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3,777 | 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 aged 40 to 85 years with a clinical diagnosis of OA of the target knee
according to the American College of Rheumatology (ACR) criteria, including:
- Symptoms for at least 6 months prior to screening, AND
- Knee pain in the target knee for 30 days of the preceding month (periarticular knee
pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND
- The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs
(NSAIDs) either over the counter (OTC) per recommendation of a physician or
prescribed.
Exclusion Criteria:
- Body mass index (BMI) > 40
- Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue
medication) during Screening Washout Period.
- Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic
neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
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 85 Years | A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis | NCT03277066 | Entailment |
5,072 | 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:
Inclusion criteria for both groups:
- Women > 65 y: 2 groups
Inclusion criteria for Osteoporosis group (Alzheimer and non-Alzheimer):
- Osteoporotic femoral neck fracture requiring hip remplacement and fullfilling WHO
definition of osteoporosis. Without any cognitive impairment for the first subgroup
(MMSE > 26 and normal IADL) and with a final diagnosis of alzheimer disease in the
other subgroup (DSM-IV-TR)
Inclusion criteria for Control group:
- Non osteoporotic (no fragility fracture (clinical or on VFA) and bone mineral density
T-score > 2.5 SD at all sites)
- No cognitive impairment (MMSE > 26 and normal IADL)
Exclusion Criteria:
Non-Inclusion Criteria for both groups:
- Other pathologies associated with autophagy: Parkinson's disease, Crohn's disease,
cancers, myopathies, type 2 diabetes
- Méd Medications interfering with autophagy: current corticosteroids, parathyroid
hormone, estrogen, chloroquine, hydroxychloroquine, lithium, metformin,
bisphosphonates,
- Dementia of non-Alzheimer type
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Autophagy and Pathological Aging | NCT03175874 | Contradiction |
3,130 | 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:
1. Subject age is between 40 and 65 years old.
2. Corneal fluorescein staining present in at least one/five sectors of at least one
cornea
3. At least one question out of 6 questions on dry eye symptom present often or all the
time.
based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry,
gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.
4. At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least
one eye
5. Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of
Marx's line in line with Meibomian orifice)
6. Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain
from non-trial topical eye medications for 6 weeks.
7. Use of lubricants during the week before recruitment (ranging from 3 times in the week
to less than 6 times a day every day).
8. Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3
times over week to less than 6 times a day in all days.
Exclusion Criteria:
1. Known history of thyroid disorders (diagnosed by physician).
2. Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).
3. No ocular surgery within 6 months and LASIK within 1 year.
4. Any intake of central nervous system and hormonal drugs within last 30 days and
inability to withhold such drugs for at least 6 weeks.
5. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with
lagophthalmos.
6. Anticipated necessity to wear contact lens in the duration of the study.
7. Not living in the same household as another participant of the study.
8. Any other specified reason as determined by clinical investigator.
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 65 Years | Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes | NCT00796926 | Contradiction |
5,513 | 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:
- Diagnosis of GCA classified according to age >/=50 years; history of ESR >/=50 mm/hr
or history of CRP >/=2.45 mg/dL; and at least one of the following: unequivocal
cranial symptoms of GCA or symptoms of polymyalgia rheumatica [PMR]; and at least one
of the following: temporal artery biopsy revealing features of GCA or evidence of
large-vessel vasculitis by angiography or cross-sectional imaging
- New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than
[>] 6 weeks before baseline and previous treatment with >/= 40 milligrams per day
prednisone [or equivalent] for at least 2 consecutive weeks at any time) GCA
- Active disease (presence of clinical signs and symptoms [cranial or PMR] and ESR >/=30
mm/hour or CRP >/=1 mg/dL) within 6 weeks of baseline visit
Exclusion Criteria:
- Major surgery within 8 weeks prior to screening or planned within 12 months after
randomization
- Transplanted organs (except corneas with transplant performed >3 months prior to
screening)
- Major ischemic event, unrelated to GCA, within 12 weeks of screening
- Prior treatment with any of the following: investigational agent within 12 weeks (or 5
half-lives of the investigational drug, whichever is longer) of screening;
cell-depleting therapies including investigational agent; intravenous (IV) gamma
globulin or plasmapheresis within 6 months of baseline; alkylating agents or with
total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A,
azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2
weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab
within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib;
cyclophosphamide within 6 months of baseline; >100 milligrams of daily IV
methylprednisolone within 6 weeks of baseline
- Participants requiring systemic glucocorticoids for conditions other than GCA, which,
in the opinion of the investigator, would interfere with adherence to the fixed
glucocorticoid taper regimen and/or to assessment of efficacy in response to the test
article
- History of severe allergic reactions to monoclonal antibodies or to prednisone
- Evidence of serious uncontrolled concomitant disease (for example, cardiovascular,
respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or
gastrointestinal [GI] disease)
- Current liver disease, as determined by the investigator
- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract
condition that might predispose to bowel perforation
- Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other
infection
- Primary or secondary immunodeficiency
- Evidence of malignancies diagnosed within previous 5 years (except basal and squamous
cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been
excised and cured)
- Inadequate hematologic, renal or liver function
- Positive for hepatitis B or hepatitis C infection
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.
| An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) | NCT01791153 | Entailment |
6,377 | 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. | A. Inclusion Criteria:
1. Minimum 18 - 80 years of age
2. Clinical Diagnosis of COVID 19 with RT-PCR test for SARS-CoV-2 (If a patient is
COVID19 positive based on Antigen test, they can participate in the trial while
awaiting result form PCR test with Ct-value)
3. Signed informed consent provided by patient's or patient's healthcare proxy.
4. Fulfills enrollment criteria ( within 6 days of symptoms onset)
5. Willing to practice celibacy OR take contraception during the study & within 7 days
after treatment
6. Mild clinical condition with at least 3 of these of these symptoms : fever, cough,
malaise/headache
7. Moderate clinical condition with at least 3 of these of these symptoms : fever, cough,
malaise/headache
B. Exclusion Criteria:
1. Pregnant (female of childbearing age with positive urine pregnancy test) or
miscarriage or within 2 weeks after delivery
2. Severe or critical clinical condition as per NMC clinical guideline for COVID19
Chronic liver with ALT/AST increased 5 times higher than the upper limit of normal or
with Child Pugh C
3. Creatinine clearance (Cockcroft-Gault Equation) < 30 ml/min or having
hemodialysis/peritoneal dialysis
4. Known allergy or hypersensitivity to Favipiravir
5. Gout or history of gout or hyperuricemia two times the upper limit of normal
6. If using Remdesivir, Lopinavir-ritonavir, Hydroxychloroquine or any other antiviral
drug with potential effect against SARS-CoV-2 virus
7. Lactating female
8. Asymptomatic COVID-19 cases
9. Mild COVID-19 cases not meeting the inclusion criteria symptoms
10. Moderate COVID-19 cases not meeting the inclusion criteria symptoms
(*All female patients age 18 - 50 years will be screened for pregnancy by urine test & any
pregnant patient will be excluded. Also, the patient must be consented to take
contraception or practice celibacy during the study period & until 7 days after treatment.
Since the expected wash out period of the study drug Favipiravir is 10hrs minimum to
27.5hrs maximum (half life is 2-5.5hrs), it is a safe practice to avoid conception for 1
week after stopping the drug of interest)
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 | Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal | NCT04694612 | Entailment |
1,498 | 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:
- Subject 19 years old and more
- Subject who understands the purpose of the study and signs with informed consent form
- Subject with chronic disease (hypertension, diabetes, dyslipidemia)
- Subject with more than one Poor Disease Control Indicator
1. HbA1C 7.0% or more
2. Systolic BP 140mmHg or more
3. LDL-cholesterol 130mg/dL or more
- Subjects who use smart phones and PCs (those who can use ICT-based health care
programs)
Exclusion Criteria:
- Inability to speak, understand, or write Korean
- Inability to understand the contents of the provided materials due to poor eyesight
and hearing
- Medical conditions that would limit adherence to participation of the clinical trial
(as confirmed by their referring physician; e.g. dyspnea, severe depression and other
mental disorders)
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.
| The Effectiveness of Smart Health Management Program for Patients With Chronic Illness | NCT03294044 | Entailment |
4,170 | 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. Subject is at least 18 years of age.
2. Subject is cooperative and capable of following instructions.
3. Healthy subjects:
1. Never smokers.
2. No known history of respiratory, cardiovascular, hepatic, renal or metabolic
disease.
3. BMI < 35.
4. No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea,
chronic cough, wheezing or phlegm).
5. No history suggesting upper respiratory infection during the three weeks prior to
testing.
4. Patients with known disease affecting the respiratory system, with previous
documentation of obstructive, restrictive, or mixed obstructive plus restrictive
ventilatory abnormality.
Exclusion Criteria:
1. Subjects who are unable to satisfactorily perform routine, full lung function
testing(due to non-compliance or claustrophobia).
2. Subjects unable or unwilling to give informed consent.
3. Subjects who have performed any significant physical activity during 1 hour prior to
the Study.
4. Patients with a tracheostomy.
5. Pregnant women.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT) | NCT01952431 | Contradiction |
5,472 | 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 referred for VWD diagnosis or previously diagnosed with VWD
Exclusion Criteria:
- Patients with other bleeding disorders
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Update in VWD Laboratory Diagnosis | NCT03896997 | Entailment |
4,204 | 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:
- Diarrhea
- constipation
Exclusion Criteria:
- Shock
- Sepsis
- Past history with GI tract surgery
- Immunodeficiency
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 3 Months old.
Subject must be at most 10 Years | Effect of Probiotics on Intestinal Bacterial Population and Immune Modulation | NCT00763399 | Contradiction |
5,709 | 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:
Participants be included if they are overweight or obese (BMI≥85th %ile) and aged 8-14
years.
Exclusion Criteria:
Participants will be excluded if they 1) are currently taking any medications known to
affect weight or appetite (e.g., antidepressants, steroids, chemotherapy drugs); 2) have a
current or past diagnosis of an eating disorder involving purging or suppressed body weight
(e.g., bulimia nervosa or anorexia nervosa); 3) are unable to read and understand English
fluently; or 4) are receiving concurrent treatment for obesity.
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 14 Years | Ecological Momentary Assessment of Eating Behavior in Overweight Youth | NCT02585518 | Entailment |
4,631 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Female with persistent (>3months) cyclical period pain associated with menstruation
(defined as 5 or more on VAS).
- Able to give written, Informed consent
- Able to wear device and keep up-to-date records of use
- Agrees to attend follow up
- If currently using hormonal contraception agrees to continue on the same dose for the
duration of the trial.
Exclusion Criteria:
- Age under 16 years.
- Trying to conceive or <6 weeks post partum
- Currently participating or planning to participate in another clinical trial
Female
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| Pulsed Electromagnetic Field Treatment for Painful Periods | NCT03394547 | Entailment |
3,423 | 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:
- Type 2 Diabetes Mellitus
- BMI more than 25
Exclusion Criteria:
- Type 1 diabetes
- pancreatic diabetes
- presence of concomitant endocrinal disorder
- non-overweight type 2 diabetes
- type 2 diabetes with secondary failure to sulfonylurea and taking insulin
- presence of proliferative retinopathy or chronic renal failure
- known cirrhosis of liver
- heavy alcoholic
- presence of active tuberculosis
- known HIV disease or any active infection
- major mental illness
- failure to comply with the exercise advice due to physical incapacity (e.g., severe
osteoarthritis, hemiparesis or any other disabling neurological disease)
- present pregnancy (or planning pregnancy)
- lactating mothers
- using any kind of hormones including oral contraceptives, systemic corticosteroids,
nicotinic acid
- use of anti-obesity drug within the past 3 months
- chronic gastroparesis or chronic severe gastrointestinal symptoms
- a history of gastric or duodenal ulcers
- abdominal surgery within 1 year will not be included in the study
- patients with congestive heart failure or overt nephropathy will also not be included,
due to unreliability of anthropometric measurements in such subjects and the relative
risk of lactic acidosis
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 70 Years | Metformin in Overweight Type 2 Diabetes Mellitus | NCT00922194 | Entailment |
2,263 | 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:
1. Participant must be a person with DMD who is 11 years or older or The parent/legal
guardian of a person with DMD who is under the age of 18 years.
2. Confirmed diagnosis of DMD with written proof of disease provided
3. Resident of the U.S.
4. Able to read, write and communicate in English
5. Able to grant informed consent
6. Willing to participate in a 45 minute telephone interview
7. Ability to view or receive a document from the interviewer before or during the
interview (web browser, ability to receive a text, fax or document by mail)
Exclusion Criteria:
1. Inability to meet any of the inclusion criteria
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 11 Years old.
| Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families | NCT03680365 | Contradiction |
4,579 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- symptomatic adenomyosis
- irregular menstrual bleeding and dysmenorrhea .
Exclusion Criteria:
- asymptomatic patients -
- non-lactating patient
- not desire for pregnancy
- no hormonal treatment more than 6 month even contraception e.g IUD
- no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis | NCT03654144 | Contradiction |
4,373 | 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: To be in the study, the participant must meet the following criteria
1. Diagnosis of hereditary aortopathy based upon:
- Confirmation of a disease causing mutation in a known aortopathy disorder OR
- Confirmation of disease based on published clinical criteria
2. Participants is male or female and greater than 30 days old
3. Participants are able to undergo standard of care cardiac monitoring including an
echocardiogram
4. Willing and able to provide written informed consent by parent(s) or guardian(s) after
the nature of the study has been explained and prior to any research related
procedures
5. Signed HIPPA compliant research authorization
Exclusion Criteria: Participant will be excluded from the study for any of the following
criteria
1. Diagnosis of a hereditary aortopathy can not be confirmed
2. Existence of an additional comorbid condition- including a co-existing genetic
syndrome, heart failure, renal disease, rheumatologic disease, history of malignancy,
thyroid disease, recent stroke, other life-limiting illness not related to
cardiovascular disease.
3. Extreme prematurity, <28 weeks gestational age
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 60 Years | Micro RNAs as a Marker of Aortic Aneurysm in Hereditary Aortopathy Syndromes | NCT02213484 | Entailment |
4,773 | 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:
- mature (above 18 years old) patients that suffer tinnitus (unilateral/bilateral) with
sensorineural hearing loss
Exclusion Criteria:
- patients that are treated for tinnitus( psychological treatment, hearing aid)
- drugs that affect the CNS
- sensitivity to amide anaesthetic
- hepatic failure
- usage of antiarrhythmic drugs
- severe depression any patients that develops during the trial local/ systemic symptoms
such as rash, pain, itching, fever, nervousness,palpitations will be omitted from the
study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Treating Tinnitus Using Eutectic Mixture of Local Anesthetics (EMLA) 5% Cream | NCT02266160 | Entailment |
638 | 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:
- Body mass index between 18 et 25 Kg/m²
- Non smoker
- No swallowing disorders
- Normal clinical exam
- Normal ECG
- Normal values for routine biological tests : serum iron, transferrin saturation,,
hemogram ferritin, C Reactive Protein, AST, ALT, HDL and LDL cholesterol,
triglycerides
- No C282Y mutation within the HFE gene
- Affiliation to social security
- Written informed consent obtained
Exclusion Criteria:
- Chronic or evolutive disease
- Infection during the 7 days before each sequence
- Drug or alcohol (>30g) abuse
- Current treatment
- Known food allergy
- stay at altitude (> 1500m) in 2 months
- Positive serology for hepatitis B or C virus or HIV.
- Transfusion or blood donation during the last three months.
- Exclusion period on the healthy volunteer National File.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Effect of Curcumin on Iron Metabolism in Healthy Volunteer | NCT01489592 | Contradiction |
1,602 | 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:
- no participation in a similar study 2-weeks prior
- may be post-menopausal or have had a hysterectomy
- if sexually active, and of child bearing potential, subjects using adequate
non-barrier method of birth control
- free from any vaginal disorders
- sexually active and monogamous, heterosexual relationship, and whose male partner is
willing and able to give informed consent and agrees to engage in sexual intercourse
at least twice each week during the two-week study or is not sexually active
- personal lubricant user and agrees to replace her usual personal lubricant with the
investigational product
- can start regardless of where they are in their cycles
- agrees to use the provided investigational product at least four times weekly over the
two week study period
- exhibits no clinically significant evidence of vulvar or vaginal irritation, as
determined by a study doctor, and no reports of sensory irritation at the baseline
exam
- willing to refrain from introducing any new vaginal products, or using vaginal
medications or local contraceptives during study
- agrees to refrain from douching or using any medications, powder, lotions or personal
care products in the vulvar or perianal area
- willing to use a urine pregnancy test provided to them at baseline and on third visit
- standard medical history form on file
- signed informed consent
- completed HIPAA
- dependable and able to follow directions as outlined
- receives a score of 0 or 0.5 for erythema and edema: and 0 for sensorial irritation
(burning, stinging, itching and dryness) during the first examination.
