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5,269 | 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:
- Adult patients, >/= 55 years of age
- Postmenopausal osteoporosis
- Patients who are in the opinion of the physician eligible to participate in this study
Exclusion Criteria:
- N/A
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis | NCT01128257 | Entailment |
4,977 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria
- Patient gives an informed consent.
- Patient is over 21 years of age.
- Having a diagnosis of a essential tremor confirmed by a trained movement disorders
neurologist;
- Having failed or not tolerated conventional medical management, at the discretion of
the neurologist managing the patient;
Exclusion Criteria
- Having alternative diagnoses to essential tremor;
- Having comorbid neurodegenerative disorders that may affect mobility or cognition
(e.g. comorbid Parkinson's disease or dystonia);
- Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
- History of prior resective brain surgery (e.g. tumor resection);
- Not being a DBS candidate;
- Receiving unilateral implants
- Having a higher surgical risk that precludes patient from having standard
intraoperative mapping.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 85 Years | Deep Brain Stimulation Effects in Essential Tremor | NCT04581941 | Entailment |
5,119 | 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 fragile bone fracture
- Patients in whom either of study site analysis value of bone density of lumbar spine,
proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
- Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
- Ambulatory
Exclusion Criteria:
- Patients with disease lowering bone volume secondarily (secondary osteoporosis)
- Patients receiving at least one time of of oral bisphosphonate preparations within 6
months before the start of administration of the study drug
- Patient with disorder delaying the passage of food through esophagus
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis | NCT00447915 | Contradiction |
93 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Men
- 18 Years of Age and Older
- Serum total testosterone level <300 ng/dl or free testosterone < 50 pg/ml
- Consumption of at least 10 mg of hydrocodone (or analgesic equivalent of another
opioid) for at least 4 weeks
- Absence of hospitalization in past 2 months
- No acute illness in past 2 months
- No prior history of any form of hypogonadism
- No current anabolic therapy (growth hormone, DHEA, etc)
- No current use or consumption in past 2 months of glucocorticoids and melatonin
- Normal digital rectal examination
- Normal PSA level
Exclusion Criteria:
- Liver enzymes >3 times upper limit of normal
- Serum creatinine > 2 times upper limit of normal
- Neurological disease
- Active psychiatric illness
- Any addictive and/or illicit drug use
- Alcoholism (>10 drinks/week)
- Patients currently receiving glucocorticoids, melatonin or anabolic agents
- Hospitalization in past 2 months
- Acute illness in past 2 months
- Consumption of < 20 mg of hydrocodone (or analgesic equivalent of another opioid)
- Severe BPH
- PSA >4.0 ng/ml
- Prostate cancer
- Breast cancer
- Any cancer or cancer related pain
- History of alcohol abuse
- Known peripheral neuropathy (any etiology) or peripheral vascular disease (including
Raynaud's disease), which may interfere with pain testing
- Concurrent warfarin treatment
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Testosterone and Pain Sensitivity | NCT01689896 | Contradiction |
6,912 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
MCI group :
- ≥ 70 years
- MCI diagnosis : New criteria (Petersen, PORTET*)
1. cognitive complaint from the patient, family, or both,
2. report by the subject or reporter of a decline in cognitive or functional
performance, relative to previous abilities,
3. cognitive disorders evidenced by clinical evaluation: impairment in memory or
another cognitive domain,
4. cognitive impairment without any repercussion on daily life, even if the subject
reports difficulties concerning complex daily activities,
5. no dementia
- Having signed an informed consent form
- Fluent in French
AD group :
- ≥ 45 years
- AD diagnosis (DSM IV-TR et NINCDS-ADRDA)
- Mild to moderate (MMSE > 15)
- Having signed an informed consent form
- Caregiver/informant to provide information on patient
Exclusion Criteria:
- Normal cognitive function
- Major depression (according to the DSMIV-TR or MINI or Geriatric depression Scale>
20/30)
- Genetic form of AD (genetic mutation known)
- All other diseases that could interfere with cognitive assessment (Epilepsy,
Parkinson's disease, schizophrenia, other dementia)
- Major sensory deficits that could interfere with cognitive assessment (visual and
auditory)
- Diseases involving the short-term survival (advanced cancer, unstable heart disease,
severe hepatic/respiratory/renal failure)
- Contraindication for MRI, for lumbar puncture (i.e. anticoagulant agents)
- Use of any experimental agent for the duration of the study
- Participation to other biomedical research that could interfere with principal
objective of the study
- For MCI patient, use of IchE or memantine medication before inclusion
- Less than 4 years of education
- Illiteracy, is unable to count or to read
- Pregnant women
- Non health insurance affiliation
- Private subjects of freedom by legal or administrative decision
- Contraindication for MRI examination:
- Claustrophobic subject
- Carrying a cardiac pacemaker
- Presence of any ferromagnetic metallic implants or foreign bodies (carrying an
internal electrical/magnetic device, carrying a valvular prosthesis)
- Carrying a ventricular valvular
Exclusion criteria specific to the lumbar puncture:
• Taking anticoagulant agents
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.
| New Biomarker for Alzheimer's Disease Diagnostic | NCT01315639 | Entailment |
4,326 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
1. Male subjects in the range of age from 18 to 55 years.
2. Body weight within ± 15% of ideal weight as related to height and body frame according
to Life Insurance Corporation (LIC) Chart. (Appendix A)
3. Subjects with normal findings as determined by baseline history, physical examination
and vital signs (blood pressure, pulse rate, respiration rate and axillary
temperature).
4. Subjects with normal findings as determined by Haemogram with ESR,
Biochemistry,Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and
Urinalysis, ECG, X-ray (X-ray if taken).
5. Willingness to follow the protocol requirement as evidenced by written, informed
consent.
6. Agreeing to, not using any medication prescription and over the counter medications
including vitamins and minerals for 14 days prior to study & during the course of the
study.
7. No history or presence of significant alcoholism or drug abuse in the past one year.
8. Non-smokers, ex smokers and moderate smokers will be included. "Moderate smokers are
defined as someone smoking 10 cigarettes or less per day, ex smokers are someone who
completely stopped smoking for at least 3 months."
Exclusion Criteria:
1. Requiring medication for any ailment including enzyme-modifying drugs in the previous
28 days, before day 1 of dosing.
2. Any medical or surgical conditions, which might significantly interfere with the
functioning of gastrointestinal tract, blood-forming organs etc.
3. History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary,
neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or
psychiatric diseases.
4. Participation in a clinical drug study or bioequivalence study 90 days prior to
present study.
5. History or presence of malignancy or other serious diseases.
6. Refusal to abstain from food for at least ten (10) hours prior to administration of
the study drug and for four (4) additional hours each, post dose during each study
period.
7. Any contraindication to blood sampling.
8. Refusal to abstain from water for at least one (1) hour prior to study drug
administration on dosing day of each study period and for at least two (2) additional
hours, post dosing except 240 mL administered during administration of the dose.
9. Use of xanthine-containing beverages or food and grapefruit or grapefruit products for
48 hours prior to each drug dose.
10. Blood donation 90 days prior to the commencement of the study.
11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
12. Subjects having contradiction or hypersensitivity to Tacrolimus or related group of
drugs or any excipients of the products.
13. Refusal to abstain from smoking or consumption of tobacco products 24 hours before
dosing until last sample collection of each period.
14. Found positive in Breath alcohol test done at the time of screening or on the day of
enrollment for each study period or for every ambulatory sample.
15. History or presence of problem in swallowing tablets or capsules.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition | NCT01080534 | Contradiction |
5,241 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
Patient
1. Age ≥ 50 and ≤ 85, male and female patients
2. Subject is able to understand the risks and benefits of participating in the study and
is willing to provide written informed consent.
3. Psychosocially, mentally and physically able to fully comply with the protocol
requirements for the duration of the study including adhering to scheduled visits,
treatment plan, completing forms and other study procedures.
Fracture
4. Fractures between the 10th thoracic and 4th lumbar vertebra, both included
5. Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment
of the screening qCT scan).
6. Fractures with the indication and possibility for augmented bi-segmental dorsal
pedicle screw and rod stabilization including kyphoplasty in the broken vertebra
7. All fractures where pedicle screws can be used
Exclusion Criteria:
Patient
1. Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse
disorders within the last 2 years before randomization.
2. BMI > 35
3. Permanent or progressive neurologic deficits (incl. upper motor neuron disease and
myelopathy)
4. Known Creutzfeldt Jacob Disease
5. Systemic infections:
- Known infection with human immunodeficiency virus (HIV) or, hepatitis B or C
requiring treatment
- Any active infection requiring the use of parenteral anti-microbial agents or
that is > grade 2 Common Terminology Criteria for Adverse Events (CTCAE) Version
4.03
6. Rheumatoid arthritis or known disorders of bone metabolism (excl.
osteopenia/osteoporosis, Vitamin D deficiency)
7. Radiation therapy of the spine in medical history
8. Contraindications to pedicle screw and rod stabilization
9. Breast feeding, pregnancy or child-bearing potential (female patients of childbearing
potential and male patients with a partner of child bearing potential must agree to
use a highly effective contraceptive method).
10. A compromised immune system or a therapy with systemic corticosteroids or
immunosuppressants
11. Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor)
<2 years ago from time of randomization
12. Known allergy to any component of the investigational device
13. History of severe allergy, anaphylactic reactions and hypersensitivity reactions
experienced in previous surgical interventions.
