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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 |
4,025 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Patients having given their written informed consent, prior to participating in the
trial.
- Patients of either sex >= 40 years of age and of sufficient good health that they will
be able to complete the 6-month follow-up.
- Patients with signs and symptoms of osteoarthritis of at least one knee:
- Diagnosed according to ACR criteria.
- Based upon a knee X-ray performed within 6 months prior to Screening, the
radiograms must be classified as a Grade II or III for osteoarthritis of the knee
according to the Kellgren & Lawrence grading system based upon a radiologist's
written report or individual certified for reading knee radiograms. (Sharpening
of the tibial spine is not considered to be an osteophyte).
- Patients with symptoms consistent with osteoarthritis of the knee for at least 6
months prior to Screening. These symptoms must include knee joint pain, and may
include crepitus, swelling and/or effusion of the knee.
- At Screening, patients on any analgesic/anti-inflammatory medication should have a
visual analogue scale (VAS) pain score after walking on a 50 ft flat surface of > 30
mm but < 90 mm using a 100 mm scale. If patients are not taking any
analgesic/anti-inflammatory medication or have not taken any pain medication
(prescription [Rx] or over-the-counter [OTC]) in the previous 3 days from Screening
then they should have a VAS pain score after walking on a 50 ft flat surface of > 40
mm but < 90 mm. If bilateral knee pain is present, the investigator will select the
more painful knee.
- At Screening and Baseline, if there is bilateral OA of the knee involvement, patients
must have a VAS pain score for walking on a 50 ft flat surface of < 30 mm in the less
painful contralateral knee at the Baseline assessment. A patient scoring an acceptable
VAS pain score at Screening but failing to meet the inclusion and exclusion criteria
at Baseline can not be randomized and enrolled.
- At Baseline, after all analgesic/anti-inflammatory medications have been discontinued
for 2 weeks (withdrawal from acetaminophen rescue medication for at least 24 hours
prior to Baseline assessment), patients should have a VAS pain score of > 40 mm but <
90 mm immediately after the 50-foot walk on a flat surface. Again, if bilateral knee
pain is present, the investigator will select the more painful knee and the
contralateral knee must have a VAS pain score of < 30 mm.
- Patients must have had knee pain in the signal knee on at least 50% of the days in the
month preceding Screening.
- Patients who are able to complete efficacy measurement questionnaires and can
understand and read English or Spanish (Spanish forms will be provided).
- Patients who can perform the 50-foot walk test without the support of crutches or
other assistive devices, except for canes. If patient uses a cane routinely in daily
activities, then they can use it for their assessments. However, this use must remain
stable for all assessments.
- Minimum flexion of 90 degrees in both knees.
- Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs
(NSAIDs) or other analgesic medication taken for any condition, including their knee
pain with the exception of acetaminophen, up to 1000 mg (2 tablets) four times a day
(q.i.d.), as needed (p.r.n.) (maximum 8 tablets or 4 grams per day). These patients
must be willing to use only acetaminophen as a rescue pain medication for the knee
pain during the study period and refrain from even acetaminophen use 24 hours prior to
any office visit. All other analgesic medications for any chronic condition must be
stopped (see exceptions for acute treatment of transient flares of pain). Patients
must also be willing to abstain from any intra-articular (i.a.) or peri-articular
injections to the knee or surgery during the course of the trial, except for the
assigned study product.
- Patients who, if they are currently taking low dose aspirin (325 mg/day or less), are
willing to remain on a stable dose throughout the study and are willing to refrain
from any aspirin dose 24 hours prior to any office visit.
Exclusion Criteria:
- Women of childbearing potential may not be entered if:
- their pregnancy tests (urine test) are positive,
- they are nursing,
- they do not use an effective method of contraception until all follow-up
procedures are complete. (Methods of contraception considered effective are an
oral, injectable or implanted contraceptive agent, or an intra-uterine device
with a failure rate of 1% per year, and abstinence).
- Patients participating in an experimental drug/device study or any clinical trial
within the previous 30 days prior to Screening.
- Patients with a prior history of any malignancy with the exception of basal cell
carcinoma of the skin treated more than 2 years prior to Screening, unless specific
permission/waiver by the Sponsor is granted.
- Patients having significant bleeding diathesis.
- Patients that are currently under litigation for injuries related to the study knee or
other injuries that might interfere with their completion of the study protocol.
Musculoskeletal Related
- Patients having any major injury (including sports) to the study knee in past 12
months.
- Patients having any surgery to the study joint within the previous 12 months prior to
Screening, and surgery to the contralateral knee or other weight-bearing joint if it
would interfere with the study assessments.
- Patients having significant surgery of lower limbs (hip, ankle, foot) that may
interfere with knee assessments.
- Patients receiving any articular procedures, such as transplants, to the study knee.
- Patients having a ligament reconstruction to the study knee.
- Patients with inflammatory arthropathies such as rheumatoid arthritis, lupus, or
psoriatic arthritis
- Patients with gout or calcium pyrophosphate (pseudogout) diseases that had flared
within the previous 6 months prior to Screening.
- Patients receiving any intra-articular or local peri-articular corticosteroid
injections to the study joint/knee within the previous 3 months prior to Screening.
- Patients receiving any intra-articular, intra-muscular or local peri-articular
corticosteroid injections to any other joint (beside the study joint) or soft tissue
area within the past 3 months.
- Patients receiving any oral corticosteroid within the previous month. Steroid
inhalants are permitted if the patient has been on a stable regimen for the past month
prior to Screening and remains on this regimen throughout the course of the trial.
- Patients receiving an intra-articular hyaluronan in the study joint within the
previous 9 months prior to screening.
- Patients receiving an intra-articular hyaluronan in any joint within the previous 6
months prior to screening.
- Patients with a history of allergic reaction to an intra-articular injection or avian
products.
- Patients taking unstable doses of glucosamine- or chondroitin sulfate-containing
compounds, or patients taking stable dose for less than 4 months prior to Screening,
or patients taking stable dose for at least 4 months prior to and unwilling to remain
on these stable doses throughout the course of the trial.
- Patients on unstable doses of bisphosphonate or patients on stable doses for the past
month prior to Screening, and are unwilling to remain on these stable doses throughout
the course of the trial.
- Patients who cannot perform the 50-foot walk test without the support of crutches or
other assistive devices, except for canes. If patient uses a cane routinely in daily
activities, then they can use it for their clinical assessments. If the patient uses a
cane for their Baseline assessment then they must use the cane for ALL subsequent
assessments.
- Patients with X-ray findings of acute fractures, severe loss of bone density,
avascular necrosis and/or severe bone or joint deformity.
- Patients with significant axial deviation of the knee.
- Patients with OA that is dominantly in the lateral compartment or any significant
valgus deformity
- Patients with significant anterior knee pain due to diagnosed isolated patella-femoral
syndrome or chondromalacia.
- Patients with symptomatic osteoarthritis of either hip, contralateral knee or spine
that may interfere with functional assessment of the signal knee.
- Patients with clinically significant medio-lateral and/or anterior-posterior
instability.
- Patients with osteonecrosis of either knee.
- Patients that are receiving or performing physical therapy regimen during the previous
month from Screening, and/or will not or cannot maintain a stable physical therapy
regimen throughout the course of the trial.
- Patients with Kellgren-Lawrence Grade IV OA (i.e., large osteophytes, marked
narrowing, severe sclerosis, and definite deformity) and Grade I OA of the knee.
- Patients having any arthrogram of the signal joint within the past 3 months prior to
Screening.
- Patients with a hemiparesis of the lower limbs
- Patients with active liver or renal disease based upon liver profile of SGOT > 2 x ULN
(upper limit of normal), and/or conjugated bilirubin > 2 x ULN, and/or renal
insufficiency (serum creatinine < 2.0 mg/dL, and/or any clinically significant
laboratory value based on clinical history which the investigator feels may affect the
evaluation of the patient.
Concomitant conditions, diseases, medications and/or clinical history
- Patients requiring chronic use of analgesia for pain (including pain in the other knee
or any other joint) that may interfere with the evaluations of the test knee (such as
possible use of rescue medication for these other conditions).
- Patients with known allergies to acetaminophen, lidocaine, hyaluronans, or avian
products.
- Patients with a recurrent medical history of severe allergic or immune-mediated
reactions.
- Patients with active infection of the skin near the potential injection site.
- Patients with any dermatological disease overlying the signal joint that would
contraindicate multiple injections or aspirations.
- Patients taking any agent reported to have symptom relief for arthritis or be a
disease/structure modifying drug (e.g. doxycycline, long-term tetracycline,
s-adenosylmethionine [SAM], dimethyl sulfoxide [DMSO], dietary supplements or any
herbal remedy taken for arthritic and joint conditions within the past month.
Exceptions are products containing glucosamine/Chondroitin/methylsulfonylmethane (MSM)
if stable for 4 months prior to Screening and remain stable throughout study and
fulfill the VAS pain entry criteria).
- Patients with peripheral neuropathy that would be severe enough to interfere with the
evaluation of the patient.
- Patients with vascular insufficiency of lower limbs that is severe enough to interfere
with the evaluation of the patient.
- Patients on concomitant therapy with anticoagulants (low dose aspirin, not exceeding
325 mg per day as an anti-thrombotic agent is permitted if stable for one month prior
to Screening and remains stable throughout the study.