Exclusion Criteria:
- pregnant, nursing or planning a pregnancy
- currently using or has used within two weeks prior to the study initiation, any
systemic or topical corticosteroids, vasoconstrictors, antibiotics,
anti-inflammatories or antihistamines
- known allergies to vaginal or any cosmetic products
- reports history of recurrent bladder, vaginal infections or incontinence
- exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days
prior to study initiation
- uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with
spermicide as a means of contraception
- participated in a study involving the vaginal area or in an investigational systemic
drug study within two weeks of study initiation
- receives a score higher than 0/5 for erythema, edema or >0 for burning, stinging, or
itching, during first examination or shows any other sign of mucosal irregularities
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects | NCT02737852 | Contradiction |
2,343 | 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:
- Subject has a diagnosis of Duchenne muscular dystrophy (DMD) (confirmed by Central
Genetic Counselor) defined as a clinical picture consistent with typical DMD and 1 of
the following:
- Dystrophin immunofluorescence and/or Western blot showing severe dystrophin
deficiency consistent with the diagnosis of DMD.
- Identifiable mutation within the DMD gene (deletion/duplication of 1 or more
exons), where reading frame can be predicted as "out-of-frame"
- Complete dystrophin gene sequencing showing an alteration (point mutation,
duplication or other) that is expected to preclude production of the functional
dystrophin protein (i.e., nonsense mutation or deletion/duplication leading to a
downstream stop codon).
- A male subject of reproductive potential (Tanner Stage 2 and above) must agree to do
either of the following from screening throughout the study until 30 days after the
last dose of the investigational product (IP):
- Abstain from sexual intercourse, OR
- If having heterosexual intercourse, must use a condom and their female partners
who are of childbearing potential must use a highly effective contraception
method.
- Subject has been on a stable daily dose of corticosteroids for 6 months prior to the
time of enrollment (at baseline).
- Subject has been on stable cardiac therapy for 3 months prior to the time of
enrollment (at baseline), if used, which may include prophylactic
angiotensin-converting enzyme inhibitors (ACE), angiotensin II receptor blocker (ARB),
aldosterone receptor antagonists (e.g., spironolactone, eplerenone), and/or
beta-blocker therapy or a combination therapy thereof.
- Subject is unable to complete the 10 meter run/walk in <10 seconds at screening.
- Subject has a PUL 2.0 entry item A score of 4, 5 or 6 at screening.
- Subject and subject's parent(s) or legal guardian agrees not to participate in another
interventional study while participating in the present study.
- For those subjects receiving exon-skipping therapy, the subject has been on a stable
dose regimen with a single commercially-available product for at least 6 months prior
to randomization at baseline.
Exclusion Criteria:
- Subject has had an acute illness (i.e., upper respiratory or viral infection) within 4
weeks prior to study enrollment (at baseline), which precludes participation.
- Subject has a cardiac ejection fraction < 55% on echocardiogram at screening.
- Subject has a mean QT interval from triplicate electrocardiogram (ECG) using
Fridericia's correction (QTcF) of > 450 msec at screening. If the mean QTcF exceeds
the limits stated above, 1 additional triplicate ECG can be taken and utilized at
screening.
- Subject has cardiac troponin I (cTnI) above the upper limit of normal (ULN) (or
cardiac troponin T [cTnT] above the ULN if cTnI is not available immediately) at
screening.
- Subject has used coenzyme Q10 (CoQ10), metformin, idebenone, carnitine, or other
mitochondrial focused supplements or drugs within 4 weeks prior to randomization at
baseline. In addition, subject has used any peroxisome proliferator-activated
receptors (PPAR) ligands such as fibrates and thiazolidinediones 4 weeks prior to
randomization at baseline.
- Subject has a known or suspected hypersensitivity to ASP0367, or any components of the
formulation used.
- Subject has inadequate renal function, as defined by serum Cystatin C > 2 x ULN at
screening.
- Subject who has any of the following liver function tests elevated: gamma-glutamyl
transferase [GGT] and/or total bilirubin [TBL]) > 1.5 x ULN at screening.
- Subject who has a positive test result for hepatitis B surface (HBs) antigen,
hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV)
antigen/antibody at screening.
- Subject has mental conditions such as schizophrenia, bipolar disorder or major
depressive disorder.
- Subject has a history of suicide attempt, suicidal behavior or has any suicidal
ideation within 1 year prior to screening that meets criteria at a level of 4 or 5 by
using the Columbia Suicide Severity Rating Scale (C-SSRS) or who is at significant
risk to commit suicide, as assessed at screening or at baseline.
- Subject has severe behavioral or cognitive problems that preclude participation in the
study.
- Subject has any condition, which makes the subject unsuitable for study participation.
- Subject is taking any other investigational therapy currently or has taken any other
investigational therapy within 3 months prior to the time of enrollment (at baseline).
- Subject and parent/guardian are unwilling and unable to comply with scheduled visits,
IP administration plan and study procedures.
- Subject has had clinical signs and symptoms consistent with coronavirus (SARSCoV-2)
infection or who has tested positive within 2 months prior to randomization at
baseline.
- Subject whose parent(s) and/or caregiver(s) have increased risk of coronavirus
(SARS-CoV-2) exposure from work history (e.g., nursing home, meat processing facility
and correctional facility) or recent travel history unless the subject's parent(s)
and/or caregiver(s) have been appropriately vaccinated with one of the COVID-19
vaccines.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 16 Years | A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD) | NCT04184882 | Entailment |
843 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Male or Female between the ages of 45 years or older
- Ultrasonography scale of 0-3 for grading of primary Knee OA of the knee(s)
- Pain perceived as a minimum of 3/10 on a 0-10 pain scale with 24 hours of the each
visit
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- OA and or Chronic knee pain, Injury/pain that began minimum of 6- weeks before the
beginning of the study.
Exclusion Criteria:
- Pregnancy
- Diabetes Mellitus
- Neuropathy
- Smoker
- Uncontrolled HTN
- Past surgery in the region to be treated by TENS or had received an intra-articular
corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
- Arthritis (RA) in the area to be treated by TENS
- Allergic to tape/electrodes
- Dementia
- History of knee joint replacement or tibial osteotomy
- Undergoing physical therapy
- Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
- Contraindications to TENS (pacemakers, dermatological conditions, and abnormal
sensation in the knees)
- Severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease,
cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumber
disc, herniation, and rheumatoid arthritis)
- The subject does not utilize stairs in daily living
- The subject is unable to walk without ambulatory assistive devices.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain | NCT04084236 | Entailment |
3,871 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Primary Knee osteoarthritis (ACR criteria)
- VAS for knee pain between 3 and 7
- No changes the NSAID intake or physical activity in the previous 3 months
Exclusion Criteria:
- Symptomatic heart or pulmonary disease
- Severe systemic disease
- Other symptomatic disease in the lower limb or in the upper limb that will carry the
cane
- Joint injection in the previous 3 months
- PT in the previous 3 months
- Previously cane use
- Start regular physical activity in the last month
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Effectiveness of Cane in Osteoarthritis (OA) Patients | NCT00698412 | Entailment |
2,832 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- patients > 18 years-old
- ALS certain or probable
- vital capacity (respiratory) > 70 %
- under riluzole
Exclusion Criteria:
- ALS in family
- other conditions affected survival and QoL
- cognitive impairment
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.
| Effects of Gastrostomy on Amyotrophic Lateral Sclerosis | NCT00337402 | Entailment |
2,576 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Adult ( more than 18 years old) patients with chronic pain after groin hernia surgery,
and pain related impairment of everyday function. The pain should have occurred after
previous open surgery.
- The patient should be able to locate to a specific area with maximum pain. Patients
should be able to understand and use pain scales, and the AAS-scale.
Exclusion Criteria:
- All that contradicts the above
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.
| Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain | NCT00627289 | Contradiction |
2,769 | 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:
ASA I-III patients undergoing inguinal hernia repair with a mesh
age between 18 and 75 years old
ability to read and write greek
-
Exclusion Criteria:
- Inability to consent to the study
- BMI >40kg/m2
- Skin infection at the puncture site
- Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
- Preoperative use of opioids or NSAID's for chronic pain conditions
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Transversus Abdominis Plane Block and Inguinal Hernia Repair | NCT02030223 | Entailment |
2,466 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
1. Male or Female aged over 18
2. Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas
consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting
diagnosis of sarcoidosis.
3. Ambulatory patient (not wheelchair or bed-bound)
4. Able to provide written informed consent
Exclusion Criteria:
1. Unable to provide informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Comparison of Accelerometers for Measuring Daily Activity in Sarcoid | NCT02626897 | Entailment |
5,561 | 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. | PROTOCOL ENTRY CRITERIA:
Turner's syndrome-compatible karyotype No Y material in peripheral karyotype Bone age no
greater than 11 years --Prior/Concurrent Therapy-- No more than 12 months of prior
estrogen, androgen, or growth hormone
Female
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 14 Years | Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome | NCT00004275 | Contradiction |
5,793 | 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:
- greater than or equal to age 18 (as NRT is not FDA approved for adolescents)
- self-report smoking cigarettes
- positive cotinine test
- motivated to quit
- own a smart phone, laptop, desktop, or tablet computer
- able to join group from a private space with Internet access
- demonstrate the ability to connect to the HIPAA-compliant videoconferencing system,
Zoom, over the internet h) speak English i) can provide Florida residency
(state-issued identification or mail with person's name and Florida address) j) living
with certain health conditions
Exclusion Criteria:
- pregnant, breastfeeding, or have other contraindications to NRT
- receiving other tobacco treatment, or
- inability to communicate coherently in English during the video-conferencing test or
other pre-enrollment interactions
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Positively Quit Trial for Smoking Cessation | NCT04449458 | Contradiction |
5,231 | 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:
- : patients with back pain who have been referred to the North of England regional back
pain service who consent to take part in the study
Exclusion Criteria:
- Exclusion criteria are patients with red flag indicators where immediate referral to
secondary is indicated (NICE 2016). In addition children less than 18 years and,
people who do not speak English and people with reduced mental capacity will be
excluded
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Comparison of Two Self-management Programmes for Patients With Back Pain | NCT03791164 | Entailment |
425 | 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:
- Body mass index (BMI) 18-30 kg / m2
- Patent tubes
- Regular cycles (26-35 days)
- FSH levels on day 3 of cycle (<10 mIU / ml)
- Estradiol levels on day 3 of cycle (<60 pg / ml)
- Progesterone levels the day of hCG (> 1 ng / ml)
- Semen donors belonging to the bank of IVI
Exclusion criteria
- Patients with ≥3 follicles of over 16 mm diameter
- No dominant follicle after two consecutive ultrasound
- Women with P <1 ng / ml on the day of hCG
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | IUI Schedule in Cases of High Progesterone | NCT02447588 | Contradiction |
3,172 | 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:
- Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60
years (no more than 9 subjects);
- Subject is using adequate non-barrier method of birth control [established us of
hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine
device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a
monogamous relationship with male partner with vasectomy];
- Subject is free of any vaginal disorders;
- Subject is sexually active and in a monogamous, heterosexual relationship, and whose
male partner is willing and able to give informed consent and agrees to engage in
sexual intercourse at least twice each week during the two-week study (at least 50%
and up to 100% of the study population) or is not sexually active (no more than 50% of
the population);
- Subject is a personal lubricant user and agrees to replace her usual personal
lubricant with the investigational product;
- Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before
or after the examination days;
- Subject agrees to use the provided investigational product at least four times weekly
(including at least twice weekly during sexual intercourse for subjects with
monogamous, male partners) over the two-week study period;
- Subject exhibits no clinically significant evidence of vulvar or vaginal irritation,
as determined by a study doctor, and no reports of sensory irritation at the baseline
examination;
- Subject is willing to refrain from introducing any new vaginal products, or using
vaginal medication or local contraceptives (including condoms and hormonal rings),
during the course of this study;
- Subject agrees to refrain from douching or using any medications, powder, lotions or
personal care products in the vulvar or perianal area for the duration of the study
(Note: subjects may continue to use their usual pantyliner, if any);
- Subject is willing to use a urine pregnancy test provided to them at baseline and on
the third visit (Week 2, day 14);
- Subject has a standard Clinical Research Laboratories, Inc. (CRL) Medical History form
on file at CRL and has completed study specific Medical History and Screener/Inclusion
forms;
- Subject has signed and, if sexually active and in a monogamous relationship, whose
partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50:
"Protection of Human Subjects";
- Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in
conformance with 45 CFR Parts 160 and 164;
- Subject is dependable and able to follow directions as outlined in the protocol;
- Subject receives a score of 0 or 0.5 for erythema and edema, and 0 for sensorial
irritation (burning, stinging, itching, and dryness) during the first examination.
Exclusion Criteria:
- Subject is pregnant, nursing, or planning a pregnancy;
- Subject is post-menopausal or has had a hysterectomy;
- Subject is currently using, or has used within two weeks prior to study initiation,
any systemic or topical corticosteroids, vasoconstrictors, antibiotics,
anti-inflammatories, or antihistamines;
- Subject has known allergies to vaginal or any cosmetic products (including lotions,
moisturizer, powder, sprays, etc.);
- Subject reports a history of recurrent bladder, vaginal infection, or incontinence;
- Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60
days prior to study initiation.
- Subject is expected to menstruate 2-4 days before or after the time of the first,
second, and third examination;
- Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms
with spermicide as a means of contraception;
- Subject has participated in a study involving the vaginal area or in an
investigational systemic drug study within two weeks of study initiation;
- Subject receives a score higher than 0.5 for erythema, edema, or >0 for burning,
stinging, or itching, during the first examination or shows any other sign of mucosal
irregularities (dryness, papules, vesticulation, fissure).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects | NCT02320227 | Entailment |
6,015 | 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:
- Adult candidates who are in overall good health but who suffer from the symptoms of
indigestion.
- Participants will be deemed to be in good health if they do not report any of the
existing medical conditions asked about in the screening questionnaire.
Exclusion Criteria:
- Age <18 years old.
- Unwilling to take test product for their symptoms.
- Are not able to swallow pills.
- Allergy to any of the following: Licorice, Artichoke Leaf, Marshmallow Root, Ginger,
Chamomile, Cellulose Capsule, Rice Hull Concentrate, Carrageenan.
- Has any of the following medical conditions:
- Has had an ulcer
- Has been diagnosed with a digestive disorder
- Diagnosed with gastroesophageal reflux disorder
- Participants with diagnosed with irritable bowel syndrome
- Participants with active HP infection or with gastric or duodenal ulcer
- Participants who have been prescribed any medication by their physician for any GI
disorder or medication that can affect the GI system.
- Participants with previous diagnosis of cancer or with previous surgery of the upper
gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy)
- Pregnant women or breastfeeding.
- Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion
- Participant who scores a 0, 3, or 4 on the Dyspepsia Symptom Severity Index
- Participants who are currently using anticoagulation medications daily. (Aspirin,
Coumadin, Heparin 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.
| Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn | NCT04153552 | Entailment |
3,906 | 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
- 19-75 years of age (inclusive)
- Symptomatic OA (1 of the following: pain, stiffness, or swelling)
- Evidence of grade I, II or III OA on radiographic images according to
Kellgren-Lawrence grading scale.
Exclusion Criteria:
- Clinical
- Previous surgery on either knee (not including a diagnostic arthroscopy
arthroscopy or simple partial meniscectomy)
- Intra-articular treatment within the last 3 months
- Ipsilateral cruciate or collateral ligament injury within past 3 months, or
evidence of ligament laxity
- Inflamed knee or pronounced effusion
- Allergy to birds, eggs, avian proteins or known HA or corticosteroid
- Venous or lymphatic stasis
- Skin condition in the injection area
- Evidence of infection in the affected joint
- History of crystalline arthropathy or inflammatory arthritis
- Pregnant or nursing
- Third Party, Medical Legal or Workers' Compensation Board
- Patient unable to understand English or unable to providing informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 75 Years | A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis | NCT01132677 | Entailment |
3,614 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- adults
- consultation during the early stages of care
- leaving after consultation
- agrees to participate in the study
Exclusion Criteria:
- minor patients
- permanently off care
- hospitalized patients
- refusal to participate in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| the Observance of Emergency Exit Treatments During the Stay of Care at the Exit of Reims Emergencies | NCT03836534 | Entailment |
2,930 | 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. Patients ≥18 years and who have provided written informed consent to participate in
the study
2. Prior to trial entry patients will have a definite diagnosis of ALS according to El
Escorial Criteria. All patients will demonstrate either:
presence of Upper Motor Neuron (UMN) (increased tone, brisk reflexes) as well as Lower
Motor Neuron (LMN) (weakness, wasting and fasciculation) signs in the bulbar region
and at least two of the other spinal regions (cervical, thoracic or lumbosacral)
or
presence of UMN and LMN signs in all three spinal regions (cervical, thoracic or
lumbosacral)
3. Electrophysiological tests (Electromyography (EMG) / Nerve Conduction Study (NCS))
that supports the diagnosis of Motor Neurone Disease (MND) and to exclude mimic
disorders
4. Forced Vital Capacity (FVC) ≥50% of predicted value for gender, height and age at
screening and a mean Sniff Nasal Inspiratory Pressure (SNIP) ≥50% of predicted value
for age
5. Adequate haematological function (Hb≥10g/dl absolute neutrophil count ≥1.5x109/L and a
platelet count ≥60 x109/L
6. International Normalised Ratio (INR) ≤ 1.5, Activated Partial Thromboplastin Time
(aPTT) 30 - 40 seconds, Prothrombin Time (PT) 11-13.5 seconds
7. Patient willing and able to comply with schedule visits, treatment plan and other
study procedures.