14. Other concurrent severe and/or uncontrolled medical conditions (e.g. insufficiently
treated diabetes (HbA1c > 8 %), active or uncontrolled infection) that could cause
unacceptable safety risks or compromise compliance with the protocol
15. Participation in other clinical investigations for drugs or devices
Fracture
16. Fracture age > 3 months
17. Major surgery to the spine planned for at least 12 months following enrolment
18. Any treatment of the fracture other than that specified in the inclusion criteria
(e.g. index screws in the fractured vertebra, vertebroplasty, additional ventral
stabilization)
19. Severe spinal deformations or fusion at the target vertebral or adjacent segments
20. Previous operations at the spine in the target or adjacent vertebrae
21. Infections or inflammatory processes at vertebral bodies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures | NCT04495439 | Entailment |
125 | 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:
- T2D arm: Males with age 30-65 years
- Obese non-diabetic arm: Obese non-diabetic males with age 30-65 years
Exclusion Criteria:
1)Coronary event or procedure(myocardial infarction, unstable angina, coronary artery
bypass, surgery or coronary angioplasty) in the previous twelve weeks; 2) PSA > 4ng/ml;
3)Hemoglobin A1c > 8%; 4)h/o prostate carcinoma; 5)Hepatic disease (transaminase > 3 times
normal) or cirrhosis; 6)Renal impairment (defined as GFR<30); 7)HIV or Hepatitis C positive
status; 9)Participation in any other concurrent clinical trial; 10)Any other
life-threatening, non-cardiac disease; 11)Use of over the counter health supplements which
contain androgens; 12)Use of an investigational agent or therapeutic regimen within 30 days
of study; 13)prostate nodule or severe enlargement on digital rectal examination; 14)Use of
testosterone currently or in the past 4 months; 15)Hematocrit > 50%; 16)History of
untreated severe obstructive sleep apnea(defined as apnea-hypopnea index ≥30); 17)symptoms
suggestive of severe BPH; 18)Congestive heart failure, class III or IV; 20)Known to have
anemia secondary to iron, B12 or folic acid deficiency; 21)bone marrow disorder such as
myelodysplasia or aplastic anemia; 22) currently suffering from symptomatic depression,
with or without treatment; 23) history of severe depression in the past which needed
hospitalization; 24)currently suffering from foot ulcer, significant periodontal disease or
any other chronic infectious condition; 25)planning to have children. 26) Subjects on
testosterone or with testosterone replacement in the past 4 months will be excluded.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 65 Years | Testosterone Replacement in Men With Diabetes and Obesity | NCT01127659 | Contradiction |
6,360 | 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. Participant aged 16 years or over AND
2. Participant triaged to Majors (High Dependency or Immediate Care) OR Participants who
are stepped down from Resuscitation room care to High Dependency or Immediate Care
Exclusion Criteria:
1. Participants under 16 years of age
2. Previous participation in the study
3. Participant in custody
4. Participants deemed high risk for absconding by clinical staff
5. Participants unable to communicate in English
6. Participants who are triaged to immediate resuscitation. These participants may be
considered for inclusion once immediate assessment and treatment have been initiated
and they are stepped down to High Dependency (HD)/Immediate Care (IC) areas
7. Patients with implantable defibrillators, pacemakers or neurostimulators will be
excluded
8. Patients who cannot have blood pressure measured in both arms e.g. patients with renal
fistula, a Peripherally Inserted Central Catheter (PICC) line or who have had a lymph
node clearance
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Detection of Deterioration by SNAP40 Versus Standard Monitoring in the ED | NCT03179267 | Entailment |
644 | 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:
- Man or woman hospitalized in critical care unit,
- between 18 and 90 years old
- clinical examination completed
- written consent from the patient or a patient's relative depending on the awareness of
the patient
- an iron injection has been prescribed by the responsible physician to the patient
- anemia defined as hemoglobin level ≤11 g/dl
- iron deficiency define by at least one of the following criteria :
- ferritin < 100 μg/l
- ferritin between 100 and 300 μg/l with transferrin saturation < 20%,
- soluble transferrin receptor (RsTf) ≥1,4 mg/l,
- ratio RsTf/log(ferritin) ≥0,7,
- blood loss ≥ 1 blood weight.
EXCLUSION CRITERIA:
- do not subscribe to the french health insurance program
- Pregnancy or nursing
- past medical history of iron overload or disfunction in iron metabolism (= primary or
secondary hemochromatosis)
- Recent bacteremia defined as positive in the 48 hours preceding the injection. Having
a non positive hemoculture is not an exclusion criteria
- Suspicion of a novel current infection defined by a new fever with temperature over
>38°5 for at least three times during the last 48hours. A persisting fever for more
than 48 hours without argument for a new infection is not an exclusion criteria.
- known allergia to the iron- hydroxide complex or one of the excipient
- active chronic alcoholism
- oral iron treatment during the last 24 hours. Usage of antioxidant (vitamin C, vitamin
E) within the 24 hours preceding the iron injection.
- person participating to another clinical trial or being in the exclusion phase of a
clinical trial
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers and Critical Care Patients | NCT01443624 | Contradiction |
1,219 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Age over 12 years
- Symptomatic recurrent pleural effusion
- Pneumothorax needing pleurodesis
Exclusion Criteria:
- Life expectancy <1 month
- Unwilling to give consent
- Empyema
- ICTD drain output >150 ml/d
- Presence of an airleak
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis | NCT00430664 | Entailment |
5,180 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal osteoporosis
- Patients who has a low bone mineral density at hip or vertebral
- Patients who has an osteoporotic fracture at hip or vertebra
Exclusion Criteria:
- Hypersensitivity either to the active substance or to any of the excipients or to any
biphosphonates.
- Known metabolic bone disease excluding osteoporosis.
- Serious systemic disorder treated with drugs interfering with bone metabolism.
- Significant liver or renal failure
- Pathologic fracture in the examined body area or elsewhere.
- Previous anti-osteoporotic treatment within 12 months or less prior to the
recruitment.
- Patients with hypocalcaemia
Other protocol-defined inclusion/exclusion criteria may apply
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 65 Years | A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years | NCT00909961 | Entailment |
1,773 | 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 (Screening) To be eligible for entry into the Study, Subjects must meet
all of the following criteria at Screening:
- Provide written Informed Consent prior to participation in the Study
- Be a healthy male between the ages of 18 and 75 years of age, inclusive, at
Randomization
- Have a Body Mass Index (BMI) ≥ 19 and ≤ 45 lbs/in2
- Have the ability to read and understand the Study procedures and have the ability to
communicate meaningfully with the Study Investigator and staff
- Be free of physical, mental, or medical conditions which, in the opinion of the
Investigator, may confound quantifying assessments for the Study
- Be willing to abstain from smoking cigarettes or using nicotine products from the time
of admission to Clinic until Study Completion
Inclusion Criteria (Pre-Randomization) To be eligible for Randomization, Subjects must meet
each of the following criteria:
- Be free of evidence of infection based upon clinical assessment and blood (Complete
Blood Count- CBC) and urine testing
- Have an average baseline oral temperature that is equal to or below 37 ºC (98.6 ºF)
and does not vary more than 0.4 ºC (0.7 ºF) from lowest to highest on three
assessments performed during a 30-minute period
- Not develop a medically significant allergic or exaggerated systemic response to
administration of a test dose of reference standard endotoxin
- Develop a core temperature of at least 38.6 ºC (101.5 ºF) after IV reference standard
endotoxin dosed per Study guidelines and have a fever response to endotoxin that is at
or near the peak temperature by virtue of two consecutive temperature assessments 5
minutes apart that are within 0.2 ºC (0.4 ºF) of each other
Exclusion Criteria:
- Has been treated with any medication having antipyretic effects (e.g.,
corticosteroid,non-steroidal anti-inflammatory drug [NSAID], aspirin, or
acetaminophen) within 2 days of clinic admission (aspirin at low dose for cardiac
prophylaxis is allowed, but should not be taken on the day of the Study)
- Has significant medical disease(s), laboratory abnormalities, or condition(s) that in
the Investigator's judgment could compromise the Subject's welfare, ability to
communicate with the Study staff, complete Study activities, or would otherwise
contraindicate Study participation
- Has known hypersensitivity or contraindication to receiving endotoxin that in the
Investigator's clinical judgment merits discontinuation from further Study
participation
- Has known hypersensitivity to acetaminophen, the inactive ingredients (excipients) of
the intravenous (IV) or oral (PO) acetaminophen formulation or the Rescue Medications
(ibuprofen, aspirin, and ketorolac)
- Has known or suspected recent history of alcohol or drug abuse or dependence as
defined by Diagnostic Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
criteria
- Has a history of nasal polyps, angioedema, significant or actively treated
bronchospastic disease, or any other significant medical condition that
contraindicates participation in the Study or receiving endotoxin, Study Medication,
or Rescue Medication
- Has an active infection or other disease or condition that may cause abnormal
alterations in body temperature
- Has impaired liver function, e.g.Alanine aminotransferase (ALT) greater than or equal
to 3 times the upper limit of normal, bilirubin greater than 3.0, active hepatic
disease, or evidence of clinically significant liver disease (e.g., cirrhosis or
hepatitis)
- Has participated in another clinical Study (investigational or marketed product)
within 30 days of Screening
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males | NCT00564629 | Contradiction |
1,476 | 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:
- Patients diagnosed with dysphaigia
- Patients living in the participating locations
Exclusion Criteria:
- Patients who are linguistically or cognitively unable to participate
- Patients who are unable to collaborate about the training
- Palliative patients
- Patients with a probe
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effect of Training of Patients With Dysphagia | NCT04402307 | Entailment |
5,581 | 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. | - Karyotype diagnosis compatible with Turner syndrome, but no presence of any Y material
in the peripheral karyotype unless a gonadectomy has been performed;
- Chronological age between 10.0 and 14.9 years;
- Bone age less than or equal to 12 years; and
- No treatment with estrogen, androgen, growth hormone, or any other growth-promoting
agents exceeding 12 months, and no treatment with any of these agents in the previous
3 months.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 14 Years | The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome | NCT00029159 | Contradiction |
3,822 | 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 ≥ 40 years of age at time of consent
- Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior
to screening with confirmation of osteoarthritis according to the American College of
Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee
(clinical and radiological) based on an X-ray performed within 6 months prior to
screening or during the screening period
- Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph
performed within 6 months prior to or during screening period
- Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating
System) during the screening period
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness and ability to comply with the study procedures and visit schedules and
ability to follow verbal and written instructions
- Willingness to stop all pain medications except acetaminophen and paracetamol 14 days
prior to implantation
Exclusion Criteria:
- Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic
conditions which could interfere with the evaluation of the index knee
- History of inflammatory arthritis including rheumatoid arthritis, juvenile
inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing
spondylitis, reactive arthritis
- Hemophilia
- Achondroplasia
- History of infection in the index joint
- Intra-articular corticosteroid (investigational or marketed) in any joint within three
months of screening
- Intra-articular hyaluronic acid (investigational or marketed) in the index knee within
three months of screening
- Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one
month of screening
- Prior arthroscopic or open surgery of the index knee within 12 months of screening
- Planned / anticipated surgery of the index knee during the study period
- Active or history of malignancy within the last five years, with the exception of
resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected
cervical atypia or carcinoma in situ
- Insulin dependent diabetes
- History of or active Cushing's syndrome
- Skin breakdown at index knee where procedure would take place
- Women of child-bearing potential
- Case history related to motor vehicle accident or workers compensation
- Presence of hardware in the index knee (e.g. screws, plates)
- Immunocompromised patients (TB, HIV, etc.)
