoxin
- Need for chronic anticoagulation therapy such as Coumadin, heparin or low molecular
weight heparin or inability to discontinue anti-platelet medication
- Bleeding diathesis; hemoglobin ≤ 12.5 g/dL (American Red Cross cut-off to donate
blood)
- International normalized ratio (INR) pro time > 1.1 or activated partial
thromboplastin time (APT) T ratio > 1.2
- Platelets < 150K/cu mm
- Cellulitis at site of iliac crest
- History of allergy to medications used in bone biopsy (demeclocycline, lidocaine)
- Inability to understand and provide informed consent.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Stem Cell Recruitment in Osteoporosis Therapy | NCT01656629 | Entailment |
4,028 | 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 with knee osteoarthritis grade II or III of the Kellgren-Lawrence
radiographic scale
- Age > 30 years
Exclusion Criteria:
- Neurodegenerative, autoimmune, genetic or psychiatric diseases
- Active infection
- Recent joint infection
- Knee surgery history
- Knee joint fracture history
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
| Autologous Stem Cells in Osteoarthritis | NCT01485198 | Entailment |
1,418 | 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:
- Greater than or equal to 65 years of age
- Primary hypercholesterolemia
- Combined dyslipidemia
- Completed study NK-104-306 (NCT00257686)
Exclusion Criteria:
- Failed to complete study NK-104-306(NCT00257686)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia | NCT00330876 | Contradiction |
153 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male, age 18-75
- Morning serum testosterone (T) <300 ng/dL on two occasions
- Naive to androgen-replacement therapy or willing to wash-out from current T therapy
Exclusion Criteria:
- Significant intercurrent disease
- Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history
of prostate cancer.
- Serum transaminases >2 times upper limit of normal
- Serum bilirubin >2.0 mg/dL
- Hematocrit <35% or >50%
- BMI >36
- Untreated, obstructive sleep apnea.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Pharmacokinetic Study to Determine Time to Steady-state | NCT00911586 | Entailment |
6,703 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. The subject is male or female, aged ≥18 and <50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study
procedures.
Exclusion Criteria:
1. The subject is obese (BMI>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver
disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP(Continuous positive airway pressure).
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject a hemoglobinopathy or history of anemia, per subject report or the first
blood sample, that in the opinion of the investigator, would make them unsuitable for
study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the
investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator
(Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject is unable or unwilling to provide informed consent, or is unable or
unwilling to comply with study procedures.
16. The subject has any other condition, which in the opinion of the investigators' would
make them unsuitable for the study -
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 50 Years | Accuracy of Pulse Oximeters With Profound Hypoxia | NCT02571686 | Contradiction |
392 | 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:
- 4- Poor responder according to ESHRE consensus; in which at least 2 of the following
should be present: Advanced maternal age (≥ 40 years old) or any other risk factor A
previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional
protocol)An abnormal ovarian reserve test (ORT); antral follicle count (AFC) < 5-7
follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml In the absence of advanced
maternal age or abnormal ORT, two previous episodes of poor ovarian response after
maximal stimulation patients are also considered poor responders according to ESHRE
consensus.
Presence and Adequate visualization of both ovaries Uterine cavity within normal anatomy
assessed with HSG, hysteroscopy and TVUS
Exclusion Criteria:
Any factor which may affect reproductive outcome other than that the patient is a poor
responder will be excluded from the study, like:
1. Severe male factor .
2. Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
3. Immunological disorder (eg: SLE, APS, … etc)
4. Thyroid or adrenal dysfunction
5. Neoplasia (especially: hypothalamic, pit, ovarian)
6. Women diagnosed with PCOS according to Rotterdam criteria
7. Hydrosalpinx that hasn't been surgically removed or ligated.
8. Untreated hyperprolactinemia
9. Abnormal bleeding disorder
10. Hepatic or renal dysfunction
11. Hypersenstivity to study medication ( GNRH antagonist)
12. Need to take medication that can influence ovarian stimulation
13. Endometriosis grade 3 or 4
14. Ovarian cyst> 10 cm.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 44 Years | The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles | NCT03457233 | Contradiction |
2,934 | 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:
- Aged 18 to 80 years old, inclusive, on Day 1.
- Diagnosis of sporadic or familial ALS.
- Onset of first ALS symptoms within 24 months prior to Day 1.
- World Federation of Neurology El Escorial criteria are met for a possible,
laboratory-supported probable, probable, or definite ALS diagnosis.
- Upright slow vital capacity (SVC) of 65% or more at screening.
- Patients taking or not taking Riluzole are eligible for this study: if a patient has
never taken Riluzole, he or she is eligible; if a patient is currently taking
Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient
has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.
- Must be able to swallow tablets at the time of study entry.
Exclusion Criteria:
- Other medically significant illness.
- Clinically significant abnormal laboratory values.
- Pregnant women or women breastfeeding.
- Prior exposure to dexpramipexole.
- Currently taking pramipexole or other dopamine agonists.
Other protocol-defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Phase 3 Study of Dexpramipexole in ALS | NCT01281189 | Entailment |
6,677 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male and female patients of any age and ethnicity
- Severe haemophilia A (FVIII:C<1%)
- Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study
- Either
- No previous treatment with FVIII concentrates or other blood products containing FVIII
(PUPs) OR
- Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products
containing FVIII (MTPs), if
- their first ED occurred after 1st January 2015, AND
- they did not develop an inhibitor at any time point, OR
- they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND
continue treatment with THIS Octapharma FVIII concentrate
- Voluntarily given, fully informed written and signed consent obtained before any
study-related data documentation is conducted (obtained from the patient's
parent/legal guardian)
Exclusion Criteria:
- Diagnosis with a coagulation disorder other than haemophilia A
- Concomitant treatment with any systemic immunosuppressive drug
- Participation in an interventional clinical trial during the time period evaluated
- Participation in another non-interventional study of Octapharma
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients | NCT03695978 | Contradiction |
4,363 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Must be between the ages of 12-21
- Diagnosis of Marfan Syndrome
- Must not have other conditions that limit the patients ability to perform exercise
Exclusion Criteria:
- Patients who have undergone aortic surgery
- Patients with major congenital heart disease
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 21 Years | Marfan Syndrome Moderate Exercise Pilot | NCT04641325 | Entailment |
19 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria
- Medically stable, ambulatory, surgically menopausal women, 21-60 years of age, who
have undergone bilateral salpingo-oophorectomy and hysterectomy at least 6 months
before study entry
- Serum total testosterone concentrations less than 31 ng/dL or free testosterone less
than 3.5 pg/ml (less than the median for healthy, young women
- Able to understand and give informed consent.
- The women will have been on a stable regimen of transdermal estrogen replacement for
at least three months. Those who are not on estrogen replacement or are taking a
different mode of estrogen replacement will be included only if they are willing to
switch to transdermal estradiol patch (see below).
- A normal PAP smear (if subject has a cervix) and mammogram in the preceding 12 months.
Exclusion Criteria:
- Significant depression, as assessed by Beck's Depression Scale.
- Any acute or chronic illness, malignant disease or fever of known or unknown origin
will be excluded.
- Poorly controlled diabetes mellitus (hemoglobin A1c greater than 8.5%)
- Uncontrolled hypertension defined as blood pressure of greater than 160/100
- Severe obesity defined as body mass index of greater than 40 kg/m2
- Current or recent (last 6 months) users of illicit drugs (which may affect appetite,
food intake, metabolism, and/or compliance with the protocol)
- Any one planning to initiate a weight-reduction diet in the subsequent six months
- Alcohol or drug dependence currently or in the preceding 6 month.
- Significant liver function abnormalities, defined as SGOT, SGPT or alkaline
phosphatase value of greater than three times the upper limit of normal in our
Clinical Pathology Laboratory or serum bilirubin levels of greater than 1.5 mg/dl will
be excluded.
- History of breast, ovarian, endometrial or cervical cancer
- History of hyperandrogenic disorders such as hirsutism, grade 2 or 3 acne, and
polycystic ovary disease. Testosterone administration to these patients may exacerbate
the underlying disorder.
- Intolerance to other transdermal formulations
- Women with abnormal PAP smears or mammograms will not be included unless they have
been evaluated by their gynecologists and breast and uterine/cervical cancers have
been excluded by appropriate tests.
- Women with dementia as assessed by the mini-mental state examination
- Women with depression, assessed by Beck's Depression Scale.
- Those with disabilities that would prevent them from participating in strength testing
(e.g., amputation of limbs, blindness, severe arthritis, neurologic disorders such as
Parkinson's disease, stroke, or myopathy).
- Women with any heart disease, including angina, congestive heart failure, or history
of myocardial infarction or coronary artery angioplasty or bypass surgery in the
previous year will be excluded.
- Subjects planning to initiate a weight-reduction diet in the subsequent six months
- Other Medications. Women who have received in the preceding three months drugs known
to affect testosterone production or metabolism such as ketoconazole, Megace, and/or
anabolic/androgenic steroids will be excluded. We will also exclude women who are
taking or have taken in the past three months medication that include sexual
dysfunction (e.g., spironolactone, SSRIs, GnRH agonists). Women who are using any
medication, device or dietary supplement known to enhance sexual function will not be
included. Women receiving thyroid hormone replacement therapy may participate in the
study only if they have been on a stable replacement dose of L-thyroxine for at least
three months.
- Intolerance to estrogen products or skin patches
- Undiagnosed vaginal or vulvar bleeding
- History of deep vein thrombosis, pulmonary embolism, or other thromboembolic disorder
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 60 Years | Testosterone Dose Response in Surgically Menopausal Women | NCT00494208 | Contradiction |
3,007 | 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:
- Clinical diagnosis of intellectual disability
- Age 16 or older and providing consent to participate.
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| North Health in Intellectual Disability | NCT03889002 | Contradiction |
380 | 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 ICSI with expected poor ovarian response according to the Bologna
criteria
Exclusion Criteria:
- Body mass index >35 Kg/m2.
- Women with a single ovary.
- Allergy to DHEA or GH.
- Diabetic women on insulin as insulin lowers DHEA levels and might reduce its
effectiveness
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 43 Years | Combined Dehydropeiandrosterone and Growth Hormone in Women With Expected Poor Ovarian Response Undergoing ICSI | NCT02766764 | Contradiction |
5,896 | 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. Subject who has signed on the written consent
2. Male and female aged 20 and over
3. Endoscopically verified Reflux Esophagitis classified into Los Angeles classification
Grade A, B, C or D within 2 weeks before randomisation
Exclusion Criteria:
1. History or presence of upper gastrointestinal anatomic or motor disorders
2. Other exclusions apply.
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.
| Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis | NCT01538849 | Contradiction |
2,269 | 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:
- Being between the ages of 9-14
- Being literate in Turkish
- Not having any physical disability preventing them from doing physical activities
- Attending physical education class regularly
Exclusion Criteria:
- Having a serious cognitive impairment
- Going to school on foot
- Physiotherapists to be selected for the physiotherapist group to work in the field of
sports
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 9 Years old.
Subject must be at most 14 Years | Encouraging Physical Activity: Action Or Direction? | NCT04300634 | Contradiction |
3,764 | 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 ≥40 and ≤ 75 years of age
- For a woman, she should meet one of the following criteria to be eligible for the
study: i) A woman of no childbearing potential ii) As for a woman of childbearing
potential, she should have a negative pregnancy test result at screening and
baseline/randomization
- Patients should be able and willing to provide the written informed consent.
- Patients should be able to read and understand the information provided for the study
and be able to record the information requested by the study.
- Patients who meet the American College of Rheumatology clinical plus radiographic
classification criteria for idiopathic osteoarthritis of the knee, which are defined
as follow: a patient who had knee pain and radiographically diagnosed osteophytes and
met at least one of the followings. i) Age> 50 years ii) Morning stiffness for less
than 30 minutes iii) Crepitus during movement of the weight-bearing knee
- Patients with symptomatic primary osteoarthritis of the knee at least in the last 3
months prior to screening.
- Patients with severity of grade 2 or 3 according to Kellgren & Lawrence scale based on
anteroposterior radiographic evidence of the tibiofemoral joints with osteoarthritis,
and who are classified in functional class of I, II or III according to the American
Rheumatism Association functional classification.
- Patients who had a score of the Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) pain subscale question 1 ≤80 mm at screening, a score of
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain
subscale question 1 ≥50 mm at baseline. a decrease in the score of the Western Ontario
and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale question 1 at
least by 15mm from screening to baseline and a decrease in the patient self-assessed
arthritis symptoms scores at least by one point from screening to baseline.
- Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2
inhibitor for the treatment of arthritis of the knee for at least 5 days a week during
4 weeks prior to screening
Exclusion Criteria:
- Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory
drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
- Patients with a clinical or biochemical abnormal finding (excluding any finding
related to the investigating disease) at the screening visit, which in the
investigator's opinion was considered to be clinically significant or might make safe
participation in the study more difficult
- Patients with a history of gastroduodenal perforation and/or occlusion, gastric or
duodenal surgery, progressive upper gastrointestinal ulcer within the last 6 months or
a history of upper gastrointestinal bleeding (including hematemesis) within the last
one year, lower gastrointestinal bleeding within the last one year (excluding
hemorrhoid), inflammatory intestinal disease within the last 6 months, coronary artery
disease, congestive heart failure or renal artery stenosis, stroke or transient
ischemic attack.
- Patients with uncontrollable hypertension
- Patients receiving aspirin therapy (low-dose aspirin in a daily dose of 325mg or less
is permitted for prevention of cardiovascular disease).
- Patients receiving anticoagulant drug or antiplatelet drug (excluding low-dose
aspirin) or who have a disease associated with hemostatic disorder.
- Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate
aminotransferase > 1.5 times the Upper Lange of normal at screening. Patients who have
any two or more of bilirubin, Alanine aminotransferase or Aspartate aminotransferase
level greater than the Upper Lange of normal will also be excluded.
- Patients with a history of drug or alcohol abuse.
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 | Efficacy and Safety Study of PG201 Tablet in Patients With Osteoarthritis | NCT01122485 | Entailment |
3,205 | 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:
- they fulfill the new American-European Consensus Group criteria for pSS and have :
- a recent (less than 10 years) and active disease as assessed by :
- values > 50 mm on 2 of 4 visual analogue scales (VAS) (0-100mm) that evaluated global
scores of the disease (activity of the disease including extra glandular
manifestations), pain, sicca syndrome and fatigue over the last week.
- Rheumatoid factor or anti SSA>1.5N or cryoglobulinemia or
- hypergammaglobulinemia or high level of beta2 microglobulinemia or
- hypocomplémentemia.
- and/or at least one of the following severe signs:
- parotidomegaly,
- arthritis,
- purpura,
- pulmonary involvement,
- tubulopathy,
- neurological involvement,
informed consent age 18-80 years, stable non-steroidal anti-inflammatory drugs and no
prescription of immunosuppressive agents for at least 4 weeks prior to inclusion Use of a
reliable mean of contraception (for patients of reproductive potential)
Exclusion Criteria:
- Patients should be excluded if they have a secondary SS,
- if they received cytotoxic drugs during the previous 4 months,
- if they have severe renal or haematological failure, a history of cancer, hepatitis B
or C, HIV, tuberculosis, severe diabetes or any other chronic disease or evidence of
infection,
- if they have had severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies
- or if they are unable to understand the protocol.
- Other : neutrophil count < 1.5 x 103/L, live/attenuated vaccine within 28 days prior
to baseline, pregnancy, breast feeding,
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Tolerance and Efficacy of Rituximab in Sjogren's Disease | NCT00740948 | Entailment |
3,241 | 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
Documented primary or secondary SS.
Absence of confounding health problems.
No contraindications to etanercept therapy.
SS patients cannot have sarcoidosis, HIV infection, or lymphoma.
Patients must have one of the following abnormal autoimmune serologies associated with SS
(i.e. positive ANA, RF, and anti-SS-A, or anti-SS-B).
Patients may use pilocarpine provided that they hold their dose on visit days when saliva
is collected.
Patients taking DMARD's, such as hydroxychloroquine, must be on a stable dose.
Participants may take NSAIDs or acetaminophen.