8. Patients taking Riluzole must have discontinued treatment ≥28 days prior to study
entry (and following consent to take part in the study)
9. Women Of Child Bearing Potential (WOCBP) who agree to use highly effective means of
contraception (as defined in the Heads of Medicines Agencies_Clinical Trials
Facilitation Group (HMA_CTFG) guideline (see Appendix 8) and in combination with a
barrier contraception method (condom, diaphragm or cap) for the entirety of the study
Exclusion Criteria:
1. Patients classified as either probable or possible ALS according to El Escorial
Criteria.
2. Subjects in whom other causes of neuromuscular weakness have not been excluded
3. Assisted ventilation of any type within 3 months before the screening visit or at
screening 4 Patients requiring Radiologically Inserted Gastrostomy (RIG) or
Percutaneous Endoscopic Gastroscopy (PEG) feeding
5. Involvement in any other interventional study involving use of another IMP or biological
product, within 3 months of screening 6. Any use of antioxidants, edaravone, tirasemtiv or
CK-2127107 within 1 month before the screening visit 7. Any botulinum toxin use within 3
months before the screening visit. 8. Any form of stem cell or gene therapy for the
treatment of amyotrophic lateral sclerosis (ALS) 9. Neuroimaging of brain and cervical
spine with Magnetic Resonance imaging (MRI) indicating compressive myelopathy as an
alternate diagnosis 10. Laboratory examinations including Acetylcholine receptor (AChR)
antibodies and Muscle Specific Kinase (MuSK) antibodies to exclude Bulbar onset Myasthenia
gravis from Bulbar onset Motor neuron disease as an alternate diagnosis and Antinuclear
Antibodies (ANA), Anti-neutrophil cytoplasmic antibodies (ANCA), Extractable Nuclear
Antigen (ENA) antibodies, Creatine Kinase (CK), electrophoresis and immunoglobulin
indicating an alternate diagnosis for muscle disease like Myositis 11. Abnormal liver
function defined as Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) >3 times
upper limit of normal 12. Any head trauma, intracranial or spinal surgery within 3 months
of trial entry 13. Patients who have had recurrent falls will be excluded to reduce the
risk of intracerebral haemorrhage with this IMP 14. Current use of an anticoagulant e.g
Warfarin, Aspirin, Clopidogrel, any novel anticoagulants (NOAC)s or low molecular weight
subcutaneous heparin 15. Uncontrolled severe hypertension defined as systolic blood
pressure (SBP) ≥ 220 mmHg or diastolic blood pressure (DBP) ≥120 mmHg 16. Current or
previous history of heparin-induced thrombocytopenia 17. Active peptic ulcer disease 18.
Known hypersensitivity to sulphur 19. Severe liver insufficiency 20. Patients with evidence
of major psychiatric illness, significant cognitive impairment or clinically evident
dementia that may interfere with the patients' ability to comply with study procedures 21.
Pulmonary illness (e.g asthma or Chronic Obstructive Pulmonary Disease (COPD)) requiring
regular treatment 22. Patient judged to be actively suicidal by the investigator during 3
months before the screening visit 23. Subjects with a diagnosis of another
neurodegenerative disease (e.g. Parkinson's disease, Alzheimer's disease and Frontotemporal
dementia)
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 and Tolerability Study of ILB in Patients With Amyothrophic Lateral Sclerosis (ALS) | NCT03705390 | Entailment |
2,693 | 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:
- Healthy males 18-80 years
- Primary inguinal unilateral hernia
Exclusion Criteria:
- Recurrent hernia
- Bilateral, scrotal or femoral hernia
- BMI above 35
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair | NCT00815698 | Entailment |
2,646 | 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:
- Patients presenting for outpatient inguinal hernia repair without significant medical
comorbidities
- Patients who consent to participating and willing to wear device for designated time
period per protocol
Exclusion Criteria:
- History of chronic opioid use
- Inability to speak English
- Inability to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Objective Measure of Recovery After Outpatient Surgery | NCT02616406 | Entailment |
2,468 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Subject is willing and able to give informed consent.
- Subject is willing and able to participate in the study as an outpatient and is
willing to comply with study requirements.
- Subject is 18 years of age or older.
- Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a
physician global assessment score of at least 4. Diagnosis (based on the
recommendations of an expert panel 24) can be made by either:
- Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with
no evidence of mycobacteria, fungus, or malignancy.
- A biopsy that does not show granulomas, but the patient has characteristic skin
lesions and another clinical feature suggesting sarcoidosis (bilateral hilar
adenopathy, erythema nodosum, uveitis, raised ACE level, BAL lymphocytosis
(CD4:CD8>3.5), panda/lambda sign on gallium scan)
- If female of childbearing potential, subject will have a negative urine pregnancy test
at Screening and Week 0.
- If female, subject will be either post-menopausal for > 1 year, surgically sterile
(hysterectomy or bilateral tubal ligation), or practicing one form of birth control
(abstinence, oral contraceptive, estrogen patch, implant contraception, injectable
contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner).
Female subjects will continue to use contraception for 6 months following the last
infusion.
- Screening laboratory results are within the following parameters:
- Hemoglobin > 9 g/dL
- White blood cells > 3.0 x 10 to the 9th power/L, <14.0 x 10 to the 9th power/L
(unless on oral corticosteroids and no signs/symptoms of infection)
- Neutrophils > 1.5 x 10to the 9th power/L
- Platelets > 100 x 10 to the 9th power/L
- Lymphocytes > 0.5 x 10 to the 9th power/L
- Serum creatinine within 1.5 times the upper limit of normal range
- AST and ALT within 2 times the upper limit of normal range
- Subject has been on a stable dose of antibiotics, thalidomide, antimalarials, oral
corticosteroids or other immunosuppressives, such cyclosporine, tacrolimus,
azathioprine, methotrexate, or mycophenolate mofetil over the previous 4 weeks.
Exclusion Criteria:
- Subject has evidence of a clinically significant, unstable or poorly controlled
medical condition including unstable systemic sarcoidosis.
- Subject has a chest X-ray consistent with an active infection or previous exposure to
TB and/or a positive purified protein derivative test at screening (>5 mm).
- Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This
includes hepatitis B and C, and HIV.
- Subject has been hospitalized for infection or received IV antibiotics within the
previous 2 months prior to baseline.
- Subject has a history of tuberculosis at anytime or close contact with a person with
active tuberculosis within the previous 6 months.
- Subject has received a live vaccination within the previous 3 months.
- Subject has a history of a central nervous system disorder/demyelinating disease or
symptoms suggestive of multiple sclerosis or optic neuritis.
- Subject has current signs or symptoms or history of systemic lupus erythematosus.
- Subject has been diagnosed with a malignancy within the past 5 years except for
successfully treated non-melanoma skin cancer.
- Subject has signs or symptoms suggestive of a possible lymphoproliferative disease.
- Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA).
- Subject has had a substance abuse problem within the previous 3 years.
- Subject has any dermatologic disease in the target site that may be exacerbated by
treatment or interfere with examination.
- Subject has been treated with an anti-TNF biologic immune response modifier, such as
infliximab, adalimumab, or etanercept within the past 8 weeks.
- Subject has been treated with topical corticosteroids, tacrolimus, or pimecrolimus
within 2 weeks or intralesional corticosteroids within 4 weeks of baseline.
- Subject has been administered an investigational drug in another clinical study within
30 days prior to baseline (or 5 half-lives, whichever is longer).
- Subject has a known allergy to adalimumab.
- Subject is female and is pregnant, is considering becoming pregnant during the study
and for 6 months afterwards, or is nursing.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy Study of Humira in the Treatment of Cutaneous Sarcoidosis | NCT00731757 | Entailment |
4,254 | 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. | Major Inclusion Criteria: The following are major inclusion criteria:
1. A diagnosis of azoospermia after semen analysis.
2. Indication to proceed with testicular sperm extraction (TESE or microTESE) based on a
urologic evaluation.
3. Presence of round spermatids from testicular sperm extraction (TESE or microTESE),
irrespective of the presence or absence of mature spermatozoa.
Major Exclusion Criteria (must not meet any): The following are exclusion criteria:
1. Under 18 years old
2. All patients who do not voluntarily give their written consent for participation.
3. Men who do not wish to use their gametes (round spermatids) for fertilization of donor
oocytes for research purposes.
Male
Subject must be at least 18 Years old.
| Round Spermatid Injection Protocol | NCT04053309 | Entailment |
1,563 | 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 Y.O.
- Have smoked Water-pipe at least once before.
Exclusion Criteria:
- Breast feeding Women.
- S/P Bacterial Or Viral infection, Last 2 weeks
- P.O. Steroids
- Water-pipe smoking, last 24 hours
- Cigarette smoking, last 6 hours
- Intensive exposure to smoke (fire), last 24 hours
- S/P Intensive Care Hospitalization, last 3 months
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System | NCT01157832 | Contradiction |
5,093 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory, postmenopausal women.
- A minimum of either one moderate or two mild atraumatic vertebral fractures, and a
minimum of seven evaluable nonfractured vertebrae.
- Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the
average bone mass for young, healthy women (T-score) only in patients with fewer than
two moderate fractures or in patients previously treated with therapeutic doses of
bisphosphonates or fluorides
- Normal or clinically nonsignificant abnormal laboratory values (serum calcium,
PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin
D must be between the lower limit of normal & 3 times the upper limit of normal at
baseline).
Exclusion Criteria:
- Fractures in areas of bone affected by diseases other than osteoporosis (for example,
cancer or Paget's disease).
- Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as
determined by the centralized x-ray quality assurance center (for example, severe
scoliosis or kyphosis).
- Current or recent (within 1 year prior to randomization) metabolic bone disorders
other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy,
osteomalacia, or any secondary causes of osteoporosis
- Current or recent (within 1 year prior to randomization) disease which affects bone
metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
- Currently suspected carcinoma or history of carcinoma in the 5 years prior to
randomization.
- Nephrolithiasis or urolithiasis in the 2 years prior to randomization.
- Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel
disease, or malabsorption syndrome, or any indication of poor intestinal absorption of
calcium, such as the combination of a low urinary calcium excretion and an elevated
serum intact parathyroid hormone level.
- Poor medical or psychiatric risk for treatment with an investigational drug, in the
opinion of the investigator.
- Treatment with androgens or other anabolic steroids in the 6 months prior to
randomization.
- Treatment with calcitonins in the 2 months prior to randomization.
- Treatment with estrogen
- Treatment with progestins in the 3 calendar months prior to randomization, or for more
than 2 months in the 12 calendar months prior to randomization.
- Treatment with corticosteroids.
- Treatment with fluorides in the 6 months prior to randomization or for more than 60
days in the 24 months prior to randomization.
- Treatment with oral bisphosphonates in the 3 months prior to randomization or for more
than 60 days in the 24 months prior to randomization; treatment with intravenous
bisphosphonates in the 24 months prior to randomization.
- Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or
agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory
value at randomization must be between the lower limit of normal and three times the
upper limit of normal.
- Treatment with coumarins and indandione derivatives in the 3 months prior to
randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6
months prior to randomization.
- Treatment with calcium- or aluminum-containing antacids
- Treatment with any other drug known to affect bone metabolism in the 6 months prior to
randomization.
- Treatment with any investigational drug during the month prior to the calcium and
vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic
classes during the month prior to the calcium & vitamin D run-in phase.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 85 Years | Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis | NCT00670501 | Contradiction |
862 | 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. A history of knee joint pain for greater than 6 months.
2. Medial or lateral tibiofemoral joint line tenderness.
3. Unilateral knee pain 6/10 or greater, on average, on the visual analog scale (VAS),
that interferes with function most days per week.
4. Prior failed treatment with acetaminophen and/or non steroidal anti-inflammatory
medications, and physical therapy (quadriceps strengthening).
5. Kellgren grade II or III radiographic changes of osteoarthritis.
Exclusion criteria:
1. Age less than 40 years.
2. Anticoagulation with warfarin or heparin.
3. Known allergy or sensitivity to any of the components of the study medications.
4. Body mass index greater than 35.
5. Previous major reconstructive surgery on the affected knee.
6. Previous arthroscopic surgery on the affected knee in the past 12 months.
7. History of crystal induced arthropathy.
8. Use of aminoglycoside antibiotics, curare-like agents, or history of neuromuscular
disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy.
9. History of or evidence of active rheumatologic disease, diabetes, severe peripheral
neuropathy, clinically evident cardiac or respiratory disease that interferes with
functional status, or other serious diseases, including psychiatric disorders.
10. Evidence of recent alcohol or drug abuse, or history of medication misuse or
addiction.
11. Females who are pregnant, breastfeeding, or planning a pregnancy during the study, or
who think that they may be pregnant at the start of the study, or females of
childbearing potential who are unable or unwilling to use a reliable form of
contraception during the study.
12. Intra-articular (knee) or systemic steroids in the past 6 months, or intra-articular
knee hyaluronic acid injection in the past 6 months.
13. Patients who rate their average daily pain as less than 6 on a 10 point VAS scale at
the screening visit.
14. Concurrent participation in another investigational drug or device study or
participation in the 30 days immediately prior to study enrollment.
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.
| Is Botox Effective in Relieving Pain From Knee Osteoarthritis? | NCT00279903 | Entailment |
4,396 | 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:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has had a self-reported oculo-visual examination in the last two years;
- Has read, understood, and signed the information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has a visual acuity of 20/30 or better (in each eye) with their habitual vision
correction, or 20/20 best-corrected vision (for binocular distance acuity);
- Must be able to achieve 20/30 or better (in each eye) with the study lenses;
- Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
- Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
- Has no more than 0.75 diopters of refractive astigmatism;
- Has clear corneas and no active* ocular disease;
- Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria:
- Is presently participating in any other clinical or research study including eye
related clinical or research study;
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Has any active* ocular pathology or severe insufficiency of lacrimal secretion
(moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Is using any systemic or topical medications that will affect a study outcome
variable, and/or ocular health.
- Has any known sensitivity to fluorescein dye or products to be used in the study.
- Has persistent, clinically significant corneal or conjunctival staining using sodium
fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active
neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal
confirmation at the screening visit).
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.
| Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens | NCT03372551 | Entailment |
2,364 | 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:
- Parents/caregivers of youth between ages 6 and 17 with a primary diagnosis of Duchenne
muscular dystrophy (DMD) who lives at home .
- Access to a smart-phone or computer and internet for the weekly web-based sessions, as
well as uploading of the Actigraph data;
- English speaking.
Exclusion Criteria:
- Unable to speak or read English
- Their child with DMD has cognitive or behavioral concerns that would limit
participation and follow-through of intervention;
- Their child/youth with DMD is currently receiving an intervention for a sleep related
disorder
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 | Sleep Intervention in Young Boys With Duchenne Muscular Dystrophy | NCT04529707 | Entailment |
4,854 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Patients with confirmed Cushing's syndrome [i.e. ectopic corticotropin syndrome,
adrenal adenoma, adrenal carcinoma, ACTH-Independent Macronodular Adrenal Hyperplasia
(AIMAH), or Primary Pigmented Nodular Adrenal Dysplasia (PPNAD)]
- For patients on medical treatment for hypercortisolism due to Cushing's syndrome, the
washout periods had to be completed prior to baseline efficacy assessments
Exclusion Criteria:
- Patients with Cushing's disease
- History of hypersensitivity to osilodrostat or to drugs of similar chemical classes
- History of malignancy of any organ system, treated or untreated, within the past 5
years
- Patients receiving treatment for within 4 weeks or ≤5 x half-life of the agent
(whichever is longer) before first dose of osilodrostat
- Patients with risk factors for QTc prolongation or Torsade de Pointes
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome | NCT02468193 | Entailment |
2,604 | 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:
- Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia
repair
Exclusion Criteria:
- Inability to consent to the study
- BMI more than 40
- Skin infection near injection site
- Chronic hepatic or renal failure
- Peripheral neuropathy
- Proven opioid dependency
- Coagulopathy
- Thrombocytopenia
- Dementia
- Lack of orientation
- Impossibility to understand VAS
- Patients suffering from chronic pain
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy | NCT01429480 | Contradiction |
1,484 | 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:
- Pathological Group
- Must have dysphagia as diagnosed by a licensed and certified otolaryngologist,
gastroenterologist, or speech-language pathologist AND must have a dysphagia
treatment plan that includes one of the following primary goals:
- Therapy to strengthen oropharyngeal musculature
- Medical or surgical management to relieve an obstruction at the upper
esophageal sphincter
- Must agree to comply with swallowing assessment, including interview and
manometry
- Must sign the Informed Consent form approved by the Health Sciences Institutional
Review Board of the University of Wisconsin
- Normal Group
- Having no swallowing disorders
- Must agree to comply with swallowing assessment, including interview and
manometry
- Must sign the Informed Consent form approved by the Health Sciences Institutional
Review Board of the University of Wisconsin.\
Exclusion Criteria:
- Pathological Group
- Therapeutic management plan already initiated prior to recruitment
- Therapy goals including only improvement of swallowing coordination
- Developmental disability, dementia, cognitive dysfunction, or difficulty
comprehending instructions
- Positive history of allergic response to topical anesthetic
- Allergy to food relevant to study participation (e.g. lactose intolerance)
- Normal Group
- Known swallowing disorder
- Developmental disability, dementia, cognitive dysfunction, or difficulty
comprehending instructions
- Positive history of allergic response to topical anesthetic
- Allergy to food relevant to study participation (e.g. lactose intolerance)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Rehabilitation Manometry Study | NCT04130867 | Entailment |
178 | 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:
- Patients older than 18 years old and younger than 70 years.