- Allergic reactions to acetaminophen and paracetamol
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 99 Years | Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis | NCT02873273 | Entailment |
4,037 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. The age range is between 40-65 years old
2. According to ACR criteria, clinically and radiographically, at least one of the knees
should be diagnosed with knee OA (within the last 6 months)
3. Having findings consistent with Kellgren-Lawrence grade II-III OA on knee radiography
4. Pain between 2-7 according to the visual analog scale
Exclusion Criteria:
1. Acute OA in the knee
2. Comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.),
injuries and surgeries where exercise is contraindicated
3. Use of NSAIDs and similar disease modifying drugs (Diacerein, Glucosamine etc.) in the
last month
4. Having exercised regularly in the last 6 months (more than 1 day a week)
5. Having had arthroplasty surgery
6. Intra-articular injection (hyaluronic acid / steroid) application in 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 45 Years old.
Subject must be at most 65 Years | Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation | NCT04588558 | Entailment |
5,822 | 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:
- A man or woman over 20 years old less than 70 years old.
- A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7
days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as
Erosive esophagitis(LA grade A~D) measured through the endoscopy which is carried out
within (-2W±D2)
* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the
weakness.
2. Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the
middle.
- A man or woman who has a full understanding of this clinical trial through the
detailed explanation, agree in writing to participate in this trial.
Exclusion Criteria:
- Who has hyper sensitivity reaction about other drugs, ingredients, components of
investigator product or compound of benzimidazole.
- Who has NERD
- Who get a diagnosis as a IBS within the last 3 months.
- Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before
the endoscopy.
- Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA)
Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (*
refer to the Concomitant medication in text.)
- Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis,
esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture,
primary esophageal motility disorder and gastrointestinal bleeding). Or who has a
history of radio therapeutics, freeze treatment about the esophagus.
- Who has clinically significant abnormal result of ECG.
- Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
- Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's
esophagus.
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 70 Years | Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) | NCT03943992 | Contradiction |
1,926 | 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:
Subjects eligible for enrollment must meet all of the following criteria:
1. Provide signed informed consent. The subject is capable of understanding and complying
with parameters as outlined in the protocol and able to sign informed consent,
approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB)
prior to the initiation of any study-specific procedures
2. Men or women aged >= 18 years.
3. Eastern Cooperative Oncology Group Performance Status (ECOG) <= 2.
4. Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or
esophagus.
5. Metastatic disease or locally advanced disease not amenable to curative surgery.
6. Radiographically assessable, non-measurable disease or measurable disease as per
RECIST criteria.
7. Life expectancy of at least 12 weeks from the time of enrollment.
8. No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix.
9. No prior chemotherapy for advanced disease.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Gastric carcinoid, sarcomas, or squamous cell cancer.
2. Pregnant or lactating females.
3. Significant neurological or psychiatric disorders (psychotic disorders, dementia or
seizures) that would prohibit the understanding and giving of informed consent.
4. Active Hepatitis B or C or history of an HIV infection.
5. Active uncontrolled infection.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study") | NCT01779583 | Entailment |
2,289 | 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:
- Evidence of signed and dated informed consent form.
- Confirmed diagnosis of Duchenne muscular dystrophy
- Age greater than or equal to 4 years and less than 8 years old
- Ability to rise independently from floor, from supine to standing
- Willingness and ability to comply with scheduled visits, drug administration plan and
study procedures
- Ability to maintain reproducible FVC measurements.
Exclusion Criteria:
- History of major renal or hepatic impairment, immunosuppression or other
contraindications to corticosteroid therapy.
- History of chronic systemic fungal or viral infections. Acute bacterial
infection(including TB) would exclude from enrolment until the infection had been
appropriately treated and resolved.
- Diabetes mellitus.
- Idiopathic hypercalcuria.
- Lack of chicken pox immunity and refusal to undergo immunization.
- Evidence of symptomatic cardiomyopathy at screening assessment (one to three months
prior to the baseline visit). Asymptomatic cardiac abnormality on investigation would
not be an exclusion.
- Current or previous treatment (greater than four consecutive weeks of oral therapy)
with corticosteroids or other immunosuppressive treatments for DMD or other recurrent
indications (e.g., asthma), unless approved by FOR-DMD Team (i.e., concurrent
participation in another allowed DMD trial).
- Inability to take tablets, as assessed by the site investigator by the end of the
screening period (the screening period ranges from one to three months prior to the
baseline visit).
- Allergy/sensitivity to study drugs or their formulations including lactose and/or
sucrose intolerance.
- Severe behavioral problems, including severe autism.
- Previous or ongoing medical condition, medical history, physical findings or
laboratory abnormalities that could affect safety, make it unlikely that treatment and
follow up will be correctly completed or impair the assessment of study results, in
the judgment of the site investigator.
- Weight of less than 13 kilograms.
- Exposure to any investigational drug currently or within 3 months prior to start of
study treatment.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | Finding the Optimum Regimen for Duchenne Muscular Dystrophy | NCT01603407 | Contradiction |
468 | 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 18-29 years old
- Unprotected vaginal or anal sex with at least one man that they perceive as engaging
in risky behavior OR
- Unprotected vaginal or anal sex with more than 1 man regardless of perceived partner
risk
- Can understand written and spoken English
Exclusion Criteria:
- Women younger than 18 years old
- Women older than 29 years old
- Cannot understand written or spoken English
- Previously participated in the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 29 Years | Reducing HIV Risk in Urban Women: Soap Opera Videos on Video-Capable Cell Phones | NCT03330522 | Contradiction |
4,505 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Women
- 18 to 35 years
- Healthy
- Physically Active (150 min / week)
Exclusion Criteria:
- Eating disorders;
- Hormonal disorders;
- Amenorrhea;
- Pregnancy;
- Polycystic ovary;
- Endometriosis;
- Tumors;
- Musculoskeletal injury in the last 6 months;
- Cardiorespiratory disease;
- Use of alcohol and illegal drugs during the study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Physical Performance of Women at Different Stages of the Menstrual Cycle, and Photobiomodulation Therapy | NCT04281446 | Contradiction |
3,225 | 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. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for
Primary Sjogren's Syndrome
2. Presence of anti Ro autoantibodies
3. Presence of interferon signature
Exclusion Criteria:
1. Use fo hydroxychloroquine within 30 days of baseline
2. Use of cyclophosphamide within 180 days of baseline
3. Use of oral corticosteroids greater than 10 mg/day
4. Known IgG4-related 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 70 Years | A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome | NCT03247686 | Entailment |
4,043 | 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 with age ≥ 40 years and ≤ 85 years except in Stage 1 cohort where age
is limited to ≤ 70 years.
- Body mass index (BMI) ≤ 35 kg/m².
- Uni- or bilateral femorotibial knee OA associated or not with femoropatellar knee OA.
- Primary knee osteoarthritis responding to the clinical and radiological criteria of
the American College of Rheumatology (ACR)
- Radiological Kellgren and Lawrence (K&L) grade II to III from a standing knee
radiograph taken less than 6 months previously.
- Symptomatic pain at least 6 months in the treatment knee not or poorly responding to
first line non-opioid analgesics and non-steroidal anti-inflammatory drug in oral
uptake.
- Pain criteria assessed prior to injection at visit 1 after mandatory 48-hour wash-out:
- Treatment knee: 7-17 points of the 5-graded Likert WOMAC pain score and at least
2 points on the WOMAC pain subscore A1 in the most affected knee.
- Non-treatment knee: not more than 6 points of the 5-graded Likert WOMAC pain
score in the contralateral knee.
- Fully ambulatory patient for functional evaluation
- Willing NOT to take any pain medication for 48 hours prior to study visit.
- For female NOT surgically sterile (tubal ligation or hysterectomy) or NOT
postmenopausal for at least one year, must have an effective contraception (pill,
patch, ring, diaphragm, implant and intrauterine device).
- Able to understand and follow the instructions of the study.
- Having signed a written informed consent.
Exclusion Criteria:
- Related to the OA pathology and related symptoms:
- Radiological K&L grade 0, I or IV from a standing knee radiograph taken less than
6 months previously.
- Exclusively patellofemoral osteoarthritis where the symptoms, including pain, are
principally of patellofemoral origin (Patellar syndrome).
- Chondromatosis or villonodular synovitis of the knee.
- Clinically-apparent knee effusion, inflammation or flare-up of the knee or
abnormal synovial fluid macroscopy or volume upon arthrocentesis on the day of
injection.
- History of injury to the treatment knee during the 6 months before inclusion or
recent trauma (<1 month) of the knee responsible of pain that is not directly
related to OA symptoms.
- Significant clinically-assessed or radiographic varus or valgus deformation of
the selected knee at the judgment of the investigator.
- Inflammatory disease.
- Pathologies interfering with the evaluation of OA pain for the knee to be
treated.
- Related to treatments:
- Contraindications: hypersensitivity or allergy to the product components of
KIO014, including chitosan, sorbitol and/or other mushroom-derived products, or
to hyaluronic acid-based products.
- Corticosteroids or Plasma Rich Platelet (PRP) or cell-based therapy injection in
the treatment knee in the last 3 months before injection.
- Hyaluronic acid injection in the treatment knee in the last 6 months before
injection.
- Arthroscopy and surgery in the treatment knee in the last 6 months before
injection.
- Oral corticotherapy ≥5 mg/day (in prednisone equivalent) in the last 3 months
before injection.
- Change in the dosage regimen of symptomatic slow-acting drugs (SYSAD) or dietary
supplement in the last 3 months before injection.
- Change in physiotherapy of the treatment knee in the last 3 months.