EXCLUSION CRITERIA
Patients must not have physical or mental conditions that may make them unable to comply.
Subjects may continue their other long-term medications with the exception of tricyclic
antidepressants and anti-cholinergics, which may affect salivary gland function.
Patients cannot take experimental drugs during the duration of the protocol.
Children will be excluded due to additional risks that may occur with etanercept.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Etanercept Therapy for Sjogren's Syndrome | NCT00001954 | Entailment |
3,851 | 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:
- Pain in the knee joint during more than a half day assessed by VAS (score more than 40
mm)
- At least three of the following 6 criteria: 50 years of age or older, stiffness
lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth
to the touch
- Patient is able to walk without assistance
- Patient is familiar with Participant information sheet
- Patient signed informed consent form
Non-inclusion Criteria:
- Medical history of endoprosthetic knee replacement
- Medical history of lower extremity osteotomy
- Medical history of knee surgery (including arthroscopy) during preceding 1 year prior
to enrollment
- Medical history of intraarticular injections during preceding 6 months prior to
enrollment
- Secondary osteoarthritis of the knee joint: posttraumatic osteoarthritis (developed
after clinically significant injury), intra-articular fractures, clinically
significant varus or valgus deformities of lower limbs, septic arthritis, joint's
inflammatory disorders, gout, advanced chondrocalcinosis, Paget's disease, ochronosis,
acromegaly, hemochromatosis, Wilson's disease, primary synovial osteochondromatosis,
osteonecrosis, hemophilia
- Patients prescribed for immunosuppressive treatment
- Medical history of systemic autoimmune and inflammatory diseases
- Significant weight loss (> 10% of body weight in the previous year) of unknown
etiology
- Medical history of venous thromboembolism or estimated high risk of venous
thromboembolism
- Patients prescribed for systemic corticosteroids or other medications treatment with
proven impact on bone or cartilage tissue metabolism
- Clinically significant abnormalities in results of laboratory tests
- Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and
alcohol abuse etc.)
- Participation in other clinical trials (or administration of investigational drugs)
during 3 months prior inclusion
- Patients with malignant tumors including postoperative period, patients receiving
chemotherapy and/or radiotherapy.
- Patient's activated partial thromboplastin time exceeds normal levels more than 1,8
times
- Patients prescribed for anticoagulants treatment or patient received anticoagulants at
least one hour prior lipoaspiration
- Medical history of heterotopic ossifications
- Patients prescribed for glycoprotein inhibitors treatment
Exclusion Criteria:
- Patient's refusal from the further participation in trial
- Patient's refusal from compliance with the requirements of contraception during the
participation in research
- Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by
Cockroft-Gault formula)
- Confirmed syphilis, HIV, hepatitis B or C infections
Dropout Criteria:
- Pregnancy
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 85 Years | Effectiveness and Safety of Autologous ADRC for Treatment of Degenerative Damage of Knee Articular Cartilage | NCT02219113 | Entailment |
3,046 | 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:
- Documentation of a full mutation with absence or deficient FMRP levels.
- Males and females ages 10 through 17 years
- Willingness of potential study participant as well as a parent or caretaker to
participate in the protocol.
- Speech is the primary means of communication with three-word or longer utterances used
on a daily basis.
- Intelligence quotient (IQ) ≤70 as measured by the Leiter- R.
- Sexually active women of childbearing potential (WCBP) must be using a medically
acceptable method of birth control and have a negative qualitative serum β-human
chorionic growth hormone (β-HCG) or urine pregnancy test collected at the initial
screening visit.
Exclusion Criteria:
- Persons who do not speak English.
- Changes in any medications (including investigational medications) within the last
month (4 weeks). All concomitant medications must have been on a stable course for at
least 4 weeks prior to enrollment into the study and maintain stability throughout the
course of the study.
- Changes in behavioral therapy or educational programming during the study. This does
not include scheduled school holidays.
- Have any disease or condition (medical or surgical) at screening that might compromise
the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic
systems; or other conditions that might interfere with the absorption, distribution,
metabolism, or excretion of the investigational product, or would place the subject at
increased risk.
- Patients who, in the opinion of the investigator, are unsuitable in any other way to
participate in this study, including being unable to comply with the requirements of
the study or displaying clinically significant abnormalities in safety assessments at
screening.
- Patients on prohibited medications
- History of recurrent status epilepticus.
- Inability to withhold grapefruit and grapefruit juice from diet during the entire
clinical trial.
- Subjects unwilling to abstain from alcoholic beverages during the trial.
- Subjects who are actively suicidal.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 17 Years | Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome | NCT02642653 | Entailment |
1,345 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Parent(s) or guardian(s) willing and able to provide signed informed consent after the
nature of the study has been explained and prior to performance of any
research-related procedure. Also, willing and able to provide written assent (as
needed) after the nature of the study has been explained and prior to performance of
any research-related procedure.
- Aged 0 to <= 17 years, inclusive, at study entry.
- Have ACH, documented by clinical diagnosis
- Are ambulatory and able to stand without assistance (not applicable for infants)
- Are willing and able to perform all study procedures as physically possible.
Exclusion Criteria:
- Have hypochondroplasia or short stature condition other than ACH (e.g., trisomy 21,
pseudoachondroplasia)
- Have any of the following disorders:
- Hypothyroidism
- Insulin-requiring diabetes mellitus
- Autoimmune inflammatory disease
- Inflammatory bowel disease
- Autonomic neuropathy
- Have an unstable clinical condition likely to lead to intervention during the course
of the study, including progressive cervical medullary compression
- Growth plates have fused
- Have a history of any of the following:
- Renal insufficiency
- Anemia
- Cardiac or vascular disease, including the following:
- Cardiac dysfunction (abnormal echocardiogram [ECHO] including left ventricle [LV]
mass) at Screening Visit
- Hypertrophic cardiomyopathy
- Congenital heart disease
- Cerebrovascular disease, aortic insufficiency
- Clinically significant atrial or ventricular arrhythmias
- Current treatment with antihypertensive medications angiotensin-converting enzyme
(ACE) inhibitors, angiotensin II receptor blockers, diuretics, beta-blockers,
calcium-channel blockers, cardiac glycosides, systemic anticholinergic agents, any
medication that may impair or enhance compensatory tachycardia, drugs known to alter
renal function that is expected to continue for the duration of the study
- Have been treated with growth hormone, insulin-like growth factor 1 (IGF-1), or
anabolic steroids in the previous 6 months or long-term treatment (> 3 months) at any
time
- Have had regular long-term treatment (> 1 month) with oral corticosteroids (low-dose
ongoing inhaled steroid for asthma is acceptable)
- Concomitant medication that prolongs the QT/QTc interval within 14 days or 5
half-lives, whichever is longer, before the Screening visit
- Have used any other investigational product or investigational medical device for the
treatment of ACH or short stature
- Have had bone-related surgery or expected to have bone-related surgery during the
study period. Subjects with previous limb-lengthening surgery may enroll if surgery
occurred at least 18 months prior to the study and healing is complete without
sequelae.
- Have any condition that, in the view of the Investigator, places the patient at high
risk of poor compliance with the visit schedule or of not completing the study.
- Concurrent disease or condition that, in the view of the Investigator, would interfere
with study participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | A Multicenter, Multinational Clinical Assessment Study for Pediatric Patients With Achondroplasia | NCT01603095 | Entailment |
3,963 | 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:
Inclusion Criteria for OA patients:
- Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of
knee osteoarthritis
- Symptomatic knee pain
- On usual care for knee osteoarthritis including paracetamol and/or NSAIDs
Inclusion criteria for Inflammatory Arthritis Patients:
- Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of
inflammatory arthritis i.e. rheumatoid arthritis (Anti-CCP antibodies & Rheumatoid
Factor checked ), psoriatic arthritis or spondyloarthropathy
- Symptomatic knee pain
- On usual care for arthritis including disease-modifying anti-rheumatic drugs (DMARDs),
paracetamol and/or NSAIDs
Exclusion Criteria:
- Other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia,
Polymyalgia Rheumatica, Gout, Giant Cell Arteritis, Sjogren's syndrome
- History of uncontrolled depression
- Recent surgery
- Uncontrolled ischaemic heart disease
- Uncontrolled diabetes mellitus
- Alcohol consumption > 14 units/week as per UK National guidelines
- Participants unable to give full informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis | NCT03533569 | Entailment |
2,482 | 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:
Men and women aged 60 years or older.
Patients ranging from no AMD with little or no drusen in either eye through end stage AMD
(geographic atrophic, retinal pigment epithelial detachment, or other signs of
neovascular/exudative disease) in their eye with worst disease will be eligible.
The ability to understand and sign an informed consent form prior to enrollment.
EXCLUSION CRITERIA:
Ocular disease which confounds assessment of the retina other than age-related macular
degeneration including diabetic retinopathy, central serous choroidopathy, optic atrophy,
retinal vein occlusion, active uveitis, significant explained or unexplained visual field
loss, or any other type of retinopathy or retinal degeneration.
Chronic requirement for any systemic or ocular medication for other diseases such as
glaucoma.
Patients has regularly been taking lutein supplements during the last 3 months or is
currently taking lutein supplements. The daily use of the new Centrum or Centrum Silver or
other similar multivitamins will be allowed but should be limited to a maximum of twice a
day.
Abnormal liver function tests.
Inability to be followed for a period of 1 year.
Acute potentially life-threatening illness such as heart attack in the last year, malignant
cancer or blood disease not in remission.
History of lung cancer.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Lutein for Age-Related Macular Degeneration | NCT00006202 | Entailment |
4,006 | 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:
- Subjects were 18 years or older
- Subjects had osteoarthritis (OA) defined by:
Presence of of typical hip and/or knee joint symptoms. Involvement of at least 1 hip or
knee joints that had warranted treatment with Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs), including cyclooxygenase-2 [COX-2] inhibitors and/or acetaminophen (APAP) for the
last 3 months.
Radiographic evidence within the last 6 months of OA in the index joint, with Grade II to
IV severity, as illustrated by the Atlas of Standard Radiographs.
- Subjects were otherwise in generally good health, as determined by the investigator,
on the basis of medical history, physical examination, electrocardiogram (ECG), and
screening laboratory results.
- Female subjects were either physically incapable of childbearing or were practicing an
acceptable method of birth control and had a negative pregnancy test result
demonstrated before dosing.
- Subjects had experienced a suboptimal response to APAP and NSAID therapy (including
COX-2 inhibitor).
- Subjects had used opioids for OA pain on an as needed (PRN) or occasional basis.
- Subjects were willing and able to discontinue or modify their current medication used
for management of OA pain per protocol.
- Subjects had steady, not transient, pain and a categorical pain rating of moderate to
severe on a scale of none, mild, moderate, or severe.
- Subjects weighed > or = to100 lbs.
- If a subject had taken any inducers or inhibitors of cytochrome P450 [CYP450j), these
were discontinued and an appropriate washout period (5 half-lives) had occurred before
entry in the study.
- Subjects were able to take oral medication and were willing to comply with the
protocol.
- Subjects agreed to abstain from alcohol consumption for the duration of the study.
- Subjects were able to read, understand, and voluntarily sign the IRB approved consent
document before the performance of any study-specific procedures.
Exclusion Criteria:
- Subjects had any clinically significant condition that would, in the investigator's
opinion, preclude study participation.
- Subjects had any other clinically significant form of disease at the index joint
(study joint) or had been diagnosed with inflammatory arthritis, gout, pseudo-gout,
Paget's disease, or any other chronic pain syndrome that, in the investigator's
opinion, might interfere with the assessment of pain and other symptoms of OA.
- Subjects had known allergies or previous, significant reactions to opioids.
- Subjects had any laboratory abnormality at screening that was considered clinically
significant by the investigator, or that, in the opinion of the investigator, would
have contraindicated study participation.
- Subjects were known to have positive test results for human immunodeficiency virus
(HIV), hepatitis B antigen, or hepatitis C antibody.
- Subjects had a history of chronic, scheduled opioid use for OA.
- Subjects had any signs or symptoms of opioid withdrawal.
- Subjects had a history of substance or alcohol abuse within 2 years before study
entry.
- Subjects tested positively on a urine screen for drugs of abuse.
- Subjects had received any steroid therapy (e.g., oral, intramuscular, intravenous, or
soft tissue) within 1 month of study entry.
- Subjects had a condition that would contraindicate the use of opioid analgesia.
- Subjects had participated in a study of an investigational drug or device, or had
donated blood, within 30 days before study entry.
- Subjects used any medication that the investigator felt would interact unfavorably
with the study medication (e.g., potentiation of sedation with tricyclic
antidepressants).
- Subjects had used opioid analgesics for more than 3 days during the 30 days before
screening.
- Subjects had a history of seizures.
- Subjects were considered by the investigator to be unsuitable for any reason.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain | NCT02222740 | Entailment |
1,866 | 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:
- The patient from over 20 to under 90 years
- The patient who is diagnosed as gastric cancer clinically by endoscopy or computed
tomography
- The patient who is informed and consent about the purpose and contents of this study
prior to the participation in this study
Exclusion Criteria:
- The patient who shows far advanced gastric cancer preoperatively or intraoperatively
- The patient with previous medical history of other treatment for gastric caner such as
endoscopic resection, chemotherapy, radiation, immunotherapy, and so on
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 90 Years | NBI for Identifying Resection Margin Status in Gastric Cancer | NCT02926716 | Entailment |
5,883 | 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:
- Participants diagnosed with reflux esophagitis of Grade A or higher by Los Angeles
(LA) classification based on the endoscopy among participants complaining of
gastroesophageal reflux symptoms (such as: Heartburn, regurgitation, globus sensation,
chronic [lasting a long time] cough [sudden, loud flow if air from the lungs],
epigastric [area above the navel] pain, non-cardiac chest pain, hoarseness, or
dysphagia), or those who diagnosed with reflux esophagitis of Grade B or higher
without complaining of symptoms
- Participants without other serious disease except the study indication (reflux
esophagitis)
- Participants with hematology (related to blood) panel, serum chemistry panel, or
urinalysis result clinically within twice the normal range
- Female Participants of child-bearing potential who are using the appropriate
contraceptive or with a negative urine pregnancy test
Exclusion Criteria:
- Participants with other serious gastrointestinal disease except reflux esophagitis
(example: digestive tract cancer [abnormal tissue that grows and spreads in the body
until it kills], hepatic disease, pancreatic disease, and ulcer. However, the scar of
an ulcer is included in study targets
- Participants with other serious concomitant disease(s) such as renal disorder,
cerebrovascular disease, cardiovascular disease, hepatic disease, and severe
respiratory disease
- Participants with medical history of upper gastrointestinal tract surgery,
esophagostenosis, or a chalasia
- Participants with hematology panel, serum chemistry panel, or urinalysis result of
above twice the normal range
- Participants who cannot discontinue proton pump inhibitors or Histamine 2 antagonist
which may have influence on the study, 4 weeks before the start of this clinical study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis | NCT01008696 | Contradiction |
5,335 | 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:
- Patients of both sexes, of any race, aged over 12 years.
- Ability to read, understand and sign the IC, in the case of minors consent of
responsible;
- Clinical diagnosis of bruises, sprains, trauma, muscle damage occurred in less than 24
hours or muscle pain, myofascial pain or tendinitis.
- Patients able to understand and maintain the clinical protocol.
Exclusion Criteria:
- Known hypersensitivity to components of the formulas of both the drug test as the
comparator.
- Known hypersensitivity to paracetamol.
- Location of the lesion with skin wound or irritated.
- Liver or kidney disease known.
- Pregnant or lactating women.
- Patients who require surgery or immobilization.
- Patients with fractures or rupture of the ligaments.
- Patients using anticoagulants.
- Patients with severe concomitant systemic diseases, such as cancer, diabetes, or
acquired heart disease, hematological diseases, seizure disorders, autoimmune
diseases, renal failure, severe infections, hormonal disorders and pulmonary
disorders.
- History of alcoholism or illicit drug use;
- Use of NSAIDs, corticosteroids or venoterápicos, topics or any other form of
administration.
