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4,509 | 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:
- Healthy women in natural cycles.
- Age: 18 to 35 years (both included).
- Normal karyotype.
- Negative serological results for HIV, HBV, HBC, RPR.
- BMI: 18-30 Kg/m2 (both included).
- Regular menstrual cycle (3-4/28-30 days).
Exclusion Criteria:
- Patients who had carried a IUD device in the previous 3 months.
- Patients who had taken hormonal contraceptives in the previous 2 months.
- Adnexal or uterine pathologies.
- Polycystic ovary syndrome.
- Patients suffering from serious or uncontrolled bacterial, fungal or viral infectious
diseases that could potentially interfere with the participation of the patient or
with the results of the study (evaluated by the principal researcher of the research
team).
- Any unstable disease or medical condition that could interfere with the study or put
in risk the health of the patient (evaluated by the principal researcher of the
research team).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Isolation and Characterization of the Extracellular Vesicles Secreted by the Human Endometrium | NCT02797834 | Contradiction |
4,725 | 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:
- premenopausal women
- healthy
- volunteer
Exclusion Criteria:
- Endocrinopathies
- Bone disease (osteoporosis, osteomalacia, paget disease etc)
- Women who used hormonal drug within last six months
- Cognitive disorders
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Sex Hormones & Serum Sclerostin Level | NCT01418924 | Entailment |
4,780 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
Adults aged 18 and over.
- Patients experiencing episodes of true vertigo, with at least two episodes within the
preceding month. Relevant medical conditions include Meniere's disease, Benign
Paroxysmal Positional Vertigo (BPPV), recurrent vestibulopathy and vestibular
migraine.
- Able to commit to 30 days of continuous wear of the trial device as per the study
plan.
- Own a telephone.
Exclusion Criteria:
- 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).
- History of hypertension or cardiac problems (uncontrolled, acute or de-compensated -
phase).
- History of ear disease, or previous ear surgery.
- History of psychotic/neurotic disorders or epilepsy.
- History of eye disease, or previous eye surgery.
- Pregnant or nursing mothers.
- Potential participants who have taken part in a previous CAVA trial.
- Potential participants who are currently taking part in another trial.
- Unable to follow the testing protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| CAVA: Dizziness Trial | NCT04026516 | Entailment |
3,848 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Male or female, aged 45 to 80 years with a BMI ≤ 40
- With an uni- or bilateral femorotibial knee osteoarthritis associated or not with a
femoro-patellar knee osteoarthritis
- Responding to clinical and radiological criteria of the ACR
- Symptomatic for more than 6 months (for the most painful knee)
- K&L radiological grade of Felson II or III
- With a cartilage lesion identified during MRI and either at least 1 out of 4 MRI
severity criteria:
- bone oedema
- meniscal lesion in the central region of the medial compartment
- effusion without answer to corticosteroids
- zone without cartilage
- or at least 1 out of 3 clinical severity criteria:
- genu varum>3°
- previous meniscal surgery
- known polyarthritis
- effusion on the target knee
- Sign an informed consent after being informed
- Able to follow the instructions of the study
- With an agreement from the physicians having established the diagnosis of
osteoarthritis (if any) to give relevant information to the investigator
- With health insurance (for France).
Exclusion Criteria:
For osteoarthritis:
- Isolated patellofemoral arthritis
- Chondromatosis or villo-nodular synovioma of the knee
- Recent trauma-induced knee pain
- Joint disease due to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's
disease, hemophilia, hemochromatosis, …
- inflammatory pathologies as rheumatoid polyarthritis, gout arthritis, infectious
arthritis
- Diseases that may interfere with the evaluation of osteoarthritis (radiculalgia of
lower limbs, arteritis, …)
- Genu valgum (degree considered as pathological by the physician)
For previous treatments:
• Treatment with strontium ranelate, bisphosphonates, SERM and PTH
For known associated diseases:
- Serious associated diseases: severe liver or renal failure, uncontrolled
cardiovascular disease, HIV, hepatitis B or C
- Knee tumor
For patients:
- Patient who participated to a therapeutic clinical trial 3 months before the T0
inclusion visit
- Patient who are the subject of a judicial protection measure or under guardianship
- Pregnant woman
For MRI contraindications:
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a
neurostimulator, cochlear implant, a stent, an insulin pump
- Patient with a ferromagnetic splinter in the body, or having wire sutures
- Serious mobility problem (Parkinson, tremors)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis | NCT02070224 | Entailment |
5,496 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Enrolled in VCRC Contact Registry
- Patient reported diagnosis of granulomatosis with polyangiitis (Wegener's
granulomatosis), Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis
Nodosa, Giant Cell Arteritis, Takayasu's Arteritis, Henoch-Schöenlein Purpura, Behçets
disease, and CNS Vasculitis
- 18 years of age or older
- English speaking
Exclusion Criteria:
- Inability to provide informed consent and complete survey
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.