- Anticipated need for any surgical or other invasive procedure during the trial
including prosthesis in the treatment knee.
- Anticipated need for any forbidden OA treatments during the trial except for
rescue treatment as defined in the study protocol.
- Anticoagulants: coumarin-based compounds or heparin.
- Related to associated diseases:
- Any Investigator-assessed clinically significant condition that may represent a
substantial risk to the patient or may have an impact on the study assessments.
- History of recurrent bacterial infection, defined as at least 3 major infections
resulting in hospitalization and/or requiring intravenous antibiotic treatment
within the past 2 years or history of synovial infection or infections or skin
diseases in the area of the injection site.
- History of symptomatic hip OA
- History of autoimmune disease.
- Severe, ongoing and uncontrolled diseases, or other major disease, or other
severe uncontrolled conditions.
- Subject addicted to alcohol or drugs or ongoing or recently recovered depression
or psychiatric disorders or any other disorder and/or that may pose a health risk
to the subject in the study and/or may have an impact on the study assessments.
- Severe alteration of mobility preventing any functional evaluation.
- High risk of hemorrhage.
- Related to patients:
- Participation in a therapeutic clinical trial in the last 3 months before
injection.
- Patient under guardianship or judicial protection.
- Pregnancy, breastfeeding, planned conception, or premenopausal women without
effective contraception, tubal ligation or hysterectomy.
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 | sAfety PerfoRmance chitOsan osteOarthritis ViscosupplEmentation | NCT03679208 | Entailment |
5,738 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
1. Male or female subjects at least 18 years of age
2. Subjects with AK lesions and subclinical AK lesions within a contiguous 25 cm2 area on
the upper extremity
3. Subjects must have a 25 cm2 area of normal skin on the inner upper arm
4. Female subjects must be of either:• Non-childbearing potential, post-menopausal, or
have a confirmed clinical history of sterility or • Childbearing potential, with a
confirmed negative urine pregnancy test prior to exposure.
5. Female subjects of childbearing potential must be willing to consent to using high
effective methods of contraception
6. Ability to follow trial instructions and likely to complete all trial requirements
7. Obtained written informed consent prior to any trial-related procedures
Exclusion Criteria:
1. Location of the selected treatment areas:• Within 5 cm of an incompletely healed wound
or infected area of the skin • Within 10 cm of a suspected basal cell carcinoma (BCC)
or squamous cell carcinoma(SCC)
2. History or evidence of skin conditions other than the trial indication that would
interfere with evaluation of the investigational product
3. Clinical diagnosis/history or evidence of any medical condition that would expose a
subject to an undue risk of a significant AE or interfere with assessments of safety
during the course of the trial, as determined by Investigator clinical judgment
4. Anticipated need for in-patient hospitalisation or in-patient surgery during the trial
period.
5. Current participation in any other interventional clinical trial
6. Subjects who have received treatment with any non-marketed drug product within the
last two months
7. Previous enrolment in this clinical trial
8. Prohibited Therapies and/or Medications 2 weeks prior to the Screening visit within 2
cm of selected treatment area:•Cosmetic or therapeutic procedures •Use of
acid-containing therapeutic products • Use of topical salves or topical steroids
9. Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit:
• Treatment with immunomodulators, cytotoxic drugs or interferon/interferon
inducers,systemic medications that suppress the immune system, or with UVB
10. Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit:
• Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of
the selected treatment areas.
11. Use of systemic retinoids
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.
| PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy | NCT01449513 | Contradiction |
5,454 | 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:
- Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10
cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age;
- Weighing at least 60 kg for males and 52 kg for females;
- Subjects who had a body mass index (BMI) less than 30;
- Medically healthy subjects with clinically normal laboratory profiles and ECGs;
Females of childbearing potential should have either been sexually inactive (abstinent) for
14 days prior to the first dose and throughout the study or have been using one of the
following acceptable birth control methods:
- surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months
minimum. Proof was required for the hysterectomy and oophorectomy;
- IUD in place for at least 3 months;
- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the
first dose and throughout the study;
- surgical sterilization of the partner (vasectomy for 6 months minimum);
- hormonal contraceptives for at least 3 months prior to the first dose of the study.
Other birth control methods were deemed acceptable. Postmenopausal women with amenorrhea
for at least 2 years were eligible.
- Voluntarily consent to participate in the study.
Exclusion Criteria:
- Female subjects who were pregnant or lactating.
- Subjects who had been on a special diet (for whatever reason) during the 28 days prior
to the first dose and throughout the study.
- Any clinically significant illness within 4 weeks prior to dosing.
- Subjects with any medical condition requiring regular treatment with prescription
drugs.
- The use of any pharmacological agents known to significantly induce or inhibit
drug-metabolizing enzymes within 30 days prior to the first dose.
- Subjects who, through completion of the study, would have donated in excess of: 500 mL
of blood and/or plasma in 14 days; 1500 mL of blood and/or plasma in 180 days; 2500 mL
of blood and/or plasma in 1 year.
- Subjects who had donated plasma within 30 days prior to the first dose.
- Subjects who ahd participated in another clinical trial within 30 days prior to the
first dose.
- Subjects who did not tolerate venipuncture.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or
psychiatric disease.
In addition, the history or presence of:
- hypersensitivity or idiosyncratic reaction to desmopressin or any other synthetic
anti-diuretic hormones;
- type IIB von Willebrand's disease;
- personal or family bleeding disorder;
- alcoholism or drug abuse within the past year.
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 | Desmopressin Acetate 0.2 mg Tablets, Fasting | NCT00835211 | Entailment |
5,926 | 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:
- Typical GERD-symptoms lasting for more than 6 months (recurrent episodes of heartburn
or acid regurgitation)
- abnormal pH-parameters (pathological acid exposure and/or symptom association)
Exclusion Criteria:
- Age <18 years
- Previous esophageal or gastric surgery
- Severe esophageal motility disorder on manometry
- Histological evidence of Barrett's mucosa
- Severe co-morbidities (including cardiopulmonary disease, portal hypertension,
collagen diseases, morbid obesity, coagulation disorders and co-morbidity hindering a
gastroscopic procedure)
- Use of anticoagulant or immunosuppressive drugs
- Inability to stop medication that can influence the test results, like PPI, for at
least 10 days before tests
- Excessive alcohol consumption (>20 units per week)
- Patients unable to give informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Epithelial Damage in GERD | NCT01867931 | Contradiction |
2,101 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- IPF patients
Exclusion Criteria:
- Patients on systemic steroid
- Patients with acute exacerbation within the last 6 months
- PFT+BDR, MBPT contra-indication
- SpO2 < 90%
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis | NCT03215147 | Entailment |
1,508 | 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:
- Signed consent form
- Newly refered patients to FEES examination
- Score 1-4 on FEDSS-scale
- Consumes 50% energy or more orally
- Consumes less energy than calculated energy need (Harris-Benedict)
- Individuals of full legal capacity
- Individuals above 18 of years
- That the patient is capable of executing examinations
Exclusion Criteria:
- Individuals with known eating disorders
- Ineligible individuals
- Individual in need of translator
- Individuals participating in another trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance | NCT04655547 | Entailment |
6,622 | 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:
- 13 to 65 years old at the time of screening
- has moderately severe or severe hemophilia A or B (FVIII/FIX level
≤2%), with or without transient inhibitors
- Hemophilia A patient currently prescribed ADVATE (FVIII) or Hemophilia B patient
currently prescribed RIXUBIS (FIX)
- previously treated with plasma-derived FVIII/FIX concentrates or recombinant FVIII/FIX
for ≥150 documented exposure days (EDs)
- is willing and able to comply with the requirements of the protocol
- is proficient in the English language to allow for use of the SPACE eDiary
Exclusion Criteria:
- inhibitor titer ≥0.6 Bethesda units or currently being treated for an inhibitor
- has participated in another clinical study involving a medicinal product or device
within 30 days prior to enrollment or is scheduled to participate in another clinical
study involving a medicinal product or device during the course of this study
- is a family member or employee of the investigator
- elective major surgery is planned within 6 months after enrollment which may interfere
with activities of daily living (at investigator's discretion)
- continuously require walking assistance devices (eg, wheelchair, crutches, etc.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 65 Years | Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS | NCT02190149 | Contradiction |
678 | 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:
HH Patients
Group A patients (untreated HH patients)
Adults 21 years or older
New York Heart Association Functional Classification Class I
Documented positive phenotyping for homozygote Cys282Tyr of Hfe gene with documented serum
ferritin level above 400 ng/ml or documented % iron saturation more than 60%.
Patient has not received standard chronic phlebotomy or deferoxamine treatment. Individuals
are allowed to have up to 3 emergency phlebotomies for alleviation of severe iron
accumulation before enrollment.
Group B patients (treated HH patients)
Adults 21 years or older
New York Heart Association Functional Classification Class I
Documented positive phenotyping for homozygote Cys282Tyr of Hfe gene with documented serum
ferritin level above 400 ng/ml or documented % iron saturation more than 60%.
Patient has been compliant with standard phlebotomy and/or deferoxamine treatment for 6
months or longer and in stable phase with iron saturation 50% or less.
Healthy Volunteers
Group C Patients (Age-Gender Matched Healthy Control Subjects)
Adults 21 years or older.
No symptoms suggestive of heart disease or any other medical conditions, negative Hfe
genotyping for Cys282Tyr or His63Asp with normal ferritin and iron saturation.
EXCLUSION CRITERIA:
HH patients
Group A patients (untreated HH patients)
Pregnant or lactating women
History or present evidence of coronary artery disease, heart failure, peripheral vascular
disease, coagulopathy, or uncontrolled hypertension (systolic blood pressure over 170 mmHg
and/or diastolic pressure over 100 mmHg).
History of significant end-organ damage secondary to HH.
Serum creatinine greater than 2.0 mg/ml
LFT's more than 2.5 times above upper limit of normal
History of structural cardiac disease except mitral valve prolapse with mild mitral
regurgitation
Uncontrolled glucose levels with hemoglobin A(1c) above 8 mg/dl or the use of more than one
oral hyperglycemic agents or insulin therapy to control diabetes.
Current use of antioxidant treatment such as vitamin E and C. However, the cessation of
this treatment 4 weeks prior to the study will allow for inclusion.