- Patients with any inter-current disease(s) or condition(s) that may interfere with the
free use and evaluation of the affected knee for the 6 month course of the trial
(cancer, other rheumatic diseases, gout, severe congenital defects, etc.).
- Patients with any inter-current chronic disease(s) or condition(s) that may predispose
them to a high probability of interfering with the completion of the 6 month follow-up
of the study such as peptic ulcer, liver disease, severe coronary disease, renal
disease, cancer, pregnancy, alcoholism, drug abuse, mental state, or other clinically
significant condition.
- Patients with excessive alcohol consumption or alcoholism that would be
contraindicated with the use of acetaminophen.
- Patients with any known current addiction to pain medications.
- Patients that have, in the opinion of the clinical investigator, a clinically
significant diagnostic test and/or abnormal laboratory test result(s) that may place
the patient at a health risk, impact the study, or affect the patient's ability to
complete the study.
- Patients unable to or with any psychiatric illness that would prevent them to legally
comprehend the details and nature of the study.
- Patients who in the judgment of the clinician are likely to violate the protocol
regulations or unlikely to complete the study for any reason.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| TREAD-20: Trial of Hyalgan Three Injection-Regimen for the Treatment of Knee Pain Due to Osteoarthritis | NCT00130468 | Entailment |
5,350 | 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:
- Age 18- 50
- Non-pregnant
- Candidate for outpatient management
- Able to understand and follow instructions
- Vital signs stable
- No severe anemia
- No medical conditions requiring transfusion
Exclusion Criteria:
- Pregnancy
- Breast cancer current or in last 5 years
- Allergy to MPA or DMPA
- Previous hormonal therapies
- Unstable vital signs
- Bleeding excessive enough to require surgical therapy or hospital admission
- Desire for pregnancy in next 6 months
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding | NCT01148420 | Contradiction |
3,949 | 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:
- are between 30 and 85 years of age
- are clinically diagnosed with moderate to severe knee OA
- are recommended for synovial fluid aspiration
Exclusion Criteria:
- are clinically diagnosed with inflammatory arthritis
- had previous joint surgery in the study knee
- had injection in the study knee within the past 12 months
- have taken glucosamine and/or chondroitin supplements within the past 3 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 85 Years | Effects of Glucosamine on Joint Fluid in Osteoarthritis Patients | NCT01074476 | Entailment |
1,891 | 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:
- Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy
- Tumor located in the posterior wall of upper and middle third stomach estimated by
endoscopy and CT scan
- Informed consent
- Eastern Cooperative Oncology Group (ECOG): 0 ot 1
- American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ
Exclusion Criteria:
- Pregnancy or female in suckling period
- Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- Severe mental disease
- Emergency operation due to complication (bleeding, perforation or obstruction) caused
by primary tumor
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 75 Years | Laparoscopic Total Gastrectomy With Versus Without Bursectomy | NCT03117283 | Entailment |
3,132 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Healthy children
- Both girls and boys
- Children whose parents agree to participation in the study through verbal informed
consent
- Children whose parents sign a privacy notice
Exclusion Criteria:
- Children who present with any pathology that interferes with the free consumption of
water or with the proper execution of the study
- Children for whom it is not possible to obtain a baseline record of beverage
consumption
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 10 Years | Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Water Consume in Child | NCT03254615 | Contradiction |
6,450 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | - INCLUSION CRITERIA:
- Eligible participants must:
- Have a dermatologic condition, as determined by the PI or AIs, OR be at risk for
developing a dermatologic condition, as determined by the PI or AIs, OR be a
family member of a person with a dermatologic condition OR be a healthy
volunteer, as defined as a person with no known significant health problems.
- Be willing to provide biospecimens for research and clinical studies, and for
storage to be used for future research.
- Subjects of age greater than or equal to 2 years old are eligible.
- Ability of subject or Parents/guardian to understand and the willingness to sign
a written informed consent document.
EXCLUSION CRITERIA:
- Presence of conditions that, in the judgment of the investigator, may put the subject
at undue risk or make them unsuitable for participation in the study.
- Inability to comply with the requirements of the protocol.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
| Studies of Dermatologic Diseases Biospecimen Acquisition Protocol | NCT02471352 | Entailment |
2,221 | 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:
- Diagnosis of acute gout arthritis as defined by the American College of Rheumatology
1977 preliminary criteria;
- Male or non-pregnant, non-nursing female;
- 18-70 years of age;
- Gout attack less ≤48 hours;
- In the week before this observation, non-steroidal anti-inflammatory drugs and
analgesic drugs and drugs affecting uric acid metabolism were not taken;
- Subjects capable of giving informed consent;
Exclusion Criteria:
- failing to meet the diagnostic criteria;
- Evidence of uncontrolled concomitant cardiovascular, nervous system,hepatic or
gastrointestinal disease. Potential participants who have active concomitant disease
can only be eligible after discussion and agreement with the treating medical team;
- the patient is in critical condition and it is difficult to evaluate the effectiveness
and safety of the clinical observation;
- severe deformity, stiffness and labor loss of patients with advanced arthritis;
- known allergic to the drug used 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 18 Years old.
Subject must be at most 70 Years | Oral Huzhang Granules for Acute Gouty Arthritis | NCT04462666 | Contradiction |
5,879 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- age > 18 years old
- able to speak and read English
- chronic cough
Exclusion Criteria:
- Cigarette smoking within the past 6 months, or greater than 10 pack year history of
prior smoking
- Any self-reported or clinically diagnosed form of active lung disease, including
asthma and emphysema
- Symptoms of persistent rhinitis within the past three months
- Dysphagia
- Symptoms of acute viral upper respiratory tract infection or sinusitis within one
month of entry into the study
- Pregnancy - based on self report
- Abnormal chest radiograph
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.
| Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux | NCT00451841 | Contradiction |
926 | 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:
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive;
- Patients diagnosed with osteoarthritis of the knee, according to American College of
Rheumatology (ACR) guidelines, by meeting at least 3 of the following: age > 50,
morning stiffness < 30 minutes, crepitus on active motion, bone tenderness, bone
enlargement, no palpable warmth of synovium;
- Grade I, II or III using Kellgren-Lawrence classification on an X-Ray of the knee
- WOMAC pain subscale ≥ 8
- R square of the Focused Analgesia Selection Task (FAST) outcome value greater than
0.70
Exclusion Criteria:
- Patients with, or with a history of, any clinically significant disorders (including
fibromyalgia and other painful disorders) which may interfere with the primary
objectives of the study
- Patients treated in the previous 3 months with topical capsaicin or intra-articular
corticosteroids;
- Patients with a contra-indication for the use of Naproxen or acetaminophen;
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 80 Years | A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain | NCT02712957 | Entailment |
5,089 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria For Patients:
- PACE beneficiaries who filled at least one prescription for a drug of any type in the
year prior to the study
- At high risk for osteoporosis: women and men 75 years or older, patients taking
glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid
arthritis, and patients with a past fracture
- Have had an outpatient visit with a participating doctor based on Medicare outpatient
claims
Inclusion Criteria For Physicians:
- Primary prescribing physicians for PACE beneficiaries
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Patient- and Physician-Based Osteoporosis Education | NCT00073190 | Contradiction |
1,022 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Patients diagnosed with essential HTN (office BP>140/90mmHg) or patients receiving at
least one antihypertensive medication (ie. RAAA inhibitors or diuretic), aged 18-85
years of age.
- Patients with at least one of the following risk factors, organ damage or other
evidence of cardiovascular disease:
- Previous stroke
- Transient ischemic attack (TIA)
- Systemic embolism
- Diabetes mellitus type 2
- Obesity
- Obstructive sleep apnea (OSA)
- Dyslipidemia
- History of coronary artery disease (CAD)
- Valvular heart disease (VHD)
- Echocardiographic findings attributed to HTN (ie. diastolic dysfunction, LVH)
- White coat hypertension (WCH), masked hypertension (MH)
- Positive family history for rhythm disturbances
Exclusion Criteria:
- Patients already diagnosed with paroxysmal or permanent AF
- Severe renal insufficiency (eGFR according to MDRD formula <25ml/min/1.73m2)
- Patients unable to attend follow-up visits
- Clinical evidence of severe heart failure
- Suspected secondary HTN
- Mental disorders
- Patients with cancer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Association of Dipping Pattern or Early Morning Surge of BP With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Subjects With Hypertension (DIMOSPAF) | NCT02563379 | Entailment |
5,699 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Girls, with Turner syndrome or ISS; height standard deviation score (SDS) ≤ -2
- Bone age ≤ 12 years
- Normal birthweight
- Body mass index (BMI) = 10th-90th percentile
- Normal childhood activity; no physical or other limitations
- Normal, balanced diet (20-40% calories from fat)
Exclusion Criteria:
- Puberty (beyond Tanner Stage 1)
- Diabetes in subject or first degree relative
- Sex steroid therapy
- Chronic conditions requiring medication (treatment for hypothyroidism is permissible)
- Significant systemic disease (pulmonary, cardiac, renal, or other)
- Non-removable metal
Female
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 14 Years | Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature | NCT00121875 | Entailment |
6,693 | 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:
- 18 years old ≤age≤65 years of age,male.
- Hemophilia A or B patients with inhibitors.
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- Provide signed informed consent.
Exclusion Criteria:
- Have any coagulation disorder other than hemophilia A or B.
- Treat with prophylactic treatment of coagulation factor.
- Treat with anticoagulant within 7d of the time of study drug administration.