| Vasculitis Illness Perception (VIP) Study | NCT02190916 | Entailment |
3,083 | 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:
- Subjects ages 15-55, with FXS who completed the study entitled "Mechanisms and brain
circuits underlying fragile X syndrome (IRB # 2015-8425). FXS is defined as full FMR1
mutations (>200 CGG repeats) confirmed by genetic testing.
- General good health as determined by physical exam, medical history and laboratory
work up.
Exclusion Criteria:
- Subjects with a history of intolerance to acamprosate, lovastatin, or minocycline will
be excluded.
- Subjects will also be excluded if they have taken any investigational drug within 3
months, have a history of substance abuse or dependence within 6 months, or
significant psychiatric or CNS neurological disease unrelated to FXS.
- Uncontrolled seizures impact EEG data as do anticonvulsants, barbiturates, lithium and
benzodiazepines and are exclusions (within 5 half-lives). Those taking other
psychiatric medications must be on stable doses for 4 weeks before any testing.
- For female subjects of child bearing potential, a positive urine pregnancy test.
- Potential subjects with a creatinine clearance < 50 mL/min will be excluded.
- Identified medical issues, inability to tolerate study procedures or study drug per
the discretion of the Principal Investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 55 Years | Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome | NCT02998151 | Entailment |
704 | 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:
- Patient must be referred to the outpatient clinic of the faculty of Physical Therapy
and Medicine, Cairo University with a confirmed diagnosis of unilateral or bilateral
osteoarthritis of the knee and having one or more of the following criteria (ASo,
2000).
- Morning stiffness for less than 30 minutes.
- Crepitus on active knee movement.
- Bony enlargement either palpable or visible in radiographs.
- Bony tenderness at joint margins.
- Age 40-60 years old.
Exclusion Criteria:
- Steroid injection within 2 months prior to inclusion.
- Presence of neurologic disorders (e.g., stroke, Parkinson's disease, or
poliomyelitis). •Presence of other rheumatoid or orthopedic disorders in the lower
extremity or spine. •A recent history of a lower extremity fracture with in the past
year.
- History of ligament deficiency, such as anterior cruciate ligament or meniscal injury.
- Severe pain with active movement.
- Poor memory or cognitive function.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 60 Years | Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis | NCT03658915 | Contradiction |
1,249 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. age 18 - 85 years,
2. pleural effusion occupying more than one third of the hemithorax on the
posteroanterior chest radiograph,
3. therapeutic thoracentesis planned on the basis of signs and symptoms as well as
imaging and functional studies,
4. no contraindications for thoracentesis,
5. signed informed consent for participation in the study.
Exclusion Criteria:
1. poor performance status requiring maximal shortening of the procedure,
2. instable hemodynamic or respiratory status unrelated to pleural effusion,
3. respiratory failure requiring mechanical ventilation.
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 | Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis | NCT02192138 | Entailment |
5,977 | 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:
- Experiencing heartburn in the past month if untreated
- Having heartburn that responds to heartburn medication
- Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion
in the study.
Exclusion Criteria:
- Having history of erosive esophagitis or gastroesophageal reflux disease (GERD)
diagnosed by a physician and confirmed by testing (endoscopy)
- Be unwilling to take only the study medication, and antacid provided as a rescue
medication for relief of acute heartburn during the study.
"Other protocol-defined inclusion/exclusion criteria may apply"
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn | NCT01037452 | Entailment |
6,072 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients with reflux symptoms present for at least 6 months, caused by documented
reflux. Reflux symptoms include:
- heartburn
- acid regurgitation
- waterbrash
- non-cardiac chest pain
- dyspepsia
- Reflux diagnosis either by endoscopy, upper gastrointestinal (GI), or 24 hour pH.
- Patients scheduled for surgical management of GERD and/or hiatal hernia
- Patients currently or commencing treatment with at least proton pump inhibitors or
pro-motility agents.
Exclusion Criteria:
- Patients unable to comprehend or complete the QOL instruments.