Evidence of impaired immunity including HIV
Chronic systemic inflammatory disease such as SLE, rheumatoid arthritis, collagen vascular
disease.
Participation in unrelated research involving investigational pharmacological agent in past
30 days.
Current alcohol use (more than 26 grams averaged ethanol intake per day) or drug abuse.
Inability to provide informed consent
Smoking in past 3 months.
Use of beta-adrenergic blocking agents and calcium channel blockers with negative
chronotropic effect within 1 week.
Inability to perform treadmill or bicycle exercise testing.
Inability to undergo MRI such as ferromagnetic implant.
Group B patients (treated HH patients)
Pregnant or lactating women
History or present evidence of coronary artery disease, heart failure, peripheral vascular
disease, coagulopathy, or uncontrolled hypertension (systolic blood pressure over 170 mmHg
and/or diastolic pressure over 100 mmHg).
History of significant end-organ damage secondary to HH.
Serum creatinine greater than 2.0 mg/ml
LFT's more than 2.5 times above upper limit of normal
History of structural cardiac disease except mitral valve prolapse with mild mitral
regurgitation
Uncontrolled glucose levels with hemoglobin A(1c) above 8 mg/dl or the use of more than one
oral hyperglycemic agents or insulin therapy to control diabetes.
Current use of antioxidant treatment such as vitamin E and C. However, the cessation of
this treatment 4 weeks prior to the study will allow for inclusion.
Evidence of impaired immunity including HIV
Chronic systemic inflammatory disease such as SLE, rheumatoid arthritis, collagen vascular
disease.
Participation in unrelated research involving investigational pharmacological agent in past
30 days.
Current alcohol use (more than 26 grams averaged ethanol intake per day) or drug abuse.
Inability to provide informed consent
Smoking in past 3 months.
Use of beta-adrenergic blocking agents and calcium channel blockers with negative
chronotropic effect within 1 week.
Inability to perform treadmill or bicycle exercise testing.
Inability to undergo MRI such as ferromagnetic implant.
Healthy volunteers
Group C Patients (Age-Gender Matched Healthy Control Subjects)
Pregnant or lactating women.
History or present evidence of any structural cardiac disease except mitral valve prolapse
with mild mitral regurgitation, heart failure, peripheral vascular disease, coagulopathy,
and uncontrolled hypertension (systolic blood pressure over 170 mmHg and/or diastolic
pressure over 100 mmHg).
Serum creatinine greater than 2.0 mg/ml.
LFT's more than 2.5 times above upper limit of normal.
Current use of antioxidant treatment such as vitamin E and C. However, the cessation of
this treatment 4 weeks prior to the study will be included.
Uncontrolled glucose levels with hemoglobin A(1C) above 8 mg/dl or the use of oral
hyperglycemic agents or insulin therapy to control diabetes.
Evidence of impaired immunity including HIV.
Chronic systemic inflammatory disease such as SLE, rheumatoid arthritis, collagen vascular
disease.
Participation in unrelated research involving investigational pharmacological agent in past
30 days.
Current alcohol use (more than 26 grams averaged ethanol intake per day) or drug abuse.
Inability to provide informed consent.
Smoking in past 3 months.
Subjects with any chronic medical problems*
Inability to undergo MRI such as ferromagnetic implant.
*For the purpose of this protocol "chronic medical problems' is defined as any current
condition not amenable to curative therapy and which requires long-term medical treatment
and/or clinical monitoring.
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.
| Cardiac Function in Patients With Hereditary Hemochromatosis | NCT00068159 | Entailment |
1,280 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Clinical indications for placement of IPC for malignant pleural effusion
a. Pleural effusion with symptomatic improvement in dyspnea after drainage of
ipsilateral effusion
- Clinically confident symptomatic malignant pleural effusion
1. Histocytological proof of pleural malignancy
2. Recurrent large pleural effusion in context of histologically proven cancer
outside the pleural space
- Plans for placement of IPC within ten days of enrollment
- Age > 17 years
- Sufficient fluid on ultrasound to allow for safe insertion of IPC
Exclusion Criteria:
- Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
- Pregnant or lactating mothers
- Previous ipsilateral chemical pleurodesis
- Current contralateral indwelling pleural catheter
- Known rib or thoracic skeletal metastasis causing pain
- Concern for active pleural infection
- Respiratory failure
- Irreversible bleeding diathesis
- Inability to provide care for indwelling tunneled pleural catheter
- Significantly loculated pleural space precluding drainage of pleural space, for which
IPC alone will likely not offer symptomatic benefit
- Estimated life expectancy of < 30 days (however, active enrollment in hospice program
is not an exclusion criteria)
- Inability to read/understand/write in the English language
- Inability to follow-up for appointments/protocol
- Subject has any clinical condition, diagnosis, or social circumstance that, in the
opinion of the investigator would mean participation in the study would be
contraindicated.
- Enrollment in alternative pleural catheter trial that would preclude enrollment within
this trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System | NCT03831386 | Entailment |
952 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Age >38 years old
- Knee pain most of the days the last month
- Crepitus on active motion
- Morning stiffness, duration less than 30 minutes
- The patient has to understand the Swedish language to follow test instructions and to
complete the self-administered questionnaires.
Exclusion Criteria:
- Already been assessed/diagnosed by a healthcare provider for current knee pain.
- knee pain due to a traumatic cause
- other rheumatic or systemic diseases
- severe somatic or mental disease
- pregnancy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 38 Years old.
| Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Care | NCT03715764 | Entailment |
2,891 | 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. Male or female subjects, between 18-80 years of age, inclusive.
2. Subjects having a diagnosis of probable or definite ALS in accordance with the
Revisited El-Escorial Criteria.
3. Subjects must have no known allergy to riluzole or inactive ingredients* in ROSF.
4. Subjects or subject's legally authorized representative must be willing and able to
complete informed consent/assent and HIPAA authorization.
5. Ability to comprehend and be informed of the nature of the study, as assessed by the
Primary or Sub-Investigator.
6. Subjects prescribed to take riluzole at or before the time of first dose. (The study
is open to subjects currently taking riluzole at screening, subjects who are not
currently taking riluzole at screening but who have taken riluzole in the past, and
subjects to be newly started on riluzole (given as ROSF in the course of this study).
7. Availability to volunteer for the entire study duration and willing to adhere to all
protocol requirements.
8. Female subjects of childbearing potential must have a negative urine pregnancy test at
Screening and Visit 1-3. Female subjects of childbearing potential (i.e. not
surgically sterile, not 2 years postmenopausal, or not with a sterile partner) must
have a negative pregnancy test at screening and Visit 1-3, agree to abstinence,
practicing double barrier contraception or using an FDA approved barrier method
contraceptive (e.g., licensed hormonal or barrier methods) for greater than 2 months
prior to screening visit and commit to an acceptable form of birth control for the
duration of the study and for 30 days after participation in the study.
9. Subjects, in the judgment of the investigator, must be suitable candidates for
administration of ROSF (riluzole oral soluble film).
Exclusion Criteria:
1. Subjects with a history of clinically significant liver disease, renal disease, or any
other medical condition judged to be exclusionary by the investigator.
2. Subjects who are unwilling to sign informed consent or subjects who for any other
reason in the judgment of investigator are unable to complete the study.
3. Female subjects who have a positive urine pregnancy test (βhCG) at screening or visit
1, are trying to become pregnant or are breastfeeding.
4. Subjects with active cancer within the previous 2 years, except treated basal cell
carcinoma of the skin.
5. Subjects who have taken any experimental drug within 30 days prior to enrollment or
within 5 half-lives of the investigational drug -whichever is the longer period.
However, subjects who have previously completed other Aquestive sponsored ROSF
clinical studies within the last 30 days prior to enrollment may be eligible for
consideration for entry into this study.
6. Subjects with known history or presence of moderate or severe renal impairment as
defined by a calculated creatinine clearance of ≤50 mL/minute.
7. Subjects currently taking riluzole with alanine aminotransferase (ALT) levels greater
than 5 times upper limit of normal or with evidence of clinical jaundice. (Riluzole
should be discontinued in these patients.)
8. Subjects who will be receiving riluzole for the first time who exhibit baseline
elevations of several liver function tests (especially elevated bilirubin). (These
findings at baseline should preclude the use of riluzole including ROSF.)
9. Use of potentially hepatotoxic drugs: (e.g., allopurinol, methyldopa, sulfasalazine).
10. Subjects with clinically significant abnormal laboratory values in the judgment of the
investigator.
11. Use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin,
fluvoxamine, methoxsalen, mexiletine, thiabendazole, vemurafenib, zileuton) and CYP1A2
inducers (e.g. rifampin and barbiturates) in the previous 30 days before first drug
administration.
12. Employee or immediate relative of an employee of the investigator, MonoSol Rx LLC, any
of its affiliates or partners, or inVentiv Health.
13. Anything else that, in the opinion of the investigator, would place the subject at
increased risk or preclude the subject's full compliance with or completion of the
study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis | NCT03457753 | Entailment |
3,292 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- Individuals ages 12-90 years with confirmed diagnosis of HPS as defined by
verification of reduced or absent platelet dense granules by electron microscopy
and/or genetic diagnosis
- Ability to provide informed consent, or consent of parent/guardian and assent for
minors
Exclusion Criteria:
- Status-post lung transplantation
- Perceived unsuitability for participation in the study in the opinion of the
investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 90 Years | A Longitudinal Study of Hermansky-Pudlak Syndrome Pulmonary Fibrosis | NCT02368340 | Contradiction |
13 | 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:
- Early to midpubertal girls (late Tanner 1 [i.e., estradiol > 20 pg/ml] to Tanner 3)
- Premenarcheal
- Approximate ages, 8-15 years
Exclusion Criteria:
- BMI-for-age < 5th percentile
- Inability to comprehend what will be done during the study or why it will be done
- Being a study of GnRH pulse regulation in adolescent girls with and without HA, boys
are excluded
- Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome,
leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.