- Have an active, ongoing bleeding for which the patient is being treated, or treatment
for a bleeding was stopped within 7d of the time of study drug administration.
- Have a history of arterial and/or venous thromboembolic events.
- Have platelet count <100,000/mL.
- Severe liver or kidney disease.
- Accept major operation or blood transfusion within 1 month of the time of screening.
- HIV antibody positive.
- Have a known allergy to Blood product.
- Participate in other clinical research within 1 month of the time of study drug
administration.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor | NCT04747964 | Contradiction |
6,325 | 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:
- RT-PCR-confirmed COVID-19.
- Symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoea, loss of taste or
smell, diarrhea, falls or confusion)
- 70 years or older OR 50-69 years and 1 or more of the risk factors described in the
protocol
Exclusion Criteria:
- Life expectancy <28 days in the opinion of the treating physician
- Patient or legal representative is unable to provide written informed consent
- Symptomatic for 8 days or more
- Being admitted to the hospital at the informed consent procedure
- Known previous history of transfusion-related acute lung injury
- Known Immunoglobulin A (IgA) deficiency
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.
| Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study) | NCT04589949 | Entailment |
3,468 | 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:
- Diagnosed type 2 diabetes
- Age: 50-79 years old
- LDL-cholesterol more than 2.9 mmol/l
Exclusion Criteria:
- Current or previous (within 6 months) use of estrogen therapy
- Cancer
- Chronic gastrointestinal diseases
- Current use of antibiotics
- Any severe liver or renal diseases
- Systolic blood pressure more than 180 mmHg or phase 3 hypertension
- Any severe mental diseases
- Severe cardio- or cerebro-vascular diseases
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 79 Years | The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus | NCT00363233 | Entailment |
1,603 | 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:
- 18 years or older
- A household with at least one smoker and one nonsmoker
- Valid contact information
- English proficiency, both speaking and reading
Exclusion Criteria:
- Insufficient contact information
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Nonsmokers Helping Smokers Quit | NCT02010697 | Contradiction |
3,017 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Adult (age>18) male and female patients from participating study providers' practices
who have an established a doctor-patient relationship with their provider and require
a minimum of 2 primary care clinic visits/year based on historical clinic data.
Exclusion Criteria:
- Patients with significant communication disability (severe speech and hearing
impairment, severe dementia, or a mental health condition resulting in a
non-communicative patient);
- patients are considered mentally incompetent to provide informed written consent;
- a life expectancy of less than 1 year.
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.
| Patient Centered Evaluation of Computerized Patient Records System | NCT00935584 | Contradiction |
3,186 | 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. Clinician diagnosis of primary or secondary SjS.
2. Positive anti-SSA
3. Diagnosis of keratoconjunctivitis sicca defined by OSDI ≥ 25 and Schirmer's test ≤
5mm/5min in at least 1 eye.
4. Stable medications for past 4 weeks
Exclusion Criteria:
1. Age <18 or >75 at screening visit
2. Pregnant or nursing, or women of childbearing potential unwilling to use a medically
acceptable form of birth control
3. Unwilling or unable to stop the use of any artificial tear formulations containing
L-carnitine.
4. Taking any form of levocarnitine supplementation or nutritional supplements containing
L-carnitine within 2 months prior to enrollment
5. Unwilling to discontinue immunomodulatory (e.g. Restasis, Xiidra), anti-inflammatory
(e.g. steroid containing) eye drops, or serum tears for 1 month prior and throughout
the duration of the study
6. Unwilling to discontinue wearing contact lenses for 1 month prior and throughout the
duration of the study
7. Planned occlusion of the lacrimal puncta with either punctal plugs or cauterization
during the study
8. Laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), or
radial keratectomy
9. Ocular surgery/trauma in the last 6 months or planned during the study
10. History of ocular infection, including severe blepharitis, in the last 3 months
11. Active ocular allergy that, in the opinion of the investigator, would compromise
interpretation of the data
12. Elevated AST, ALT, alkaline phosphatase or bilirubin above the upper limit of normal
at screening
13. Renal insufficiency defined by a creatinine clearance of less than 30 ml/min (CKD-EPI
or MDRD formula)
14. Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the
investigational drug, whichever is longer) of the screening visit
15. Laboratory parameters at the pre-treatment visit showing any of the following abnormal
results: neutrophil count < 1,500/mm3; platelet count < 100,000/mm3; hemoglobin < 9
g/dL
16. Contraindications to the class of drugs under study, e.g. known hypersensitivity or
allergy to class of drugs or the investigational product
17. The patient has a known defect in oxidative phosphorylation (such as a confirmed
mitochondrial myopathy)
18. Any medical or psychiatric condition, which in the opinion of the investigator, places
the subject at unacceptable risk or which might compromise the validity of the
collected data
19. Allogeneic BMT or chemotherapy in the past 3 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Levocarnitine for Dry Eye in Sjogren's Syndrome | NCT03953703 | Entailment |
5,068 | 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. | - Female, aged 60-80,
- Postmenopausal greater than or equal to 5 years,
- BMD -2.5 to -4.0 at lumbar spine or femoral neck and one standard deviation below
young adult mean in the other site, or -2.0 with fracture.
- Vertebral fracture 0-1.
Exclusion Criteria:
- More than 1 vertebral fracture in lumbar spine or more than 4 fracture in the T-L
spine.
- Weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight.
- Present cardiac disease present.
- Diseases or conditions known to affect bone metabolism.
- Therapies with drugs that affect bone metabolism within 6 months.
- Fluoride or Biophosphonates at any time.
Female
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 80 Years | Combination Osteogenic Therapy in Established Osteoporosis | NCT00018447 | Contradiction |
2,532 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion criteria:
- Aged 6 months through 11 years
- Patients with atopic dermatitis
Exclusion criteria:
- Main itching scores are 4 or less than 2 on last three consecutive days before
registration.
- Patients who have itching only on face, head, or diaper area.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 11 Years | Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD) | NCT01244230 | Entailment |
3,613 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18
years of age.
- Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.
- Patients who are eligible and able to participate in the trial and who consent to do
so in writing after the purpose and nature of the investigation have been explained to
them.
Exclusion Criteria:
- History of endometrial ablation or dilatation and/or curettage within the 3 months
prior to screening
- Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to
screening
- Abnormal liver function or jaundice
- Renal insufficiency
- Other hormonal treatment (sexual steroids),
- Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous
myomas of any size, or myometrial myomas > than 3 cm, adenomyosis, atypical
hyperplasia, carcinoma)
- Abnormal uterine morphology
- Presence of ovarian cyst > 3 cm
- Lower genital tract infection
- Current or recurrent PID (present or recurrent pelvis infection (including history of
postpartum endometritis, infected miscarriage) during the past 3 months
- Uncontrolled hypertension
- Congenital or acquired valvular disease (including corrections with prosthetic valves)
- Known or suspected pregnancy
- Known or suspected hormone-dependent tumor
- BMI > 30
- Abnormal Pap smear test or other evidence of cervical/endometrial mancy
- Unexplained amenorrhea
- Known hypersensitivity to device material and/or Levonorgestrel
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding | NCT01695902 | Entailment |
6,830 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male and/or Female subjects with Hemophilia A.
- Subjects/parents/legal representatives must be able to comply with registry procedures
(informed consent/assent process, clinical visits, reporting of infusion and bleed
data, reporting of adverse events, etc).
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative, parent(s)/legal guardian) has
been informed of all pertinent aspects of the study.
Exclusion Criteria:
- Presence of any other bleeding disorder in addition to hemophilia A.
- Treatment with immunomodulatory therapy (e.g., intravenous immunoglobulin, routine
systemic corticosteroids, cyclosporins, anti-TNF agents) within 30 days prior to study
entry or planned use for the duration of their study participation.
- Subjects with a past history of, or current factor VIII inhibitor. For
laboratory-based assessments, any Bethesda inhibitor titer greater than the
laboratory's normal range or ≥0.6 BU/mL.
- Subjects with known hypersensitivity to the active substance or to any of the
excipients of Xyntha.
- Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.
- Unwilling or unable to follow the terms of the protocol.
- Any condition which may compromise the subject's ability to comply with and/or perform
study-related activities or that poses a clinical contraindication to study
participation (these conditions include, but are not limited to, inadequate medical
history to assure study eligibility; expectation of poor compliance in provision of
observations for study-related documentation), in the opinion of the Investigator.
- Participation in other studies involving investigational drug(s) (Phases 1-4) within
30 days before the current study begins and/or during study participation (exception
for studies on Xyntha).
- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A | NCT02492984 | Entailment |
5,037 | 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:
To be eligible for entry into the study, candidates must meet all the following criteria:
Be 18 years of age or older.
Able to provide informed consent.
Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET:
- The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and
confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic
- The diagnosis of primary (generalized or segmental), hemidystonia, or cervical
dystonia will be confirmed on clinical examination in the NIH Movement Disorders
Clinic
- The diagnosis of ET will be confirmed on clinical examination in the NIH Movement
Disorders Clinic (the diagnosis of ET will be based on bilateral, largely symmetric
postural or kinetic tremor involving hands and forearms that is visible and
persistent. Additional or isolated tremor in head may be present but there should be
the absence of abnormal posturing).
History of appropriate response to dopaminergic medication, with at least a 30% improvement
in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients OR:
Patients with tremor-dominant PD that do not respond to dopaminergic therapy and that
exhibit a tremor score of at least 2 for tremor severity on at least one side of the body
on the motor UPDRS examination.