- Patients less than 18 years of age.
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.
| Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease | NCT00260572 | Entailment |
4,382 | 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. Agrees to wear the study lenses on a daily wear basis without the use of ocular
lubricants.
2. Has an up to date pair of glasses and is willing to wear these glasses at different
times during the study.
3. Is correctable to a visual acuity of 6/6 or better with their habitual correction.
4. Is willing and able to follow product usage instructions and maintain the visit
schedule.
5. Is at least 18 years of age and has full legal capacity to volunteer.
6. Can be successfully fitted with study lens type.
7. Has read, understood and signed an Information Consent Letter.
8. Has a distance contact lens prescription is between -0.50 D and -9.00 D
9. Has astigmatism of ≤ 1.00 D Cyl
10. Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤
1.00D
11. Has no systemic disease affecting ocular health.
12. Is not using any systemic or topical medications that will affect ocular health,
accommodative function, or the ocular physiological response to the contact lenses.
13. Has clear corneas and no active ocular disease.
14. Has no known ocular or systemic allergies, which could interfere with contact lens
wear.
15. Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar
injection or corneal staining, which in the investigator's opinion is clinically
significant.
16. Has not worn rigid contact lenses in the last 30 days or has corneal distortion
resulting from rigid lens wear.
17. Has not worn extended wear contact lenses in the last 30 days.
18. Has had an oculo-visual examination in the last two years
Exclusion Criteria:
1. Has any active ocular disease.
2. Has any lid or conjunctival abnormalities that may, in the opinion of the
investigator, interfere with the wear of contact lenses.
3. Has edema, staining, clinically significant corneal opacity, dystrophy,
vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal
and bulbar injection or corneal staining is permissible at the discretion of the
investigator.)
4. Is using ocular lubricants or contact lens rewetting drops on a regular basis (at
least once per day)
5. Is using topical ocular prescription or any topical over-the-counter medication.
6. Is actively involved in any other research/clinical study.
7. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30
days.
8. Has had corneal refractive surgery.
9. Has known sensitivity to any of the study solutions.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort | NCT00349843 | Entailment |
5,131 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Healthy women and men between 55 and 70 years of age; women will be at least 5 years
post-menopause. Presence of a chronic illness does not exclude participation if the
condition is stable and managed by a physician.
- Baseline lumbar spine and total hip bone mineral density (BMD) T-score above 2.5 as
assessed using dual x-ray absorptiometry (DXA).
Exclusion Criteria:
- A serum 25-[OH] vitamin D (25OHD) of <30 nmol/L (<12 ng/mL) or >125 nmol/L (50 ng/mL).
- Hypercalcemia (serum calcium >2.55 mmol/L), hypocalcemia (serum calcium <2.10 mmol/L)
or eGFR <30 mL/min.
- Surgical cure of Primary Hyperparathyroidism within the last year.
- Active kidney stone disease (recurrent stones, recent kidney stone [within last 2
years])
- Known hypersensitivity or allergy to Vitamin D
- Serum creatinine, AST, ALT, PTH, calcium, or alkaline phosphatase greater than 1.5
times the upper limit of normal at the screening visit
- BMD exclusions:
1. High 10-year risk for osteoporotic fracture, as defined by the Canadian
Association of Radiologists/Osteoporosis Canada calculator, or the World Health
Organization's FRAX calculator.
2. DXA T-score below or equal to -2.5 SD.
- Have taken bone active osteoporosis prescription drugs in the past 2 years
(bisphosphonates) or 1 year (other osteoporosis prescription therapies).
- Any medical condition that would prevent participation in a clinical trial for a full
three years.
- Medications such as prednisone >2.5 mg daily (or equivalent); other bone active
medications such as tamoxifen or aromatase inhibitors for breast cancer, or androgen
deprivation therapy of prostate cancer.
- Disorders known to affect vitamin D metabolism such as sarcoidosis or renal failure or
malabsorption disorders (e.g. pancreatic insufficiency or celiac disease).