- Pregnancy or lactation
- Virilization
- Total testosterone > 150 ng/dl (confirmed on repeat)
- DHEAS > upper limit of age-appropriate normal range (confirmed on repeat) (mild
elevations may be seen in adolescent HA, and elevations < 1.5 times the
age-appropriate upper limit of normal will be accepted in such girls)
- Follicular phase 17-hydroxyprogesterone > 250 ng/dl (for girls < 12 years old) or >
300 ng/dl (for girls 12 and older) (confirmed on repeat), which suggests the
possibility of congenital adrenal hyperplasia. NOTE: If an elevated follicular
17-hydroxyprogesterone is confirmed on repeat testing, an ACTH stimulated
17-hydroxyprogesterone < 1000 ng/dl will be required for study participation
- History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before
age 8)
- A previous diagnosis of diabetes
- Fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c > 6.5% (confirmed on repeat)
- Abnormal TSH (confirmed on repeat) (subjects with adequately treated hypothyroidism,
reflected by normal TSH values, will not be excluded)
- Abnormal prolactin (confirmed on repeat) (mild elevations may be seen in HA girls, and
elevations < 1.5 times the upper limit of normal will be accepted in this group)
- Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired
growth in children, striae)
- Hematocrit < 36% and hemoglobin < 12 g/dl (confirmed on repeat)
- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected
congestive heart failure; asthma requiring intermittent systemic corticosteroids;
etc.)
- Persistent liver test abnormalities (confirmed on repeat), with the exception that
mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome
- Persistently abnormal sodium, potassium, or elevated creatinine concentration
(confirmed on repeat)
- Bicarbonate concentrations < 20 or > 30 (confirmed on repeat)
- No medications known to affect the reproductive system, glucose metabolism, lipid
metabolism, or blood pressure can be taken in the 3 months prior to the first
inpatient GCRC study (or in the 2 months prior to screening)
- Such medications include oral contraceptive pills, progestins, metformin,
glucocorticoids, psychotropics, and sympathomimetics/stimulants (e.g.,
methylphenidate)
- Patients taking restricted medications will be excluded unless written permission
(for the subjects to discontinue the medication) is received from the subject's
physician
- Weight < 22 kg is an absolute exclusion criterion (to ensure safe blood withdrawal)
Female
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 15 Years | Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia | NCT00930007 | Contradiction |
782 | 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. Males or females in the age 40 - 70 years (both inclusive)
2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and
Lawrence radiographic criteria.
3. History of primary idiopathic osteoarthritis of the knee characterized by pain which
requires intake of analgesics.
4. Self-reported difficulty in at least one of the following activities attributed to
knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a
chair, or going up and down stairs.
5. Patients who have been on stable medication which may be NSAIDs / Opioid or opiate
analgesics, for the past three months.
6. Female patients of childbearing age must be willing to use accepted methods of
contraception during the course of the study
7. Ability to provide written informed consent.
Exclusion Criteria:
1. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition,
alcoholism, drug abuse), medical history, physical findings, ECG findings, or
laboratory abnormality that, in the investigator's opinion, could adversely affect the
safety of the subject, makes it unlikely that the course of treatment or follow-up
would be completed, or could impair the assessment of study results.
2. History of surgery, or major trauma to the study joint
3. Arthroscopy on the study joint in the previous 12 months
4. Signs of active study joint inflammation including redness, warmth, and/or, if
qualifying with osteoarthritis of the knee, a large, bulging effusion of the study
knee joint with the loss of normal contour of the joint at the screening visit or at
the baseline examination
5. Patients who had received intraarticular steroids or hyaluronan within the last three
months.
6. Infections in or around the knee.
7. Patients awaiting a replacement knee or hip joint
8. Patients with other conditions that cause pain
9. Patients with deformity of the knee joint.
10. Significantly incapacitated or disabled and would be categorized as ACR Functional
Class IV (largely or wholly incapacitated), or unable to walk without assistive
devices
11. Patients with other known rheumatic or inflammatory disease such as rheumatoid
arthritis
12. Other pathologic lesions on x-rays of knee
13. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human
immunodeficiency virus (HIV) antibody test, or RPR
14. History of Bleeding disorders
15. Known hypersensitivity to Hyaluronan products or animal sera
16. For women of child-bearing potential: positive pregnancy test or lactating [Females
who are planning pregnancy within next one year should be excluded]
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Allogeneic Mesenchymal Stem Cells in Osteoarthritis | NCT01453738 | Entailment |
4,441 | 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:
- At least 18 years old.
- Medicare patients may be selected.
- Both male and female patients will be selected.
- A negative x-ray of the elbow
- Diagnosis of lateral epicondylitis by history and exam with symptoms for no longer
than one year.
- Females of childbearing potential must be willing to use acceptable methods of
contraception (birth control pills, barriers, or abstinence).
- Patient understands and is willing to participate in the clinical study and can comply
with weekly visits and the follow-up regimen.
- Patient has read and signed the IRB/IEC approved Informed Consent Form before
screening procedures are undertaken.
Exclusion Criteria:
- Prior surgery at the site
- Site exhibits clinical signs and symptoms of infection.
- History of chronic soft tissue inflammation of more than 6 months.
- A positive X-ray for fracture or significant anatomic abnormality including fracture,
advanced arthritis, excessive calcification, etc.
- No history of corticosteroid injection within the past 30 days.
- Joint instability
- No rheumatologic conditions involving the elbow.
- No evidence of significant neurological entrapment or neurological disease of the
forearm
- Concurrent cervical radiculopathy
- The presence of comorbidities that can be confused with or can exacerbate the
condition including:
- Previous elbow trauma
- Previous elbow surgery
- Patients with a history of more than two weeks treatment with immuno-suppressants
(including systemic corticosteroids), cytotoxic chemotherapy within one month prior to
initial screening, or who receive such medications during the screening period, or who
are anticipated to require such medications during the course of the study. (i.e. a
one month "washout period" for these drugs.)
- Patients on any investigational drug(s) or therapeutic device(s) within 30 days
preceding screening.
- History of radiation at the site.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Patients who are unable to understand the aims and objectives of the trial.
- Presence of any condition(s) which seriously compromises the subject's ability to
complete this study, or has a known history of poor adherence with medical treatment.
- Pregnant or breast feeding. No pregnancy within the past 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.
| Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis | NCT01921569 | Contradiction |
2,365 | 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:
- Documented diagnosis of DMD (severe dystrophinopathy) and clinical features consistent
of typical DMD at diagnosis (i.e., documented delayed motor skills and muscle weakness
by age 5 years) and who in the opinion of the Treating physician would benefit from
treatment with idebenone. DMD should be confirmed by mutation analysis in the
dystrophin gene or by substantially reduced levels of dystrophin protein (i.e., absent
or <5% of normal) on Western blot or immunostaining.
- Minimum 8 years old at Prescreening.
- PEF or FVC ≤80% and >25% of predicted value based on most recent assessment noted in
the patient's medical record and subsequently confirmed at the Enrollment Visit.
- Able to understand program requirements and swallow program medication.
- Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from
patient or parent/legal guardian (if applicable) prior to performing any
program-specific procedures and dispensing idebenone to the patient).
Exclusion Criteria:
- Eligible for and able to participate in an ongoing clinical trial of idebenone.
- Is at high-risk of a fatal outcome from lung infection and/or advanced cardiomyopathy
in the opinion of the Treating physician.
- Known moderate or severe impairment of hepatic function or severe impairment of renal
function.
- Prior or ongoing medical condition or laboratory abnormality which in the Treating
physician's opinion may put the patient at significant risk or may interfere
significantly with the patient's participation in the program.
- Abuse of drugs or alcohol, which in Treating physician's opinion would interfere with
the compliance to treatment.
- Known individual hypersensitivity to idebenone or to any of the ingredients/excipients
of the program medication.
No condition on gender to be admitted to the trial.
Subject must be at least 8 Years old.
| Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD) | NCT03433807 | Entailment |
902 | 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:
- Subject smust be able to understand the terms of the written informed consent and must
agree to date and sign it before any study procedure is carried out,
- Patient having signed the informed consent
- Aged 45 to 90
- With chronic osteoarthritis of the knee
- Patient with or without analgesic and anti-inflammatory treatment
Exclusion Criteria:
- Patient at the stage of surgical osteoarthritis (grade 4 plus limitation of amplitude)
- Patient with a limited walking perimeter (<100m) for any reason whatsoever
- Patient allergic to one of the components of the study product
- Patient not benefiting from social security
- Patient cannot be followed for the duration of the study
- Participation in another clinical trial within 30 days before V0
- Subjects who cannot understand or perform study procedures.
- Pregnant or breastfeeding women
- People with a history of convulsive or epileptic disorders
- People allergic to salicylates.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 90 Years | Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee | NCT04736563 | Entailment |
3,160 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Patients over 18 years old
- Patients seen in the psychiatry department requiring the prescription of psychotropic
drugs (antidepressants anxiolytics) for over 6 weeks
- Patients complaining of xerostomia
- Patients having not taken a palliative therapy against xerostomia for at least 2 weeks
- Patients having signed a free and informed consent form
- Patients affiliated to a social security system
Exclusion Criteria:
- Patients suffering from psychotic illness
- Patients suffering from Sjogren's syndrome
- Patients having been treated by radiation therapy for head or neck cancer
- Patients having stopped a palliative therapy against xerostomia for less than 2 weeks
- Patients under 18
- Pregnant or Breastfeeding women
- Incapacitated adults
- Patients placed under tutorship or curatorship
- Patients under judicial protection
- Patients suffering from milk allergy or lactose intolerance
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications. | NCT02705937 | Contradiction |
1,051 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria: a diagnosis of vasovagal syncope as the cause of loss of consciousness,
>1 lifetime syncope spell preceding enrolment, >-3 points on the S3 score for structurally
normal hearts, >18 yrs of age with informed consent -
Exclusion Criteria: subjects with a negative Physical Activity Readiness Questionnaire
(PARQ), those who are unable to provide informed consent, those with a VO2max >55ml/kg/min,
those who exercise more than 30 minutes per day, 3 times per week, other causes of syncope,
individuals with valvular, coronary, myocardial, or conductive abnormality, significant
arrhythmia, hypertrophic cardiomyopathy, permanent pacemaker, seizure disorder, heart
failure, major chronic cardiovascular disease, or renal dysfunction.