Unsatisfactory clinical response to maximal medical management (with trials of both higher
and lower doses of drugs), including:
- good benefit from dopaminergic medication but associated with insufficient duration of
action or unacceptable side-effects OR
- intractable disabling motor fluctuations (severe off periods, dyskinesias, or freezing
spells) OR
- intractable symptoms of ET or dystonia impacting at least 2 activities of daily
living.
Agree to undergo DBS if indicated to treat medically refractory movement disorder.
EXCLUSION CRITERIA:
Candidates will be excluded if they meet any of the following criteria:
Clinically significant medical disease that would increase the risk of developing pre or
postoperative complications, including but not limited to uncontrolled systemic
hypertension with values above 170/100; active heart disease needing immediate
intervention; active respiratory disease needing immediate intervention; uncorrected
coagulation abnormalities or need for therapeutic anticoagulation which cannot be
interrupted; current or pre-existing life-threatening respiratory disease, such as
respiratory failure or ARDS.
Unable to complete cognitive assessments and testing necessary to adequately evaluate risks
and benefits of surgery
Evidence of secondary or atypical parkinsonism/dystonia/tremor as suggested by:
- History of CVA, exposure to toxins, neuroleptics, or encephalitis
- Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze
palsy, or orthostatic hypotension.
- MR-imaging with evidence indicative of secondary disease such as tumor, or stroke,
which could cause the movement disorder.
- Features atypical of idiopathic Parkinson s disease.
Dementia as evidenced by formal neuropsychological evaluation, Mattis Dementia Rating Scale
(DRS-2) score, and clinical evaluations.
Depression or evidenced by self-report on the Beck Depression Inventory-2 (score above 20).
Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm
clips, metallic prostheses (including metal pins and rods, heart valves or cochlear
implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that
welders and other metal workers may have, or if candidates are uncomfortable in small
closed spaces (have claustrophobia), or cannot lie comfortably on their back for up to one
hour.
Pregnant women.
Patients with tremor-dominant PD with Scans Without Evidence of Dopaminergic Effect (SWEDD)
will be excluded based on clinical and historic information, including DaT functional
imaging obtained during routine clinical evaluation of PD as needed.
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.
| Deep Brain Stimulation Surgery for Movement Disorders | NCT01581580 | Entailment |
1,933 | 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:
- AGC or EGC confirmed by endoscopy
- Histologically confirmed adenocarcinoma of stomach
- Helicobacter pylori infection was confirmed by biopsy and CLO
- Pre op CT stage: IA, IB, II, IIIA according to UICC TNM classification system
- Pre op biopsy (body LC side) shows either intestinal metaplasia or glandular atrophy
(at least grade 1)
- Tumor location is suitable for subtotal gastrectomy- i.e. at or distal to lower body
- Informed consent should be signed
Exclusion Criteria:
- Recurrent gastric cancer
- Previous serious side effect to antibiotics
- H. pylori eradication treatment history
- Other malignancy within the past 5 years
- Pregnant or nursing women
- Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal
failure, cardiovascular diseases
- Psychiatric disorder that would preclude compliance
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 | Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer | NCT01002443 | Entailment |
1,976 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients who are scheduled for upper endoscopy and agree to the terms of "fast track"
offer.
Exclusion Criteria:
- If a patient expresses concern about service denial, confusion about the bargain, or
refuses to participate, the investigators will schedule these patients routinely.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Reducing VA No-Shows: Evaluation of Predictive Overbooking Applied to Colonoscopy | NCT01639443 | Entailment |
301 | 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:
- Diagnosis of a urinary tract infection with complicating factors such as anatomical or
functional abnormalities
- capable of taking medication by mouth
- previous antibacterial therapy of less than 24 hours, or previous antibacterial
therapy of greater than 24 hours that did not eliminate or stabilize the infection.
Exclusion Criteria:
- Patients having any medical condition that requires antimicrobial therapy to be given
intravenously or by hypodermic needle
- complete obstruction of any part of the urinary tract
- inflammation of the prostate gland
- previous allergic or serious adverse reaction to similar antibiotics
- pregnant or nursing females, or those lacking adequate contraception.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections | NCT00258089 | Contradiction |
6,062 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Adult Subjects (From 16 to 85 years old)
- The subjects with GERD symptom who received 8 week PPI therapy
Exclusion Criteria:
- Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal
motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and
systemic disease requiring chronic medication (except for hypertension and diabetes
mellitus)
- Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 85 Years | Analysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life | NCT01536080 | Entailment |
5,191 | 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:
- Subject has provided informed consent/assent prior to initiation of any studyspecific
activities/procedures, or subject's legally acceptable representative has provided
informed consent prior to any study-specific activities/procedures being initiated
when the subject has any kind of condition that, in the opinion of the Investigator,
may compromise the ability of the subject to give written informed consent.
- Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or
spotting for 12 consecutive months prior to screening)
-≥ 55 to ≤ 90 years of age at the time of informed consent
- Ambulatory
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by
the central imaging vendor at the time of screening, based on DXA scans -Subject has
at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the
principal investigator or designee
- Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator
or designee
- Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets
at least 2 of the following clinical risk factors for fracture
- ≥ 70 years of age at the time of informed consent
- BMD T-score ≤ -3.00 at the lumbar spine, total hip, or femoral neck, as assessed
by the central imaging vendor at the time of screening, based on DXA scans
- current smoker
- consumption of ≥ 3 glasses of alcohol a day
- parental history of fragility (ie, osteoporosis-related) fracture
- body weight ≤ 125 pounds/56 kilogram
- Ability to follow and understand instructions and the ability to self-inject, per
investigator judgement
Exclusion Criteria:
- History of osteonecrosis of the jaw and/or atypical femoral fracture
- History of metabolic or bone disease (except osteoporosis) that may interfere with the
interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid
arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing
spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
- Subject with reported history of hearing loss associated with cranial nerve VIII
compression due to excessive bone growth (eg, as seen in conditions such as Paget's
disease, sclerosteosis and osteopetrosis)
- Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as
determined by the central laboratory. Vitamin D repletion will be permitted a nd
subjects may be rescreened
- Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by
subject report or by chart review, per principal investigator evaluation
- Current clinical hypothyroidism (unless well controlled on stable thyroid replacement
therapy) by subject report or by chart review, per principal investigator evaluation
normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined
as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent
hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in
normocalcemic subjects.
- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the
normal range, as assessed by the central laboratory. Serum calcium levels may be
retested once in case of an elevated serum calcium level within 1.1x the ULN as
assessed by the central laboratory
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 Years | A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis | NCT03432533 | Entailment |
27 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. ED complaint ongoing for over 3 months;
2. Age comprise between 45 and 80 years old;
3. Had a stable heterosexual relationship for more than 3 months and anticipates having
the same partner for all the study
4. Has not responded adequately to the highest available dosage of Tadalafil or other
PDE5 inhibitors (20 mg for Tadalafil and Vardenafil, 100 mg for Sildenafil) taken at
least at 4 separate occasions, defined as: a score of 2,3 or 4 at Question 3 of the
IIEF AND a score of 2 or 3 at Question 4 of the IIEF; measured prior to Visit 1
5. Low or low-to-normal serum testosterone level (either on total or bioavailable
testosterone levels) with respect to the range of men under aged than 50 y.o. (TT < 4
ng/ml and/or BT < 1 ng/ml) according to a first assay done prior to Visit 1 and a
confirmation by a second assay at central laboratory Biolille on blood sampled at
Visit 1
6. Agrees to make at least 4 attempts at sexual intercourse on 4 separate days during the
4 weeks run-in period with daily Tadalafil 10 mg
7. At least 50% of attempts during this period must be unsuccessful according an answer
"No" at one of the questions 1 ("were you able to achieve at least some erection (some
enlargement of the penis)?"), 2 ("were you able to insert your penis in your partner's
vagina?") or 3 ("did your erection last long enough for you to have successful
intercourse?").