- To have diagnosis of erectile dysfunction by IIEF. Qualification less than 46 points
and/or GAQ with Answer "NO".
- Patients with Inform consent letter signed.
- Patients without any therapy with other type of testosterone, gonadotrophines and/or
PDE-5 in the previous 4 weeks of their inclusion at the study.
- Diagnosis of hypogonadism according to the criteria:
- Testosterone dosage lower than 12 nmol/L
- Free testosterone shall be below 180 pmol/L o 52 pg/mL
Exclusion Criteria:
- People less than 18 years old and older than 70 years.
- Patients with history of or with known or suspected sleep apnea.
- Patients who participate in other study protocols
- Known or suspected active systemic infection.
- Patients with HIV + and/ or known HTLV+.
- Patients with hyperprolactinemia
- Patients with known or suspected coagulopathies
- Patients with Klinefelter
- Known or suspected psychiatric illness.
- Patients who have received prior therapy with some kind of testosterone in the last 4
months or a PDE-5 inhibitor in the last month.
- Patients with contraindications for the use of PDE-5 inhibitors
- Patients having a diagnosis of erectile dysfunction but with total and/ or free
testosterone levels within the physiological range.
- Patients with APE ≥ 2.5 ng/ml in younger than 60 years, or > de 3 ng/ml in older than
60 years.
- Abnormal prostate findings during the digital rectal examination (that is to say,
irregularities, hard consistency when examined).
- Concomitant malignant diseases or history of prostate cancer
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate | NCT00555087 | Entailment |
2,404 | 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:
- Patients with conclusive DMD diagnosis
- Written consent
- Able to perform physical exercise and answer questions
Exclusion Criteria:
- Lack of consent
- Cognitive disabled unable to answer questionnaire, understand instructions, and able
to know what they participate in.
- Language difficulties
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 18 Years | Regular Physical Exercise in Duchenne Muscular Dystrophy | NCT03963453 | Entailment |
199 | 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 18-65
- Morning serum testosterone (T) <300 ng/dL on two occasions
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 65 Years | Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation | NCT00924612 | Entailment |
2,444 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
1. Subject is > 18 years of age.
2. Subject must have moderate to severe cutaneous sarcoidosis with chronic indurated
lesions (papules, nodules, and/or plaques), which histopathologically show
non-caseating granulomas with negative special stains for microorganisms (AFB and PAS
or GMS). Accepted clinical variants include, but are not necessarily limited to the
following:
- lupus pernio
- nodular
- subcutaneous
- annular
- angiolupoid
- plaque
- papular
- lichenoid
- psoriasiform
3. For purposes of this study "moderate to severe cutaneous sarcoidosis" is defined as
the presence of sarcoidal skin lesions with any of the following features:
- At least 5 easily visible facial lesions, or
- Disease which involves > 3% BSA, or
- Disease which confers functional impairment (e.g. nasal or visual field
obstruction), or
- Disease which confers significant symptoms of itching and/or pain.
4. If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy), or is using one of the following methods of birth
control for the duration of the study and 90 days after study completion:
- condoms, sponge, foams, jellies, diaphragm, or intrauterine device
- contraceptives (oral or parenteral) for three months prior to study drug
administration
- a vasectomized sole partner
5. Females of childbearing potential must have a negative serum pregnancy test at
screening visit.
6. Subject must have no history of nor evidence of tuberculosis, either active or
previously treated. This determination will be based on a negative PPD skin test and
negative chest radiograph at screening, negative history of previous tuberculosis, and
negative history of previous exposure to tuberculosis.
7. Subject must be willing and able to give informed consent and to comply with the
requirements of the protocol.
8. Subject must be willing and able to self-administer SC injections or to have a
qualified person available to administer SC injections.
9. The following criteria for concomitant treatments of sarcoidosis must be met:
- Topical therapies (corticosteroids) must be discontinued at least 2 weeks prior
to baseline visit.
- Intralesional therapies (corticosteroids) must be discontinued at least 4 weeks
prior to baseline visit.
- Systemic therapies (MTX, antimalarials, prednisone, immunosuppressants,
thalidomide, tetracycline derivatives) must be discontinued at least 4 weeks
prior to baseline visit.
OR if a subject is on such topical or oral medications, the dose has been stable for these
same time intervals and is likely to remain stable for the duration of the study. Patients
whose non-cutaneous disease is being managed by other physicians will continue to have
their care directed by these physicians. The managing physicians will be kept informed of
the patients' status, consistent with study blinding. If the patient's dose of a
concomitant systemic therapy for non-cutaneous sarcoidosis must change by more than 20% of
the dose at study entry due to a change in medical condition during the double-blind phase,
the subject will be discontinued from the study. During the open-label phase the need for a
greater than 20% increase in dose of concomitant treatment for non-cutaneous sarcoidosis
will be viewed as treatment failure and the patient will be discontinued from the study.
Reduction of the dose of such treatment of any magnitude will not result in discontinuance.
Continued use of intralesional therapies is not permitted. Inhaled corticosteroids for a
stable medical condition are allowed.
Exclusion Criteria:
1. Evidence of other active skin diseases or skin infections during screening that may
interfere with evaluation of sarcoidosis.
2. Subject has a known sensitivity to any component of the study medication. (See Table
4.)
3. Subject has an active infection requiring systemic antibiotics at time of screening.
4. Subject has a history of malignancy or lymphoproliferative disease within the past 5
years, excluding successfully treated non-melanoma epithelial skin cancer and/or
localized carcinoma in situ of the cervix.
5. Subject has a history of congestive heart failure.
6. Subject has a poorly controlled medical condition including, but not limited to,
unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of
recurrent infections, or any other condition for which, in the opinion of the
investigator, participation in the study would place the subject at risk.
7. Subject has a history of demyelinating CNS disease.
8. Subject has a history of listeriosis, treated or untreated tuberculosis, exposure to
individuals with tuberculosis, persistent or active infections requiring
hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV
antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or
antifungals for purpose of treating infection, within 14 days of baseline.
9. Subject is currently using or plans to use antiretroviral therapy at any time prior to
or during study.
10. Previous use of anti-TNF agent(s).
11. Receipt of any other investigational product within 30 days prior to the first dose of
investigational product.
12. Subject is known to have immune deficiency or is immunocompromised.
13. Female subjects who are pregnant, breast feeding, or are considering becoming pregnant
during the study or within 150 days of the last dose of study medication.
14. Subject has a history of clinically significant drug or alcohol abuse in the last
year.
15. Subject is considered by the investigator, for any reason, to be an unsuitable
candidate for study participation.
16. Clinically significant ECG abnormalities at screening visit.
17. Hgb < 8.5 g/dL in females and < 9.0 in males.
18. WBC count < 3000/mm2
19. AST or ALT > 2.0 times the upper limit of normal for the age range, confirmed by a
repeat measure.
20. Bilirubin > 3mg/dL
21. Creatinine > 1.6 mg/dL in women, and > 1.8 mg/dL in men.
22. Subject plans to receive any live vaccines during the study.
23. Subject has a variant of sarcoidosis that is not amenable to study evaluation, in the
absence of chronic indurated lesions, such as:
- Acute, "benign" sarcoid associated with erythema nodosum
- Acute iritis
- Ichthyosiform sarcoidosis
- Hypo- or hyperpigmented macular sarcoidosis
- Ulcerative sarcoidosis
- Erythroderma
- Alopecia
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 89 Years | A Study of Adalimumab to Treat Sarcoidosis of the Skin | NCT00274352 | Entailment |
2,432 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar
lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities)
- Indication for tissue verification of noncaseating granuloma's
- Provision of a written informed consent
Exclusion Criteria:
- Life expectancy of less than 6 months
- Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas
with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph
node)
- Positive acid-fast bacilli sputum test
- Contra-indication for endosonography
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| EBUS vs EUS-B for Diagnosing Sarcoidosis | NCT02540694 | Contradiction |
6,160 | 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:
- Men and women over 18 and under 65.
- Household contact with a confirmed case of COVID-19 by PCR for Sars-CoV-2.
- Initiate study medication within 4 days from the last close contact with the index
case.
- The patient must not present symptoms suggestive of Covid19 (cough, dyspnea, fever>
37.5 C, fatigue, sore throat, myalgia, diarrhoea) at the time of admission to the
study and from previous 14 days.
- Informed consent from the patient or legal representative.
Exclusion Criteria:
- History of infection confirmed by SARS-CoV-2.
- Positive IgG antibodies test for SARS-CoV-2 at the time of admission.
- Have received any dose of nitazoxanide within 7 days prior to screening.
- Known hypersensitivity to any of the study medication components.
- Use of any investigational or unregistered drug or vaccine within 30 days prior to
screening, or use planned during the study period.
- Inability to comply with study procedures.
- Current breastfeeding.
- Pregnancy.
- Intolerance or inability to take oral medication.
- History of severe liver disease (Child-Pugh B or C) and/or chronic kidney disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts | NCT04788407 | Contradiction |
4,403 | 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:
- Must have pain at lateral elbow (lateral epicondylitis) for at least six months
- Pain must not come from trauma
- Painful palpation of the lateral epicondyle
- At least one out of two positive test: Cozen's, Mill's
Exclusion Criteria:
- Fibromyalgia
- Diabetes
- Patient taking more than three medications at the time of inclusion
- Cervical radiculopathy
- Painful shoulder
- Cold intolerance / allergies
- Smoking
- Cortisone infiltration at the painful lateral epicondyle in the month previous to the
inclusion
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 | Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study | NCT02308514 | Contradiction |
6,949 | 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. | Key Inclusion Criteria:
- Age 55 to 85 years
- Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at the Screening visit
- Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on
Aging-Alzheimer's Association criteria (McKhann, 2011)
- Reliable and capable support person/caregiver
- Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment,
defined as:
- Treatment-naïve, OR
- Subjects who received continuous dosing for at least 6 months, and are on a
stable, approved dose of an AChEI for at least 3 months before Screening OR
- Subjects who received an AChEI in the past and discontinued, e.g., due to
tolerability issues
- For subjects who received high dose donepezil at 23 mg PO, or galantamine at 24
mg PO or patch, a 3-month drug-free period is required between the last dose
received and Screening.
Key Exclusion Criteria:
- History of significant neurologic disease, other than AD, that may affect cognition,
or concurrent with the onset of dementia
- History of unexplained loss of consciousness, and epileptic fits (unless febrile)
- Subject has atypical variant presentation of AD, if known from medical history,
particularly non-amnestic AD
- History of brain MRI scan indicative of any other significant abnormality
- Hearing test result considered unacceptable for auditory ERP P300 assessment
- Diagnosis of severe major depressive disorder even without psychotic features
- Significant suicide risk
- History within 2 years of Screening, or current diagnosis of psychosis
- Myocardial infarction or unstable angina within the last 6 months
- Clinically significant (in the judgment of the investigator) cardiac arrhythmia
(including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note:
pacemaker is acceptable)
- Subject has either hypertension (supine diastolic blood pressure > 95 mmHg), or
symptomatic hypotension in the judgment of the investigator
- Clinically significant ECG abnormality at Screening or Baseline
- Renal insufficiency (serum creatinine > 2.0 mg/dL)
- Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2
times the upper limit of normal, or Child-Pugh class B and C
- Malignant tumor within 3 years before Screening
- Memantine (Namenda®) and combination product of donepezil and memantine product
(Namzaric®) within 6 weeks prior to Screening
- The subject has received active amyloid or tau immunization at any time, or passive
immunization within 12 months of Screening
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.
Subject must be at most 85 Years | A Translational Study of ATH-1017 in Mild to Moderate Alzheimer's Disease | NCT04491006 | Entailment |
1,749 | 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 or cytologically confirmed diagnosis of gastric adenocarcinoma or
gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the
stomach)
2. patients must present with stage IV disease not amenable to surgery, radiation or
combined modality therapy with curative intent. Patients previously undergoing local
treatment (surgery and/or radiation) must have subsequently progressed or recurred
3. measurable or evaluable disease according to RECIST
4. age, 18 years or older
5. ECOG performance status 0 - 2
6. adequate organ function as defined by the following criteria absolute neutrophil count
(ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver
involvement Total serum bilirubin ≤ 3.0 mg/dL
7. signed written informed consent
Exclusion Criteria:
1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids
4. active and uncontrollable bleeding from gastrointestinal tract
5. known history of hypersensitivity to study drugs
6. patients who are already on statin treatment for hyperlipidemia control (if ≥ 1 year
interval from the last statin dose, the patient is eligible for study entry)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients | NCT01099085 | Contradiction |
851 | 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:
Or at least two of criteria 2-6 established by the American College of Rheumatology (ACR):
1. Kellgren and Lawrence (K/L) grade ≥II
2. morning stiffness <30 min in duration
3. crepitus on movement of the knee joint
4. bony tenderness at the knee joint margins
5. palpable or visible bony enlargement
6. no palpable warmth.
Exclusion Criteria:
1. the presence of knee joint effusion determined by ultrasonography
2. a history of knee injury or surgery
3. a history of knee injection within 3 months
4. a history of inflammatory arthritis
5. taking anticoagulants
6. balance or gait disturbance
7. diabetes mellitus.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| The Effects of Joint Effusion on Proprioception | NCT01060215 | Entailment |
6,690 | 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 diagnosed with hemophilia A and B
- Patients adults (over 18 years)
- Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment
with the Hemophilia Joint Health Score)
- Patients pn prophylactic treatment with FVIII / FIX concentrates.
Exclusion Criteria:
- Patients without ambulation ability
- Patients with inhibitors
- Patients with neurological or cognitive alterations that impede the comprehension of
the questionnaires and physical tests
- Patients who have not signed the informed consent document.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Fascial Therapy in Elbow Hemophilic Arthropathy | NCT03009591 | Contradiction |
4,361 | 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. | Myopic volunteers, ages 20 to 35, who had not worn contact lenses were eligible to
participate in the study if they were free of ocular disease, were in good physical health,
and were not taking systemic medications that could have ocular side effects. In addition,
eligibility was limited to persons with corneal curvature between 40.50 and 47.00 D
(flatter keratometry reading), corrected visual acuity of 6/6 (20/20) or better in each
eye, astigmatism less than 0.75 D, anisometropia less than 1 D, and myopia between 1 and 4
D.
No condition on gender to be admitted to the trial.
Subject must be at least 20 Years old.
Subject must be at most 35 Years | The Berkeley Orthokeratology Study | NCT00000123 | Entailment |
227 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Age: between 35 and 40 years of age,
2. Physiological menstrual cycles (24-35 day cycle),
3. Normal endocrine function (normal PRL and TSH, FSH ≤ 15 IU / ml),
4. Transvaginal ultrasound (TVS) without pathological findings,
5. Free personal medical history,
6. Indication for IVF / ICSI (NICE, 2016)
7. 1st or 2nd IVF / ICSI cycle
Exclusion Criteria:
1. Endocrine or metabolic disorders, e.g. PCO (S)
2. Pathology of the uterus and / or endometrium,
3. Pelvic inflammatory disease (PID),
4. Basal FSH levels> 15 IU / ml,
5. Surgery in the ovaries,
6. Body Mass Index (BMI) ≥ 35 kg / m2,
7. Age: <35 years &> 41 years old
Female
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 40 Years | Low-dose HCG as an Adjunct to Ovarian Stimulation in Subfertile Women Undergoing ART | NCT03423537 | Contradiction |
2,130 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- Ability to produce semen sample
Exclusion Criteria:
- Cognitive impairment
- Inadequate language skills for informed consent
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility | NCT02932865 | Entailment |
6,198 | 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:
- Patients with IBD +/- flare +/- COVID 19 positivity
Exclusion Criteria:
- Patients below 16
- Patient with inactive IBD
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
Subject must be at most 100 Years | PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic | NCT04410484 | Contradiction |
249 | 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. Subject is informed and has been given ample time and opportunity to think about
his/her participation and has given his/her written informed consent
2. Subject is ≥18 years of age
3. Subject's health status: individual is considered to be healthy (hypertension and
hypotension is permissible. Other stable diseases at the time of testing are also
permissible)
4. Subject is capable of undergoing controlled hypoxaemia to the levels called for the in
the protocol with minimal medical risk (unless only participating in the blood
pressure study).