- Conditions in the opinion of the researcher make the patient unsuitable to participate
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 12 Years old.
| To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury. | NCT01097798 | Contradiction |
4,816 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Cushing's disease of endogenous origin: Who have failed surgery (or) who are awaiting
surgery (or) for whom surgery is not an immediate option.
- The diagnosis of Cushing's disease must be confirmed by each of the following:
- The clinical criterion of decreasing growth percentiles with increasing weight
(as evidenced by the presence of a contrast in height and BMI standard deviation
(SD) scores, defined as height standard deviation score (SDS) < 0 and BMI SDS >
0, and a strong clinical suspicion of Cushing's disease, such as photographic
evidence of a change in facial appearance);
- Abnormal low-dose (0.5 mg Q6h x 48 hours) dexamethasone suppression test, defined
as plasma cortisol levels > 1.8 mcg/dl, at time point 48 hours after the first
dose of dexamethasone;
- Measurable morning ACTH levels, assessed before 10 am;
- Two 24-hour urinary free cortisol values > 1.3 x ULN
- If the dexamethasone suppression test does not meet the above mentioned criteria,
the diagnosis of Cushing's disease may be confirmed by the following: Midnight
serum cortisol levels > upper limit of normal (ULN), assessed while the patient
is sleeping and after pre-cannulation (OR) two samples of late night salivary
cortisol greater than ULN for the assay
- Able to swallow study drug tablets (not crushed or split)
- Parents or legal guardians able to provide consent/assent
Exclusion Criteria:
- Patients with macroadenoma complicated by compressive symptoms (requiring urgent
surgical intervention) or at high risk for compressive symptoms due to mass effect of
tumor (concern of corticotroph tumor progression)
- Hypercortisolism not due to Cushing's disease
- Insufficient washout period from any other medication used to lower cortisol levels (5
half-lives of any drug)
- Use of other investigational drugs at the time of enrollment, or within 30 days, or
prior to completion of a wash-out duration that is at least 5 half- lives of the drug,
at the time of enrollment, whichever is longer. Local regulations may require a longer
wash-out period or specify other limitations for participation in an investigational
trial, in which case they will be applicable as well.
- Body weight <30kg
Other protocol-defined inclusion/exclusion may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 18 Years | Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease | NCT03708900 | Contradiction |
3,543 | 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:
- age > 18 years
- chronic adrenal failure with disease duration > 12 months and hormone replacement
therapy for cortisol deficiency
Exclusion Criteria:
- adrenal insufficiency due to adrenocortical carcinoma
- AI due to long-term pharmacological glucocorticoid treatment
- glucocortiocid doses above 7.5 mg prednisolone equivalent for other reasons than AI
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Survey in Patients With Chronic Adrenal Insufficiency in Germany | NCT00444119 | Entailment |
1,612 | 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:
- Part 1: 1.Must understand and voluntarily sign a written Informed Consent prior to any
study-related procedures being performed.
2.Must be able to communicate with the Investigator, understand and comply with the
requirements of the study, and agree to adhere to restrictions and examination
schedules.
3.Must be male or postmenopausal* women of any race between ≥61 to ≤85 years of age
(inclusive) at the time of signing the Informed Consent, and in good health as
determined by a physical exam, clinical laboratory safety test results, vital signs,
and 12 lead Electrocardiogram.
* =Naturally postmenopausal for at least 24 consecutive months (ie, who has not had
menses at any time in the preceding 24 consecutive months) 4.Subjects must be a non
smoker. 5.Clinical laboratory tests must be within normal limits or acceptable to the
Principal Investigator (PI).
6.Must have a normal or clinically acceptable 12-lead Electrocardiogram. 7.Must be
afebrile (febrile is defined as ≥ 38.0ºC or 100.4 Fahrenheit), with supine systolic
blood pressure (BP): 90 to 150 mmHg, supine diastolic blood pressure: 60 to 95 mmHg,
and pulse rate: 40 to 110 bpm and controlled on medications if they are indicated
(especially for blood pressure).
1. If a subject has a diagnosis of hypertension, the range for BP and pulse rate
will be the one that is considered well controlled on medication.
8.Must practice true abstinence* or agree to use a condom during sexual contact
with a pregnant female or a female that can get pregnant while participating in
the study, during dose interruptions and for at least 28 days following study
drug discontinuation, even if he has undergone a successful vasectomy.
* = True abstinence is acceptable when this is in line with the preferred and
usual lifestyle of the subject. Period abstinence (e.g., calendar, ovulation,
symptothermal, post ovulation methods) and withdrawal are not acceptable methods
of contraception 9.Must agree to refrain from donating sperm or semen while
participating in this study and for at least 28 days following the last dose of
study drug.
10.Must agree to refrain from donating blood or plasma (other than for this
study) while participating in this study and for at least 28 days following the
last dose of study drug.
11.Must agree to comply with the conditions described in the counseling document
(part of the pomalidomide Pregnancy Prevention Risk Management Plan.
Part 2
1. Must understand and voluntarily sign a written informed consent prior to any
study-related procedures being performed.
2. Must be able to communicate with the Investigator, understand and comply
with the requirements of the study, and agree to adhere to restrictions and
examination schedules.
3. Must be male of any race between 40 to 80 years of age (inclusive) at the
time of signing the Informed Consent, and in good health as determined by a
physical exam, clinical laboratory safety test results, vital signs, and 12
lead electrocardiogram.
4. Cohort A subjects (smokers) must have a history of smoking for >5 years and
currently smoke ≥1 pack (20-25) cigarettes per day; and urine cotinine level
at screening and baseline (Day -1) indicate subject is heavy smoker.
5. Cohort B subjects (non-smokers) must have not smoked for >5 years (Cohort
B).
6. Clinical laboratory tests must be within normal limits or acceptable to the
Principal Investigator.
7. Must have a normal or clinically acceptable 12-lead Electrocardiogram, with
a QTcF value ≤ 450 msec.
8. Must be afebrile (febrile is defined as ≥ 38.0ºC or 100.4 Fahrenheit), with
supine systolic blood pressure (BP): 90 to 150 mmHg, supine diastolic blood
pressure: 60 to 95 mmHg, and pulse rate: 40 to 110 bpm and controlled on
medications if they are indicated (especially for blood pressure).
9. Must practice true abstinence or agree to use a condom during sexual contact
with a pregnant female or a female that can get pregnant while participating
in the study, during dose interruptions and for at least 28 days following
study drug discontinuation, even if he has undergone a successful vasectomy.
10. Must agree to refrain from donating sperm or semen while participating in
this study and for at least 28 days following the last dose of study drug.
11. Must agree to refrain from donating blood or plasma (other than for this
study) while participating in this study and for at least 28 days following
the last dose of study drug.
12. Must agree to comply with the conditions described in the counseling
document (part of the pomalidomide Pregnancy Prevention Risk Management
Plan.
Exclusion Criteria:
- Both Parts:
1. History of any clinically significant and relevant neurological,
gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary,
metabolic, endocrine, hematological, allergic disease, drug allergies, known
hypersensitivity to a member of the class of drugs that can modulate the immune
system, or other major disorders.
1. Subjects with well-controlled hypertension, hyperlipidemia, gout,
asthma/chronic obstructive pulmonary disease, hypothyroidism and other
common age-related disorders, requiring treatment and being well-controlled
on concomitant prescription medication(s) will be eligible for inclusion in
the study.
2. Subjects with diabetes, significant gastrointestinal diseases or hematologic
disorders should not be included in the study.
2. Any condition, including the presence of laboratory abnormalities, which places
the subject at unacceptable risk if he were to participate in the study, or
confounds the ability to interpret data from the study.
3. Used any prescribed systemic or topical medication within 30 days of the first
dose administration, unless these medications are chronically administered and
Sponsor agreement is obtained.
4. Used any non-prescribed systemic or topical medication (including vitamin/mineral
supplements, and herbal medicines) within 14 days of the first dose
administration, unless these medications are chronically administered and Sponsor
agreement is obtained.
5. Has any surgical or medical conditions possibly affecting drug absorption,
distribution, metabolism and excretion, e.g., bariatric procedure.
6. Donated blood or plasma within 8 weeks before the first dose administration to a
blood bank or blood donation center.
7. History of drug abuse (as defined by the current version of the Diagnostic and
Statistical Manual within 2 years before dosing, or positive drug screening test
reflecting consumption of illicit drugs.
8. History of alcohol abuse (as defined by the current version of the DSM) within 2
years before dosing, or positive alcohol screen.
9. Known to have serum hepatitis or known to be a carrier of the hepatitis B surface
antigen, or hepatitis C antibody, or have a positive result to the test for Human
Immunodeficiency Virus antibodies at Screening.
10. Exposed to an investigational drug (new chemical entity) within 30 days preceding
the first dose administration, or 5 half-lives of that investigational drug, if
known (whichever is longer).
11. Received vaccination (excluding seasonal flu vaccination) within 90 days of the
study drug administration.
12. Subjects who are part of the staff personnel or family members of the
investigational study staff.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Food Effect and CYP1A2 Induction Study in Healthy Subjects | NCT02168205 | Contradiction |
3,288 | 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:
- Healthy term, gestational age of 38-42 weeks inclusive.
- Able to be transported to the Eye Clinic.
- No longer monitored. On no intravenous or other lines.
Exclusion Criteria:
- History of hyperglycemia in the infant (a blood sugar greater than 100mg%, per
Laboratory Policy on Critical Values for infants less than 20 days old).
- Feeding intolerance.
- Green-tinged aspirates/emesis.
- Abdominal distention.
- History of genetic consult indicating any abnormality.
- Any known ocular disorder.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 38 Weeks old.
Subject must be at most 42 Weeks | Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates | NCT01404247 | Contradiction |
3,966 | 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:
- Male or female, 18 years of age and older.
- Participants must meet American College of Rheumatology (ACR) criteria for
osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes knee
pain and at least three of the following 6 criteria: 50 years of age or older,
stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement,
and/or no warmth to the touch.
- Any medications (prescription and/or over-the counter) must be maintained on a stable
schedule for ≥ 2 weeks prior to treatment. No washout period is allowed.
- An average Visual Analog Scale (VAS) for pain ≥ 4 over the last 30 days.
- Subject is willing and able to give written informed consent.
- Subject is willing and able to comply with study instructions and commit to all
follow-up visits for the duration of the study.
- Subject is in good general health and free of any systemic disease state or physical
condition that might impair evaluation or which in the investigator's opinion, exposes
the subject to an unacceptable risk by study participation.
Exclusion Criteria:
- A partial or full knee replacement (in the treated knee).
- Any use of systemic injections (in any area) within the last 6 months.
- Current enrollment in an investigational drug or a device study that specifically
targets pain treatment.
- Any additional diagnosis that in the opinion of the investigator may directly
contribute to knee pain.
- Any concomitant inflammatory disease or other condition that affects the joints (e.g.
rheumatoid arthritis, metabolic bones disease, gout, active infection, etc.).
- Any clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel,
etc.) within seven (7) days prior to administration of the device.
- Allergy or intolerance to lidocaine.
- Any local skin condition at the treatment site that in the investigator's opinion
would adversely affect treatment or outcomes.
- Any chronic medical condition that in the investigator's opinion would prevent
adequate participation.
- Any chronic medication use (prescription, over-the-counter, etc.) that in the
investigator's opinion would affect study participation or subject safety.
- For any reason, in the opinion of the investigator, the subject may not be a suitable
candidate for study participation (i.e., history of noncompliance, drug dependency,
any related knee injury due to a worker's compensation claim, etc.).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device | NCT01704157 | Entailment |
5,752 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Symptomatic lesions.
- OLP lesions with the diagnosis confirmed both clinically and histopathologically.
- Clinical score higher than 3.
- Disease duration of more than 2 months.
- Absence of dysplasia in histological section
Exclusion Criteria:
- Presence of any visible oral lesion other than OLP.
- Pregnant or breast-feeding women,
- Immuno-deficiency diseases.
- Current malignancy or malignancy in history.
- Concomitant treatment potentially effective on OLP within the previous 2 months such
as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs.
- Severe or recurrent infections.
- Lichenoid reaction.
- Patients presents with skin lesions which may require systemic corticosteroid therapy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 17 Years old.
Subject must be at most 80 Years | Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus | NCT03415165 | Contradiction |
1,722 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Age 18-45 years, inclusive, of both genders
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
- No history of episodic wheezing, chest tightness, or shortness of breath consistent
with asthma, or physician-diagnosed asthma.
- Forced expiratory volume at one second (FEV1) of at least 80% of predicted and FEV1/
forced vital capacity (FVC) ≥0.70.
- Oxygen saturation of ≥93%
- Ability to provide an induced sputum sample.
- Subject must demonstrate a ≥10% increase in sputum %PMNs 6 hours following inhaled WSP
exposure, when compared to baseline sputum (to be completed in a separate protocol
IRB# 15-1775).
Exclusion Criteria:
Clinical contraindications:
- Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic renal
disease, chronic thyroid disease, history of chronic infections/immunodeficiency.
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
- Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85
mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading
less than 93%.
- Physician diagnosis of asthma
- If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic
rhinitis at the time of study enrollment.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
- Medications which may impact the results of the WSP exposure, interfere with any other
medications potentially used in the study (to include steroids, beta antagonists,
non-steroidal anti-inflammatory agents)
- Cigarette smoking > 1 pack per month
- Unwillingness to use reliable contraception if sexually active (IUD, birth control
pills/patch, condoms).
- Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS.
Oral contraceptives are acceptable, as are antidepressants and other medications may
be permitted if, in the opinion of the investigator, the medication will not interfere
with the study procedures or compromise safety and if the dosage has been stable for 1
month.
- Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.
- Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
- Allergy/sensitivity to study drugs or their formulations
- Pregnant/lactating women and children (< 18 years as this is age of majority in North
Carolina) will also be excluded since the risks associated with WSP exposure to the
fetus or child, respectively, are unknown and cannot be justified for this
non-therapeutic protocol. Individuals over 45 years of age will not be included due to
the increased possibility of co-morbidities and need for prohibited medications.
- Inability or unwillingness of a participant to give written informed consent
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 45 Years | Woodsmoke Particulate + Prednisone | NCT03861390 | Entailment |
3,754 | 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 eligible for the study were:
- older than 50 years and
- had primary knee OA diagnosed according to the clinical and radiological criteria of
the American Rheumatism Association.
Further inclusion criteria were:
- clinical signs of joint inflammation (warmth, swelling or effusion) and
- a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification
Exclusion Criteria:
- allergy to NSAIDs,
- progressive serious medical conditions (such as cancer, AIDS or end-stage renal
disease),
- history of gastrointestinal ulcer or bleeding,
- a hemoglobin concentration lower than 11.5 g/dL,
- renal diseases (serum creatinine concentration more than 1.2 times the upper limit of
the normal range according to the central laboratory definition reference values), or
- liver dysfunction (serum alanine or aspartate transaminase concentrations more than
1.5 times the upper limit of normal range according to the central laboratory
definition reference values).