8. At the end of the run in phase with Tadalafil 10 mg daily, the patient should provide:
a score of 2, 3 or 4 at Question n°3 of the IIEF AND a score of 2, 3 at Question n°4
of the IIEF
9. Agrees not to use any other ED drug or non-drug (devices) treatment during the full
course of the study;
10. Provides a signed informed consent.
Exclusion Criteria:
1. Impotence caused by other primary sexual disorder (e.g. premature ejaculation);
2. History of penile implant or significant penile deformity;
3. Body mass index >35kg/m2;
4. Diabetes mellitus that is uncontrolled (HbA1c level > 10%). HbA1c will be checked at
screening for each diabetic patient or suspected to be;
5. Uncontrolled thyroid disorders;
6. Known hyperprolactinemia (serum prolactin > 30ng/ml in local laboratory);
7. Organic hypothalamic-pituitary pathology;
8. History of alcohol, drug or substance abuse within 6 months before Visit 1;
9. Renal insufficiency defined as receiving renal dialysis, having a creatinine clearance
< 30 ml/mn, or serum creatinine > 30 mg/ml;
10. Severe hepatic impairment, Child Pugh class C, elevation of AST and/or ALT > 3 x the
ULN;
11. Systolic Blood Pressure > 170 or < 90 mm Hg or diastolic blood pressure > 110 or < 50
mm Hg at screening;
12. Cardiac disease contra-indicating any sexual activity;
13. Unstable angina within 6 months before Visit 1;
14. Angina during sexual intercourse within 6 months before Visit 1;
15. Myocardial Infarction within 90 days before Visit 1;
16. Coronary artery by-pass graft surgery or percutaneous coronary intervention
(angioplasty or stent insert) within 90 days before Visit 1;
17. Severe cardiac rhythm disturbances e.g. supraventricular arrhythmia with a ventricular
response >100 bpm. at rest despite medical or device therapy, history of refractory
spontaneous or induced sustained ventricular tachycardia (heart rate > 100 bpm. for >
30 sec) or fibrillation, automatic internal cardioverter-defibrillator, history of
sudden cardiac arrest) within 6 months before Visit 1;
18. Known new and significant conduction defect that was not evaluated with regard to
significance within 90 days prior to Visit 1;
19. Congestive heart failure (NYHA Class II or above) within 6 months before Visit 1;
20. History of stroke within the 6 last months;
21. Epilepsy not adequately controlled by treatment;
22. Polycythemia with hematocrit >52% at study entry (i.e. screening visit/visit 1);
23. Suspicion of current, or past history of prostate or breast cancer;
24. Severe symptomatic Benign Prostate Hyperplasia;
25. PSA value exceeding the age specific reference ranges published by Richardson and
Oesterling, Urol Clin North Am, 1997, 24: 339-351
26. Diagnosed sleep apnea;
27. Extensive skin abnormalities that could affect absorption of the gel;
28. Any clinically significant chronic disease that might, in the opinion of the
investigator, compromise patient's safety, interfere with the evaluations, or preclude
completion of the trial (e.g. hemochromatosis, chronic lung disease, chronic
malabsorption disease);
29. History of HIV infection;
30. Severe psychiatric disease;
31. Illiteracy, lack of fluency in the language used for the writing of the protocol and
questionnaires, unwillingness, medical, psychiatric or other conditions that
compromise the patient's ability to understand the patient information, to give
informed consent, to understand or complete diary or questionnaires or otherwise
comply with the trial protocol, or to complete the study;
32. Known hypersensitivity to Cialis(Tadalafil);
33. Hypersensitivity to the active substances or any of the excipients of Androgel®/
Testogel®;
34. Use of androgen therapy or anabolic steroids within 6 months of entry into the study
(i.e. screening visit/visit 1);
35. Concurrent use of the following medications:
androgens including dehydroepiandrosterone (DHEA) and anabolic steroids,
antiandrogens, estrogens, corticotrophin (ACTH), oxyphenylbutazone, clomipramine,
Serotonin Reuptake Inhibitors, long or short-acting nitrates, NO donors, potent
cytochrome P3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, saquinavir,
macrolides like erythromycin), cancer chemotherapy;
36. Patients unwilling to cease use of vacuum devices, intracavernosal injection, Viagra,
or other therapy for ED;
37. Patients seeking conception or on treatment for infertility;
38. Concurrent participation in another clinical trial within 1 month of entry into this
study (i.e. screening visit/visit 1) or throughout the duration of the study;
39. Previous randomization into this study.
40. History of temporary or permanent partial or complete blindness
Male
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Double-Blind, Placebo Controlled Randomized Study of Co-Administering Testosterone With PDE5 Inhibitors in Patients Non-Responders to PDE5 Inhibitors Alone | NCT00244023 | Contradiction |
320 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Age 21 through 45 years (inclusive) at Screening
2. Able and willing to provide written informed consent
3. Able and willing to comply with all study procedure requirements, including, clinical
and laboratory assessments, vaginal and rectal examinations, urine and blood testing,
as well as attendance at all scheduled study visits
4. In general good health at Screening and Enrollment as determined by the Investigator
of Record (IoR)/ or designee
5. Negative pregnancy test at Screening and Enrollment
6. HIV-negative at Screening and Enrollment
7. Able and willing to provide adequate locator information
8. Willingness to use study-provided male condoms for the duration of study participation
for penetrative intercourse
9. Per participant report at Screening, regular menstrual cycles with at least 21 days
between menses (does not apply to participants who report using a progestin-only
method of contraception at screening, e.g., Depo-Provera, progesterone-containing IUDs
or extended use of oral contraceptives)
10. Per participant report at Enrollment, using an effective method of contraception and
intending to use an effective method for the duration of study participation;
effective methods include:
- Hormonal methods, excluding vaginal rings
- Intrauterine device (IUD) inserted at least 42 days prior to Enrollment (but not
past the maximum length of recommended usage according to package instructions)
- Sterilization of participant or partner at least 42 days prior to Enrollment
- Self-identifies as a woman who has sex with women exclusively
- Sexually abstinent for the at least 90 days prior to enrollment and the intention
to remain sexually abstinent for the duration of study participation
11. Per participant report at Screening, states a willingness to refrain from inserting
any non-study vaginal or rectal products or objects into the vagina or rectum,
including but not limited to, spermicides, female condoms, diaphragms, contraceptive
vaginal rings, vaginal medications, menstrual cups, cervical caps (or any other
vaginal barrier method), vaginal/rectal douches, enemas, non-study approved
lubricants, sex toys (vibrators, dildos, etc.), and tampons for the duration of the
study product use periods and for 24 hours prior to each scheduled study clinic visit.
12. Pap result consistent with Grade 0 according to the Female Genital Grading Table for
Use in Microbicide Studies Addendum 1 to the Division of AIDS (DAIDS) Table for
Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004
(Clarification dated August 2009) or satisfactory evaluation of non-Grade 0 Pap result
with no treatment required per clinical judgment of IoR or designee in the 12 calendar
months prior to the Enrollment Visit
13. At Screening, participant agrees not to take part in other research studies involving
drugs, medical devices, or vaginal/rectal products for the duration of study
participation (including the time between the Screening and Enrollment visits)
Participants in the biopsy subset must also meet the following criteria at Screening
to be eligible for inclusion:
14. Willing to abstain from inserting anything into the vagina or rectum for 72 hours
prior to and following the collection of these samples, including vaginal and rectal
intercourse
15. Willing to restrict the use of non-steroidal anti-inflammatory drugs (NSAIDs), aspirin
and/or other drugs that are associated with the increased likelihood of bleeding
following mucosal biopsy collection for 72 hours prior to and following the collection
biopsies
Exclusion Criteria:
1. Participant report of any of the following:
1. Known adverse reaction to the study product (ever)
2. Known adverse reaction to latex (ever)
3. Current male sex partner with known history of adverse reaction to latex (ever)
4. History of serum HBsAg positivity (ever)
5. Non-therapeutic injection drug use in the 12 calendar months prior to Enrollment
6. STI or reproductive tract infection (RTI) requiring treatment in the 6 calendar
months prior to Enrollment
7. Post-exposure prophylaxis (PEP) for possible HIV-1 infection within the 6
calendar months prior to Enrollment
8. Last pregnancy outcome within 90 days or less prior to Enrollment
9. Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage)
within the 42 days prior to Enrollment Note: This does not include biopsy for the
evaluation of an abnormal pap result or endometrial biopsy that occurred more
than 7 days prior to Enrollment, provided that all other inclusion/exclusion
criteria are met.
10. Participation in any other research study involving drugs, medical devices or
vaginal products 42 days or less prior to Enrollment
11. Anticipated IUD replacement within the next 3 months or an IUD inserted 42 days
or less prior to Enrollment
12. Participant report at Screening and/or Enrollment intention of becoming pregnant
in the next 3 months
13. Currently breastfeeding at the time of Screening and/or Enrollment
14. History of bleeding problems (Participants in the biopsy subset only)
2. Laboratory abnormalities at Screening greater than or equal to a Grade 2*:
1. Aspartate aminotransferase (AST) or alanine transaminase (ALT)
2. Hemoglobin
3. Platelet count
4. Serum creatinine Otherwise eligible participants with an exclusionary test
result(s) listed above may be re-tested during the screening process. If a
participant is re-tested and a non-exclusionary result is documented within the
42 days of providing informed consent, the participant may be enrolled.
3. Urinary tract infection (UTI) at Screening and/or Enrollment Note: Otherwise eligible
participants diagnosed with UTI during Screening will be offered treatment and may be
enrolled after completing treatment and all symptoms have resolved. If treatment is
completed and symptoms have resolved within 42 days of obtaining informed consent, the
participant may be enrolled.
4. Pelvic inflammatory disease or an STI or RTI requiring treatment per current WHO
guidelines at Screening and/or Enrollment
5. Clinically apparent Grade 2 or higher pelvic** and/or rectal*** examination finding
(observed by study staff) at Screening and/or Enrollment Note: Cervical bleeding
associated with speculum insertion and/or specimen collection judged to be within the
range of normal according to the clinical judgment of the IoR/designee is considered
expected non-menstrual bleeding and is not exclusionary.
Note: Otherwise eligible participants with exclusionary pelvic and/or rectal
examination findings may be enrolled/randomized after the findings have improved to a
non-exclusionary severity grading or resolved. If improvement to a non-exclusionary
grade or resolution is documented within 42 days of providing informed consent, the
participant may be enrolled.
6. Any other condition that, in the opinion of the IoR/designee, would preclude informed
consent, make study participation unsafe, complicate interpretation of study outcome
data, or otherwise interfere with achieving the study objectives
- per the Division of AIDS Table for Grading the Severity of Adult and Pediatric
Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009) **
per the Division of AIDS Table for Grading the Severity of Adult and Pediatric
Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009),
Addendum 1 Female Genital Grading Table for Use in Microbicide Studies *** per
the Division of AIDS Table for Grading the Severity of Adult and Pediatric
Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009),
Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification
dated May 2012).