Exclusion Criteria:
1. Subject cannot expose their face fully for a reading to be taken
2. Subject is unable to give informed consent
3. Subject is outside of the specified age range
4. Subject has already taken part in the study (all 4 sub studies)
5. Subject with significant irregular heart rhythm or any disease that might affect the
results of the study
6. Subject is not capable of undergoing controlled hypoxia and would be placed at undue
medical risk if this occurred
7. Subject has any contraindications identified that would deem them unsuitable to take
part
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application | NCT03998098 | Contradiction |
1,683 | 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:
- above 12 years old
Exclusion Criteria:
- unclear Korotkoff sounds
- wrist circumference outside of the designated range (13.5-23 cm)
- arrhythmias
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
| Validation of Wrist Type Oscillometric Blood Pressure Monitorings | NCT04633785 | Entailment |
1,968 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients who have the indication for upper gastrointestinal endoscopy
Exclusion Criteria:
- Cannot be in prone position
- The endoscopist deny the assigned position in any reason.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Position of EGD in Droplet Spreading | NCT04329013 | Entailment |
2,118 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- Participant must have a body mass index (BMI; weight in kg divided by the square of
height in meters) between 18.0 and 30.0 kilogram per square meter kg/m^2, extremes
included, and a body weight not less than 50.0 kg, extremes included
- Participant must have a normal 12-lead electrocardiogram (ECG) consistent with normal
cardiac conduction and function at screening, including: a) normal sinus rhythm (heart
rate between 45 and 100 beats per minute [bpm], extremes included); b) QT corrected
according to Fridericia's formula (QTcF) interval less than or equal to (<=)430
milliseconds (ms) for male participants and <=450 ms for female participants; c) QRS
interval <=110 ms; d) PR interval <=200 ms; e) ECG morphology consistent with healthy
cardiac conduction and function. Any evidence of heart block, or of left or right
bundle branch block is exclusionary
- Participants must have normal values for alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) (less than or equal (<=)1.0×upper limit of laboratory normal
range [ULN])
- Contraceptive use by female participants should be consistent with local regulations
regarding the use of contraceptive methods for participants participating in clinical
studies. Before randomization, a woman must be either: a) Not of childbearing
potential defined as: 1) Postmenopausal: A postmenopausal state is defined as greater
than (>)45 years and no menses for 12 consecutive months without an alternative
medical cause and a serum follicle stimulating hormone (FSH) level in the
postmenopausal range (>40 International units per liter [IU/L] or milli-international
units per milliliter [mIU/mL]), OR; 2) Permanently sterile: Permanent sterilization
methods include hysterectomy, bilateral salpingectomy, bilateral tubal
occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy
b) Of childbearing potential and, if heterosexually active, 1) Practicing a highly
effective method of contraception (failure rate of less than (<)1percent (%) per year
when used consistently and correctly) 2) Agrees to remain on a highly effective method
throughout the study and for at least 44 days after the last dose of study drug
- A female participant, except if postmenopausal, must have a negative serum beta human
chorionic gonadotropin (beta- hCG) pregnancy test at screening, and a negative urine
pregnancy test on Day 1 in each treatment period
- Participant must be able to taste and smell normally, to their own opinion.
Participants who have an impaired sense of taste and/or smell due to any conditions
such as allergic rhinitis, common cold, or sinusitis are not eligible to take part in
the study
Exclusion Criteria:
- Participant has a mouth pathology including, but not limited to, pain, ulcer, edema,
mucosal erosion, gingivitis and/or (dental) abscesses, or receives treatment for oral
pathologies (eg, antifungals or antibiotics) or oral treatment for any disease
- Participant with a history of clinically significant drug allergy such as, but not
limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous
studies with experimental drugs
- Participant is hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV)
antibody positive with HCV RNA positive, or has another clinically active liver
disease at screening
- Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV 2
antibody positive, or tests positive for HIV-1 or -2 at screening
- Participant has previously been dosed with JNJ-64041575 in more than 3 single-dose
studies with JNJ-64041575 or has previously been dosed with JNJ-64041575 in a
multiple-dose study with JNJ-64041575
- Participants with 1 or more of the following laboratory abnormalities at screening as
defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity
Table a) Serum creatinine grade 1 or greater (greater [>]1.0* upper limit of
laboratory normal range [ULN]) b) Hemoglobin grade 1 or greater (<=10.5 gram per
decilitre [g/dL]) c) Platelet count grade 1 or greater (<=99.999/millimeter [mm]^3) d)
Reticulocyte count (absolute) below the lower limit of laboratory normal range (LLN)
e) Absolute neutrophil count grade 1 or greater (<=1,500/mm^3) f) Total bilirubin
grade 1 or greater (>1.0*ULN) g) Any other toxicity grade 2 or above, except for grade
2 elevations of low density lipoprotein (LDL) cholesterol and/or cholesterol
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 55 Years | A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations | NCT03010059 | Contradiction |
3,430 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Male and female subjects between the ages of 18 to 55.
2. BMI between 30 to 50 kg/m2. Subjects with BMI ≥ 35 to 50 kg/m2 inclusive, and subjects
with a BMI of 30.0 to 34.9 kg/m2 are required to have one or more of the following
obesity-related co-morbidities.
1. Diabetes: controlled diabetic, and if on insulin, has been on the medication of
less than two years.
2. Sleep apnea: Apnea/hypopnea index or AHI > 30 events/hour.
3. Hypertension: arterial blood pressure > 140 mmHg systolic or > 90 mmHg diastolic
4. Osteoarthritis of the hip or knee.
5. Gastro Esophageal Reflux Disease (GERD): Persistent reflux that occurs more than
twice a week.
3. History of stable weight (defined as a < 10% change in excess weight) for one year
prior to screening visit.
4. Female subjects of childbearing potential must have a negative urine pregnancy test
and must agree to practice a medically acceptable form of birth control for the
duration of their participation in the trial.
5. History of obesity for at least five years.
6. Subjects must be able to read and understand their native language at a level allowing
the subject to understand and sign the informed consent prior to the performance of
any study-specific procedure.
7. Lives within the drawing area of the hospital.
8. Willing and able to return for all study visits.
Exclusion Criteria:
1. Currently untreated thyroid and adrenal gland disease.
2. Females who are either pregnant or breastfeeding.
3. Insulin-dependent diabetic, where the subject has been on medication for more than two
years.
4. Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or diastolic
blood pressure > 95 mmHg.
5. Ischemic heart disease.
6. Previous stroke.
7. Previous myocardial infarct within 180 days of the study.
8. Prior history of bariatric surgery, such as gastric bypass, or any surgery that has
altered the esophagus, stomach, or pylorus, and restrictive procedures such as the
LAP-BAND® or equivalent.
9. Prior treatment with an intragastric balloon for the purpose of weight loss, where the
balloon was removed less than 12 months prior to screening.
10. A structural abnormality in the esophagus, pharynx (such as a stricture), or pylorus
(such as an incompetent pylorus).
11. Portal hypertension, cirrhosis, and/or varices.
12. Inflammatory disease, such as Crohn's disease, where the disease is affecting the
stomach.
13. Acute abdominal infections.
14. Active gastric or duodenal ulcer.
15. A history of severe dyspepsia or gastric or duodenal ulcer disease.
16. After treatment for H. pylori, patient still tests positive for H. pylori.
17. Evidence of erosive esophagitis.
18. Subject with a hiatal hernia ≥ 2 cm.
19. Subjects with motility disorders of the GI tract such as esophageal motility
disorders, gastroparesis diabeticorum, or intractable constipation.
20. Use of any prescription or over-the-counter weight loss medication, including herbal
supplements, within three months of TPS device placement.
21. Subjects requiring continuous therapy with known ulcerogenic medication (e.g. aspirin,
including 80 mg ASA or NSAIDs).
22. Subjects on anticoagulant therapy, such as those taking Coumadin, Warfarin, Heparin or
Plavix.
23. Subjects unable to take a daily 40+ mg dose of Nexium or generic equivalent or 800+
mcg of Misoprostol or general equivalent.
24. Clinically significant abnormal laboratory values or EKG that make the subject a poor
study candidate in the opinion of the investigator.
25. Subjects with autoimmune connective tissue disorders.
26. A history of cardiac arrhythmia or severe cardiac disease (NYHA Class III or IV).
27. Cannot walk at least 0.8 kilometers per day (10 minutes of continuous walking).
28. Subjects who have started on a prescribed concomitant medication regimen within the
last three weeks, and/or whose concomitant medication regimen is expected to change
during the course of the study, and where the Investigator determines the medication
may affect the study outcome.
29. Treatment for drug abuse, alcohol abuse, or inpatient psychiatric treatment within the
past year.
30. Any medical condition (including psychiatric disease) that would interfere with the
interpretation of the study results, the conduct of the study, or would not be in the
best interest of the subject.
31. A score of ≥ 10 on the Patient Health Questionnaire 9 (PHQ-9), indicating moderate
depression.
32. Subjects who are in a dysfunctional relationship (e.g. an alcoholic spouse, the victim
of sexual, verbal, or physical abuse, etc.).
33. Participation in a trial of an investigational drug or device within 30 days prior to
Screening Visit or plans to enroll in an investigational drug or device trial at any
time during this study.
34. Works for BAROnova or the study doctor or is directly-related to anyone that works for
BAROnova or the study doctor.
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 55 Years | A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects | NCT01386905 | Entailment |
3,930 | 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:
- Participants who have suffered from knee osteoarthritis at least for one year and meet
the criteria of American College of Rheumatology
- Participants who are taking stable dose of meloxicam 7.5 milligram (mg) or 15 mg daily
or aceclofenac 100 mg twice a day at least for four weeks
- Participants whose mean pain intensity has been 5 or higher on the numeric rating
scale (NRS) for the last 48 hours
- Participants whose general health conditions are favorable, according to the criteria
below: Medical and medication history, Physical examination before the study
medication administration, Vital signs: Blood pressure, pulse, Clinical laboratory
tests: Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate
transaminase (SGPT) less-than or equal to (=<) 2 X normal range, Renal function:
Creatinine less than (<) 2.0 milligrams per deciliter (mg/dl)
- Female participants of childbearing potential to use the proper contraceptive methods
during the study period (Urine pregnancy test prior to the study participation should
be negative)
Exclusion Criteria:
- Participants who are applicable to Kellgren and Lawrence grade
- Participants who had failed tramadol treatment before or stopped taking tramadol due
to adverse event(s)
- Participants who are applicable to one of the following conditions: Rheumatoid
arthritis, Ankylosing spondylitis, Active gout or active pseudo-gout, Diagnosis of
fibromyalgia (according to ACR Criteria), Anserine bursitis, Major trauma of the
target joint within six months prior to the study medication administration, Infection
of the target joint within six months prior to the study medication administration,
Apparent avascular necrosis of the target joint within six months prior to the study
medication administration, Anatomical deformities of the target joint, which may
interfere with assessment of the target joint, Surgical procedures associated with the
target joint within one year prior to the study medication administration,
Arthroscopic procedures associated with the target joint within six months prior to
the study medication administration
- Participants who have one of the following diseases: Significantly unstable diseases
such as sleep disorder (e.g., sleep apnea or narcolepsy) or dementia, Functional
damage or disease which may cause malabsorption, excessive accumulation, or metabolism
or excretion disorder
- Participants who are pregnant or breast-feeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis | NCT00635349 | Entailment |
2,713 | 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:
- Male
- Age 30-70 years referred to hospital with a primary inguinal hernia.
Exclusion Criteria:
- Recurrent hernia
- Scrotal or bilateral hernia
- Previous lower abdominal surgery
- Unable to participate in follow up
- ASA more than 3
- Bleeding diathesis.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia | NCT00568269 | Entailment |
1,546 | 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:
Inclusion criteria for the adolescent include:
- age between 13- to 17-years, inclusive
- resident of one of the three parishes in and around Kingston, Jamaica (the study area)
- plan to reside in the "study area" for the next 12 months
- able to read, write and understand English
- unmarried and
- agrees to participate and
- mother or primary female guardian also agrees to participate.
Inclusion criteria for the mother/female guardian include:
- age greater than 18
- resident of one of the three parishes in and around Kingston, Jamaica (the study area)
- plan to reside in the "study area" for the next 12 months
- able to read, write and understand English and
- agrees to participate
Exclusion Criteria:
- adolescent and/or mother who is/are disruptive and/or otherwise unable to participate
in small group intervention activities
- adolescent who is married
Female
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 17 Years | Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program | NCT03411577 | Contradiction |
6,312 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Written documentation of SARS-CoV-2 infection confirmed by a validated test.
2. Presence of greater than or equal to ≥1 of the following COVID-19-related symptoms
indicating mild disease: fever (temperature ≥100.4), anosmia (loss of taste or smell),
cough, sore throat, gastrointestinal complaints (e.g. nausea, vomiting, or diarrhea),
chills, congestion, or runny nose, headaches, muscle or body aches, fatigue, or
asymptomatic patients who have tested positive for COVID-19 via a validated test
within the past 4 days.
3. If symptomatic, symptom onset less than or equal to ≤ 8 days.
4. For female participants of childbearing potential, a negative urine (or serum)
pregnancy test.
5. For female participants of childbearing potential, willingness to use a
protocol-recommended method of contraception from the start of the screening period
until greater than or equal to ≥30 days after the final dose of study therapy. Note: A
female subject is considered to be of childbearing potential unless she has had a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically
documented ovarian failure (with serum estradiol and follicle-stimulating hormone
[FSH] levels within the institutional laboratory postmenopausal range and a negative
serum or urine beta human chorionic gonadotropin [βHCG]); or is menopausal (age ≥50
years with amenorrhea for ≥6 months).
6. For male participants who can father a child and are having intercourse with females
of childbearing potential who are not using adequate contraception, willingness to use
a protocol-recommended method of contraception from the start of study therapy until
≥30 days after the final dose of study therapy and to refrain from sperm donation from
the start of study therapy until ≥90 days after administration of the final dose of
study therapy. Note: A male subject is considered able to father a child unless he has
had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy.
7. Willingness and ability of the participant to ingest study drug capsules.
8. Willingness of the participant to comply with scheduled visits, drug administration
plan, protocol-specified laboratory tests, study procedures, and study restrictions.
9. Evidence of a personally signed informed consent indicating that the participant is
aware of the nature of the disease and has been informed of the procedures to be
followed, the experimental nature of the therapy, alternatives, potential risks and
discomforts, potential benefits, and other pertinent aspects of study participation.
Exclusion Criteria:
1. Respiratory rate greater than or equal to ≥20 breaths per minute.
2. Oxygen saturation by pulse oximetry less than or equal to ≤93 percent % on room air or
requirement for supplemental oxygen to maintain oxygen saturation greater than >93
percent %.
3. Total NEWS score greater than or equal to ≥6 or presence of a score of 3 on any of the
individual NEWS parameters.
4. Radiographic evidence of pulmonary infiltrates (clinical X-ray within 2 days of
referral)
5. Hepatic profile showing any of the following:
- Serum alanine aminotransferase (ALT) greater than >5 × upper limit of normal
(ULN) (CTCAE Grade greater than or equal to ≥3).
- Serum aspartate aminotransferase (AST) greater than >5 × ULN (CTCAE Grade greater
than or equal to ≥3).
- Serum bilirubin greater than >1.5 × ULN (CTCAE Grade greater than or equal to
≥2).
6. Renal profile showing an estimated creatinine clearance (eClCR) less than <30
mL/minute (with eClCR to be calculated by the method at the laboratory performing the
serum creatinine test).
7. Presence of a cancer with disease manifestations or therapy that could adversely
affect subject safety or longevity, create the potential for drug-drug interactions,
or compromise the interpretation of study results.
8. Significant cardiovascular disease (e.g. myocardial infarction, arterial
thromboembolism, cerebrovascular thromboembolism) within 1 month prior to start of
study therapy; unstable angina; symptomatic peripheral vascular disease; CTCAE Grade
greater than or equal to ≥2 congestive heart failure; or uncontrolled CTCAE Grade
greater than or equal to ≥3 hypertension (diastolic blood pressure greater than or
equal to ≥100 mmHg or systolic blood pressure greater than or equal to ≥160 mmHg)
despite antihypertensive therapy.