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 85 Years | NSAID Treatment in Knee Osteoarthritis | NCT01860833 | Contradiction |
625 | 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:
- Age > 18 years
- Admission to the general cardiology or heart failure services and under the care of a
cardiologist at the study institution
- New York Heart Association Class II-IV heart failure
- Ejection fraction < 40%
- Serum hemoglobin < 12.0 g/dL
- Ferritin < 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) < 20%
- Patients deemed by an attending physician to require intravenous iron therapy based on
previous attempts to correct iron deficiency or other patient-specific circumstances
Exclusion Criteria:
- Anemia of other known etiology (e.g., malignancy, malabsorption syndromes)
- Use of iron or erythropoietin-stimulating agents within previous 12 weeks
- Blood transfusion within previous 12 weeks; additionally, if patients receive blood
transfusions during the study period, they will remain in the safety analysis but will
be excluded from efficacy analysis
- Active bleeding
- Known infection at admission
- Immunosuppressant therapy
- Renal replacement therapy
- Known pregnancy
- Any other criteria deemed by the attending physician to warrant exclusion
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.
| Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure | NCT01925703 | Contradiction |
354 | 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 in good general health with regular, ovulatory menstrual cycles
- age 18-35
- not pregnant
- not sexually active or reliably use barrier methods of contraception
- normal liver and renal functions and normal laboratory exams
Exclusion Criteria:
- pregnant or breastfeeding
- oral contraception, IUD or other hormonal treatment
- use of agents known to induce hepatic P450
- cardiovascular disorder
- hepatic, renal, or gastrointestinal disorder
- metrorrhagia
- abnormal transvaginal ultrasound (at baseline)
- history of abnormal endometrial biopsy,
- cancer
- depression
- mental illness
- epilepsy
- migraines
- abnormal Pap Smear requiring further exploratory examination
- anovulatory cycle before treatment
- extreme overweight or underweight (body mass index < 16 ou >28)
- subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability
to return for follow-up visits, and unlikelihood of completing the study
- use of narcotics
- more than 10 cigarettes per day, more than 2 glasses of wine/beer per day
- surgical procedures planned in the 6 months following screening visit
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914 | NCT00456924 | Contradiction |
6,908 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Age: 70-85 years old
- Presence of memory impairment
- Completed educational level: middle school
- Visual and auditory acuity: normal or corrected-to-normal
Exclusion Criteria:
- Monogenic AD
- Presence of a neurological disorder
- Stroke that has occurred in the last three months
- Prohibited medications
- Residence in skilled nursing facility
- Illiteracy, is unable to count or to read
- Claustrophobia
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 70 Years old.
Subject must be at most 85 Years | Neuroelectrical Biomarkers for Alzheimer's Disease Stages | NCT01880151 | Entailment |
2,399 | 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. | Diagnosis of DMD or Becker muscular dystrophy with confirmed dystrophin nonsense mutation.
Measurable limb or pulmonary weakness.
Signed consent.
Must not have a history of hypersensitivity reaction to an aminoglycoside.
Must not have abnormal baseline hearing.
Must not have abnormal baseline kidney function or serum creatinine level.
Must not be currently enrolled in another clinical trial.
Must not have recent (within past 3 months) initiation of prednisone or creatinine therapy.
Must not have a history of significant concomitant illness.
Must not have concomitant use of aminoglycoside or other nephrotoxic agent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Gentamicin Treatment of Muscular Dystrophy | NCT00005574 | Entailment |
5,139 | 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:
- Present with osteoporosis based on total hip, femoral neck or lumbar spine BMD T-score
of less than or equal to -2.5 but must never have had any osteoporotic fragility
fracture.
- Are ambulatory and are 60 to 85 years of age, inclusive. Aside from diagnosed
osteoporosis (Inclusion Criterion [1]), all women must be free of severe or
chronically disabling conditions, have a life expectancy of at least 5 years in the
opinion of the investigator, be expected to remain ambulatory throughout the entire
study, and be expected to return for follow-up visits.
- Had their last natural menstrual period at least 2 years before beginning the study.
- Are able to comprehend the requirements and procedures for the study and to provide
informed consent before entering the study.
- Have at least two lumbar vertebrae (L1 to L4) that are evaluable via dual energy X-ray
absorptiometry (DXA) and lateral thoracic and lumbar spine x-ray films that can be
adequately evaluated for existing vertebral fractures at screening.
- Have centrally read total hip, femoral neck or lumbar spine T-score less than or equal
to -2.5
Exclusion Criteria:
- Have known current metabolic bone disorders other than low bone mass, such as
hyperparathyroidism, renal osteodystrophy, or osteomalacia.
- Have known, suspected, or history of carcinoma of the breast or estrogen-dependent
neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized
patients with a history of carcinoma in situ of the uterus. For other cancers, be
disease free and in remission from all other cancers for 5 or more years, except for
excised superficial lesions, such as basal cell carcinoma or squamous cell carcinoma
of the skin.
- Have demonstrated or suspected allergy to raloxifene or arzoxifene
- Have unexplained or abnormal vaginal bleeding within 6 months prior to Visit 1 or
between Visit 1 and Visit 2.
- Are experiencing clinically severe postmenopausal symptoms that may require
estrogen-replacement therapy.
- Have a history of or suggestion on ultrasound or pelvic examination of a pre-existing
gynecologic abnormality that would require further gynecologic treatment (e.g.,
ovarian cysts, large fibroids, undiagnosed adnexal masses) or of baseline endometrial
thickness of >5 mm.
- Have Papanicolaou's tests showing malignant or premalignant findings.
- Have active or any past history of thromboembolic events
- Have active or any past history of atrial fibrillation.
- Have a history of cerebrovascular accident or documented transient ischemic attack at
any time in the past.
- Have acute or chronic liver disease defined as alanine aminotransaminase (ALT) >100
U/L, gamma-glutamyl transferase (GGT) >400 U/L, or late stage cirrhosis without
transaminase elevations.
- Have impaired kidney function (serum creatinine >177 micromol/L or >2.0 mg/dL).
- Have vitamin D deficiency prior to enrollment (Visit 2; 25-hydroxyvitamin D less
than10 ng/mL or less than 24.9 nmol/L).
- Have any known, severe, or untreated malabsorption syndromes.
- Have endocrine disorders requiring pharmacologic therapy except for type II diabetes
and hypothyroidism. Patients on a stable dose of thyroid replacement therapy during
the 6 months preceding randomization (Visit 2) who are clinically euthyroid in the
opinion of the investigator may enroll in the trial.
- Consume an excess of alcohol or abuse drugs
- Represent an unacceptable medical or psychiatric risk for treatment with an
investigational drug
- Have active or any history of seizure disorder.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 85 Years | A Study of Arzoxifene to Treat Korean Women With Osteoporosis | NCT00767299 | Contradiction |
875 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Age ≥ 18 years.
2. Informed consent obtained.
3. Patients with hand OA as defined by the American College of Rheumatology
Classification Criteria for hand OA:
- Hand pain, aching or stiffness
And 3 or 4 of the following features:
- Hard tissue enlargement of ≥2 of the 10 selected joints*.
- Hard tissue enlargement of ≥2 of the 10 DIP joints.
- Fewer than 3 swollen MCP joints.
- Deformity of at least 1 of 10 selected joints*. *The 10 selected joints are the second
and third DIP, the second and third PIP, and the first carpometacarpal joints of both
hands.
Exclusion Criteria:
1. Known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, gout, psoriatic
arthritis, psoriasis, inflammatory bowel disease), or other joint diseases
(haemochromatosis)
2. Positive anti-cyclic citrullinated peptide (>10 kU/L)
3. Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
4. Foreign material/metallic implants at the area of interest will be excluded to avoid
artefacts on CBCT [68].
5. Other diseases in the area - e.g. skin disease, known previous fracture in the joint
of interest.
6. Participation in experimental device or experimental drug study 3 months prior to
enrolment.
7. Pregnancy or breast-feeding.
8. Previous septic arthritis at the target joint.
9. Previous surgical procedures at the target joint.
10. Injection into the target joint within 3 months prior to enrolment.
11. Inability to speak and read Danish fluently.
12. Treatment with Colchicine within the last 30 days.
13. Treatment with systemic steroids ≥7.5 mg prednisolone within the last 30 days.
14. Lack of sample obtained for reference standard, i.e. unable to obtain either synovial
fluid, joint lavage fluid, joint biopsy or excite joint.
15. Any other condition that in the opinion of the investigator may interfere with study
participation.
There will be no restriction on sex or Kellgren-Lawrence (KL) grading.
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 Dual-energy CT | NCT04585113 | Entailment |
3,490 | 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:
- All adults above the age of 18 presented to the Assiut university Clinic with
cholesteatoma will be included in the study.
Exclusion Criteria:
1. Patients with previous mastoid surgery
2. Patients with Craniofacial anomalies or cleft lip and palate
3. Pediatric populations ≤ 18 years old
4. Patients with congenital ear anomalies
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.
| Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma | NCT04551612 | Entailment |
1,097 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
1. All patients that present with hypertrophic obstructive cardiomyopathy (HOCM) with
mean pressure gradient>50 mm Hg at rest or on provocation
2. HOCM patients with severe mitral regurgitation.
3. HOCM patients with New York Heart Association (NYHA) functional class II to IV despite
optimal medical treatment consisting of -blocking agents, calcium channel blockers, or
both.
Exclusion Criteria:
b. Exclusion criteria:
1. Non-obstructive physiological characteristics.
2. Previous MV surgery.
3. Patient with intrinsic pathology of the mitral valve.
4. Patients <18 years.
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 60 Years | Hyp Obst Cardiomyopathy | NCT04329689 | Entailment |
2,049 | 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:
- Healthy volunteers
- Volunteers with active Pneumothorax, detected by prior imaging studies up to 24 hours
before the ultrasound scan
- Volunteers with active Pleural effusion, detected by prior imaging studies up to 48
hours before the ultrasound scan ult
Exclusion Criteria:
- Volunteers with the aforementioned diagnosis, which was not detected during the actual
ultrasound exam
- Volunteers who expressed their desire to be excluded from the study at any given time
point.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Diagnosis and Classification of Pleural Diseases Using Ultrasound Channel Data | NCT04418804 | Contradiction |
3,527 | 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:
- Written informed consent.
- Patients with adrenal diseases.
- A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the
adrenal region within the previous 6 months prior to dosing day is available
Exclusion Criteria:
- Pregnant or breast-feeding women.
- Prior or planned administration of a radiopharmaceutical within 8 half-lives of the
radionuclide used on such radiopharmaceutical including at any time during the current
study.
- Any mental condition rendering the patient unable to understand the nature, scope and
possible consequences of the study, and/or evidence of an uncooperative attitude
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 | Gallium-68 Labeled Pentixafor PET/CT in Adrenal Masses | NCT04859959 | Entailment |
6,652 | 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%. | - Males with severe hemophilia B with Factor IX activity level < 1% of normal.
- Life expectancy of > 1 year.
- Age > 18 years old.
- Ability to give informed consent.
- Greater than twenty exposure days of treatment with Factor IX protein.
- No history or presence of an inhibitor to Factor IX protein.
- Subjects must be able to receive Factor IX protein on a home infusion protocol.
- Subjects must have a normal protime (PT).
- Hepatitis C infected subjects will be evaluated for liver fibrosis based on liver
biopsy data graded on a scale of 0-4 (Poynard et. al., 1997). Subjects who are
Hepatitis C antibody and RNA positive and have not had a liver biopsy within the last
36 months will be required to have one.
- Subjects must have low AAV titer.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety of a New Type of Treatment Called Gene Transfer for the Treatment of Severe Hemophilia B | NCT00076557 | Contradiction |
5,638 | 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:
- Diagnosis of Turner syndrome
- Less than the 50th percentile for length for the general female population
Exclusion Criteria:
- Prior Growth Hormone (GH) therapy
- Diabetes
- Allergy to metacresol (a preservative in the GH liquid that is injected)
- Contraindications for Magnetic Resonance Imaging (MRI) (such as metal in the body)
- Part of a Y chromosome in child's karyotype
- Parent/guardian is not willing for child to be randomized to be in the treatment group
(receives Growth Hormone injections for one year) or the control group (receives no
Growth Hormone during the study)
- Parent/guardian is not willing for child to have some of her developmental testing
digitally recorded for scoring
Female
No healthy subjects accepted to join the trial.
Subject must be at least 11 Months old.
Subject must be at most 13 Months | Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome | NCT01367834 | Contradiction |
2,914 | 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:
1. Lab supported probable or more definite ALS by El Escorial Criteria
2. Age greater than or equal to 18 years
3. Willing and able to provide informed consent
4. On riluzole at a stable dose for at least 30d or not taking this
5. On Radicava at a stable dose for at least 30d or not taking this
6. Life expectancy at least 6 months
7. Currently managed on a reasonably stable diet, avoidance of fasting, carnitine or
medium chain triglyceride (MCT) oils
8. Must stop any other experimental ALS treatment for at least 30 days prior to screening
9. If sexually active, must agree to use contraceptive or abstinence for duration of
treatment with triheptanoin
10. Females of child bearing age must have negative pregnancy test at screening
Exclusion Criteria:
1. Unwilling or unable to provide informed consent
2. Previous intolerance or adverse reaction to triheptanoin or MCT
3. Conditions that will prohibit MRI scanning (metal in eye, some surgical implants,
claustrophobia, inability to lie supine)
4. Have any other co-morbid conditions that in the opinion of the study investigator,
places the participant at increased risk of complications, interferes with study
participation or compliance, or confounds study objectives
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS) | NCT03506425 | Entailment |
5,862 | 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:
- persons undergoing wireless pH testing for diagnosis and treatment of GERD
Exclusion Criteria:
- those under the age of 18
- pregnant and lactating women
- those who do not meet the inclusion criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux | NCT00584259 | Contradiction |
1,823 | 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. 18 years ~ 75 years;
2. the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous
adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);
3. clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);
4. to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0
resection (multiple primary cancers also apply)
5. ECOG performance status 0/1;
6. ASA score I-III;
7. patient informed consent.
Exclusion Criteria:
1. pregnant or lactating women;
2. serious mental illness;
3. upper abdominal surgery (except laparoscopic cholecystectomy );
4. gastric surgery (including for gastric ESD / EMR);
5. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
6. other malignant diseases in 5 years;
7. implemented or recommended neoadjuvant therapy in patients with gastric cancer ;
8. have unstable angina or myocardial infarction within six months; (9) have cerebral
infarction or cerebral hemorrhage within 6 months; (10) sustained systemic
glucocorticoid treatment history within 1 month; (11) have other diseases needed
operative treatment at the same time; (12) complications (bleeding, perforation,
obstruction) required emergency surgery; (13) Pulmonary function tests FEV1 <50% of
predicted value.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery | NCT02302794 | Entailment |
2,626 | 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:
- 6 to 16 year old patients of both gender
- ASA (American Society of Anesthesiologists) I and ASA II patients
- Scheduled for elective lower abdominal surgery (inguinal hernia repair or
circumcision) or orthopedic surgery (upper and lower limb) under General anesthesia.
Exclusion Criteria:
- Patients with risk of aspiration (incomplete NPO (Nil per oral), Gastroesophageal
reflux disease, Congenital anatomic abnormalities of aero digestive tract, delayed
gastric emptying, altered mental status)
- Difficult airway(difficult mask ventilation or difficult laryngoscopy, Cormack-Lehane
grade more than 2 in patient history, trismus, limited mouth opening, trauma or mass)
- Children who are unable to self-report pain using a four-point categorical pain scale
- Refusal of the parent
- Refusal of the child to give assent
- Patients having pre-existing sore throat or symptoms of Upper respiratory tract
infection.
- Obese children i.e. BMI for age percentile equal to or greater than the 95th
percentile on BMI-for-age percentile growth charts.
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 16 Years | Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®. | NCT03140228 | Contradiction |
76 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Men >18 years of age
- Diagnosis of an incomplete SCI involving spinal segments T12 or above, for >12-months
- Low serum total testosterone (<300 ng/dL), bioavailable testosterone (<75 ng/dL), or
free testosterone (<64 ng/dL)
- Presence of one or more sign or symptom that may be related to low testosterone,
including: loss of body hair or reduced shaving, very small testes (<6 mL), reduced
sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning
erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss,
low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation,
initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a
depressed mood, or having a persistent low-grade depressive disorder, poor
concentration or memory, sleep disturbances or increased sleepiness, mild unexplained
anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical
performance, Increased body fat or body mass index, any other sign or symptom commonly
associated with low testosterone
- Locomotor dysfunction
- Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic
pathology
- Medically-stable condition that is asymptomatic for conditions that will interfere
with the study participation
- Willingness to administer TRT as instructed by the study staff and to abide by study
protocol
- Documented approval from the study physician verifying medical status
Exclusion Criteria:
- Currently participating in another research protocol that may influence study
outcomes.
- Mental state that precludes understanding the study protocol.
- Life expectancy <12-months.