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel | NCT01768962 | Contradiction |
6,935 | 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:
1. Subjects must be diagnosed with probable AD in accordance with the National Institute
on Aging and Alzheimer's Association (NIA-AA) (2011) criteria.
2. Subjects must have a Mini-Mental State Examination (MMSE) score of ≥15 and ≤26 at
screening and baseline.
3. Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistent
with a clinical diagnosis of probable AD.
4. Subjects should not have received Aβ-based or tau-based treatment for AD.
5. Subjects who were previously treated with Acetyl cholinesterase inhibitor (AChEI) or
memantine, must have been off of the therapy for at least 3 months prior to baseline
assessments. Subjects who have been taking AChEI or memantine for ≤7 days may be
considered for enrollment in this study.
6. For subjects who are currently receiving other non-excluded prescription or
over-the-counter medications that might affect cognitive function (eg,
non-anticholinergic antidepressants, atypical antipsychotics, non-benzodiazepine
anxiolytics, soporifics, centrally acting anticholinergic antihistamines, centrally
acting anticholinergic antispasmodics):
- Treatment must be at a stable dose for ≥1 month prior to randomization and
throughout the duration of the study.
- Treatment given intermittently and on a short-term basis must not be administered
within 5 half-lives prior to the screening of neurocognitive assessments.
7. Subjects must be male or female between 50 years to 85 years of age (inclusive), at
screening.
8. Female subjects must be post-menopausal for at least 2 consecutive years or surgically
sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at
least 6 months prior to screening.
9. Male subjects with partners of reproductive potential must agree to use a reliable
means of contraception (eg, minimum condom + spermicide) during the study and 30 days
after discontinuing the study drug.
10. Subjects must have a reliable caregiver with contact at least 3 times per week
(combination of face to face visits and telephone contact acceptable). The caregiver
must be able to oversee the subject's compliance with study drug and participate in
the subject's clinical assessment, to provide meaningful input into the NPI, ADCS-ADL,
and CIBIC+.
11. Subjects (or subject's legally authorized representatives and their caregivers) must
be able to provide informed consent.
12. Subjects (and their caregivers) must be able to read, write, speak, and understand
English to ensure compliance with cognitive testing and study visit procedures.
13. Subjects (and their caregivers) must be willing and able to comply with the protocol's
requirements.
14. Subjects must weigh between 45 kg and 90 kg (inclusive), at screening.
15. Subjects must be in general good health in the opinion of the Investigator, based on
medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) in
triplicate, and clinical laboratory values.
Exclusion Criteria:
1. Lack of peripheral venous access.
2. Uncorrected impairment of vision or hearing that would preclude the subject from
taking tests, or subjects lacking the ability to communicate.
3. Inability to tolerate MRI procedures or contraindication to MRI, including but not
limited to MRI incompatible pacemakers; implantable cardioverter defibrillators;
cochlear implants; cerebral aneurysm clips; implanted infusion pumps; implanted nerve
stimulators; metallic splinters in the eye; other magnetic, electronic, or mechanical
implants; or any other clinical history or examination finding that, in the judgment
of the Investigator, would pose a potential hazard in combination with MRI.
4. Severe or unstable medical condition that, in the opinion of the Investigator or
Sponsor, would interfere with the subject's ability to complete the study assessments.
5. History or presence of clinically evident vascular disease potentially affecting the
brain (eg, stroke, clinically significant carotid or vertebral stenosis or plaque,
aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous
malformation).
6. History of severe, clinically significant (persistent neurologic deficit or structural
brain damage) central nervous system trauma (eg, cerebral contusion).
7. History or presence of intracranial tumor (eg, meningioma, glioma).
8. Presence of infections that affect the brain function or history of infections that
resulted in neurologic sequelae (eg, syphilis, neuroborreliosis, viral or bacterial
meningitis/encephalitis,human immunodeficiency virus encephalopathy).
9. History or presence of systemic autoimmune disorders potentially causing progressive
neurologic disease (eg, multiple sclerosis, lupus erythematosus, anti-phospholipid
antibody syndrome, Behçet disease).
10. History or presence of psychiatric disease other than AD that may affect cognition or
prevent completion of study procedures, including but not limited to clinically
significant major psychiatric disorder according to the criteria of the Diagnostic and
Statistical Manual of Mental Disorders-V (DSM-V) (eg, major depression, schizophrenia,
bipolar disorder).
• A history of major depression is acceptable if no episode has been reported within
the previous 5 years.
11. History or presence of a neurologic disease other than AD that may affect cognition,
including but not limited to Parkinson's disease, corticobasal degeneration, dementia
with Lewy bodies, Creutzfeldt-Jakob disease, progressive supranuclear palsy,
frontotemporal degeneration, Huntington's disease, normal pressure hydrocephalus, and
hypoxia.
12. History of seizures with the exception of childhood febrile seizures.
13. Known or suspected history of alcohol or drug abuse within the previous 5 years (DSM-V
criteria).
14. Evidence of malignancies, acute infections, renal failure that requires dialysis, or
other unstable medical disease not related to AD that in the Investigator's opinion
would preclude subject participation.
• This does not include any cancer (except adequately treated basal or squamous cell
skin cancer) that is not being actively treated with anti-cancer drugs or radiotherapy
as well as cancers that are considered to have low probability of recurrence (with
supporting documentation of this from the treating oncologist, if possible).
15. History or presence of atrial fibrillation that poses a risk for future stroke in the
Investigator's judgment.
16. Severe heart disease (history of myocardial infarction, congestive heart disease,
history of unstable angina pectoris, clinically significant ECG abnormality) within 6
months prior to screening. Subjects with peripheral arterial disease will not be
excluded if they are stable for at least 6 months prior to screening.
17. Clinically significant vital signs, laboratory, or ECG abnormalities (eg, abnormally
prolonged or shortened heart rate, clinical significant arrhythmias, corrected QT
interval [QTcF] >450 ms) in the Investigator's judgement. ECG abnormalities should be
confirmed by Investigator based on the central read results provided by the ECG core
laboratory (Medpace Cardiovascular Core Laboratory [MCCL]).
18. Subjects must not have an estimated glomerular filtration rate of <30 mL/min/1.73 m2,
at screening.
19. Impaired hepatic function, as indicated by transaminases >2 times the upper limit of
normal or abnormalities in synthetic function tests judged by the Investigator to be
clinically significant.
20. Evidence of poorly-controlled diabetes (glycosylated hemoglobin >8.0%).
21. Presence of superficial siderosis of central nervous system, or >4 cerebral
microhemorrhages, or evidence of a prior cerebral macrohemorrhage as assessed by
T2*-weighted gradient-recalled-echo (GRE) MRI.
22. Presence of significant cerebral vascular pathology as assessed by MRI.
23. Treatment with any investigational agent within 5 half-lives or 4 weeks prior to
screening, whichever is longer.
24. Cognitive dysfunction that might be due to past or current medication (eg,
chemotherapy, steroids).
25. Treatment with any biologic therapy within 5 half-lives or 3 months prior to
screening, whichever is longer, or any subject who has been in an Alzheimer Aβ or tau
vaccination trial unless known to have received only placebo.
26. Treatment with anticholinergic antidepressants, typical antipsychotics, or
barbiturates.
27. Chronic use of opiates, opioids, or benzodiazepines:
• Intermittent short-term use is allowed except within 5 half-lives prior to any
neurocognitive assessment.
28. Use or intention to use any medications/products that are cytochrome P450 (CYP)3A4
substrates with narrow therapeutic indexes.
29. Use or intention to use any medications/products that are known to be strong
inducers/inhibitors of CYP3A4 within 7 days prior to the first dose and throughout the
period of study drug administration.
30. Consumption of grapefruit juice or grapefruit-containing products within 7 days prior
to the first dose and throughout the period of study drug administration.
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 | Efficacy and Safety of AD-35 in Treatment of Subjects With Mild to Moderate Alzheimer's Disease | NCT03625401 | Entailment |
424 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- women undergoing IVF/ICSI with POR according to the Bologna criteria
Exclusion Criteria:
- Body mass index >35 Kg/m2.
- women with a single ovary.
- Allergy to DHEA.
- Diabetic women on insulin as insulin lowers DHEA levels and might reduce its
effectiveness
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 43 Years | Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response | NCT02736591 | Contradiction |
6,042 | 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:
- Primary diagnosis: Current evidence of symptomatic GERD/NERD that comply with the
Montreal definition of GERD/Nonerosive Esophageal Reflux Disease (NERD). GERD is a
condition which develops when the reflux of stomach contents causes troublesome
symptoms and/or complications. The concept of NERD is preserved in the typical reflux
syndrome without esophageal injury, while reflux esophagitis falls under the category
of esophageal syndromes with esophageal injury.
- GERD status: patients will be recruited by the Investigator from out-patient clinics,
hospital database or those who respond to the advertising. Patients must have a GERD
history of frequent episodes of GERD-related symptoms during the last 3 months, and
must have had troublesome heartburn and/or regurgitation of at least moderate
intensity on at least 4 days during the week before the start of screening.
- Patients must be sufficiently literate to be able to complete the RDQ unaided.
Exclusion Criteria:
- Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥
140g).