-
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.
| Exercise and Prevention of Syncope: EXPOSE | NCT00203593 | Contradiction |
2,085 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Type of subject: Outpatient.
- Informed Consent: A signed and dated written informed consent prior to study
participation.
- Age: 40 years of age or older at Visit 1.
- Gender: Male or female subjects.
- Diagnosis: An established clinical history of COPD in accordance with the definition
by the American Thoracic Society/European Respiratory Society [Celli, 2004]
- Smoking History: Current or former cigarette smokers with a history of cigarette
smoking of ≥ 10 pack-years
- Severity of Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a
post-albuterol/salbutamol FEV1 of >35% and <70% of predicted normal
- Dyspnea: A score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC)
at Visit 1
- Resting Lung Volumes: A resting FRC of ≥120% of predicted normal FRC at Visit 1.
Exclusion Criteria:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant
during the study.
- Asthma: A current diagnosis of asthma.
- Other Respiratory Disorders: Known respiratory disorders other than COPD including but
not limited to alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis,
sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.
Allergic rhinitis is not exclusionary.
- Other Diseases/Abnormalities: Subjects with historical or current evidence of
clinically significant cardiovascular, neurological, psychiatric, renal, hepatic,
immunological, endocrine (including uncontrolled diabetes or thyroid disease) or
haematological abnormalities that are uncontrolled and/or a previous history of cancer
in remission for < 5 years prior to Visit 1 (localized carcinoma of the skin that has
been resected for cure is not exclusionary). Significant is defined as any disease
that, in the opinion of the investigator, would put the safety of the subject at risk
through participation, or which would affect the efficacy or safety analysis if the
disease/condition exacerbated during the study. Any physical or mental abnormality
which would affect the patient carrying out exercise tests including peripheral
vascular disease should be excluded at the investigators discretion.
- Chest X-Ray: A chest X-ray or computed tomography (CT) scan that reveals evidence of
clinically significant abnormalities not believed to be due to the presence of COPD. A
chest X-ray must be taken at Visit 1 if a chest X-ray or CT scan is not available
within 6 months prior to Visit 1. For subjects in Germany, if a chest X-ray (or CT
scan) is not available in the 6 months prior to Visit 1 the subject will not be
eligible for the study.
- Contraindications: A history of allergy or hypersensitivity to any
anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or
magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic
hypertrophy or bladder neck obstruction that, in the opinion of the study physician
contraindicates study participation or use of an inhaled anticholinergic.
- Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit
1.
- Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior
to Screening (Visit 1).
- 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at
Visit 1, including the presence of a paced rhythm on a 12-lead electrocardiogram (ECG)
which causes the underlying rhythm and ECG to be obscured. Investigators will be
provided with ECG reviews conducted by a centralized independent cardiologist to
assist in evaluation of subject eligibility.
- Screening Labs: Significantly abnormal finding from clinical chemistry and hematology
tests at Visit 1.
- Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour
period required prior to spirometry testing at each study visit.
- Medications prior to Screening, including depot,oral corticosteroids, combinations of
LABA/ICS, LABA, PDE4 inhibitors.
- Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed
for greater than 12 hours a day. As-needed oxygen use (i.e., <12 hours per day) is not
exclusionary.
- Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use)
of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy
- Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary
rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the
maintenance phase of a pulmonary rehabilitation program are not excluded.
- Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2
years prior to Visit 1.
- Affiliation with Investigator Site: Is an investigator, sub-investigator, study
coordinator, employee of a participating investigator or study site, or immediate
family member of the aforementioned that is involved in this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A | NCT01328444 | Entailment |
413 | 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 thin endometrium without scar
- Patients with acute thin endometrium post-therapy (medicamentosa)
- Patients who are willing to participate in the study
Exclusion Criteria:
- Patients with thin endometrium due to TB
- Patients with cancer in the reproductive system
Female
No healthy subjects accepted to join the trial.
Subject must be at most 40 Years | Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients | NCT04676269 | Contradiction |
2,180 | 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. Patients of either gender and of any race ≥18 years of age.
2. If female, patients must be postmenopausal as evidenced by lack of menses for ≥12
consecutive months.
3. Patients must present with a confirmed diagnosis of gout.
4. Patients must have experienced ≥2 acute gouty arthritic attacks in the 12 months prior
to randomization.
5. Patients on urate lowering therapy must be on a stable dose and schedule with no
changes in therapy for 4 weeks prior to randomization and expected to remain on a
stable regimen during study participation.
6. Patients must be willing to adhere to the study schedule and the protocol
requirements.
7. Patients must be willing and able to give written informed consent. A HIPAA and/or
state privacy consent must also be signed.
Exclusion Criteria:
1. Patients with acute polyarticular gout (>4 joints).
2. Patients who have experienced >2 acute gouty arthritic attacks per month, or >12
attacks overall, in the 6 months prior to randomization.
3. Patients with arthritis due to any cause other than gout that may confound any study
assessments per Investigator discretion.
4. Patients with a history of myocardial infarction, unstable angina, cerebrovascular
events, or coronary artery bypass grafting within the previous 6 months prior to
screening.
5. Patients with active myeloid leukemia, obstructive gastrointestinal cancer, or
metastatic cancer.
6. Patients with chronic renal dysfunction (creatinine clearance <60 mL/min as estimated
with the Cockcroft Gault formula).
7. Patients with chronic hepatic dysfunction.
8. Patients with a history of alcohol or substance abuse within the 12 months prior to
randomization.
9. Patients who have any concomitant illness or other finding that, in the opinion of the
Investigator, would confound the study data or place the patient at unacceptable risk
if the patient were to participate in the study, or that would require frequent
adjustments in concomitant medications during the course of the study.
10. Patients using systemic corticosteroid, cyclosporine, adalimumab, etanercept,
infliximab, anakinra, abatacept, mycophenolate, azathioprine, anticoagulants
(warfarin, heparin, low molecular weight heparin [LMWH], antithrombin agents, thrombin
inhibitors, or selective Factor Xa inhibitors [note, use of aspirin ≤325 mg/day is
allowed]), or chronic use of non steroidal anti inflammatory drugs (NSAIDs),
acetaminophen, tramadol, and other analgesics such as opiates at screening
11. Use of any investigational drug within 30 days prior to randomization.
12. Patients currently participating in another research study or anticipated to enroll in
such during participation in this study.
13. Patients for whom informed consent cannot be obtained.
14. Patients who have previously been randomized into this study and begun ingestion of
study drug.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| MPC-004 for the Treatment of an Acute Gout Flare | NCT00506883 | Contradiction |
1,408 | 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:
- The Stroke Center inpatients and outpatients with known or suspected dysphagia can be
included for study as well as patients who are admitted specifically for this
protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or
choking when eating, shortness of breath during swallowing, food backing up into the
mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing,
unexplained loss of weight.
Exclusion Criteria:
- Patients who are severely demented or severely compromised will be excluded if they do
not have sufficient cognitive ability to follow directions. Non-ambulatory patients
will be excluded if they cannot be braced or supported within the fluoroscopy unit.
Highly agitated individuals will also be excluded if they are unable to remain
confined in the equipment.
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 70 Years | Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients | NCT01249300 | Contradiction |
3,351 | 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:
Determined to have chronic Eustachian tube dysfunction of at least 3 month duration based
on a score of ≥ 14.5 on the Eustachian tube dysfunction questionnaire-7 (ETDQ-7),
regardless of tympanogram status
Exclusion Criteria:
- Insurance that does reimburse for ET balloon dilation
- Patients with acute upper respiratory infection
- Tympanic membrane perforation
- Known middle ear disease such as cholesteatoma, acute otitits media, history of head
and neck radiation, history of cleft palate, cystic fibrosis, ciliary dyskinesia,
nasopharyngeal mass and patulous eustachian tube
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.
| Tympanostomy Tubes Versus Eustachian Tube Dilation | NCT03886740 | Contradiction |
4,071 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion criteria
- ≥ 18 years of age
- Conversational English and capacity to consent
- Availability to take part in the study
Exclusion criteria
- Potential participants who have a diagnosed sleep disorder, ongoing neurological or
psychiatric disorders, or any potentially life-threatening conditions.
- Potential participants who have a history of dermatological disease, fragile skin, or
damage around the forehead.
- Potential participants who have an allergy to plasters and/or medical adhesives
(similarly to materials used in the device).
- Pregnant or nursing mothers.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
| sCAVA - Sleep Assessment Using the CAVA Device | NCT04583826 | Contradiction |
1,643 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. Males or females who meet the inclusion/exclusion criteria, females are not pregnant
or nursing, and agree to use a double-barrier method of birth control (condoms or
diaphragm plus spermicide) throughout the trial (alone or in addition to other methods
of birth control such as oral contraceptives)
2. Age ≥18 and <60 years
3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
4. Ability to give signed and dated written informed consent prior to admission to the
study in accordance with Good Clinical Practice and the local regulations
Exclusion Criteria:
1. Current (symptomatic within the last 30 days) and medically relevant gastrointestinal,
hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal
disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Currently active (symptomatic within the last 30 days) diseases of the central nervous
system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant
to the trial as judged by the investigator
6. Intake of drugs with a long half-life (>24 hours) within one month prior to
administration of study drug or during the trial (review with clinical monitor if
questionable)
7. Use of drugs within 10 days prior to administration or during the trial, which might
reasonably influence the results of the trial based on the knowledge at the time of
protocol preparation (review with clinical monitor if questionable)
8. Participation in another trial with an investigational drug within one month prior to
administration or during the trial
9. Current smoker
10. Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit
prescription or non-prescription drugs or drugs of abuse).