- History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele,
intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g.,
spinocerebellar degeneration, syringomyelia) that may complicate study procedures
- Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or
injury
- Current prostate, breast, or other organ cancer or a history of prostate or breast
cancer
- Any other diagnosed or treated cancer within the past 24-months, with the exceptions
of basal or squamous cell carcinoma of the skin that has been successfully treated
- Serum prostate-specific antigen (PSA) >3.0 ng/mL [men treated with 5-alpha reductase
inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA
values are ≤1.5 ng/mL]
- Prostate nodule or induration noted on digital rectal exam (DRE) during screening that
tests positive for prostate cancer
- Currently seeking fertility or expected during the duration of the study
- Gynecomastia
- Hematocrit (HCT) >49%
- Any major cardiovascular (CV) event within the last 12-months (defined as a history of
acute myocardial infarction, any cardiac revascularization procedure including
angioplasty, stenting, or coronary artery bypass grafting, revascularization of the
carotid or middle cerebral artery or procedures to treat critical limb ischemia, or
hospitalization due to unstable angina, transient ischemic attack, stroke, or
peripheral vascular disease)
- Angina that is not controlled on a current medical regimen (Canadian class II, III, or
IV)
- Poorly compensated congestive heart failure (NYHA class III or IV)
- Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or
diastolic BP ≥100 mmHg), while on medications
- Poorly controlled arrhythmia of any type
- Severe valvular heart disease
- Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked
ECG abnormalities that would preclude serial screening evaluations for occult ischemic
events
- History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism,
history of recurrent DVT or known thrombophilia
- LDL cholesterol >160 mg/dL with history of any major CV event, defined above, within
the last 12-months
- Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days
prior to screening and/or a major surgery scheduled at the time of screening
- Liver enzymes (AST or ALT) >1.5 times the normal upper limit
- Severe or end-stage chronic kidney disease documented by estimated glomerular
filtration rate (eGFR) <30 mL/min
- Diagnosed, but untreated severe obstructive sleep apnea
- Lower extremity fracture in the last 12-months (exclusion criterion for participation
in LT+TRT group only)
- Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD <0.70
g/cm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT
group only)
- Current anticoagulant therapy (contraindication for i.m. injections)
- Use of any of the following pharmacologic agents in the previous 90-days: any TRT
formulation, any compounded or over-the-counter androgenic hormones or androgen
precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or
growth hormone
- Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days
- Acute use (>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic
glucocorticoids >7.5 mg/d prednisone equivalent (e.g., hydrocortisone 30 mg,
methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening
visit, except men who are taking these medications for a chronic condition and are
anticipated to continue treatment for the study duration
- Known allergy to any component of the TRT formulation (e.g., sesame oil)
- Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or
reason that might pose a risk to the participant, make participation not in the
person's best interest, confound the study results (e.g., inability to comply with
study requirements), make the participant unsuitable to receive study intervention, or
interfere with the person's ability to participate for the entire study duration
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury | NCT04460872 | Contradiction |
6,347 | 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:
- Inclusion criteria :
- Adult aged 18 to 75 years old
- Taken into primary health care for suspicion of early-stage COVID-19 infection
(maximum 5 days of evolution). The patient must have presented within the previous 5
days at least one of the following criteria: fever (≥38°C), cough, anosmia, agueusia,
diarrhea, headache, myalgia.
Criteria for randomization at D2 :
- Positive PCR on deep nasopharyngeal swab.
- Kalemia ≥ 3.5 mmol/L
- Normal magnesium and calcium levels (according to laboratory standards)
- QTc ≤ 460ms for women or QTc ≤ 450ms for men
- Beta-hCG negative
Exclusion criteria :
- Comorbidity(ies) or clinical condition of the patient requiring immediate oxygen
therapy, hospitalization and/or ventilatory assistance
- Concomitant treatment contraindicated, not recommended, or with precautions for use in
combination with hydroxychloroquine or azithromycin:
- drug likely to induce torsades de pointe or at increased risk of ventricular
arrhythmia, and in particular citalopram, escitalopram, hydroxyzine, domperidone,
piperazine, class IA and III antiarrhythmics, tricyclic antidepressants,
antipsychotics and certain anti-infectives (macrolides, fluoroquinolones).
- Alkaloids of ergot of rye, colchicine, cisapride
- proconvulsant or epileptogenic threshold lowering drugs: imipraminic
antidepressants, selective serotonin reuptake inhibitors, neuroleptics
(phenothiazines and butyrophenones) and tramadol.
- Known history of contraindications or increased risk of treatment with
hydroxychloroquine or azithromycin (retinopathy,renal failure, significant liver
failure, severe cholestasis, porphyria, known G6PD deficit, hypomagnesemia and
hypokalemia, diabetes, myasthenia gravis, Heart diseases (heart failure, infarction,
arrhythmia, congenital QTc prolongation, abnormalities that interfere with QTc
measurement such as Left Bundle Branch Block, Right Bundle Branch Block, Pace maker
with ventricular pacing), epilepsy, allergy to hydroxychloroquine, chloroquine,
azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of
Plaquenil® or Zithromax® or any of the components of Azinc form and vitality®.
- Ongoing treatment with hydroxychloroquine or azithromycin, regardless of the
indication.
- Taking other antiviral targeted therapy used in COVID-19 disease
- Women who are pregnant or breastfeeding or planning to become pregnant within 8 months
of discontinuing hydroxychloroquine therapy.
- No National Health Insurrance (sécurité sociale, CMU or AME) coverage.
- Major under guardianship or curatorship
- Participation in another therapeutic clinical trial for COVID-19
- Refusal to participate in the study and/or lack of signature of a 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 75 Years | Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients | NCT04371406 | Entailment |
5,729 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- BMI 19-27 kg/m2
- smokes >10 cigarettes per day for preceeding 6 months
Exclusion Criteria:
- inability to stop smoking during study
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 55 Years | A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers | NCT01702519 | Contradiction |
2,045 | 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:
- confirmed diagnosis of stomach cancer
- advanced stomach cancer stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and to sign an informed consent document
Exclusion Criteria:
- prior chemotherapy for stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding 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.
| Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer | NCT00555672 | Entailment |
1,220 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Age >18 years Presence of undiagnosed exudative pleural effusion as determined by the
criteria detailed by Light et al where a specific diagnosis was not obtained after
initial cytological and/or microbiological examinations.
Adequate rib spaces for successful performance of thoracoscopy as judged by clinical
examination Adequate pleural fluid space as judged by pre-procedural USG chest
Exclusion Criteria:
1. Pregnancy
2. Coagulopathy (platelet count < 50000/mm3, INR > 1.5)
3. Unstable hemodynamic status ( SBP > 180, DBP> 100 or SBP< 90 mm Hg / heart failure
4. Myocardial infarction or unstable angina in the last 6 wk
5. Hypoxemia not correctable with low flow oxygen (SpO2 <90% despite low flow oxygen @
1-2 l/min)
6. Extensive rib crowding as judged by clinical examination
7. Extensive adhesions and lack of pleural space on USG chest
8. Refusal of 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.
| Mini Thoracoscopy vs Semirigid Thoracoscopy in Exudative Pleural Effusions | NCT02851927 | Entailment |
5,223 | 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:
- Clinical diagnosis of Osteoporosis
- Must be able to swallow tablets
Exclusion Criteria:
- N/A
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis | NCT02306187 | Entailment |
6,737 | 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:
- Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS
as their only source of FVIII, decision taken by the investigator to administer
KOGENATE® FS. For pretreated patients with more than 100 exposure days an inhibitor
assessment within three months prior to enrollment should be available; for pretreated
patients with less than 100 exposure days an inhibitor assessment at baseline should
be available.
Male
No healthy subjects accepted to join the trial.
| Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America | NCT00969319 | Contradiction |
827 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Knee pain and crepitus with active motion and morning stiffness ≤ 30 min ages ≥ 38 and
≤ 80
2. Knee pain and crepitus with active motion and morning stiffness >30 minutes and boney
enlargement ages ≥ 38 and ≤ 80
3. Knee pain and no crepitus and boney enlargement ages ≥ 38 and ≤ 80 Note: knee x-rays
taken in each case to determine grades (0-4) Kellgren Lawrence x-ray scale - but not
required for diagnosis - (and if needed lumbosacral/pelvic, hip, ankle or foot x-rays
obtained) see exclusions below)
4. Knee pain (mild to moderate) of 1 year duration and age ≥ 38 and ≤ 80 years of age and
able to stand and walk (see informed consent)
5. Diagnosis of concurrent subluxation/joint dysfunction (S/JD) complex a) Diagnosis of
S/JD will be supported throughout using the PART(S) system 6).A patient must have a
score of ≥720 mm on the WOMAC to be included (≥30%) 7).Additionally, KOA patients, who
are + for the Berg Balance Scale (BBS) will be monitored as a subgroup (with OLST and
BBS) at all clinic assessments.
Exclusion Criteria:
Rule out: General and internal medical disorders such as significant visual disorders,
severe vestibular disorders (i.e., Meniere's), neurological (including Alzheimer's and
other degenerative brain and mental disorders, disease and dysfunction) peripheral sensory
disorders (severe insulin dependent diabetes), knee and hip joint replacement on side of
knee that is treated (case by case otherwise), RA, instability, fracture/ and severe
osteoporosis, frank avascular necrosis with or without moderate or severe deformity, lumbar
herniated disc and injury, severe balance and proprioception problems (i.e., inability to
stand with and/or without marked spinal, knee or hip deformity) etc. Symptoms (moderate to
severe) in both knees or hips (case by case), etc. Recent history of meniscal or other knee
surgery (not less than 6 months). Severe/constant self reported knee crepitus. Severe loss
of knee or hip ROM and or severe deformity (in valgus, varus etc) particularly with
instability. Severe depression per Beck Depression Index. Marked or severe fear of
chiropractic adjustments/manipulative and or exercise procedures. Breaks for treatment
longer than 3-4 weeks depending on each circumstance or merit may be construed as
non-compliance and may be excluded.
-
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.
Subject must be at most 80 Years | Comparing Manipulation, Rehabilitation and Combination of the Two in the Treatment of Knee Osteoarthritis | NCT01188837 | Entailment |
1,873 | 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 gastric adenocarcinoma
2. ≥ D2 resection
3. Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외)
4. 18 ≤ age ≤ 75
5. ECOG 0-2
6. No distant metastasis
7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul,
haemoglobin ≥ 10g/dl)
8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
10. Written informed consent
Exclusion Criteria:
1. Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer
2. Active infection requiring antibiotics
3. Pregnant, lactating women
4. Psychiatric illness, epileptic disorders
5. Concurrent systemic illness not appropriate for chemotherapy
6. Resection margin (+)
7. Pathologic stage IA
8. History of other malignancy within 5 years except for non-melanoma skin cancer, cervix
in situ carcinoma
9. M1 lymph node (+)
10. D0, D1 resection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma | NCT00323830 | Entailment |
2,530 | 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:
- Children with atopic eczema according to Hanifin and Rajkas criteria with a mother
breastfeeding the child or a sibling.
- The eczema spots in the treatment and control areas were to be similar in features and
extent as well as being localized on contralateral parts of the body.
Exclusion Criteria:
- Children were excluded if the severity of the eczema spots indicated need for
treatment with antibiotics and/or steroids.
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 | Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children | NCT02381028 | Entailment |
4,175 | 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:
General and Demographic Criteria
- Age of 18 to 40 years
- Access to a participating HVTN clinical research site (CRS) and willingness to be
followed for the planned duration of the study
- Ability and willingness to provide informed consent
- Assessment of understanding: volunteer demonstrates understanding of this study;
completes a questionnaire prior to first vaccination with verbal demonstration of
understanding of all questionnaire items answered incorrectly
- Agrees not to enroll in another study of an investigational research agent before the
last required protocol clinic visit
- Willing to be contacted by phone, text message, or e-mail 6 months after completion of
the scheduled clinic visits
- Good general health as shown by medical history, physical exam, and screening
laboratory tests
HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction
counseling.
- Assessed by the clinic staff as being at "low risk" for HIV infection and committed to
maintaining behavior consistent with low risk of HIV exposure through the last
required protocol clinic visit.
Laboratory Inclusion Values:
Hemogram/Complete Blood Count (CBC)
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female,
greater than or equal to 13.0 g/dL for volunteers who were born male
- White blood cell count equal to 3,300 to 12,000 cells/mm^3
- Total lymphocyte count greater than or equal to 800 cells/mm^3
- Remaining differential either within institutional normal range or with site physician
approval
- Platelets equal to 125,000 to 550,000/mm^3
Chemistry
- Chemistry panel: ALT, AST, and alkaline phosphatase less than 1.25 times the
institutional upper limit of normal; creatinine less than or equal to institutional
upper limit of normal.
Virology
- Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved
enzyme immunoassay (EIA). Non-US sites may use locally available assays that have been
approved by HVTN Laboratory Operations.
- Negative Hepatitis B surface antigen (HBsAg)
- Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
chain reaction (PCR) if the anti-HCV is positive
Urine
- Normal urine:
- Negative urine glucose, and
- Negative or trace urine protein, and
- Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a
microscopic urinalysis with red blood cells levels within institutional normal
range).
Reproductive Status
- Volunteers who were born female: negative serum or urine beta human chorionic
gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of
initial vaccination. Persons who are NOT of reproductive potential due to having
undergone total hysterectomy or bilateral oophorectomy (verified by medical records),
are not required to undergo pregnancy testing.
Reproductive status:
United States
A volunteer who was born female must:
- Agree to consistently use effective contraception (see the protocol for more
information) for sexual activity that could lead to pregnancy from at least 21 days
prior to enrollment through the last required protocol clinic visit. Effective
contraception for participants in the United States is defined as using any 1 or more
of the following methods:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- Successful vasectomy in the male partner (considered successful if a volunteer
reports that a male partner has [1] documentation of azoospermia by microscopy,
or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite
sexual activity postvasectomy), or
- Any other contraceptive method approved by the HVTN 108 protocol safety review
team (PSRT)
- Or not be of reproductive potential, such as having reached menopause (no menses for 1
year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
- Or be sexually abstinent.
Southern Africa
A volunteer who was born female must:
- Agree to consistently use effective contraception (see the protocol for more
information) for sexual activity that could lead to pregnancy from at least 21 days
prior to enrollment through the last required protocol clinic visit. Effective
contraception for participants in Southern Africa is defined as using 2 methods of
birth control. These include 1 of the following methods:
- Condoms (male or female)
- Diaphragm or cervical cap
- PLUS 1 of the following methods:
- IUD,
- Hormonal contraception (in accordance with applicable national contraception
guidelines), or
- Successful vasectomy in the male partner (considered successful if a volunteer
reports that a male partner has [1] documentation of azoospermia by microscopy,
or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite
sexual activity postvasectomy), or
- Any other contraceptive method approved by the HVTN 108 PSRT
- Or not be of reproductive potential, such as having reached menopause (no menses for 1
year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
- Or be sexually abstinent.
- Volunteers who were born female must also agree not to seek pregnancy through
alternative methods, such as artificial insemination or in vitro fertilization until
after the last required protocol clinic visit
Other
Volunteers 21 years of age and older who were born female consenting to provide cervical
samples:
- Pap smear within:
- the 3 years prior to enrollment with the latest result reported as normal or
atypical squamous cells of undetermined significance (ASCUS), or
- the 5 years prior to enrollment, with the latest result reported as normal, or
ASCUS with no evidence of high risk human papillomavirus (HPV).
- If no pap smear was done within the last 3 years (or within the last 5 years, if high
risk HPV testing was performed), the volunteer must be willing to undergo a pap smear
with the result reported as normal or ASCUS prior to sample collection.
Exclusion Criteria:
General
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35
with 2 or more of the following: systolic blood pressure greater than 140 mm Hg,
diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
- Intent to participate in another study of an investigational research agent or any
other study that requires non-HVTN HIV antibody testing during the planned duration of
the HVTN 108 study
- Pregnant or breastfeeding
- Active duty and reserve US military personnel
Vaccines and Other Injections
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
control/placebo in an HIV vaccine trial, the HVTN 108 PSRT will determine eligibility
on a case-by-case basis.
- Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine
trial. Exceptions may be made for vaccines that have subsequently undergone licensure.
For volunteers who have received control/placebo in an experimental vaccine trial, the
HVTN 108 PSRT will determine eligibility on a case-by-case basis. For volunteers who
have received an experimental vaccine(s) greater than 5 years ago, eligibility for
enrollment will be determined by the HVTN 108 PSRT on a case-by-case basis.