- Regular (monthly or more frequent) use of tanning salons.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 70 Years | Dose-dependent Effects of Vitamin D on Bone Health | NCT01900860 | Contradiction |
2,204 | 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. Age>18 years
2. able to provide written informed consent
3. diagnosis of acute gout according to ACR/EULAR classification criteria -
Exclusion Criteria:
1. pregnancy/lactation
2. unable to provide written informed consent -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| ACTH vs Betamethasone in Hospitalized Patients With Acute Gout | NCT04306653 | Contradiction |
1,306 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Must have completed Study 111-301
- Female >= 10 years old or who have begun menses must have a negative pregnancy test at
the Baseline Visit and be willing to have additional pregnancy tests during the study
- If sexually active, willing to use a highly effective method of contraception while
participating in the study
- Are willing and able to perform all study procedures
- Parent(s) or guardian(s) are willing and able to provide written, signed informed
consent after the nature of the study has been explained and prior to performance of
any research-related procedure. Also, subjects under the age of majority are willing
and able to provide written assent (if required by local regulations or the IRB/IEC)
after the nature of the study has been explained and prior to performance of any
research-related procedure. Subjects who reach the age of majority in their country
while the study is ongoing will be asked to provide their own written consent again
upon reaching the legal age of majority.
Exclusion Criteria:
- Permanently discontinued BMN 111 or placebo prior to completion of the 111-301 study
- Have a clinically significant finding or arrhythmia on Baseline ECG that indicates
abnormal cardiac function
- Evidence of decreased growth velocity (<1.5 cm/year) as assessed over a period of at
least 6 months or of growth plate closure (proximal tibia, distal femur) through
bilateral lower extremity X-rays.
- Require any investigational agent prior to completion of study period
- Current therapy with medications known to alter renal function
- Pregnant or breastfeeding or plan to become pregnant during study
- Concurrent disease or condition that, in the view of the investigator, would interfere
with study participation or safety evaluations, for any reason.
- Have a condition or circumstance that, in the view of the investigator, places the
subject at high risk for poor treatment compliance or for not completing 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 6 Years old.
| An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia | NCT03424018 | Contradiction |
2,044 | 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... | DISEASE CHARACTERISTICS:
- Hematologic malignancy or solid tumor
- Must be undergoing remission induction and/or consolidation therapy for hematologic
malignancy only OR
- Must be undergoing allogeneic or autologous bone marrow transplantation
- Granulocyte count less than 500/mm^3 and profound granulocytopenia expected to last
for greater than 5 days
- Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than
84 hours to broad spectrum antimicrobials, after exclusion of current bacterial,
fungal, viral, parasitic, and mycobacterial infections
- Peripheral blood cultures and central venous catheter cultures negative for infections
- No microbiological documentation of a bacterial infection (e.g., abscess at catheter
site)
- No invasive fungal infection
- No probable noninfectious cause of fever
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 40-100% OR
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior anaphylactic reaction to amphotericin B
- No psychological, familial, sociological, or geographical conditions that would
prevent compliance
- Not pregnant or nursing
- Normal chest X-ray or normal high resolution CT scan of the lungs
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g.,
azoles or polyenes)
- No prior IV amphotericin B during same neutropenic episode
- No change in antibacterial regimen within 48 hours prior to study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients | NCT00003938 | Entailment |
1,952 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Patients' admission date: 1996-2006.
2. Histologically confirmed gastric adenocarcinoma patients and underwent gastrectomy.
3. Adequate paraffin- embedded tumor tissue sample for pathologic and human epidermal
growth factor receptor 2 (HER2) status analysis.
4. Integrity medical records with regular survival follow up, the overall survival (OS)
could be sourced.
Exclusion Criteria:
1. Age<18 years old.
2. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,
or basal cell carcinoma.
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.
| Lauren Classifications and HER2 Status in Gastric Cancer Patients | NCT01927146 | Entailment |
417 | 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. Patients with history of one fresh embryo transfer failure
2. Patients with Primary infertility
3. Patients with at least one embryo with excellent quality
Exclusion Criteria:
1. Female age over 40 years old
2. Severe male factor (Azoospermia)
3. Endometriosis diagnosis and the presence of hydrosalpinges
4. Uterine factor ( polyps, myoma and previous myomectomy, …)
5. Patients with polycystic ovarian syndrome diagnosis
6. Cases with pre-implantation genetic diagnosis (PGD)indication
7. Cases with difficult embryo transfer or use of Tenaculum
8. Patients with repeated implantation failures and repeated miscarriages.
9. Female smokers
Female
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 39 Years | Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Embryo Transfer on Pregnancy Outcomes in Frozen Embryo Transfer Cycles. | NCT02825108 | Contradiction |
3,052 | 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:
- patient with syndromic psychomotor delay
- patient with a apparently balanced de novo chromosomal translocation
- patient with health insurance
- informed consent signed by patient or by parents or by the legal representative for
children
Exclusion Criteria:
- patient with an inherited translocation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Breakpoint Analysis of de Novo Apparently Balanced Chromosomal Translocations | NCT01826708 | Entailment |
5,799 | 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:
- Candidate with skin lesions.