- Patients who have suffered cardiac chest pain within the last year.
- Patients who have suffered a recent, significant unexplained weight loss of more than
6 kg in the last 6 months.
- Female patients of childbearing potential who, for the duration of the study, are
either unwilling or unable to take adequate contraceptive precautions or are unwilling
to be sexually abstinent.
- Pregnancy or lactating mother.
- Patients with a history and/or symptom profile suggestive of the following: any other
gastrointestinal (GI) disease (e.g. gastric or duodenal erosions and polyps larger
than 0.5 cm), erosive GERD (Los Angeles [LA] classification grades C-D), Barrett's
esophagus, peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome,
gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal
obstruction, current pernicious anaemia, indication for H-pylori eradication, hiatal
hernias greater than 3 cm, known gastro-intestinal bleeding (hematochezia or
hematemesis) within the last 3 months, and severe diseases of other major body
systems.
- Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for
treating gastrointestinal disease, Ulcermin or misoprostol preparations within 7 days
prior to screening or throughout the study.
- Patients who have taken Proton Pump Inhibitors (PPIs) during the 10 days prior to
screening, prokinetics or H2 antagonists during the 5 days prior to screening, or
systemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs except
low dose aspirin given for cardioprotection) on more than 3 consecutive days during
the last 28 days prior to screening or PPI-based triple or quadruple therapy for
eradication of H-pylori during the last 28 days prior to screening and throughout the
study.
- Patients who have taken any antacids within 24 hours before randomisation (Visit 2)
and are unwilling or unable to withhold from taking them for the duration of the
study.
- Patients taking mucous membrane protection drugs or motility stimulants within the 5
days prior to screening and are unwilling or unable to withhold from taking them for
the duration of the study.
- Patients with difficulty in swallowing.
- Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
- Patients with severe constipation, or history of intestinal obstruction.
- In the opinion of the Investigator, patients with insufficient heart or kidney
function and patients who require a low sodium diet.
- Patients with any co-existing condition which, in the opinion of the Investigator,
would be likely to compromise patient safety or interfere with assessment of efficacy.
- Patients with any clinically significant abnormal laboratory values.
- Patients with severe/impaired renal function or insufficiency.
- Any previous history of allergy or known intolerance to any of the formulation
constituents.
- Relevant clinically significant abnormalities in the physical examination, ECG and
safety analysis.
- Previously randomised into the study.
- Employee at study site.
- Partner or first-degree relative (e.g. parents, siblings or children) of the
Investigator.
- Participation in a clinical study in the previous 6 months.
- Unable in the opinion of the Investigator to comply fully with the study requirements.
- Patients taking or requiring to take macrolide antibiotics, such as erythromycin,
azithromycin, from the day before screening
- Patients who failed screening will not be allowed to re-enter the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study | NCT02623062 | Entailment |
3,870 | 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:
- Aged 45 years and onward.
- Clinical diagnosis of knee arthritis with complaints of knee pain for 3-6 months,
early morning stiffness <30 minutes, crepitus, bony tenderness, and no palpable warmth
and radiographically established osteoarthritis (at least score 1 on K/L scale)
- Able to read and write English
- Able to use/access computer or tablet and have access to internet
Exclusion Criteria:
- Inability to give informed consent - (capacity levels are already established under
General practitioner care)
- Terminal or mental illness
- Neurological conditions, inflammatory joint diseases including rheumatoid arthritis,
gout or calcium pyrophosphate deposition disease (CPPD), and dementia
- Patients with sleep apnea
- Acute soft tissue injury to the knee within last 3 months before recruiting
- Unstable heart condition or rapid fluctuations in hypertension
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.
| Effects of Internet / Web-based Exercises on the Population With Knee Arthritis | NCT03545048 | Entailment |
3,429 | 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:
- On a stable dose of >/= 40 mg Simvastatin or atorvastatin daily for >/= 3 months prior
to baseline and expected to remain on this dose for the remainder of the study
- LDL-cholesterol between 2.60 and 5.70 mmol/L (100 and 220 mg/dL), inclusive at
screening
- Females not of childbearing potential.
Exclusion Criteria:
- History of CHD or CHD-equivalent (such as diabetes mellitus, or another clinical form
of atherosclerotic disease, e.g., peripheral arterial disease, abdominal aortic
aneurysm, or symptomatic carotid artery disease)
- Fasting triglyceride >2.26 mmol/L (200 mg/dL) at screening
- Any uncontrolled medical/surgical/psychiatric condition, including conditions that may
predispose to secondary hypercholesterolemia
- Current diagnosis or known history of complement deficiency or abnormality
- A positive hepatitis B surface antigen or hepatitis C antibody, or a known positive
HIV status
- Current diagnosis or known history of liver disease, or has an ALT >ULN at screening
- Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained
muscle pain, or has a CPK >ULN at screening
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin
that has been adequately treated
- The advisability of a subject taking any prescription medication (apart from
simvastatin or atorvastatin) within 6 weeks prior to screening should be discussed
with the Isis Medical Monitor
- Subject unwilling to discontinue taking alternative/herbal medication for the duration
of the study
- History of drug abuse within 2 years of screening
- Subject unwilling to limit alcohol consumption for the duration of the study: male
subjects to a maximum of 3 drinks (30 g) per day, and <12 drinks (120 g) per week;
female subjects to a maximum of 2 drinks (20 g) per day, and <8 drinks (80 g) per week
- Known allergy or hypersensitivity to simvastatin
- Undergoing or has undergone treatment with another investigational drug, biologic
agent, or device within 3 months, or 3 half lives, prior to screening, whichever is
longer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Dose-escalating Safety Study in Subjects on Stable Statin Therapy | NCT00231569 | Entailment |
5,020 | 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:
- Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.
- Tremor has to be severe enough to produce disability.
- Patients must sign a written informed consent according with the approval of the
Regional Ethical Board of University of Pécs
Exclusion Criteria:
- Exclusion criteria are established in accordance to the guidelines of Elble et al3.
- Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism,
drug withdrawal, neuropathy, etc.).
- Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g.
dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)
- Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic
tremor, task-specific tremor, etc.)
- Presence or suspicion of psychogenic tremor
- Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate,
etc.)
- Concomitant administration of any drugs potentially capable of improving ET (e.g.
antiepileptics, beta-receptor blockers).
- Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).
- Presence of serious concomitant disorders capable of interfering with the study (e.g.
heart failure, tumorous disorders, etc.)
- Presence of any contraindication for pramipexole treatment (e.g. impulsive control
disorder, known hypersensitivity to any components of the tablets, etc.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor | NCT01441284 | Entailment |
2,544 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria
1. Able to comprehend and follow the requirements of the study (including availability on
scheduled visit dates) based upon research site personnel's assessment;
2. Caregiver is able and willing to provide written informed consent for the participant
to participate in the trial;
3. Male or female of any race or ethnicity, 2 months to 35 months of age;
4. Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by
Hanifin and Rajka
5. Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per
Rajka-Langeland severity index
6. Willing to stop all emollients, moisturizers and/or other skin barrier cream or
emulsion treatments for the AD condition during the test period. If using
corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be
on a stable dose for a minimum of 1 month;
7. Willing to undergo a washout period of 2 days before the trial initiation where no use
of moisturizers or emollients will be allowed; and
8. Willing and able to comply with scheduled visits, treatment plan, and other trial
procedures.
Exclusion Criteria:
1. Known sensitivity to any investigational product ingredient;
2. Use of a therapeutic (over the counter or prescription) body wash that contains an
active ingredient for eczema;
3. Participation in any clinical study within 30 days of Visit 1;
4. Relative, partner or staff of any clinical research site personnel;
5. Active infection of any type at the start of the study;
6. Severe AD as determined by the Rajka-Langeland Severity Index
7. AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical
corticosteroids. If a participant requires any of these medications as rescue therapy
during the study, the participant will be discontinued from the trial;
8. Requires any inhaled or intranasal corticosteroids;
9. Other medical condition that may increase the risk associated with study participation
or investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the participant
inappropriate for entry into this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Months old.
Subject must be at most 35 Months | A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin | NCT02120833 | Entailment |
4,058 | 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:
- Osteoarthritis of the knee for a minimum of six months
- Patient´s rating of pain in the index knee while not taking oral NSAIDs of at least 3
using a 5-point Likert scale
- Presenting two out of the three following criteria - Morning stiffness of less than 30
minutes duration, Crepitus on motion, Age >= 40 years
- Patients must have used oral NSAIDs at least 3 days per week for the 3 months prior to
screening or the patient was taking an NSAID on a regular basis (>25 out of 30 days)
at a therapeutic level for at least 30 days prior to screening
- Each of the following three criteria (the osteoarthritis flare criteria) must be met -
Index knee pain assessment at walking at least 40 mm on VAS at baseline, Increase of
index knee pain at walking by at least 15 mm on VAS at baseline compared to screening,
Physician´s global assessment of osteoarthritis 3-5 and at least 1 grade increase from
screening
Exclusion Criteria:
- Grade 1 or Grade 4 severity of the index knee based on Kellgren and Lawrence
radiographic criteria
- Intraarticular injections or arthroscopy of the index knee within 3 months prior to
screening
- Signs of any clinically important inflammation of the index knee including redness,
warmth and or a large bulging effusion with the loss of normal contour
- Crystalline-induced synovitis in the index knee
- History, physical examination or radiographic suggestive of acute inflammatory
arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout,
pseudogout, fibromyalgia, lupus erythematosus, or other types of inflammatory
arthritis of the index knee
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee | NCT00317733 | Entailment |
1,156 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Age ≥ 18 years.