- Live attenuated vaccines other than influenza vaccine received within 30 days before
first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and
rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
- Influenza vaccine or any vaccines that are not live attenuated vaccines and were
received within 14 days prior to first vaccination (eg, tetanus, pneumococcal,
Hepatitis A or B)
- Allergy treatment with antigen injections within 30 days before first vaccination or
that are scheduled within 14 days after first vaccination
Immune System
- Immunosuppressive medications received within 168 days before first vaccination. (Not
exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical
corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of
oral/parenteral corticosteroids at doses less than 2 mg/kg/day and length of therapy
less than 11 days with completion at least 30 days prior to enrollment.)
- Serious adverse reactions to vaccines or to vaccine components including history of
anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema,
and/or abdominal pain. (Not excluded from participation: a volunteer who had a
nonanaphylactic adverse reaction to pertussis vaccine as a child.)
- Immunoglobulin received within 60 days before first vaccination
- Autoimmune disease
- Immunodeficiency
Clinically significant medical conditions
- Untreated or incompletely treated syphilis infection
- Clinically significant medical condition, physical examination findings, clinically
significant abnormal laboratory results, or past medical history with clinically
significant implications for current health. A clinically significant condition or
process includes but is not limited to:
- A process that would affect the immune response,
- A process that would require medication that affects the immune response,
- Any contraindication to repeated injections or blood draws,
- A condition that requires active medical intervention or monitoring to avert
grave danger to the volunteer's health or well-being during the study period,
- A condition or process for which signs or symptoms could be confused with
reactions to vaccine, or
- Any condition specifically listed among the exclusion criteria below.
- Any medical, psychiatric, occupational, or other condition that, in the judgment of
the investigator, would interfere with, or serve as a contraindication to, protocol
adherence, assessment of safety or reactogenicity, or a volunteer's ability to give
informed consent
- Psychiatric condition that precludes compliance with the protocol. Specifically
excluded are persons with psychoses within the past 3 years, ongoing risk for suicide,
or history of suicide attempt or gesture within the past 3 years.
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as
defined in the most recent US National Asthma Education and Prevention Program (NAEPP)
Expert Panel report). Exclude a volunteer who:
- Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- Uses moderate/high dose inhaled corticosteroids, or
- In the past year has either of the following:
- Greater than 1 exacerbation of symptoms treated with oral/parenteral
corticosteroids;
- Needed emergency care, urgent care, hospitalization, or intubation for asthma.
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
excluded: history of isolated gestational diabetes.)
- Thyroidectomy, or thyroid disease requiring medication during the last 12 months
- Hypertension:
- If a person has been found to have elevated blood pressure or hypertension during
screening or previously, exclude for blood pressure that is not well controlled.
Well-controlled blood pressure is defined as consistently less than or equal to
140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without
medication, with only isolated, brief instances of higher readings, which must be
less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg
diastolic. For these volunteers, blood pressure must be less than or equal to 140
mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
- If a person has NOT been found to have elevated blood pressure or hypertension
during screening or previously, exclude for systolic blood pressure greater than
or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or
equal to 100 mm Hg at enrollment.
- Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)
- Malignancy (Not excluded from participation: Volunteer who has had malignancy excised
surgically and who, in the investigator's estimation, has a reasonable assurance of
sustained cure, or who is unlikely to experience recurrence of malignancy during the
period of the study)
- Seizure disorder: History of seizure(s) within past 3 years. Also exclude if volunteer
has used medications in order to prevent or treat seizure(s) at any time within the
past 3 years.
- Asplenia: any condition resulting in the absence of a functional spleen
- History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
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 | Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults | NCT02915016 | Contradiction |
3,553 | 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:
- Age > 18 years
- patient's written informed consent
- Ability to comply with the protocol procedures
- patients with primary or secondary adrenal insufficiency under established stable
replacement therapy
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.
| National Education Programme for Patients With Chronic Adrenal Insufficiency | NCT02694926 | Entailment |
2,096 | 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:
- IPF, diagnosed according to the American Thoracic Society (ATS) and European
Respiratory Society (ERS) consensus statement (with or without surgical lung biopsy)
- Pulmonary hypertension, defined as mean pulmonary artery pressure (MPAP) greater than
or equal to 25 mm Hg by right heart catheterization (RHC)
Exclusion Criteria:
- Interstitial lung disease due to conditions other than IPF
- Recent lung or upper respiratory tract infection within 4 weeks of study entry
- Acute or chronic impairment other than dyspnea (e.g., angina pectoris, intermittent
claudication) limiting the ability to comply with study requirements (e.g., 6-minute
walk test)
- Known hypersensitivity to sildenafil
- Known or suspected coronary artery disease (CAD)
- Unstable angina
- Nitrate use
- Known or suspected aortic stenosis (AS)
- Known or suspected heart attack, stroke, or life-threatening arrythmias within 1 month
of study entry
- Severe chronic heart failure, defined as New York Heart Association (NYHA) class
III/IV and/or left ventricular ejection fraction less than 25%
- Known penile deformities
- Known kidney or liver dysfunction
- Uncontrolled diabetes (blood glucose less than 60 mg/dl or greater than 300 mg/dl)
- Severe serum sodium abnormalities (serum sodium less than 130 mEq/L or greater than
150 mEq/L)
- Condition that may predispose participant to priapism (e.g., sickle cell anemia,
multiple myeloma, leukemia)
- Retinitis pigmentosa
- Known or suspected idiopathic hypertrophic subaortic stenosis (IHSS)
- Low blood pressure (systolic blood pressure [SBP] less than 100 mm Hg or diastolic
blood pressure [DBP] less than 50 mm Hg)
- Uncontrolled systemic high blood pressure (SBP greater than 180 mm Hg or DBP greater
than 100 mm Hg)
- Cardiopulmonary rehabilitation program started within 8 weeks of study entry or likely
to start prior to the conclusion of the study
- Treatment with an endothelin receptor antagonist, iloprost, epoprostenol, inhibitors
of CYP3A4 (e.g., cimetidine, erythromycin, ketoconazole, itraconazole, mibefradil),
protease inhibitors (e.g., amprenavir, indinavir, or ritonavir), rifampin,
alpha-blockers (e.g., doxazosin), or other phosphodiesterase-5 inhibitors
- Current use of alcohol, grapefruit juice, or St. John's wort
- Pregnant or breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension | NCT00352482 | Entailment |
6,025 | 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 older than 20 years
- Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic
cavity)
- Performance of laparoscopic hiatal hernia repair
- Informed Consent as documented by signature
Exclusion Criteria:
- Cases of conversion to open surgery
- Age < 20 years and > 80 years
- History of oesophageal/gastric/duodenal surgery including vagotomy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Approach to Hiatal Hernia Repair Based on Collagen Study | NCT04152798 | Entailment |
3,419 | 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:
In order to be eligible to participate in this study as a subject with HI, an individual
must meet all of the following criteria:
1. Provision of signed and dated informed consent.
2. Stated willingness to comply with all study procedures and availability for the
duration of the study
3. All genders, aged 18-65 years
4. Diagnosed with hearing instability, defined as documented hearing instability on
serial audiometry with sensorineural hearing loss (SNHL) greater than 30 dB HL at one
or more frequencies (Jose A. Lopez-Escamez et al., 2015) on at least one hearing test.
Inclusion will require documentation of clinically significant change in hearing
(either worsening or improvement) between at least 2 hearing tests or documentation of
a sudden change in hearing. Clinically significant change in hearing will be defined
by a change of 10 dB at any three frequencies, 15 dB at any two frequencies, or at
least 20 dB at one frequency. A sudden change in hearing will be defined as at least a
30 dB difference at 3 consecutive frequencies in the affected ear as compared to the
contralateral ear (Chandrasekhar et al., 2019).
5. No air-bone gaps in excess of 10 dB for 500-4000 Hz indicative of conductive HL.
6. Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally,
defined as middle ear pressure between plus minus 100 decaPascals, and peak
compensated static compliance between 0.3-1.5 milliliters (Margolis & Heller, 1987)
7. For females of reproductive potential: Negative pregnancy test at start of study
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Presence of non-MRI compatible devices (cardiac pacemaker, meta<specific devices
(e.g., cardiac pacemaker)
2. Pregnancy or lactation
3. Known allergic reactions to gadolinium
4. Febrile illness within 2 weeks that could affect immune profiling*
5. Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic
ear canal, otorrhea)
6. History of chronic, as defined by fluid in the middle ear for more than 4 months, or
recurrent otitis media, as defined by more than 4 episodes of acute otitis media in
one year.
7. Current PE tubes
8. Bilateral profound (Pure tone average (PTA) > 90 dB HL) sensorineural hearing loss
9. History or diagnosis of a central nervous system disorder, including but not limited
to:
1. Intracranial tumors
2. Cerebrovascular disease
3. Degenerative CNS disorder
4. CNS trauma
5. Encephalitis
6. Meningitis
10. Unable to discontinue medications that can interfere with vestibular test results for
the 48 hours immediately preceding a vestibular study session. These include any and
all anti-dizziness medications (such as Antivert), alcohol, caffeine, prescription
pain medications (such as Percocet), prescription headache medications (such as
Imitrex), sleeping pills (such as Ambien), anti-seizure medications (such as Topamax),
and/or antihistamines (such as Benadryl).
11. Current diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM
IV) of schizophrenia, bipolar disorder, or psychosis.
12. Unstable intercurrent illness that in the judgment of the PI could prevent or confound
collection of data. Prospective study subjects who are cognitively impaired and lack
consent capacity, will not be enrolled.
- Participants suspected of having COVID-19 will be moved to the designated
COVID-19 unit and tested for SARS CoV-2 and Respiratory Pathogen Panel per
guidance from NIH CC Clinical Practice Safety Guidelines. Possible COVID-19
infections identified by phone screen will not be eligible for study protocol
until infection resolved.
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 | Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets | NCT04806282 | Entailment |
5,292 | 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:
- seek primary care (GP, physiotherapist or chiropractor)
- new episode of back pain
- no visit of primary care the preceding 6 months for back pain
Exclusion Criteria:
- cognitive impairments
- difficulties speaking and writing Norwegian
- severe mobility impairments (can not attend physical examination)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| BACk Pain in Elders in Norway (BACE-N) | NCT04261309 | Entailment |
4,275 | 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. Subjects ≥ 6 years of age at time of Informed Consent Form (ICF) or Assent Form
signing.
2. Confirmed diagnosis of CF, determined by having clinical features consistent with the
CF phenotype, plus one of the following:
1. Positive sweat chloride test (value ≥ 60 mEq/L),
2. Genotype with 2 mutations consistent with CF (i.e., a mutation in each of the
cystic fibrosis transmembrane conductance regulator [CFTR] genes).
3. Positive sputum culture or a throat swab culture for MRSA at Screening.
4. In addition to the Screening sample, have at least 2 prior sputum or throat swab
cultures positive for MRSA, of which at least 1 sample is more than 6 months prior to
Screening. At least 50% of all MRSA cultures (sputum or throat swab culture) collected
from the time of the first positive culture (in the previous 1 year) must have tested
positive for MRSA. (Note: Screening sample may count towards 50% positive count)
5. Forced expiratory volume in 1 second (FEV1) ≥ 30% and ≤ 90% of predicted that is
normal for age, gender, race, and height, using the Global Lung Function Initiative
(GLI) equation.
6. At least 1 episode of acute pulmonary infection treated with non-maintenance
antibiotics within 12 months prior to the Baseline visit. (Initiation of treatment
with intermittent inhaled anti-Pseudomonal therapy will not qualify as treatment with
non-maintenance antibiotics).
7. If female of childbearing potential, an acceptable method of contraception must be
used during the study and must be combined with a negative pregnancy test obtained
during Screening; sexually active male subjects of reproductive potential who are
non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6
months, and were not diagnosed with infertility through demonstration of azoospermia
in a semen sample and/or absence of vas deferens through ultrasound) must be willing
to use a barrier method of contraception, or their female partner must use an
acceptable method of contraception, during the study.
For purposes of this study, the Sponsor defines "acceptable methods of contraception"
as:
1. Oral birth control pills administered for at least 1 monthly cycle prior to
administration of the study drug.
2. A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle
prior to the study drug administration but not beyond the 4th successive year
following insertion.
3. Intrauterine devices (IUDs), inserted by a qualified clinician for at least 1
monthly cycle prior to study drug administration.
4. Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1
monthly cycle prior to administration of the study drug and continuing through 1
month following study completion.
5. Hysterectomy or surgical sterilization.
6. Abstinence.
7. Double barrier method (diaphragm with spermicidal gel or condoms with
contraceptive foam).
NOTE: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal
contraceptive exposure, reducing the effectiveness and increasing the incidence of
menstruation-associated adverse reactions. Hormonal contraceptives, including oral,
injectable, transdermal, and implantable, should not be relied upon as an effective
method of contraception when co-administered with Orkambi.
8. Able and willing to comply with the protocol, including availability for all scheduled
study visits and able to perform all techniques necessary to use the AeroVanc inhaler
and measure lung function.
9. Agree not to smoke during any part of the clinical trial (Screening visit through end
of study).
10. Subjects with a P. aeruginosa co-infection must either be stable on a regular
suppression regimen of inhaled antibiotics or must be, in the opinion of the
Investigator, stable despite the lack of such treatment.
Exclusion Criteria
1. Use of anti-MRSA treatments prescribed as maintenance therapy (intravenous [IV] or
inhaled treatment within 28 days; oral treatment within 14 days) prior to the Baseline
visit.
2. Use of non-maintenance antibiotic for pulmonary infection or extrapulmonary MRSA
infection (IV or inhaled antibiotic within 28 days; oral antibiotic within 14 days)
prior to the Baseline visit.
3. History of previous allergies or sensitivity to vancomycin, or other component(s) of
the study drug or placebo except for a history of red-man syndrome.
4. Inability to tolerate inhaled products.
5. First time sputum culture or throat swab culture yielding B. cepacia, or
nontuberculous Mycobacteria in the previous 6 months to Screening.
6. History of lung or other solid organ transplantation or currently on the list to
receive lung or other solid organ transplantation.
7. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus
[VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with
minimum inhibitory concentration [MIC] ≥ 8 μg/mL).
8. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone
every other day, or equipotent doses of other corticosteroids.
9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid
medications within 14 days, or changes in CFTR modulators within 28 days, prior to the
Baseline visit.
10. Abnormal laboratory findings or other findings or medical history at Screening that,
in the Investigator's opinion, would compromise the safety of the subject or the
quality of the study data.
11. Inability to tolerate inhalation of a short acting beta2 agonist
12. SpO2 <90% at Screening.
13. Changes in physiotherapy technique or physiotherapy scheduled within 1 week of the
Baseline visit.
14. Administration of any investigational drug or device within 4 weeks prior to the
Screening visit and during the study
15. Female with positive pregnancy test result during Screening, pregnant (or intends to
become pregnant), lactating or intends to breastfeed during the study.
16. Renal insufficiency, defined as creatinine clearance < 50 mL/min using the
Cockcroft-Gault equation for adults or Schwartz equation for children at the Screening
visit.
17. Abnormal liver function, defined as ≥ 4x upper limit of normal (ULN), of serum
aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT), or known
cirrhosis at Screening.
18. Diagnosed with clinically significant hearing loss.
19. History of positive result for human immunodeficiency virus (HIV), hepatitis B virus
(HBV) or hepatitis C virus (HCV).
20. Planned hospitalizations for prophylaxis antibiotic treatment within 28 days prior to
Baseline visit or during the double-blind period (Period 1).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients | NCT03181932 | Entailment |
4,346 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | INCLUSION CRITERIA:
Individuals and their family members will be offered enrollment if they have a suspected or
established diagnosis of Marfan, Stickler, Ehlers-Danlos, or a closely related syndrome.