- Signed study-specific informed consent prior to study entry.
Exclusion Criteria:
- Prior surgery or radiotherapy to the area to be treated.
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 in Diagnosing Patients With Skin Lesions | NCT03914846 | Entailment |
5,881 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Healthy, H. pylori negative status (by Urea Breath Test)
- Male or female subjects
- Age 18-55 years
- Able to tolerate the placement of a nasogastric pH probe at screening
- Baseline Gastric pH≤2
- Use of acceptable form of birth control in females with child-bearing potential
- Had not used any form of tobacco (e.g. smoking or chewing) for the last year
- Can swallow a size "00" capsule without difficulty
- Willing to comply with study protocol
- Signed Informed Consent form
Exclusion Criteria:
- BMI > 40
- Slow or poor Omeprazole metabolizers (heterozygous or homozygous, respectively) based
on CYP2C19 genotyping test.
- Any significant history of / or concurrent gastrointestinal diseases or conditions
such as:
- GERD
- Acute gastrointestinal bleeding
- Zollinger Ellison Syndrome or Gastric hypersecretory condition
- Known Barrett's esophagus
- Esophageal stricture
- Peptic ulcer disease (gastric or duodenal) or family history of peptic ulcer
disease
- Gastric outlet obstruction
- Gastroparesis
- Significant medical history or concurrent illness as determined by the principal
investigator
- Any medical disorder that alters the normal gastric acid secretion profile as
determined by the principal investigator
- History of diabetes mellitus
- Significant laboratory abnormalities as determined by the principal investigator
- Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia,
respiratory alkalosis
- Pregnant or lactating women
- Had been treated with any investigational drug or therapy or participated in a
clinical trial within 30 days prior to entering the trial
- Use of any medication other than contraception or hormone replacement therapy; OTC
drugs other than vitamins or occasional acetaminophen within 30 days prior to entering
the trial or during the trial
- Use of NSAID medications within 30 days prior to entering the trial (e.g. Ibuprofen,
Aspirin, Naproxen etc)
- Positive urine test for alcohol or other drugs
- Concurrent use of gastric anti-secretory drugs such as defined below:
- Use of a PPI 30 days prior to each stage or during the trial
- Use of H2RA 14 days prior to each stage or during the trial
- Concurrent use of antacids (including over-the-counter) 24 hours prior to each
stage or during the trial
- Use of any medication that modifies gastric acid secretion 30 days prior to or during
the trial.
- Had ingested grapefruit within 14 days of dose administration in any trial period
- Significant drug allergy or known hypersensitivity to any of the ingredients in the
trial drugs Omeprazole, Succinic Acid or to Lidocaine
- Consumption of coffee within 48 hours of dose administration in any trial period.
- Had donated blood within 30 days of entering the trial
- Known positive serology for HBV, HCV or HIV
- Any reason which makes the subject a poor candidate based on the physician's
discretion
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 | Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH | NCT00818870 | Contradiction |
44 | 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. Men age 65 years or older
2. Serum testosterone level less than or equal to 350 ng/dl
3. Subject is able to complete an informed consent
EXCLUSION CRITERIA:
1. History of Stroke
2. History of Dementia
3. History of Diabetes
4. Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading
renders subject ineligible
5. Chronic medical condition, i.e. congestive heart failure
6. Arthritis, severe enough to prevent completion of the strength testing, history of
joint replacement of knees or hip.
7. Inability to walk 50 meters
8. Known disease of the bone and/or taking medications to treat osteoporosis, i.e.
Fosamax, Evista, Miacalcin
9. History of Gastric surgery
10. History of prostate cancer or any other cancers, including blood dyscrasias
11. History of severe benign prostatic hyperplasia (causing urinary problems)
12. History of heart attack or open-heart surgery within the past 6 months
13. Use of steroids within the past 3 months, including prednisone and/or cortisone
injections, and inhaled steroids. Topical steroid cream is acceptable.