11. Recent blood donation (more than 100 mL within 4 weeks prior to administration or
during the trial)
12. Excessive physical activities (within 1 week prior to study drug administration or
during the trial)
13. Any laboratory value outside the normal reference range that is of clinical relevance
at screening, according to the judgment of the investigator
14. Inability to comply with dietary regimen required by the protocol
15. Chronic or relevant acute infections
16. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B
surface antigen, or hepatitis C antibody positive)
17. HIV-1 infected as defined by a positive HIV ELISA test
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 59 Years | Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects | NCT02256774 | Entailment |
6,172 | 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. Male and female subjects ≥ 18 years of age;
2. SARS-CoV-2-positive, confirmed by Food and Drug Administration (FDA)- or European
Medicines Agency (EMA)-authorized COVID-19 test ≤ 7 days prior to randomization;
3. Less than or equal to 7 days from first symptom onset to randomization;
4. Subjects with moderate COVID-19 who have fever (temperature ≥ 38 ̊C / 100.4 ̊F) and
shortness of breath (with exertion), not requiring oxygen, and meeting the definition
of "moderate" as set forth by the May 2020 FDA Guidance for Industry: COVID-19:
Developing Drugs and Biological Products for Treatment or Prevention (FDA, 2020),
which includes all of the following criteria when the subject is sitting:
1. Respiratory rate: ≥ 20 breaths/minute,
2. SpO2: > 93% and ≤ 96% on room air at sea level, and
3. Heart rate: ≥ 90 beats/minute;
5. Subject must possess at least one of the following high-risk conditions known to have
an underlying increased level of cytokine production:
1. 70 years or more of age,
2. Obesity (BMI ≥ 30 kg/m2),
3. Diabetes (type 1 or 2),
4. Uncontrolled hypertension, defined as diastolic > 100 mm Hg and/or systolic > 150
mm Hg without any current anti-hypertensive medications. At the time of screening
if the subject is on anti- hypertensive medication(s) and diastolic or systolic
rates are elevated, subject may be enrolled after consultation with the Medical
Monitor,
5. Known respiratory disease (including asthma or chronic obstructive pulmonary
disease [COPD]),
6. Known heart failure (note: subjects with New York Heart Association Class IV
congestive heart failure cannot be enrolled per Exclusion Criterion 4), or
7. Known coronary disease;
6. Plasma CRP level ≤ 20 mg/L within 72 hours of Screening/Baseline/Day 1 Visit;
7. Acceptable overall medical condition to be safely enrolled in and complete the study
(with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion
of the Investigator;
8. Ability to provide written, informed consent prior to initiation of any study- related
procedures, and ability in the opinion of the Investigator to understand and comply
with all the requirements of the study, which includes abstaining from the use of
prohibited medications.
9. Subject must present with at least moderate symptomatology, based on having symptoms
in the prior 24 hours that were uncomfortable and interfered with daily activities or
required treatment other than study drug and having at least one of the following
symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat;
nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills,
shivering, and/or sweating.
Exclusion Criteria:
1. Women of childbearing potential, or men whose sexual partner(s) is a woman of
childbearing potential, who:
1. Are or intend to become pregnant (including use of fertility drugs) during the
study;
2. Are nursing (female subjects only);
3. Are not using an acceptable, highly effective method of contraception until all
follow-up procedures are complete.
2. Evidence of pre-existing or new-onset organ failure;
3. Evidence of moderate concurrent nervous system, renal, endocrine, or gastrointestinal
disease, unrelated to COVID-19 as determined by the Investigator;
4. Evidence of cardiovascular disease with significant arrhythmia, congestive heart
failure (New York Heart Association Class IV), unstable angina, cor pulmonale, or
symptomatic pericardial effusion, not related to COVID-19 as determined by the
Investigator;
5. Required use of vasoactive drug support;
6. History of myocardial infarction in the 6 months prior to the Screening/Baseline/Day 1
Visit;
7. Evidence of current liver disease, not related to COVID-19 as determined by the
investigator;
8. History or evidence of active tuberculosis (TB) infection at Screening/Baseline/Day 1
Visit or one of the risk factors for tuberculosis such as but not limited or exclusive
to:
1. History of any of the following: residence in a congregate setting (e.g., jail or
prison, homeless shelter, or chronic care facility), substance abuse (e.g.,
injection or non-injection), health-care workers with unprotected exposure to
subjects who are at high risk of TB or subjects with TB disease before the
identification and correct airborne precautions of the subject or
2. Close contact (i.e., share the same air space in a household or other enclosed
environment for a prolonged period (days or weeks, not minutes or hours)) with a
person with active pulmonary TB disease within the last 12 months.
9. History of or currently active primary or secondary immunodeficiency;
10. Past or present requirement for oxygen (e.g., nasal cannula, proning, mechanical
ventilation and/or supplemental oxygen).
11. Use of any prohibited concomitant medications/therapies over the defined or planned
use of any concomitant medications/therapies during the
Treatment Period, including specifically:
1. use of ibuprofen or diclofenac
2. use of colchicine
3. use of systemic steroids within 30 days of randomization
4. use of janus kinase (JAK) inhibitors
5. use of off-label agents (e.g., hydroxychloroquine, remdesivir, dexamethasone) and
biologic and oral anti-cytokine agents (e.g., current treatment with adalimumab,
infliximab, etanercept, golimumab, certolizumab pegol, tocilizumab, sarilumab,
anakinra, canakinumab, rilonacept, baricitinib, tofacitinib, or upadacitinib);
Note: During the treatment period a patient may meet the criteria for a treatment
approved by the FDA specifically for COVID-19 (e.g. remdesivir). In this situation the
investigator and medical monitor should confer and take the most appropriate decision
for the patient. If possible, the preference would be for the patient to complete the
14 days of dosing before adding on the 2nd treatment. If that is not possible the
preference would be for the patient to continue their 14 days on dapansutrile and
complete all study related visits.
12. Known history of renal impairment (e.g., calculated glomerular filtration rate [GFR] <
45 mL/min);
13. Evidence of malignant disease, or malignancies diagnosed within the previous 5 years
(except for local basal or squamous cell carcinoma of the skin or carcinoma in situ of
the cervix uteri that has been excised and cured);
14. History of infection or known active infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);
15. Any other concomitant medical or psychiatric conditions, diseases, or prior surgeries
that, in the opinion of the Investigator, would impair the subject from safely
participating in the trial and/or completing protocol requirements;
16. Individuals who have been in a chronic care facility in the past 30 days;
17. Individuals who are incarcerated;
18. Participation in any clinical trial and/or use of any investigational product within
the immediate 30-day period prior to the Screening/Baseline//Day 1 Visit; or receipt
prior to Screening/Baseline/Day 1 Visit or intending to receive during the trial a
COVID-19 vaccination.
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.
| Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome | NCT04540120 | Contradiction |
245 | 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. Comply with all study procedures, sign, initial and date back, of their own free will,
the IC;
2. Women aged between 18 and 35 years, regardless of race and class;
3. Make use of safe non-hormonal method of contraception such as tubal ligation,
non-hormonal IUDs or condoms, or be hysterectomised or be vasectomized sexual partner;
4. Examination of Beta-HCG negative;
5. with regular menstrual cycles every 24 to 32 days, at least the last three months;
6. present normal Pap test (current or during the past 02 years);
7. Present or vaginal examination found that the changes do not interfere in the study;
8. present levels of FSH, LH, estradiol and TT for the normal menstrual cycle, as well as
normal transvaginal sonographic reports.
Exclusion Criteria:
1. Provide a contraindication to the use of steroids;
2. Use regular or prediction of drugs that interfere with the metabolism of the
investigational products, such as antibiotics, anticonvulsants, anticoagulants and
hypoglycemic drugs;
3. smokers or have stopped smoking less than 12 months;
4. Diabetic;
5. Toxic-dependent;
6. BMI <18 and> 25;
7. have made use of topical or systemic sex hormone for at least two months before the
start of the study;
8. Background and personal or family history of thrombosis or bleeding disorders or
vascular disorders or cardiovascular disease;
9. Laboratory tests, gynecological ultrasound or changed, the medical criteria;
10. Individuals with allergies or rheumatic diseases for which is indicated the use of
cortico-steroid medication;
11. carry any endocrine changes, especially pituitary and gonadal and / or who are advised
to use hormones;
12. with lesions or abnormalities suspected or confirmed in the gonads.
13. personal or family history of breast cancer or other hormone-dependent breast
pathology;
14. with hypertension or diabetes mellitus (for drug interactions between the COC and
hypoglycemic agents and antihypertensives);
a) History of nausea with oral use of COCs; p) Any condition that may interfere with the
discretion of the investigator in the study data as well as being the measurement of the
study be deleterious to the patient.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®. | NCT01480778 | Contradiction |
End of preview. Expand
in Data Studio
Natural Language Inference for Patient Recruitment (NLI4PR)
Dataset Summary
This dataset card aims to be a base template for new datasets. It has been generated using this raw template.
Supported Tasks and Leaderboards
Natural Language Inference.
Language
English
Dataset Structure
Data Instances
Each instance of the dataset has the following fields and the following types of fields.
{
"id": "621",
"topic_id": "2",
"statement_medical": "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 \u03b2-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.",
"statement_pol": "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 \u03b2-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.",
"premise": "Inclusion Criteria:\n\n - women with PUL\n\n Exclusion Criteria:\nFemale\nAccepts Healthy Volunteers\n\n",
"NCT_title": "Hysteroscopy for Pregnancy of Unknown Location",
"NCT_id": "NCT02637739",
"label": "Entailment"
}
Data Fields
Each instance has the following fields: id, topic_id, statement_medical, statement_pol, premise, NCT_title, NCT_id, label.
Data Splits
Train: 4904 instances Validation: 525 instances Test: 1578 instances
Dataset Creation
Source Data
Initial Data Collection and Normalization
premise (CTRs) and statement_medical taken from TREC-CT 2022.
Annotations
Annotation process
Automatic mapping of TREC-CT 2022's ranking to NLI annotations. eligible mapped as Entailment and excluded mapped as Contradiction.
Manual rephrasing of original statement_medical
Annotators
Paper's first author.
Dataset statistics
| Split | # Entailment | # Contradiction |
|---|---|---|
| Train | 2757 | 2147 |
| Dev. | 295 | 230 |
| Test | 887 | 691 |
Licensing Information
MIT
Citation Information
@misc{aguiar2025ieligiblenaturallanguage,
title={Am I eligible? Natural Language Inference for Clinical Trial Patient Recruitment: the Patient's Point of View},
author={Mathilde Aguiar and Pierre Zweigenbaum and Nona Naderi},
year={2025},
eprint={2503.15718},
archivePrefix={arXiv},
primaryClass={cs.CL},
url={https://arxiv.org/abs/2503.15718},
}
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