Personal or family history of one or more of the following features in a pattern suggestive
of a heritable connective tissue disorder:
Marfanoid body habitus;
Aortic dilatation and/or dissection;
Ectopia lentis, detached retina, vitreous degeneration and/or early onset high myopia;
Posterior cleft palate; joint laxity and/or dislocation;
Premature osteoarthritis;
Skin fragility, striae, easy bruisability and/or hyperextensibility;
Pectus excavatum or carinatum;
Scoliosis, spondylolisthesis, and/or dural ectasia;
High frequency sensorineural hearing loss.
EXCLUSION CRITERIA:
Inability to provide informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Study of Heritable Connective Tissue Disorders | NCT00001641 | Entailment |
3,962 | 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 OA symptoms resulting in contact with the health care system
Exclusion criteria (both study groups):
- Another reason than OA for the problems; includes tumour or inflammatory joint disease
- Other symptoms that are more pronounced than the OA symptoms; i.e. chronic,
generalised pain or fibromyalgia.
In addition, for the on-line study group:
- Previous participation in similar exercise and education programs (i.e. the on-site
version)
- Lack of necessary equipment or skills to administer on-line participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| On-line Neuromuscular Exercise and Education for Knee Osteoarthritis | NCT04437134 | Entailment |
4,422 | 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:
- Clinical diagnosis of Lateral Epicondylitis Disease
- has been doing professional sports for at least three years
Exclusion Criteria:
- Having systemic problems,
- Having health problems,
- Has undergone any surgical operation in the upper extremity
- Has suffered upper extremity injury in the last three months
- Lack of inclusion criteria
- Neurological and orthopedic problems of the upper extremity.
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 40 Years | Investigation of Acute Effect of ESWT and ESWT+KT on Pain and Grip Strength | NCT03763513 | Contradiction |
3,687 | 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:
- Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment
- American Rheumatism Association (ARA) functional Class I, II or III
- Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID),
a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or
tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing
to maintain treatment during baseline phase
- Moderate to severe daily pain intensity on his or her current pain regimen
- Excepting osteoarthritis, patient is judged to be in otherwise general good health
based on medical history, physical examination, and routine laboratory tests
- Negative serum pregnancy test
Exclusion Criteria:
- Has not experienced at least 3 consecutive days of daily pain intensity >4 on 10-point
scale
- Severe hepatic insufficiency
- Advanced renal insufficiency
- Presence of gastro-intestinal ulcer disease with active bleeding or history of the
same within the past 6 months or a presence or history of inflammatory bowel disease
- History of gastric, biliary (including gastric bypass surgery), or small intestinal
surgery that results in clinical malabsorption
- Receiving or will likely require treatment with ≥14 consecutive days or repeated
courses of pharmacologic doses of corticosteroids
- Established ischemic heart disease, peripheral arterial disease, and/or
cerebrovascular disease including a history of stroke, myocardial infarction or
transient ischemic attack, and recent revascularization procedures
- Any other contraindications mentioned in the approved study drug European Union (EU)
Summary of Product Characteristics (SmPC)
- Therapy with glucosamine and/or chondroitin sulfate for <6 months prior to study
start.
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.
| A Study of Etoricoxib in Participants With Osteoarthritis Not Responding to Analgesic Drugs (MK-0663-142) | NCT01429168 | Contradiction |
2,108 | 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:
- Diagnosis of IPF according to international guidelines
Exclusion Criteria:
- Unable to provide written informed consent
- Radiologic, histologic, or clinical findings inconsistent with a diagnosis of IPF
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.
| Early Diagnosis of Pulmonary Fibrosis - Diagnostic Delay | NCT02772549 | Entailment |
1,266 | 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:
- Thoracocentesis
- Chest X-ray and
- CT-scanning are performed
Exclusion Criteria:
- Lung cancer
- Other thoracic malignancy
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.
| The Added Value of CT Scanning in Patients With an Unilateral Pleural Effusion | NCT03270215 | Entailment |
405 | 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:
- Infertility
- The length of menstrual cycle longer than 35 days or shorter than/amenorrhea
- Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤7, on at least two
occasion >4 weeks apart
Exclusion Criteria:
- Polycystic Ovarian Syndrome
- other causes of amenorrhea
Female
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 39 Years | Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women | NCT03518918 | Contradiction |
5,667 | 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:
Volunteers will qualify if they meet the following criteria:
1. Age between 12 and 17 years (at the start of the study).
2. Female sex.
3. BMI at or above the 85th percentile for age and sex according to the Centers for
Disease Control US Standards (101).
4. Right handedness.
LOC sample only:
5. Greater than or equal to 1 episodes of LOC eating during the past month prior to
assessment, assessed using a clinical diagnostic interview for eating disorders.
No-LOC sample only:
6. No episodes of LOC eating during the past month prior to assessment, assessed using a
clinical diagnostic interview for eating disorders.
EXCLUSION CRITERIA:
Individuals will be excluded (and provided treatment referrals as needed) for the following
reasons:
1. An obesity-related health comorbidity requiring medical treatment, such as
hypertension (defined by age-, sex-, and height-specific standards) or fasting
hyperglycemia consistent with diabetes.
2. Presence of other major illnesses: renal, hepatic, gastrointestinal, most
endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism),
hematological problems or pulmonary disorders (other than asthma not requiring
continuous medication). Nonserious
medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case
basis.
3. Regular use of any medication known to affect body weight or eating behavior (e.g.,
stimulants prescribed for attention deficit hyperactivity disorder, or ADHD).
Medication use for non-serious conditions (e.g., acne) will be considered on a
case-by-case basis.
4. Current pregnancy or a history of pregnancy.
5. A significant reduction in weight during the past three months, for any reason,
exceeding 5% of body weight.
6. Presence in the child of any significant, full-threshold psychiatric disorder based on
DSM criteria (102), such as schizophrenia, bipolar disorder, alcohol or substance
abuse, anorexia or bulimia nervosa, or any other disorder that, in the opinion of the
investigators, would impede competence or compliance or possibly hinder completion of
the study. These individuals will not be permitted to enroll in the current study and
will be referred for treatment. Individuals who present with other psychiatric
disorders, including subthreshold psychiatric disorders, will be permitted to enroll
in the study. If, based on the opinion of the investigators, a participant requires
treatment for his/her psychiatric symptoms, the individual will be referred for
treatment. Participants who develop any psychiatric disorder or significant
psychiatric symptoms at any follow-up assessment during the study will be excluded and
be provided with treatment referrals.
7. Current and regular substance use, including the use of alcohol and/or tobacco
products (including e-cigarettes).
8. A history of significant or recent brain injury that may considerably influence
performance (i.e., any history of loss of consciousness greater than or equal to 30
minutes associated with a head injury, any history of memory loss or hospitalization
associated with a head injury, or greater than or equal to 2 concussions within last
year).
9. Current involvement in a weight loss program, participating in psychotherapy aimed at
weight loss or treatment of eating behavior (e.g., binge eating).
10. All parents/guardians will be asked to indicate if their child has any food allergies.
To be conservative, children who report allergies to gluten, nuts, dairy, fruit, or
any other item in the array, will be excluded from the test meal portion of the study.
11. A condition under which MEG is contradicted (e.g., metal in the body, pregnancy,
claustrophobia, history of significant neurological insult or injury).
12. Non-English speaking participants will be excluded from the study as they may be
unable to complete questionnaires and follow the instructions which are only provided
in English.
Female
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 17 Years | Mobile Attention Retraining in Overweight Female Adolescents | NCT02977403 | Contradiction |
837 | 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:
- Female gender
- Less than 70 years old
- Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of
thumb base osteoarthritis:
1. Hand pain, aching or stiffness most of the days during the preceding month
2. Hard tissue enlargement of at least two of 8 selected joints *
3. Hard tissue enlargement of at least two distal interphalangeal joint
4. Swelling of fewer than three metacarpophalangeal joint
5. Deformity of at least one of 10 selected joints * Patients have to fulfil
criteria 1, 2 AND 3 + 4 OR 5 * the 8 selected joints are the second and third
distal interphalangeal joint and the second and third proximal interphalangeal of
both hands Then confirm by experts' committee
- Exclusively symptomatic treatment
- For women of child-bearing age, use of an effective contraceptive method
- French spoken and read
Exclusion Criteria:
- Male gender
- More than 70 years old
- Hemochromatosis
- Inflammatory arthritis
- Cristal induced arthritis
- Active diseases such as infection or cancer
- Use of DMARDs
- Pregnant or breast-feeding woman
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis | NCT02370771 | Entailment |
6,402 | 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:
- Be male or female, ≥18 years of age
- Be willing and able to give informed consent
- Screening/Randomization telemedicine visit within 2 days of testing positive test for
COVID-19
- Having self-reported fever or cough for not more than 72 hours prior to COVID-19
testing
- Mild to moderate COVID-19
- Able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
- Patients who are hospitalized for in-patient treatment or currently being evaluated
for potential hospitalization at the time of informed consent for conditions other
than COVID- 19
- History of chronic lung disease
- Ongoing requirement for oxygen therapy
- Shortness of breath in resting position
- Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) /
Continuous Positive Airway Pressure (CPAP)
- Female patients who are pregnant, trying to become pregnant or lactating
- Is considered, in the opinion of the PI, to be unlikely for any reason to be able to
comply with study 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.
| A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19 | NCT04414124 | Entailment |
2,500 | 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:
- No disease that effect the fundus photograph or visual field
Exclusion Criteria:
- any disease that effects the fundus photograph or visual field
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Study to Determine the Location of the Blind Spot and the Macula-disc Centre Distance on a Fundus Photograph | NCT01843582 | Entailment |
5,940 | 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 between the ages of 15 and 80 years
- with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the
stomach,
- who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are
recruited.
Exclusion Criteria:
1. coexistence of peptic ulcer or gastrointestinal malignancies,
2. pregnancy,
3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis
and uremia),
4. previous gastric surgery,
5. allergy to esomeprazole,
6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and
7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 80 Years | Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy | NCT01874535 | Contradiction |
4,113 | 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:
- Symptomatic subjects with moderate to severe COPD
- Age greater than/equal to 40 years
- History of smoking greater than/equal to 20 pack-years of cigarettes
- No history of asthma (in the opinion of the investigator)
- No COPD exacerbations within the past 2 months requiring oral corticosteroids or
hospitalization.
- No continuous oxygen therapy
- Subjects with a body mass index less than 15 or greater than 38
- Patients must be without other clinically significant illnesses or condition that
might interfere with the study, including but not limited to uncontrolled
hypertension, cardiovascular disease, cardiac arrhythmia, diabetes, hyperthyroidism,
seizure disorder or any history of pheochromocytoma
- Be using medically acceptable birth-control measures if a female of child-bearing
potential
- Not be pregnant or breastfeeding
- Be willing to withhold any existing short or long-acting bronchodilators for the
appropriate time period prior to each test day (see below). Use of inhaled
corticosteroids is not exclusionary, but will be maintained at a constant level
throughout the study.
- Must be willing and able to perform spirometry, slow vital capacity, plethysmography,
DLCO, and 6 minute walk after appropriate instruction.
- No known allergy or contradiction to albuterol or formoterol or prior significant
adverse reactions to other beta agonists.
- No hypersensitivity to milk protein. Bloating or gas from lactose is not an exclusion.
- No use of beta-blockers (selective or non-selective), phenothiazines (thioridazine),
or other drugs that may interact with formoterol or albuterol for the duration of the
study. Washout of greater than seven half-lives of the drug prior to the study.
- No use of cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide,
quinidine), or class III (e.g., amiodarone, dofetilide, ibutilide, sotalol),
terfenadine, astemizole, mizolastine and any other drug with potential to
significantly prolong the QT interval.
- No use of non-potassium sparing diuretics unless in fixed combination with potassium
sparing diuretic.
- No investigational drugs within 30 days
- No subjects affiliated with the Division of Pulmonary, Critical Care Medicine and
Hospitalists, David Geffen School of Medicine
- Informed consent
Exclusion Criteria:
- Post-albuterol FEV1/FVC less than lower limit of normal (Hankinson)
- Post-albuterol FEV1 between 30% and 60% predicted (Hankinson)
- An increase in FEV1 after albuterol sulfate HFA of at least 5% and 50 ml
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.
| Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT) | NCT00633776 | Contradiction |
6,597 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male patients who are diagnosed with severe (laboratory tested FVIII:C <2%) hemophilia
A;
- Patients Who Completed trial of SCT800-A302 or SCT800-A 303 and New PTP(previously
treated patients)(Previously received FVIII prophylactic or bleeding treatment, have
the relevant records and are verified to have accumulated exposures days( EDs) ≥150
days;
- Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay
result <0.6 BU(Bethesda unit)/mL);
- The treatment records of at least 50EDs before screening can be obtained;
- HIV negative; if HIV positive, the viral load <200 particles/uL or <400,000 copies/mL,
and HIV patients must satisfy CD4+ count >200/μL;
- The patient or his guardian voluntarily signed the Informed Consent Form.
Exclusion Criteria:
- Known allergy to any coagulation factor VIII or any excipient; known allergy to
bovine, rodent or hamster bovine;
- Has a history or family history of blood coagulation factor VIII inhibitor;
- Patients with other coagulation dysfunction diseases in addition to hemophilia A;
- Patients with other clinically significant diseases, alcoholism, drug abuse, mental
disorders or intellectual disabilities;
- Patients with other severe or clinical significant diseases verified by the
investigator to be unable to benefit from the clinical study;
- Patients who participated in other clinical studies within one month before the first
drug administration (except FVIII trials) and patients who participated in other FVIII
clinical trials after signing the Informed Consent Form;
Male
No healthy subjects accepted to join the trial.
| Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients. | NCT03947567 | Contradiction |
5,535 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- At least 50 years old.
- Suffering from GCA as per investigator judgement, newly diagnosed or not.
- Starting or under treatment for GCA.
- Informed verbally and in writing about this study and not objecting to their data
being electronically processed or subjected to data quality control.
Non-inclusion Criteria:
- Unable to consent
- Participation to a randomised controlled clinical trial
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.
| Assessment of Giant Cell Arteritis Medical Practices in France | NCT03658889 | Entailment |
4,401 | 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:
- history of medial and lateral elbow pain for at least three months in duration
- local tenderness for at least three months in duration
- pain on the epicondyle upon active resistive flexion (medial) and extension (lateral)
of the wrist
Exclusion Criteria:
- previous elbow conservative managements such as physical therapy and elbow
injection-based therapies
- previous surgical management of the elbow
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 65 Years | Clinical Trial for High Intensity Laser Therapy (HILT) for Elbow Epicondylosis | NCT01992627 | Contradiction |
462 | 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:
- Woman older than 18 years
- Patients with gestational trophoblastic disease resistant to mono-chemotherapy
(methotrexate and/or actinomycine-D) or polychemotherapy (such as EMA-CO; EMA-EP; BEP;
… regimens) without . limitation in the number of previous chemotherapy lines without
limitation in the number of previous chemotherapy lines
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patients with adequate bone marrow function measured within 28 days prior to
administration of study treatment as defined below : Absolute granulocyte count ≥ 1.5
x 10 9 /L ; Platelet count ≥ 100 x 10 9 /L ; Haemoglobin ≥ 9.0 g/dL (may have been
blood transfused)
- Patients with adequate renal function : Calculated creatinine clearance ≥ 30 ml/min
according to the Cockcroft-Gault formula (or local institutional standard method)
- Patients with adequate hepatic function : Serum bilirubin ≤ 1.5 x UNL and AST/ALT ≤
2.5 X UNL (≤ 5 X UNL for patients with liver metastases)
- Patients must have a life expectancy ≥ 16 weeks
- Confirmation by a gynecologist of non-childbearing status for women of childbearing
potential.
An evolutive pregnancy can be ruled out in the following cases: previous hysterectomy ; if
serum hCG level ≥ 2 000 IU/L and no intra or extra-uterine gestational sac is detected on
pelvic ultrasound ; if serum hCG level < 2 000 IU/L on a first measurement and serum hCG
increases <100% on a second measurement performed 3 days later.
- Highly effective contraception if the risk of conception exists. (Note: The effects of
the trial drug on the developing human fetus are unknown; thus, women of childbearing
potential must agree to use 2 highly effective contraceptions, defined as methods with
a failure rate of less than 1 % per year. Highly effective contraception is required
at least 28 days prior, throughout and for at least 60 days after avelumab treatment.