9. Significant screening ECG abnormalities, including atrial fibrillation/flutter, 2nd
degree atrioventricular (AV) block type II, 3rd-degree AV block, Grade greater than or
equal to ≥2 bradycardia, or corrected QT (QTc by Fridericia [QTcF]) greater than >480
msec (Grade greater than >1).
10. Gastrointestinal disease (e.g. gastric or intestinal bypass surgery, pancreatic enzyme
insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic
diarrheal illness, bowel obstruction) that might interfere with drug absorption or
with interpretation of gastrointestinal AEs.
11. Pregnancy or breastfeeding.
12. Prior solid organ transplantation.
13. Use within 5 days prior to randomization of an approved or investigational therapy
intended to treat COVID-19 (e.g. remdesivir, , anti-interleukin [IL]-6 antibodies,
therapeutic anti-SARS CoV-2 antibodies or post-convalescent plasma, anti- SARS CoV-2
vaccine, Bruton tyrosine kinase [BTK] inhibitor), use within 3 months of chloroquine
or hydroxychloroquine. Note: participants are not precluded from undergoing
evaluations involving observation, noninvasive diagnostic procedures or sampling, or
questionnaires as follow-up to a prior study or as components of a concurrent
noninterventional study.
14. Use within 5 days prior to randomization of a strong inhibitor or inducer of
cytochrome P450 (CYP) 3A4 or expected requirement for chronic use of a strong
inhibitor or inducer of CYP3A4 during study therapy.
15. Use within 5 days prior to randomization of drug that is a moderate-to-strong
substrate of CYP2C9 (including warfarin, tolbutamide, phenytoin, glimepiride) or
expected requirement for chronic use of such drugs during study therapy.
16. Use within 5 days prior to randomization of a drug known to prolong the QT interval
17. Ongoing immunosuppressive therapy including systemic or enteric corticosteroids.
(Note: At study entry, participants may be using intraarticular, inhaled, or topical
corticosteroids. During study therapy, participants may use systemic, enteric,
intraarticular, inhaled, or topical corticosteroids as required for intercurrent
conditions.)
18. Any illness, medical condition, organ system dysfunction, or social situation,
including mental illness or substance abuse, deemed by the investigator to be likely
to interfere with a participant's ability to provide informed consent, adversely
affect the participant's ability to cooperate and participate in the study, or
compromise the interpretation of 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.
| A Study of LAM-002A for the Prevention of Progression of COVID-19 | NCT04446377 | Entailment |
2,839 | 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 years and older
- patients diagnosed with amyotrophic lateral sclerosis or other neurodegenerative
disease, and healthy controls
Exclusion Criteria:
- Subjects with acute bacterial infection of the GI tract
- Subjects on treatments with antibiotics or probiotics within 28 days prior to sampling
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Establishment of a Human Tissue Bank for Studying the Microbial Etiology of Neurodegenerative Diseases | NCT01954875 | Entailment |
5,429 | 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:
- Women aged 18-50 years having regular menstrual cycles
- Women willing to collect all sanitary protection for 6 cycles
- Women with no contraindications to use of combined hormonal contraception
- Women not using any hormonal contraception or any treatment for HMB
- Women who have no demonstrable uterine pathology on pelvic ultrasound
- Women who have demonstrated a menstrual blood loss (MBL) >80mls in 2 of 3 menstrual
periods during the pre-treatment phase will be eligible to enter the treatment phase
Exclusion Criteria:
- Women for whom combined oral contraceptives are contraindicated
- Women unwilling to collect all sanitary protection for 6 cycles
- Women using hormonal contraception or any treatment for HMB
- Women who have demonstrable uterine pathology on pelvic ultrasound
- Women who have demonstrated a MBL ≤80mls in 2 of 3 consecutive menstrual periods
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | A New Treatment Option for Heavy Menstrual Bleeding | NCT01715025 | Entailment |
335 | 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 post-menopausal with abnormal uterine bleeding, ultrasound with thick
endometrial distorted
Exclusion Criteria:
- Women with uterine malformations
- Women with mental retardation
- Women underwent pelvic radiotherapy
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques | NCT01376934 | Contradiction |
4,477 | 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. | Individuals who meet all of the following criteria are eligible for enrollment into the
study:
Inclusion Criteria:
- Adult between 18-45 years of age
- Pain over the lateral humeral epicondyle provoked by at least two of the following:
gripping, palpation, stretching of forearm extensor muscles and resisted wrist or
middle finger extension
- Persistent pain for at least 3 months despite conservative treatments including
medication (oral nonsteroidal antiinflammatory drugs (NSAIDs) and analgesics), brace
application, or physiotherapy
- Patients with structural tendon changes at the origin of the extensors, demonstrated
during musculoskeletal ultrasound
Individuals who meet any of the following criteria are disqualified from enrollment of the
study:
Exclusion Criteria:
- Patients with a history of advanced cervical arthrosis in the C4-C6 segments.
- Bilateral LE with central sensitization
- Symptoms compatible with posterior interosseous nerve entrapment.
- Previous surgery, fractures, trauma or previous history of rheumatic disorders in the
area of the lateral epicondyle
- History of corticosteroid injection at the lateral epicondyle within the last 3 months
Two experienced professionals performed recruitment and examination of subjects in order to
assess for eligibility criteria. All eligible patients provided written informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Clinical and Ultrasonographic Results of Intratissue Percutaneous Electrolysis in Lateral Epicondylitis | NCT02085928 | Entailment |
5,230 | 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:
- 20 to 79 residents in urban Beijing, China.
Exclusion Criteria:
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 79 Years | Prevalence and Predictors of Osteoporosis in the Beijing's Urban Population | NCT01476150 | Entailment |
5,347 | 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:
- Female at least 30 years of age who is premenopausal and for whom childbearing is
complete.
- Excessive menstrual bleeding documented by a diary score of at least 150.
- Have documented 3 months failed medical therapy or either a) contraindicated for or b)
refused medical therapy.
- Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than
12cm.
- Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the
procedure.
- Agree not to switch from hormonal to non-hormonal contraception or vice versa during
or just prior to the study.
- Agree to use reliable contraception throughout the study.
- Freely agree to participate in the study, including all study related procedures and
evaluations, and document this agreement by signing informed consent documentation.
Exclusion Criteria:
- Active pelvic inflammatory disease (PID) or recurrent chronic PID.
- Active genital or urinary tract infection at the time of the procedure.
- History of malignancy of the reproductive system within 5 years of the procedure or
have ever had malignancy of the endometrium.
- Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of
procedure.
- Cavity distorting submucous myoma(s) determined by preoperative hysterogram,
hysteroscopy, or transvaginal sonography within 6 months of the procedure.
- Previous endometrial ablation procedure.
- Previous uterine surgeries (such as full thickness myomectomy, subserosal myomectomy,
uterine reconstruction, or any surgery in which thinning of the uterine musculature
could occur) except for low transverse caesarean section.
- Pregnant or desirous of future pregnancy.
- Taken endometrial suppression medication, except for oral contraceptives, within 3
months of the procedure.
- Concurrent open or laparoscopic surgery.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
| Uterine Balloon Treatment for Heavy Period Bleeding. | NCT00215618 | Contradiction |
4,168 | 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;
provides answers to 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 clinic visit
- 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 (see the study protocol for more information about low
risk guidelines).
Laboratory Inclusion Values:
Hemogram/Complete Blood Count (CBC):
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female
sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male
sex at birth. For transgender participants who have been on hormone therapy for more
than 6 consecutive months, determine hemoglobin eligibility based on the gender with
which they identify (ie, a transgender female who has been on hormone therapy for more
than 6 consecutive months should be assessed for eligibility using the hemoglobin
parameters for persons assigned female sex at birth).
- 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 ALP 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 assigned female sex at birth: negative serum or urine beta human
chorionic gonadotropin 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: Africa - A volunteer who was assigned female sex at birth must:
- Agree to consistently use effective contraception (see the study 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 Africa is defined as using 2 methods
of birth control. These include 1 of the following methods:
- Condoms (male or female), or
- Diaphragm or cervical cap, PLUS 1 of the following methods:
- Intrauterine device (IUD),
- Hormonal contraception (in accordance with applicable national contraception
guidelines),
- Successful vasectomy in any partner assigned male at birth (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 after vasectomy); or
- Any other contraceptive method approved by the HVTN 120 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.
- Reproductive status: United States - A volunteer who was assigned female sex at birth
must:
- Agree to consistently use effective contraception (see the study 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 of birth control:
- Condoms (male or female) with or without spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- Successful vasectomy in any partner assigned male at birth (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 after vasectomy); or
- Any other contraceptive method approved by the HVTN 120 PSRT
- Or must 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 must be sexually abstinent.
- Volunteers who were assigned female sex at birth 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 assigned female sex at birth consenting
to provide cervical samples:
- Pap smear within:
- the 3 years prior to enrollment with the latest result reported as normal or
ASCUS (atypical squamous cells of undetermined significance), OR
- the 5 years prior to enrollment, with the latest result reported as normal,
or ASCUS with no evidence of high risk HPV.
- If no pap smear was done within the last 3 years prior to enrollment (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 120 study
- Pregnant or breastfeeding
- Active duty and reserve U.S. 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 120 PSRT will determine eligibility
on a case-by-case basis.
- Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational;
the HVTN 120 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 120 PSRT will determine eligibility on a case-by-case basis. For volunteers who
have received an experimental vaccine(s) more than 5 years ago, eligibility for
enrollment will be determined by the HVTN 120 PSRT on a case-by-case basis.
- Live attenuated vaccines received within 30 days before first study vaccination or
scheduled within 14 days after first study vaccination (eg, measles, mumps, and
rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated
influenza vaccine)
- Any vaccines that are not live attenuated vaccines and were received within 14 days
prior to first study vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
- Allergy treatment with antigen injections within 30 days before first study
vaccination or that are scheduled within 14 days after first study vaccination
Immune System:
- Immunosuppressive medications received within 168 days before first study 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 prednisone or equivalent at doses less than or equal to 60 mg/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 such as eggs, egg
products, or neomycin, 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 study vaccination (for mAb see
criterion above)
- Autoimmune disease
- Immunodeficiency
Clinically Significant Medical Conditions:
- 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. (Not excluded: type 2 cases controlled with diet
alone or a 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 ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants | NCT03122223 | Contradiction |
5,713 | 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:
- short stature children aged 2 years or more
- children with GHD,TS, CRF, SGA or ISS
- written informed consent from the person, person's parent or legal guardian
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
| Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children | NCT01604395 | Entailment |
1,407 | 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
1. Sex: Male and Female; similar proportion of each preferred.
2. Age: At least 18 years.
3. Weight: BMI (Body Mass Index) less than or equal to 30.
4. Qualifying subjects must be in good health and physical condition as determined by
medical history, complete physical examination, and laboratory tests, all obtained
within four (4) weeks prior to study start. The subjects may not have a history of
significant past illness expected to affect the investigation. The normal status of
subjects will be confirmed by the following procedures:
- Laboratory Tests: Hemoglobin, hematocrit, RBC, WBC, differential count, serum
electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin,m creatinine,
AST, ALT, LD, alkaline phosphatase and urinalysis. HIV, Hepatitis B, Hepatitis C,
breath alcohol test, and drugs of abuse testing will be done for screening
purposes only. Urine drugs of abuse testing and breath alcohol testing will be
repeated at each check-in. Female subjects will have a serum pregnancy test done
at screening and a urine pregnancy test prior to each study period at check-in.
Laboratory values which are greater than ±20% of the normal range will not qualify
unless specifically accepted (with comment) by the Principal Investigator. Results of
HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for
the subject to qualify for the study.
- Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all
subjects. The original tracings, plus interpretation, will be included in the
case report form packet.
5. Subjects must read and sign the Consent Form.
Exclusion Criteria
1. Subjects not complying with the above inclusion criteria must be excluded from the
study.
2. In addition, any one of the conditions listed below will exclude a subject from the
study:
- History of treatment for alcoholism, substance abuse, or drug abuse within past
24 months.
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or
other serious illness.
- History of GERD (gastroesophageal reflux disease), stricture of the esophagus,
achalasia, malabsorption syndrome, colon cancer, or chronic colitis, including
Crohn's disease.
- History of upper gastrointestinal disorder such as dysphagia, esophagitis,
gastritis, ulcers.
- History of treatment for asthma within the past five (5) years.
- History of marked treatable anxiety, tension, agitation.
- History of glaucoma
- History of motor tics
- Family history or diagnosis of tourettes syndrome
- History of treatment with monoamine oxidase inhibitors
- History of seizures
- Inability to sit upright for a period of at least 30 minutes
- Females who are pregnant or lactating
- History of hypersensitivity to dexmethylphenidate hydrochloride, methylphenidate
or any central nervous system stimulant
3. Conditions upon screening which might contraindicate or require that caution be used
in the administration of dexmethylphenidate hydrochloride, including:
- Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm
Hg.
- Heart rate less than 50 beats per minute after a 5-minute rest in a seated
position.
4. Inability to read and/or sign the consent form.
5. Treatment with any other investigational drug during the four (4) weeks prior to the
initial dosing for this study.
6. Subjects who have donated blood within four (4) weeks prior to the initial dosing for
this study.
7. Subjects who smoke or use tobacco products or are currently using nicotine products
(patches, gums, etc.). Three (3) months abstinence is required.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions | NCT00829673 | Contradiction |
8 | 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:
- Healthy males between 18 and 50 years of age.
- Ambulatory, physically active, but not in competitive sports.
- Eugonadal: Normal Serum Testosterone (300-1100 nmol/L).
- Normal LH
- Normal FSH
- Able and willing to comply with the trial protocol.
Exclusion Criteria:
- Known to have a primary or secondary hypogonadism? (e.g. pituitary disease, HIV
infection, Klinefelter's Syndrome)
- BMI > 35
- Disability that precludes participation in exercise testing
- Alcohol or illicit drug use in the preceding 6 months that would interfere with
participation and compliance with the protocol
- Known disorder that would be exacerbated by androgen treatment e.g. benign prostate
hyperplasia, prostate Ca, erythrocytosis, sleep apnea)
- Any abnormalities in the following laboratory tests PSA > 4 ng/ml AST, ALT or Alkaline
Phosphatase > 3x ULN? Creatinine level > 2 mg/dL Hematocrit > 51%
- Osteoporosis by DEXA BMD T-Score < -2.5
- Use of medications that affect muscle or bone metabolism within the previous 3 months
?(e.g. glucocorticoids, growth hormone, androgenic steroids, oral androgen precursors
-i.e. androstenedione or DHEA)
- Use of medications that affect androgen metabolism, action or clearance within the
previous 3 months? (e.g. dilantin, phenobarbital, aldactone, flutamide, finasteride
and Ketoconazole)
- Use of ketoconazole or other potent CYP3A4 inhibitors that may affect clearance of
dutasteride
- Use investigational medication as part of a research study in the last 3 months?
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | The Role of 5-alpha Reductase in Mediating Testosterone Actions | NCT00493987 | Contradiction |
6,770 | 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
- Severe Hemophilia A (FVIII:C <1%)
- No previous treatment with FVIII concentrates or other blood products containing FVIII
Exclusion Criteria:
- Diagnosis with a coagulation disorder other than Hemophilia A
- Severe liver or kidney disease
- Concomitant treatment with any systemic immunosuppressive drug
Male
No healthy subjects accepted to join the trial.
| Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients | NCT01712438 | Entailment |
6,348 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Confirmed diagnosis of COVID-19 disease.
Exclusion Criteria:
- The patients were excluded patients <18 years age and without confirmed diagnosis of
disease.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Role of Lymphocyte Subsets and Laboratory Measurements in COVID-19 Disease | NCT04779359 | Entailment |
4,245 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Non-smoking, male or female, age ≥18 years and ≤55 years old at the time of informed
consent (note: to be considered non-smokers, participants must have discontinued
smoking for at least 4 weeks before dosing)
- Body mass index (BMI) ≥18 and <32 kilograms per meters squared (kg/m^2) at Screening
Exclusion Criteria:
- Clinically significant illness that requires medical treatment within 8 weeks or a
clinically significant infection that requires medical treatment within 4 weeks of
dosing
- Females who are breastfeeding or pregnant at Screening or Baseline (documented by a
negative beta human chorionic gonadotropin [β-hCG] (or human chorionic gonadotropin
[hCG]) test with a minimum sensitivity of 25 International Units per Liter [IU/L] or
equivalent units of β-hCG [or hCG]). A negative urine pregnancy test is required
before the administration of the first dose per cohort.
- Females of childbearing potential who:
- Had unprotected sexual intercourse within 30 days before study entry and do not
agree to use a highly effective method of contraception (eg, total abstinence, an
intrauterine device, a double barrier method [such as condom plus diaphragm with
spermicide] or have a vasectomized partner with confirmed azoospermia but
hormonal contraceptives are not permitted) throughout the entire study period and
for 28 days after study drug discontinuation
- Are currently abstinent, and do not agree to use a double barrier method (as
described above) or refrain from sexual activity during the study period or for
28 days after study drug discontinuation
NOTE: All females will be considered to be of childbearing potential unless they are
postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age
group, and without other known or suspected cause) or have been sterilized surgically (ie,
bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery
at least 1 month before dosing).