- Patients with a previous thoracentesis of a unilateral exudative pleural effusion
according to Light's criteria (1) without malignant cells.
- CT thorax or PET-CT with contrast performed.
- Clinical suspicion of cancer such as (but not limited to) weight loss or PET-CT
results or former cancer diagnosis.
- Patients must be able to give informed consent.
Exclusion Criteria:
- Bilateral pleural effusions.
- Known cause of pleural effusions.
- Life expectancy <3 months.
- Inability to understand written or spoken Danish.
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.
| Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura | NCT04236037 | Contradiction |
6,232 | 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:
- Patient > or =18 years
- Hospitalization in intensive care
- PCR COVID 19+ or compatible clinical signs (fever, cough, myalgia, asthenia, loss of
taste, anosmia) associated with compatible radiological signs
Exclusion Criteria:
- Pregnancy in progress
- Patient <18 years
- Patients deprived of freedoms or under guardianship
- Patient or family opponent of protocol participation
- patient on curative anticoagulant for more than 48H00
- impossible Venous Doppler Echo
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.
| Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU | NCT04363528 | Contradiction |
6,910 | 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:
- Elderly patients with diagnosis of Alzheimer's Disease according to DSM-IV criteria
- MMSE >20
Exclusion Criteria:
- None
- Motor or psychiatric disorders
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
Subject must be at most 75 Years | Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases | NCT00833274 | Entailment |
5,212 | 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:
1. Subject is between 55 and 85 years of age at time of study treatment.
2. Subject has only one (1) acute VCF. Note that subjects are eligible if they have an
asymptomatic, chronic VCF(s) at any non-target, non-adjacent vertebral level.
3. The acute VCF meets all of the following criteria:
1. Due to diagnosed or presumed underlying osteoporosis
2. T1 to L5 inclusively
3. Target VCF-related pain < 12 weeks at time of study treatment
4. Target VCF shows loss of height of the vertebral body ≤ 40% based on X-ray at
baseline.
5. Pedicles for access to the target VCF have diameters that are ≥ 4 mm.
6. Target VCF is acute or persistent (not healed), as demonstrated on imaging, including
T2 weighted STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or
other serial imaging demonstrating acuity.
7. Focal tenderness to palpation of the spinal process of the target VCF on the physical
exam correlates with imaging.
8. Subject has failed conservative medical therapy (bed rest, observation, chiropractic
care, orthotics, opioid and non-opioid analgesics, and/or physical therapy), defined
as either having a VAS back pain score of ≥ 70 mm after 2 to 6 weeks of conservative
care or a VAS back pain score of ≥ 50 mm after more than 6 weeks of conservative care.
9. Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.
10. Subject is capable of giving written informed consent to participate in the study.
11. The subject's willingness, ability, and commitment to participate in screening,
treatment, and all follow-up evaluations for the full length of the study has been
documented.
Exclusion Criteria:
1. Target VCF is unstable, including split or burst fracture.
2. Subject has a bleeding disorder.
3. Subject has an active infection of the spine or has an infection being actively
treated with antibiotics.
4. Target VCF is due to underlying or suspected tumor.
5. Target VCF is due to high-energy trauma.
6. Target VCF is due to osteonecrosis.
7. Target VCF has a local kyphotic angle of > 30 degrees, measured as the angle between
the superior endplate and inferior endplate at the target VCF.
8. Subject has had any prior surgical treatment at the target vertebral level or adjacent
vertebral levels.
9. Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF.
10. Subject has spinal canal compromise causing clinical manifestations of cord, neural
foramen, or nerve root compression at the level to be treated.
11. Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus
or spinal stenosis.
12. Subject has spondylolisthesis > Grade 1 at target vertebral body.
13. Subject requires daily opioid medication for pain not related to the target VCF.
14. Subject has severe cardiopulmonary deficiencies.
15. Subject has a Body Mass Index (BMI) > 35.
16. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's
disease, renal osteodystrophy, or osteomalacia).
17. Subject has a history of tuberculous spondylitis.
18. Subject has a history of invasive malignancy within the last five (5) years, other
than non-melanoma skin cancer. Subject is not excluded if they have a history of
malignancy over 5 years ago treated with curative intent and without clinical signs or
symptoms since then.
19. Subject is on oral or parenteral immune-suppressive drugs.
20. Subject has uncontrolled diabetes mellitus.
21. Subject has severe renal insufficiency defined as an estimated glomerular filtration
rate (eGFR) < 30 mL/min.
22. Subject has abnormal albumin-corrected serum calcium levels or a calcium metabolism
disorder (e.g., hypercalcemia).
23. Subject has known allergies to calcium-based bone void fillers.
24. Subject is pregnant or planning to become pregnant during participation in the study.
25. In the judgment of the Investigator, the subject is not a good study candidate.
26. Subject is currently enrolled in another interventional clinical study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures | NCT04835428 | Entailment |
2,569 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
1. Patients subjected to an elective unilateral inguinal hernia repair.
2. American Society for Anesthesiologists physical status grades I and II.
Exclusion Criteria:
1. Parental refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, etc.) 3.
Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5.
Local skin infection and sepsis at the site of the block. 6. Known intolerance to the study
drugs.
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 8 Years | Lumbar Paravertebral in Hernia Surgery | NCT03408184 | Contradiction |
2,179 | 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:
- >/= to 18 yrs of age with Current physician diagnosed gout
- current hyperuricemia (serum urate level >6.8 mg/dl)
- self-report of at least two gout flares in the previous 6 months
- current smartphone user utilizing a FitBit compatible smart Phone (with the ability to
download RheumPRO from Apple/Google Play store).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Novel Methods for Ascertainment of Gout Flares -A Pilot Study | NCT02855437 | Contradiction |
3,261 | 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 for Sjogren's syndrome patients:
- Primary Sjogren's syndrome patients: primary Sjogren's syndrome patients who meet the
revised criteria for SjS diagnosis by the American-European Consensus Group.
- Secondary Sjogren's syndrome patients: secondary Sjogren's syndrome patients who meet
the criteria for primary Sjogren's syndrome in association with other autoimmune
diseases such as systemic lupus erythematosus , dermatomyositis, scleroderma,
idiopathic arthritis, mixed connective tissue disease, etc.
Inclusion Criteria for healthy controls:
-Subjects who does not have history of autoimmune diseases.
Exclusion Criteria:
- Pregnant women.
- Patients with history of lymphoma or malignancy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 9 Years old.
Subject must be at most 21 Years | Examining the Immunological Process of Autoimmune Patients | NCT02123147 | Entailment |
2,111 | 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:
- Age 18 years or older patients with single previous thoracentesis of a unilateral
pleural exudate according to Lights criteria without malignant cells.
- Lights Criteria:
Pleural fluid protein/serum protein ratio greater than 0.5 pleural fluid LDH/serum LDH
ratio greater than 0.6 Pleural fluid LDH greater than two-thirds the upper limits of the
Laboratorys normal Serum LDH
- Contrast enhanced CT of the Chest and abdomen performed
- Clinical suspicion of cancer such as, but not limited to, weight loss, malaise, anemia
- Pet-CT results or former cancer diagnosis Informed consent
Exclusion Criteria:
- bilateral pleural effusions
- known cause of pleural effusion
- likely non-malignant course of a unilateral pleura effusion such as (but not
restricted to) pneumonia, trauma, pleuritis, heart failure
- any contraindication to the study procedures
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer. | NCT04233359 | Entailment |
4,316 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- willing to follow a BLS/AED course
Exclusion Criteria:
- CPR training within the last five years
- professional health care provider
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Retention and Retrieval for Three Different Training Methods | NCT00933660 | Entailment |
317 | 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. Woman undergoes IVF treatment, 18-40 years old
2. The endometrial thickness <7mm on the day of human chorionic gonadotropin during IVF
or after taking oral estradiol valerate 6mg/d for 14 days.
3. Embryo transfer is cancelled because of thin endometrium
4. No intrauterine adhesion according to the 3-D ultrasonography
Exclusion Criteria:
1. Systemic diseases unable to conceive
2. Chromasome abnormal
3. History of G-CSF or GM-CSF allergy or untoward effect
4. Thin endometrium related to clomid
5. Severe or moderate uterine adhesion
6. The influence factor of embryo implantation: hydrosalpinx, endometriosis,
adenomyosis,myoma of uterus
7. Uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm.
8. Patients who is allergic to granulocyte-macrophage colony stimulating factor
9. Patients with inflammation of reproductive organs, pelvic cavity inflammation,
malignant tumor of reproductive organs and other systemic diseases that could cause
metrorrhagia
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium | NCT04100655 | Contradiction |
1,918 | 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:
- Histologic diagnosis of gastric adenocarcinoma
- No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3
weeks before the enrollment in study
- Performance status of 0, 1, 2 on the ECOG criteria
- ASA class I, II
- Patient compliance that allow adequate follow up
- Informed consent from patient or patient's relative.
Exclusion Criteria:
- Second primary malignancy
- EMR (Endoscopic mucosal resection) indication
- Laparoscopic gastrectomy
- Radiologic or clinical evidence of metastasis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Antiangiogenic Factors in Gastric Cancer | NCT00735566 | Entailment |
Subsets and Splits