- Patients who gave its written informed consent to participate to the study
- Patients affiliated to a social insurance regime
- Patient is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including follow
up.
Exclusion Criteria:
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-cytotoxicT lymphocyte-associated antigen 4 (CTLA 4) antibody (including
ipilimumab, tremelimumab or any other antibody or drug specifically targeting T-cell
co-stimulation or immune checkpoint pathways).
- Illness, incompatible with avelumab, such as congestive heart failure; respiratory
distress; liver failure; allergy.
- Patients with second primary cancer, except: adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
curatively treated with no evidence of disease for ≥ 5 years.
- All subjects with brain metastases, except those meeting the following criteria: Brain
metastases that have been treated locally and are clinically stable for at least 2
weeks prior to enrollment ; No ongoing neurological symptoms that are related to the
brain localization of the disease (sequelae that are a consequence of the treatment of
the brain metastases are acceptable) ; Subjects with brain metastases must be either
off steroids except a stable or decreasing dose of <10mg daily prednisone (or
equivalent).
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative
reasons), within 2 weeks from the last dose prior to study treatment (or a longer
period depending on the defined characteristics of the agents used). The patient can
receive a stable dose of bisphosphonates for bone metastases, before and during the
study as long as these were started at least 4 weeks prior to treatment with study
drug.
- Persistent toxicities (>=CTCAE grade 2) with the exception of alopecia and sensory
neuropathy, caused by previous cancer therapy.
- Treatment with other investigational agents.
- Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral
medication such as malabsorption.
- Known severe hypersensitivity reactions to monoclonal antibodies, any history of
anaphylaxis, or uncontrolled asthma
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
related illness.
- Active infection requiring systemic therapy.
- Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV
antibody tested positive)
- Administration of a live vaccine within 30 days prior to study entry.
- Current or prior use of immunosuppressive medication within 7 days prior to start of
study treatment. The following are exceptions to this exclusion criterion: Intranasal,
inhaled, topical steroids, or local steroid injections (eg, intra-articular
injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or equivalent; Steroids as premedication for hypersensitivity reactions
(eg, CT scan premedication).
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
disease not requiring immunosuppressive treatment are eligible.
- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method of birth control.
- Treatment with oral anticoagulant such Coumadin.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias | NCT03135769 | Contradiction |
6,446 | 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 females at least 18 years of age
- diagnosis of stable erythematous rosacea
- < 3 inflammatory lesions
- in good general health
- females must be non-pregnant and non-lactating
- must be willing to sign a consent form
Exclusion Criteria:
- have ocular, phymatous or other types of rosacea
- allergy to any ingredient in study drug
- participation in other investigational studies within 30 days of enrollment
- use of systemic steroids within 28 days of Baseline
- use of tetracycline antibiotics within 28 days of baseline
- use of products containing oxymetazoline within 14 days of baseline
- use of topical steroids witin treatment area 14 days prior to baseline
- use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline
- use of any product for reducing redness within the treatment area witin 14 days prior
to baseline
- use of monoamine oxidase (MAO) inhibitors
- use of niacin >/= 500mg/day
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.
| Dose Response Study of Patients With Erythematous Rosacea | NCT01186068 | Entailment |
5,718 | 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 :
- girls aged from 1 to 25 years included,
- with Turner syndrome or mosaic
- patients aged more than 18 will only have ovarian insufficiency dated less than 5
years
- without any severe disease, particularly of cardiovascular type
- whose agreement to participate to the study has been signed by the parents
- whose agreement to participate to the study has been signed by majority age patient
Exclusion criteria :
- girls aged less than one year and over 25 years old
- if any surgery would be contra-indicated
- ovary alone presence
- Well-known infection by HIV, and/or HBV, and/or HCV and/or syphilis TPHA VDRL
- No social coverage affiliate
Female
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 25 Years | Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome | NCT01410045 | Entailment |
4,306 | 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:
- Clinical diagnosis of cystic fibrosis
- Able to engage in intense physical activities
Exclusion Criteria:
- FEV1 <35%predicted
- Esophageal varicosis
- Pulmonary bullae
- Drop in arterial oxygen saturation with exercise <80%
- Non-CF related chronic diseases
- Signs of pulmonary hypertension (ECG and echocardiogram)
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.
| Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis | NCT00231686 | Entailment |
1,738 | 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:
- Girl or boy aged ≥ 8 years and ≤ 12 years old for children,
- Girl or boy aged ≥ 13 years and ≤ 19 years old for teenagers,
- Woman or man age ≥ 20 years and ≤ 35 years old for young adults,
- French mother tongue,
- With the right to a social security scheme or similar,
- With informed consent form signed by the legal representatives and the subject, for
minors,
- Has signed the informed consent form, for adults.
Exclusion Criteria:
- Known acquired neurological disorders, including epilepsy,
- Known psychiatric disorders,
- Complications at birth requiring admission to neonatal intensive care unit,
- Ongoing treatment with drugs affecting the central nervous system,
- Significant hearing impairment,
- Uncorrected visual inadequacy,
- Left manual preference,
- Contraindications to the MRI examination (people using a pacemaker or an insulin pump,
people wearing a metal prosthesis or an intracerebral clip as well as claustrophobic
subjects),
- Refusal of the subject or parents of the subject to be informed of any anomalies
detected on the MRI,
- Pregnancy for women of childbearing age: the possibility of pregnancy will be ruled
out on questioning for inclusion,
- Protected persons other than children
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 35 Years | Impact of Another Person's Presence on Brain and Behavioral Performance | NCT03453216 | Entailment |
632 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Patients with age equal to or over 18 years old,
- Patients with proved hereditary hemochromatosis with homozygosity for the C282Y
mutation of the HFE gene,
- Patients with rheumatism related to hemochromatosis, considered by the rheumatologist
refractory to usual treatment defined by a persistent painful symptomatology despite a
treatment of at least one month with level 2 analgesics (weak opioids) at maximal
dose, NSAID, colchicine, steroid injection or a combination of these treatments,
- Patients with pain > 40/100mm measured by VAS (pain of the last 48 hours),
- Effective contraception to be used during treatment and until 48h after the last
administration for women of reproductive age,
- Patients who have given written informed consent.
Exclusion Criteria:
- Other cause of inflammatory rheumatisms such as Rheumatoid Arthritis,
Spondyloarthropathies, psoriatic arthritis, or systemic diseases,
- Ongoing treatment with Methotrexate, Hydroxychloroquine, biologic or immunosuppressive
drugs
- Malignant pathology, monoclonal gammopathy,
- Intolerance to anakinra,
- Contraindications to the use of anakinra: pregnancy or breastfeeding, hypersensitivity
to any of the excipients or to proteins from E. coli, severe renal impairment
(creatinine clearance <30 ml / minute), neutropenia (neutrophil count <1.5 x 109 / l),
ongoing infection
- Patients that cannot follow the protocol,
- Persons subject to major legal protection (safeguarding justice, guardianship,
trusteeship), persons deprived of liberty.
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.
| Treatment of Refractory Hemochromatosis Rheumatism by Anakinra: a Preliminary Phase II Study | NCT02263638 | Contradiction |
1,302 | 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:
If a subject meets any one of these criteria, he/she will potentially be eligible to
participate:
- Short stature (height less than - 2 SDS), either currently or previously - or
- Tall stature (height greater than + 2 SDS) or
- Bone age delay (greater than 3 years) or
- Bone age advancement (greater than 2.5 years or greater than 1.5 years with short
stature) or
- Predicted adult height < - 2SD
- Growth disorder that was treated promptly, thus maintaining the child s height within
the normal range, e.g. a subject with congenital growth hormone deficiency or multiple
pituitary hormone deficiency of unknown genetic etiology who received growth hormone
treatment beginning in early life or
- Family member of subjects who meet any of the above criteria
- Subjects have a current height at a low normal percentile but has short adult height
prediction based on bone age (> 5 inches shorter than mid-parent height)
In addition, subjects are only eligible, if, the pedigree suggests a monogenic inheritance,
and, in the judgement of the investigators, there is a reasonable likelihood of identifying
a novel gene responsible for the condition.
EXCLUSION CRITERIA:
- A non-genetic disorder or condition, either congenital or acquired, that explains the
growth abnormality, for example, pituitary injury, chronic thyroiditis, whole body
irradiation, or celiac disease.
- In the opinion of the investigators, there is an established diagnosis of a genetic
disorder or condition that explains the growth abnormality and for which the molecular
genetic etiology has already been identified, for example, SHOX deficiency,
hypochondroplasia, or Noonan syndrome.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Genetic Causes of Growth Disorders | NCT02311322 | Contradiction |
4,752 | 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:
Plus Tinnitus Plus Hearing loss subjects.
- Adults, between the ages of 30 to 65 years.
- Are able to hear and perceive sounds used in the experiment in the range 250 Hz to 2
KHz and have high-frequency sensorineural hearing loss beginning no lower than 2 KHz.
- In good health and not currently taking certain medications regularly (e.g.
antidepressants, antiseizure medications, antipsychotics, etc.).
- Experience tinnitus daily.
- Have had non-pulsatile tinnitus for at least 1 year.
- Have bilateral or bilateral with unilateral dominance tinnitus.
Minus Tinnitus Plus Hearing loss subjects.
- Adults, between the ages of 30 to 65 years.
- Are able to hear and perceive sounds used in the experiment in the range 250 Hz to 2
KHz and have high-frequency sensorineural hearing loss beginning no lower than 2 KHz.
- In good health and not currently taking certain medications regularly (e.g.
antidepressants, antiseizure medications, antipsychotics, etc.).
- Have never or rarely (i.e. transient episodes experienced by virtually everyone)
experienced tinnitus.
Minus Tinnitus Minus Hearing loss subjects or normal volunteers.
- Adults, between the ages of 30 to 65 years.
- Have normal hearing.
- In good health and not currently taking certain medications regularly (e.g.
antidepressants, antiseizure medications, antipsychotics, etc.).
EXCLUSION CRITERIA:
- Subjects who have pacemakers, aneurysm clips, metallic prostheses or shrapnel
fragments.
- Subjects incapable of giving informed consent.
- Subjects with a positive pregnancy test.
- Children below the age of 18 years.
- Subjects with hyperacusis or misophonia (hyper-sensitivity to loud noises).
- Subjects with mood disturbances such as depression or anxiety.
- Subjects with a history of temporomandibular joint problems or who present symptoms of
pain and tenderness of the temporomandibular joint on examination.
Subjects may be excluded for the following reasons that may cause difficulty with
interpretation of the imaging data:
- Subjects with mental or physical illnesses, other than tinnitus that may cause
problems with participation in the study.
- Subjects with current uncontrolled hypertension, or significant past history of
cardiovascular disease and diabetes melitus.
- Subjects with a history of head trauma with loss of consciousness, epilepsy, seizures,
a history of chemotherapy (neurotoxic or ototoxic) and other medical conditions that
may alter cerebral functioning.
- Subjects who are taking or have a history of taking recreational drugs or alcoholism.
- Subjects with unilateral or asymmetrical hearing loss who have not had (or cannot
provide documentation of) comprehensive neuro-otologic workup will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 65 Years | Brain Imaging of Tinnitus | NCT00359931 | Entailment |
4,998 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Men and women age 22 years or older
2. Diagnosis of medication-refractory Essential Tremor
3. Has previously underwent an Exablate index procedure in a clinical trial or in a
commercial setting at least 9 months prior to enrolling in this trial
4. Able to communicate sensations during the Exablate thalamotomy procedure
Exclusion Criteria:
1. Has experienced any non-transient neurological event or worsening following the
Exablate index procedure
2. Presence of unknown or MR unsafe devices anywhere in the body
3. Non-transient hemiparesis as determined by physical examination
4. Clinically significant abnormal speech function as determined by a speech pathologist
5. Pregnant or breastfeeding
6. Unstable cardiac status
7. Behavior(s) consistent with ethanol or substance abuse
8. History of bleeding disorder
9. Has received anticoagulants within one month of Exablate procedure
10. Cerebrovascular disease
11. Intracranial tumor
12. Active or suspected acute or chronic uncontrolled infection
13. Has previously had deep brain stimulation or a prior stereotactic ablation of the
basal ganglia or thalamus
14. Implanted objects in the skull or the brain
15. Currently in a clinical trial involving an investigational product or non-approved use
of a drug or device or in any other type of medical research
16. Unable to communicate with the investigator and staff
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
| Bilateral Treatment of Medication Refractory Essential Tremor | NCT04112381 | Entailment |
5,649 | 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 (boys age: > 3 and <12 years or girls: age >3 and <11 years)
with isolated GH insufficiency, GH insufficiency as part of multiple pituitary hormone
deficiencies, or organic GH insufficiency. If GH insufficiency occurred after
treatment for any brain tumour, the patient has to be at least one year in clinical
remission which has to be confirmed by computer tomography (CT) or magnetic resonance
imaging (MRI) scan (with contrast) within 3 months prior to study entry
- Children with negative signs for intracranial tumour or tumour growth as confirmed
with a CT or MRI scan (with contrast) within 12 months prior to inclusion or at
inclusion visit
- Confirmed diagnosis of GH insufficiency as determined by two different GH provocation
tests, defined as a peak plasma GH level of ≤7 ng/ml
- No prior exposure to rhGH therapy (GH-treatment naive)
- Height (HT), except in children suffering from organic GH insufficiency, of at least
2.0 standard deviations (SD) (HT SDS £-2.0) below the mean height for chronological
age (CA) and sex according to the 2000 standards from the Centers for Disease Control
and Prevention (CDC).
- Height velocity (HV) of at least 1 SD (HV SDS £-1) below the mean HV for CA and sex
according to the standards of Prader. The minimum time between two standard height
measurements should be at least 6 month before inclusion.
- Baseline IGF-I level of at least 0.5 SD (IGF-1 SDS£-0.5) below the mean IGF-1 level
standardised for age and sex according to the central laboratory reference values.
- Written informed consent of parent or legal guardian of subject.
Exclusion Criteria:
- Any clinically significant abnormality likely to affect growth or the ability to
evaluate growth, such as, but not limited to, chronic diseases like renal
insufficiency, spinal cord irradiation, and malnutrition (BMI must be above -2SD and
below +2SD of mean BMI for the chronological age and sex according to the CDC
standards, and albumin must be above lower limit of normal (LLN) of the central
laboratory for a patient to be included).
- Patients with overt diabetes mellitus (Fasting blood sugar >126 mg/dl) and impaired
fasting sugar (Fasting blood sugar >100 mg/dl after repeated blood analysis)
- Chromosomal abnormalities and medical "syndromes" (Turner's syndrome, Laron syndrome,
Noonan syndrome or absence of growth hormone receptors), with the exception of
septo-optic dysplasia
- Congenital abnormalities (causing skeletal abnormalities), Russell-Silver Syndrome,
skeletal dysplasias
- Closed epiphyses
- Other growth promoting medication such as anabolic steroids, with the exception of
pituitary hormone replacement therapy, thyroxine, hydrocortisone and desmopressin
(DDAVP) replacement therapies
- Children requiring glucocorticoid therapy (e.g. asthma) that are on the dose of more
than 400 µg/d of inhaled budesonide or equivalents inhaled for longer than 1 month
during a calendar year
- Bone age (BA) higher than chronological age
- Poorly controlled or uncontrolled pituitary insufficiencies of other axes (e.g.,
thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol, vasopressin
deficiency): Children who are on stable replacement therapy for less than 6 months for
thyroid replacement therapy, and less than 3 months for other hormonal deficiencies
prior to enrolment
- Major medical conditions and/or presence of contraindication to rhGH treatment
- Known or suspected HIV-positive patient or patient with advanced diseases such as AIDS
or tuberculosis
- Drug, substance, or alcohol abuse
- Known hypersensitivity to the components of study medication
- Evidence of tumour growth or malignant disease
- Presence of anti-hGH antibodies at screening
- The patient and/or the parent/legal guardian are likely to be non-compliant in respect
to study conduct.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 11 Years | Treatment of Children With Insufficient Secretion of Growth Hormone | NCT00271518 | Contradiction |
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