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and
their female partners do not meet the criteria above (ie, not of childbearing
potential or practicing highly effective contraception throughout the study period or
for 28 days after study drug discontinuation). No sperm donation is allowed during the
study period or for 3 months after study drug discontinuation.
- Evidence of disease that may influence the outcome of the study within 4 weeks before
dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver,
kidney, respiratory system, endocrine system, hematological system, neurological
system, or cardiovascular system, or participants who have a congenital abnormality in
metabolism)
- Any history of seizures, including those experienced in childhood
- Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of
E2730 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening
- Any clinically abnormal symptom or organ impairment found by medical history, physical
examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results
that require medical treatment at Screening or Baseline
- A prolonged QT/QT corrected (QTc) interval (QC interval corrected using Fridericia's
formula [QTcF] >450 milliseconds) demonstrated on ECG at Screening or Baseline (based
on average of triplicate ECGs). A history of risk factors for torsade de pointes (eg,
heart failure, hypokalemia, family history of long QT Syndrome) or the use of
concomitant medications that prolonged the QT/QTc interval
- Left bundle branch block at Screening or Baseline
- Persistent systolic blood pressure (BP) >130 or <100 millimeters of mercury (mmHg) or
diastolic BP >85 or <50 mmHg at Screening or Baseline
- Persistent heart rate less than 50 beats/min or more than 100 beats/min at Screening
or Baseline
- History of myocardial infarction, ischemic heart disease, or cardiac failure at
Screening
- History of clinically significant arrhythmia or uncontrolled arrhythmia
- Known history of clinically significant drug allergy at Screening or Baseline
- Known history of food allergies or presently experiencing significant seasonal or
perennial allergy at Screening or Baseline
- Known to be human immunodeficiency virus positive at Screening
- Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or
those who have a positive drug test (including cannabinoids) or alcohol test at
Screening or Baseline
- Intake of caffeinated beverages or food within 72 hours before dosing
- Intake of nutritional supplements, juice, and herbal preparations or other foods or
beverages that may affect the various drug-metabolizing enzymes and transporters (eg,
alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or
orange juice, vegetables from the mustard green family [eg, kale, broccoli,
watercress, collard greens, kohlrabi, Brussel's sprouts, mustard], and charbroiled
meats) within 1 week before dosing
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
- Use of prescription drugs within 4 weeks before dosing
- Intake of over-the-counter (OTC) medications within 2 weeks before dosing
- Currently enrolled in another clinical study or used any investigational drug or
device within 30 days or 5 half-lives, whichever is longer, preceding informed consent
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or
donation of plasma within 1 week of dosing
- Engagement in strenuous exercise within 2 weeks before check-in (eg, marathon runners,
weight lifters)
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 55 Years | Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 | NCT03054194 | Entailment |
2,194 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Adult (age 21-75 inclusive) men and women of non child bearing potential with
established or symptomatic gout which is defined as having at least ONE of any of the
3 following factors:
1. ≥ 1 tophus
2. 1 gout flare within the last 6 months
3. Chronic gouty arthropathy
2. Screening serum uric acid of >6ng/dL
3. On a gout flare prophylactic regimen for 7 days prior to first dose
4. Willing to provide written informed consent prior to first study procedure is
performed.
5. Understands and is willing and able to comply with study requirements, including the
schedule of follow-up visits.
Exclusion Criteria:
1. History of anaphylaxis or severe allergic reaction.
2. History of an allergy to pegylated products.
3. Women of child bearing potential, Defined as:
- <6 weeks after surgical bilateral salpingooperhectony with or without
hysterectomy
- Pre or perimenopausal ( < less than 24 months of natural amenorrhea)
4. Initiation or change in dose of hormone-replacement therapy for menopausal women less
than 1 month prior to the Screening Visit or during the Screening Phase would be
exclusionary. If after being on a stable dose of hormone-replacement therapy for one
month the patient may be considered for the study if she continues to meet all other
inclusion and exclusion criteria
5. Uncontrolled diabetes with baseline HbA1c ≥8%;
6. Glucose-6-phosphate dehydrogenase deficiency;
7. Uncontrolled hypertension
8. Ongoing treatment for arrhythmia, including placement of an implantable defibrillator;
9. History of coronary artery disease, including myocardial infarction;
10. Congestive heart failure, New York Heart Association Class III or IV;
11. ECG with evidence of prior myocardial infarction, clinically significant arrhythmia,
or other abnormalities that, in the opinion of the investigator, are consistent with
significant underlying cardiac disease;
12. History of hematological or autoimmune disorders, is immunosuppressed or
immunocompromised;
13. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek,
Fasturtec), pegloticase (Krystexxa®), pegsiticase (SEL-037)
14. History of malignancy within the last 5 years other than basal skin cancer;
15. Subjects who, in the opinion of the investigator, present with a condition that would
compromise their safety or that would make study completion unlikely.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 75 Years | Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid | NCT02959918 | Contradiction |
6,535 | 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
-Adult subjects who participated in prior intrahepatic AAV2-hFIX16 gene transfer studies
Exclusion Criteria
- Subjects who will not consent for study
- Subjects who the investigators believe are not capable of performing endpoints of the
study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| LTFU for Gene Transfer Subjects With Hemophilia B | NCT00515710 | Contradiction |
748 | 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: • 40-60 years of age paients will be included in this study
- BMI (25.1±4.2) kg/m2
- Subjects with stiffness and knee pain
- Subjects with objection of pain in knee joint that was aggravated by performing 2 or
more of the following functional activities: prolonged cross sitting, stair assents
and descent, squatting and kneeling.
- Subjects who are willing to take participation
- Individuals who obeys the commands properly
- Individuals exhibiting the subsequent biomechanical changes on screening
- Q angle >12 degree for male and >15 degree for female, femoral anteversion, external
tibial torsion >15 degree, lack of ≥ 5 degree of knee extension in supine position.
Exclusion Criteria:
- • Knee meniscal injuries or ligament injuries
- Lately history of lower limb trauma and surgery
- In recent times fracture in lower extremity
- In lower extremity metal plantation
- Cardio vascular conditions
- Patella Dislocation/subluxation
- Abnormality in foot or deformity
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 60 Years | Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis | NCT04324931 | Contradiction |
4,711 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. 18 years of age or older with a history of receptive vaginal intercourse.
2. HIV negative by EIA within 28 days of enrollment.
3. Understand and agree to local STI reporting requirements.
4. Able and willing to provide written informed consent to take part in the study.
5. Able and willing to provide adequate information for locator purposes.
6. Availability to return for all study visits, barring unforeseen circumstances.
7. Availability to return for the second formulation dosing at the same time in the
subject's menstrual cycle as when the first formulation was administered, at least 10
days before menses.
8. Willing to abstain from vaginal intercourse and insertion of anything (e.g., drug,
vaginal douche, or sex toy) in vagina for 72 hours before each study product exposure,
and 7 days following each vaginal sampling procedure.
9. Willingness to have partner(s) use condoms (must not contain Nonoxynol-9) for the
duration of the study.
10. Agree not to participate in other research studies involving drugs and/or medical
devices.
11. Negative qualitative urine pregnancy test.
12. Per participant report, using an effective method of contraception at enrollment;
hormonal method (except vaginal ring) used continuously for the past 30 days;
intrauterine device (IUD [copper or hormonal] inserted at least 30 days prior to
enrollment); female sterilization; abstinent from sexual activity with male partner
for the past 30 days; or sexual activity with vasectomized partner; and willingness to
use effective method of contraception until the completion of final scheduled study
visit if enrolled.
13. Willingness to remain in the research unit for up to 24 hours on each of two dosing
days, -
Exclusion Criteria:
1. Current sexual partner known by participant to be HIV seropositive.
2. Individuals who, by history, engage in condom-less intercourse with HIV-infected
partners, or partners that have unknown HIV serostatus, or women who exchange sex for
money, shelter, or gifts.
3. Active sexually transmitted infection or documented treatment of sexually transmitted
infections including, but not limited to: chlamydia, gonorrhea, syphilis, trichomonas,
cervicitis or PID within 6 months prior to enrollment.
4. Known history of genital HSV (diagnosed by either clinical or laboratory test).
5. Symptomatic vaginal candidiasis or bacterial vaginosis.
6. Undiagnosed irregular uterine bleeding
7. Pathology of the female genital tract, which in the judgment of the investigator might
increase the risk of the study to the research participant.
8. Individuals who are status post hysterectomy.
9. History of any cervicovaginal procedure (i.e. colposcopy with cervical biopsy) within
the past 2 months. Individuals who have a history of cone biopsy or extensive loop
electrosurgical excision procedure (LEEP), which in the judgment of the investigator
may affect permeability assessment.
10. Any known primary or secondary uro-genital malformations, which in the assessment of
the investigator may interfere with the intended urine collection for PK studies.
11. Use of vaginally administered medications within 4 week of enrollment
12. Any active urinary tract infection
13. By history, subjects with irregular menstrual cycles.
14. At screening:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than
1.5 X the site laboratory ULN (upper limit of normal)
- Hemoglobin less than 10.0 g/dL
- Platelet count less than 100,000/mm3
- Other safety tests outside of the normal range that in the judgment of the
investigator may interfere with conduct of the study.
- Positive findings on urinalysis that are clinically significant in the opinion of
the investigator
15. Estimated creatinine clearance < 60 ml/min based on established nomograms
16. Recent history (past 6 months) of injection drug use or, a level of alcohol use that,
in the judgement of the Investigator of Record, may interfere with the conduct of this
study.
17. Unwillingness to refrain from aspirin and NSAIDs product use for one week prior to and
one week post study procedures.
18. Use of warfarin or heparin.
19. Use of systemic immunomodulatory medications within 4 weeks of enrollment.
20. Use of product containing nonoxynol-9 within 4 weeks of enrollment.
21. Use of any investigational products within 4 weeks of enrollment.
22. Any other medical conditions deemed not safe for participation by the investigator.
23. Any individual that is actively breast feeding.
24. Post-menopausal defined as 12 months of amenorrhea.
-
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| PK/PD of Single Dose Dapivirine Vaginal Film | NCT01924091 | Entailment |
5,276 | 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:
For inclusion in the study, subjects must fulfil the following criteria:
1. Willing and able to give written informed consent for participation in the study.
2. Healthy women in early post-menopausal phase (at least two [2] years but a maximum of
12 years since the last menstruation and at least one [1] year since the last intake
of hormone replacement therapy).
3. BMI ≥ 18 and ≤ 30 at screening.
4. BMD T-score in the lumbar spine (L1-L4) > -2.5, as measured by DXA.
5. Commitment not to use any products that may influence the study outcome in the opinion
of the Investigator.
6. Ability to understand and comply with the requirements of the study, as judged by the
Investigator.
Exclusion Criteria:
Subjects must not enter the study if any of the following exclusion criteria are fulfilled:
1. Relevant history of >1 previous fracture after 50 years of age, as judged by the
Investigator.
2. T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be
forwarded to a GP for further investigation.
3. History of metabolic bone disease.
4. Unstable weight (± five [5] kg) during the last six (6) months.
5. History of hyperthyroidism or unstable hypothyroidism.
6. Diagnosed with disease causing secondary osteoporosis within the last year, including
primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel
disease (IBD), celiac disease or diabetes.
7. Known history of rheumatoid arthritis, clinically significant kidney or heart disease,
as judged by the Investigator.
8. Gastric bypass surgery performed.
9. History of immunodeficiency or immunosuppressive treatment.
10. Chronic or acute diarrheal disease.
11. Recently diagnosed malignancy (within the last five [5] years).
12. Use of products containing probiotic bacteria (more than once per week) within four
(4) weeks prior to baseline.
13. Per-oral use of corticosteroids.
14. Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.
15. Use of any anti-resorptive therapy, including e.g. systemic hormone replacement
therapy, bisphosphonates (currently or during last 12 months)
16. Use of any bone-formation stimulating therapy (currently or during the last 12
months).
17. Use of antibiotics during the last two (2) months.
18. Frequent user of antibiotics (>2 courses during the last 12 months) due to
inter-current infection episodes.
19. Smoking or use of nicotine-containing products (currently or during the last six [6]
months).
20. History of alcohol abuse, or excessive intake of alcohol, as judged by the
Investigator.
21. Consumption of alcohol within 24 hours prior to the Baseline Visit.
22. Participation in any other clinical interventional study during the last three (3)
months.
23. History of any clinically significant disease or disorder which, in the opinion of the
Investigator, may either put the subject at risk because of participation in the
study, or influence the results or the subject's ability to participate in the study
24. Known hypersensitivity to any of the ingredients in the IP or the placebo
(maltodextrin, silicon dioxide, capsule [hypromellose, water] ± bacterial culture).
25. Blood or plasma donation within three (3) months prior to baseline.
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 70 Years | Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase | NCT02722980 | Entailment |
1,959 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | - INCLUSION CRITERIA:
- Patients must have histologically or cytologically confirmed gastric adenocarcinoma or
gastroesophageal junction (Siewert I-III) adenocarcinoma confirmed by the Laboratory
of Pathology, NCI
- Must have received systemic chemotherapy, minimum 3 months or maximum 6 months, prior
to enrollment
- Systemic therapy should consist of at least fluoropyrimidine-based and/or platinum
based chemotherapy
- Trastuzumab may be added for HER2-neu over-expressing cancers as clinically indicated
- Last dose of chemotherapy within 8 weeks of enrollment with recovery to Grade 1 from
chemotherapy-related toxicities
- Documentation of chemotherapy administration must be obtained
- Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at
staging laparoscopy.
- Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the
absence of disseminated peritoneal disease must be obtained. If cytologic analysis
reveals atypical cells of undetermined significance, a repeat lavage with
cytopathologic analysis will be performed and must demonstrate evidence of malignancy.
- Limited peritoneal involvement found at staging laparoscopy or on final pathology that
is deemed completely resectable is permitted
- Age >18 years.
- ECOG performance status <2
- Patients must have normal organ and marrow function as defined below:
hemoglobin > 8.0 g/dL
absolute neutrophil count greater than or equal to 1,000/mcL
platelets greater than or equal to100,000/mcL
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
creatinine < 1.5 mg/dl
eGFR (creatinine clearance) greater than or equal to 60 mL/min/1.73 m2.
- Physiologically able to undergo HIPEC and gastrectomy
- No history of malignancy within 2 years of enrollment except for basal cell carcinoma
of the skin, squamous cell skin cancer or carcinoma in situ of the cervix.
- Ability of subject to understand and the willingness to sign a written informed
consent document
- Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage
is permitted.
- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while she or her partner is participating in this study, she should inform
her treating physician immediately
- Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor,
Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection
of Solid Tumors .
EXCLUSION CRITERIA:
- Patients who are receiving any investigational agents
- Disseminated extra-peritoneal or solid organ metastases
- Includes carcinomatosis associated with clinically or radiographically evident ascites
(greater than 500cc)
--Excludes greater omentum and ovarian metastases
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
- Pregnant women are excluded from this study because HIPEC and gastrectomy have not
been studied in pregnant women and has the potential for teratogenic or abortifacient
effects. Because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with HIPEC and gastrectomy, breastfeeding
should be discontinued if the mother is treated on this study.
- HIV-positive patients may be considered for this study only after consultation with a
NIAID physician.
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.
| Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology | NCT03092518 | Entailment |
253 | 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:
- Infertile women who were indicated for IUI cycles
- bilateral tubal patency
- at least one follicle ≥ 18mm in diameter on the day of trigger, and
- men with more than five millions total motile sperm after preparation.
- Only the first cycles of IUI were studied
Exclusion Criteria:
- No mature follicle
- Disagree to be enrolled
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination. | NCT03825445 | Contradiction |
3,211 | 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:
- Weighs at least 40 kg (88.2 lbs)
- Meets European criteria proposed by the American-European Consensus Group for primary
Sjogren's syndrome
- Has 1 or more of the following symptoms of Sjogren's syndrome: fatigue; joint pain;
peripheral neuropathy; interstitial lung disease; leukocytoclastic vasculitis; renal
tubular acidosis; interstitial nephritis; severe parotid swelling; or other
extraglandular manifestations causing organ system dysfunction
- Agrees to use acceptable methods of contraception during the study and for 12 months
after the end of treatment
Exclusion Criteria:
- Active infection
- Chronic or persistent infection which might be worsened by immunosuppressive treatment
(e.g., HIV, hepatitis B or C, tuberculosis [TB])
- Known coronary artery disease, significant cardiac arrhythmias, or severe congestive
heart failure (New York Heart Association class III or IV)
- Current use of anticoagulants
- Prior use of rituximab
- Cyclophosphamide treatment within 24 weeks prior to screening
- Certain medications that may cause dry mouth
- Cytotoxic therapy with azathioprine, cyclosporine, methotrexate, or mycophenolate
mofetil within 4 weeks prior to screening
- Etanercept within 4 weeks prior to screening
- Adalumimab within 8 weeks prior to screening
- Infliximab within 12 weeks prior to screening
- Prednisone at greater than 10 mg/day within 2 weeks prior to screening. Patients who
have their steroid doses tapered to 10 mg/day or less within 2 weeks of screening are
not excluded.
- Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus
erythematosus, scleroderma, rheumatoid arthritis)
- History of alcohol or substance abuse
- History of immunoglobulin E (IgE)-mediated or non-IgE-mediated hypersensitivity
- Known anaphylaxis to mouse-derived proteins
- History of head and neck radiation therapy
- History of sarcoidosis (inflammation of unknown cause occurring in the lymph nodes,
lungs, liver, eyes, skin, or other tissues)
- History of graft-versus-host disease
- History of cancer. Patients who have had resected basal or major squamous cell
carcinoma, cervical dysplasia, or in situ cervical cancer Grade I within the last 5
years prior to study entry are not excluded.
- History of positive PPD without documentation of treatment for TB infection or
chemoprophylaxis for TB exposure
- Live vaccines within the 3 months prior to study entry
- Severe pulmonary disease. Patients who do not have undue fatigue or dyspnea following
ordinary physical activity are not excluded.
- Psychiatric disorder precluding informed consent
- Inability or unwillingness to follow study requirements
- Any current condition or treatment that, in the opinion of the investigator, may
interfere with the study
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Anti-CD20 Antibody Therapy for Sjogren's Syndrome | NCT00101829 | Entailment |
6,872 | 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. | Exclusion criteria for AD will be:
- frontotemporal dementia;
- behavioural variant of frontotemporal dementia;
- vascular dementia;
- extra-pyramidal syndromes;
- reversible dementias (including pseudodementia of depression);
- Lewy body dementia.
The exclusion criteria for aMCI will be:
- mild AD, as diagnosed by standard protocols including National Institute on
Aging-Alzheimer's Association workgroups (McKhann et al. 2011);
- evidence (including magnetic resonance imaging -MRI procedures) of concomitant
dementia such as frontotemporal, vascular and reversible dementias (including
pseudo-depressive dementia), marked fluctuations in cognitive performance compatible
with Lewy body dementia and/or features of mixed dementias;
- evidence of concomitant extrapyramidal symptoms;
- clinical and indirect evidence of depression as revealed by the Geriatric Depression
Scale GDS (Yesavage et al. 1982); scores lower than 14 (no depression);
- other psychiatric diseases, epilepsy, drug addiction, alcohol dependence, use of
neuro/psychoactive drugs including acetylcholinesterase inhibitors;
- current or previous uncontrolled or complicated systemic diseases (including diabetes
mellitus) or traumatic brain injuries.
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.
| Sustainable Method for Alzheimer's Prediction | NCT03654911 | Contradiction |
4,140 | 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. Patients who have provided written informed consent for participation in this study
2. Male and female patients aged at least 40 years at the time of enrolment who are given
diagnosis of COPD by a physician*1
3. Patients whose respiratory function test values after bronchodilators (FEV1, FVC, IC)
are available*2
4. Patients whose DLCO values and data on the presence/absence of emphysema by a chest CT
scan are available*3
5. Outpatients who are able to answer the questionnaires and start measurement with an
activity meter within four weeks after informed consent and measure activities for 14
consecutive days
- 1: Guideline 12) should be referenced for the diagnostic criteria of COPD.
- 2: Patients whose respiratory function test values after bronchodilators at the
time of enrolment or within three months prior to enrolment are available. For
patients on a bronchodilator as a long-term controller, respiratory function test
values after bronchodilator in the morning of the test are acceptable.
- 3: This refers to patients who have undergone tests within past one year.
Exclusion Criteria:
1. Patients who have participated in any other interventional studies such as clinical
trials within the past eight weeks
2. Patients determined to be inappropriate to be enrolled in this study by investigators
because they cannot comply with the procedures, limitations, and requirements of this
study, or for other reasons.
3. Patients with an exacerbation of COPDa within the past eight weeks a Exacerbation of
COPD: Conditions with increased shortness of breath, increased cough and sputum,
occurrence of chest discomfort/uneasiness or its intensification, and which require
changes in treatment on disease stable state, excluding cases where there is any other
precedent disease (heart failure, pneumothorax, pulmonary thromboembolism, etc.).
4. Patients who require home oxygen therapy (excluding those who use it only during
nighttime)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The Study for Evaluating Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients With COPD. | NCT03642613 | Contradiction |
501 | 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. Between 18-40 years of age at the time of study initiation; 1.1 Enrollment will be
targeted for 225 subjects aged 18-35 (for safety and effectiveness analyses) and an
additional 25 subjects aged 36-40 (for safety only) (note: all subjects will be
included in the analysis for device placement and tolerability);
2. Pre-menopausal, as determined by regular menstrual cycle (28 ± 7 days) for the last 3
months; 2.1 Based on patient history, when not on hormonal contraceptives;
3. Sexually active with a male partner who has not had a vasectomy;
4. Reasonably expected to have to coitus at least once monthly during the study period.
5. In a mutually monogamous relationship of at least 3-6 months duration;
6. Seeking to avoid pregnancy for the next 12 months;
7. Willing to use the study device as the sole form of contraception;
8. Willing to accept a risk of pregnancy;
9. Normal PAP or ASC-US with negative high risk HPV test result within the appropriate
screen timeframe, and prior to LevoCept insertion;
10. Able and willing to comply with all study tests, procedures, assessment tools and
follow-up; and
11. Able and willing to provide and document informed consent and Authorization for
Release of Protected Health Information (PHI).
Exclusion Criteria:
1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse
earlier in current cycle
2. Subject who anticipates separation from her partner for more than 1 cycle within the
next 12 months;
3. A previously inserted IUD that has not been removed by the time LevoCept is placed;
4. History of previous IUD complications, such as perforation, expulsion, infection
(pelvic inflammatory disease) or pregnancy with IUD in place.;
5. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;
5.1 Must have had 2 normal menstrual cycles since the last injection;
6. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
during the 12 months of study participation;
7. Postpartum, prior to a minimum of 6 weeks and complete uterine involution;
8. Exclusively breastfeeding before return of menses; Lactating women will be excluded
unless they have had have had two normal menstrual periods prior to enrollment.
8.1 Must have had 2 normal spontaneous menstrual cycles since delivery
9. Unexplained abnormal uterine bleeding (suspicious for serious condition), before
evaluation; Immediately post-septic abortion or puerperal sepsis;
10. Severely heavy or painful menstrual bleeding;
11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically
significant abnormal pap smear requiring evaluation or treatment.
12. Any history of gestational trophoblastic disease with or without detectable elevated
ß-hCG levels, or related malignant disease without an intervening normal pregnancy;
13. Any congenital or acquired uterine anomaly that may complicate IUD placement, such as:
13.1 Submucosal uterine leiomyoma 13.2 Asherman's syndrome 13.3 Pedunculated polyps
13.4 Bicornuate uterus 13.5 Didelphus or uterine septa
14. Any distortions of the uterine cavity (e.g. fibroids), in the opinion of the
investigator, likely to cause issues during insertion, retention or removal of the
IUD;
15. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior
trachelectomy or extensive conization that, in the opinion of the investigator would
prevent cervical dilation and study device placement;
16. Current or recent (within the last 3 months) untreated acute cervicitis or vaginitis;
17. Known or suspected breast cancer or other progestin-sensitive cancer now or in the
past;
18. Known acute liver disease or liver tumor;
19. Subjects who have an established immunodeficiency;
20. High risk for STDs (e.g., multiple sexual partners);
21. Known or suspected HIV infection or clinical AIDS;
22. Known intolerance or allergy to any component of the LevoCept system; including
nickel, silicone or tantalum;
23. Subject had LevoCept placed previously or had 2 attempts at placement;
24. Known or suspected alcohol or drug abuse within 12 months prior to the screening
visit;
25. Any general health or behavioral condition that, in the opinion of the Investigator,
could represent an increased risk for the subject or would render the subject less
likely to provide the needed study information.
26. Subject is currently participating or has participated in another clinical study
involving another investigational agent within 30 days of the planned LevoCept
insertion date or is planning participation in another clinical trial with an
investigational agent within 52 weeks (visit 6) after insertion.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Evaluation of the Efficacy and Safety of LevoCept | NCT02882191 | Contradiction |
518 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Patients with unexplained infertility
- Age between 18 - 37 years
- Period of infertility > 1 year
- Patent Fallopian tubes detected by hysterosalpingography and/or laparoscopy
- Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and
prolactin concentrations
- Normal recent semen analysis (according to World Health Organization criteria)
Exclusion Criteria:
- FSH> 10 IU/L
- Irregular menstrual cycles
- Polycystic ovary syndrome
- Endometriosis
- Endocrinologic disorders
- Systemic disease contraindicating pregnancy
- Previous IUI cycles
- liver or kidney diseases
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 37 Years | Extended Letrozole Regimen Versus Clomiphene Citrate for Superovulation in Patients With Unexplained Infertility Undergoing Intrauterine Insemination | NCT01232075 | Contradiction |
4,433 | 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:
- Subjects with clinical diagnosis of tennis elbow within the last 3 months
- Subjects both male and female, aged 18-60 years (both inclusive)
- Subjects who are willing to give informed consent and adhere to the study protocol
Exclusion Criteria:
- Subjects aged less than 18 and more than 60 years
- Subjects with autoimmune diseases
- Subjects with immuno-compromised system
- Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
- Subjects taking concomitant therapy that might interfere with the study results in
investigators opinion or who had concomitant other injury of the tennis elbow tendons.
- Subjects who have received treatment with corticosteroid injections within the last 6
months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow) | NCT01668862 | Contradiction |
6,671 | 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:
PTPs:
- Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII
activity levels < 1%) and who participated in a previous CSL-sponsored clinical study
with rVIII-SingleChain.
- Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A
(FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who
are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.
PUPs:
- Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A
(FVIII activity levels < 1%)
- No prior exposure to any Factor VIII product (with the exception of short-term use of
blood products).
ITI substudy:
- PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.
Exclusion Criteria:
- Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of
rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
- Currently receiving a therapy not permitted during the study.
- Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate
aminotransferase > 5 x upper limit of normal at Screening (if specified)
- Any first-order family (eg, siblings) history of FVIII inhibitors
- For PTPs not rolling over directly from a CSL-sponsored clinical study with
rVIII-SingleChain: any history of or current FVIII inhibitors
Male
No healthy subjects accepted to join the trial.
| An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A | NCT02172950 | Contradiction |
900 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one)
is allowed if already used at screening but should be avoided during the study up to
the 6-month follow-up visit)
- Diagnosed with primary knee OA, fulfilling the following American College of
Rheumatology (ACR) criteria at the target knee:
- Pain present for most days of the preceding month
- Morning stiffness < 30 minutes
- Kellgren-Lawrence grade II or III (confirmed by appropriate X-rays taken within 6
months prior to screening visit)
- Target knee pain ≥ 200 mm and ≤ 400 mm out of 500 mm on the WOMAC® VA3.1 pain
questionnaire (sum of 5 questions) at screening and baseline
- Insufficient/failed response or intolerance to analgesics and/or non-steroidal
anti-inflammatory drugs (NSAIDs) as reported by the subject
- Willing and able to abstain from initiation of physical therapy and of use of knee
braces at the target knee up to the 6-month follow-up visit (a subject undergoing
physical therapy or using knee braces at a stable frequency for at least 2 weeks prior
to screening is allowed to continue at same frequency (frequency increase is not
allowed))
- Capable to understand and comply with study requirements and to provide a written,
dated, and signed informed consent prior to any study procedure for participation in
the study and transmission of personal "pseudo-anonymized" data
Exclusion Criteria:
1. History of trauma or surgery or arthroscopy at the target knee within 12 months before
inclusion
2. Concomitant inflammatory disease or other conditions affecting the joints (e.g.,
infectious arthritis, rheumatoid arthritis, psoriatic arthritis or
spondyloarthropathy, Paget's disease, hemochromatosis…)
3. Any target knee abnormality that could impact safety or efficacy assessment
4. Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate
disease (pseudo-gout) or gout if believed likely to interfere with the study
endpoints, in the opinion of the Investigator
5. Clinically significant valgus/varus deformities at the Investigator's discretion
6. Any musculoskeletal condition (such as symptomatic hip OA, amputation, neurologic
disorder, chronic back pain with or without radiculopathy, sciatica) that would impede
measurement of efficacy at target knee
7. Contralateral knee pain equal to or exceeding the pain in the target knee (on the
WOMAC® VA3.1 pain questionnaire) at screening and/or baseline
8. Knee arthroplasty planned within 12 months after the screening visit Current or
previous diagnoses, signs and/or symptoms
9. Uncontrolled diabetes mellitus (hemoglobin A1c [HbA1c] > 10% or > 86 mmol/mol),
end-stage hepatic or renal disease (severe and clinically significant abnormalities
according to local laboratory ranges) documented in the subject's file
10. Any relevant cardiovascular disease (severe coronary insufficiency, conduction
disturbances, recent myocardial infarction, cerebrovascular disease) or any clinically
significant electrocardiogram (ECG) abnormality as judged by the Investigator
11. Subject with neuropathic pain or chronic pain syndrome including fibromyalgia
12. Current (or within the last 5 years prior to entering the study) history of solid or
hematological neoplasia or bone marrow transplantation (except for basal cell
carcinoma and completely excised squamous cell carcinoma)
13. Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or
laboratory abnormalities, as judged by the Investigator
14. Current or past history of coagulation disorders (according to local laboratory
ranges), as judged by the Investigator
15. Hypersensitivity to any components of hyaluronic acid (HA)-based injection products
16. Hypersensitivity to human biological material including blood and blood-derived
products, potential excipients and residues from manufacturing process, documented
clinically or by laboratory tests
17. Hypersensitivity to avian proteins Current or previous treatment
18. Participation in another clinical trial within 3 months prior to screening (within 1
year prior to screening if disease-modifying OA drug (DMOAD) received and if the
Investigator considers it could impact the safety or efficacy assessment)
19. Subject previously treated with JTA-004 within 2 years prior to screening
20. Subject treated with intra-articular viscosupplement or blood-derived product (e.g.,
platelet-rich plasma) injection in the target knee within 6 months prior to screening
21. Subject treated with intra-articular glucocorticoid injection in the target knee
within 4 months prior to screening
22. Subject having started the use of slow acting drugs for OA such as glucosamine,
glucosamine sulfate, chondroitin sulfate, diacerein, curcumin, soybean/avocado
extracts or related products within 1 month prior to screening
23. Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy
24. Chronic (≥ 3 days/week within the last 3 months) use of opioids other than weak
opioids (such as codeine, dihydrocodeine, tramadol…)
25. Chronic (> 15 consecutive days) use of systemic steroids Safety aspects concerning
female subjects of childbearing potential
26. Breast-feeding
27. Pregnancy
28. Woman with positive pregnancy test
29. Woman not willing or not able to use a highly effective contraceptive method during
the 6-month active follow-up period. Highly effective birth control methods are:
1. Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal, transdermal)
2. Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, implantable)
3. Intrauterine device
4. Intrauterine hormone-releasing system
5. Bilateral tubal occlusion Other exclusion criteria
30. Body Mass Index (BMI) of 40 kg/m2 or greater at baseline
31. Signs of an active drug or alcohol dependence, serious current illness, mental illness
or any other factors which may interfere with subject's ability to understand and
comply with study requirements, as judged by the Investigator
32. Life expectancy less than 12 months at screenin
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.
| Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis | NCT04333160 | Entailment |
1,709 | 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. | 1. Men and women, aged 18 to 50 years. Women of non-childbearing potential may be
included.
2. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or
greater than 50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, and 12 lead
electrocardiogram (graphic trace of the pattern of your heart beat).
4. Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined
by history. Must abstain from smoking during inpatient stay.
5. Have a high probability for compliance with and completion of 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 | Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate | NCT00369304 | Entailment |
3,072 | 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:
- Subject has previously been identified through molecular testing at Esoterix Genetic
Laboratories as a Fragile X intermediate, premutation (carrier) or full mutation
(affected).
- In the opinion of the subject's physician, the subject is medically stable and able to
provide the required quantity of saliva.
- If Subject is at least 18 years of age:
- Subject must be willing to give written informed consent
- Subject must be willing to comply with the collection procedure
- If Subject is under 18 years of age, the legally authorized representative must give
written informed consent and agree to comply with study procedures.
Exclusion Criteria:
- Subject has been determined to be an individual with a normal FMR1 gene.
- Subject has a known medical condition that would cause risk to the donor or, if
relevant, the fetus as a result of saliva collection.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Validation of Saliva in the Esoterix Genetic Laboratories Fragile X Assay | NCT01616589 | Entailment |
Subsets and Splits