14. If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the
duration of the study
15. Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone)
Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs
of growth hormone
16. Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens
17. Use of Dilantin or Phenobarbital
18. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of
wine or cocktail daily)
19. Currently smokes any tobacco product
20. Having started a new medication during the past three months which may interfere with
the outcome measures of the study
21. Polycythemia
22. Prostate specific antigen > 4.0 ng/dl
23. Hematocrit < 36
24. Liver function tests greater than 2 times upper normal limits or abnormal
electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
25. Mini Mental Status Exam score less than or equal to 24
Male
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial. | NCT00104572 | Contradiction |
3,724 | 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 patients aged 30-50 years
- History of symptomatic unilateral primary or secondary knee OA for more than 6 months
- Signed written informed consent
- Radiographic evidence of Kellgren-Lawrence Grade I or II OA of the target knee
- Body Mass Index (BMI) < 30 kg/m2
- Activity criteria (Tegner score > 3)
- Continued target knee OA pain despite conservative treatment ≥ 3 months (e.g., weight
reduction, physical therapy, analgesics)
- Willing to withhold intake of NSAIDs (including COX-2 inhibitors) and analgesics, for
a washout period of minimum 3 days up to 21 days prior to baseline visit (depending on
medication)
- Willing to discontinue prohibited treatments and medications throughout study period
Baseline inclusion criteria
- Completed OA medication washout period
- Target knee pain 4-8 (0-10 NRS) during most painful knee movement (Worst Knee Pain)
- If female, must have had a negative urine pregnancy test and used a medically
acceptable form of contraception for at least 1 month prior to baseline and agree to
continued use of contraception for the duration of the study. Otherwise, females must
be surgically sterile, or postmenopausal (as documented in medical history) for at
least 1 year. The fetal safety profile for G-F 20 is unknown. Pregnancy will affect
the individual's regular activity levels. Females who become pregnant during the study
will be excluded from the study. Subjects who become pregnant will be followed up by
telephone every 3 months to check for any adverse effects. They will also be
recommended to follow routine obstetric visits. Males should be able to father
children as it has no expected effects on activity levels.
Exclusion Criteria:
- Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs,
feathers, down, or poultry
- Clinically apparent tense effusion or other acute inflammation of the target knee at
baseline
- History of target knee viscosupplementation treatment
- History of major surgery for OA in target knee including arthroplasty or tibial
osteotomy
- Arthroscopic surgery or intraarticular steroid injection in target knee within six
months of baseline visit
- Significant (as judged by the Investigator) alignment deformity of target knee
- Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee,
or ankle
History of:
- Septic OA of any joint
- Inflammatory arthropathy such as RA, gout, pseudogout, lupus, crystalline inflammatory
arthropathy
- Active infection of lower extremity
- Known significant acute and/or concurrent medical disease including, but not limited
to current malignancy, history of transplant surgery, congestive heart failure,
significant unstable cardiovascular disease, renal hepatic pulmonary, endocrine,
metabolic, or GI condition
- Any known contraindication to acetaminophen
- Venous or lymphatic stasis in either leg
- Peripheral vascular disease
- Patient has been prescribed chronic opioid analgesics at time of baseline visit
- Concurrent multi-system or multi-limb trauma
- Patient plans to become pregnant during study period
- Patient plans to move significantly out of area, have surgery, or initiate or cease
other OA treatments
- Knee pain improves during washout period
- Workman's Comp patient
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 50 Years | Synvisc-One for Younger, Active Patients With Osteoarthritis | NCT01625013 | Contradiction |
4,551 | 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. | Female Inclusion Criteria
In order to enroll into the clinical trial, potential subjects must:
- be healthy sexually active women, at risk for pregnancy and desiring contraception;
- be within the age range of 18 through 40 years, inclusive;
- be at low-risk for HIV or STI infection, currently have (at least 4 months) a single
sexual partner who is also at low-risk for HIV or STI infection, and expect the same
partner for the study;
- have a negative urine pregnancy test ;
- have normal menstrual cycles with a usual length of 24 to 35 days over the last 2
months ;
- have a documented history of at least 6 weeks and two spontaneous, normal menstrual
cycles since last pregnancy outcome, one spontaneous normal menstrual cycle after
discontinuing hormonal contraception or therapy and 10 months since last DepoProvera
injection;
- not be actively desiring pregnancy for approximately 7 months and willing to accept an
unknown risk of pregnancy;
- be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle
;
- be willing to be fitted with a standard diaphragm and use the SILCS diaphragm with
assigned study gel during the study;
- be willing to only use the assigned study gel with the SILCS diaphragm as the sole
method of contraception over the course of the study;
- agree not to participate in any other clinical trials during the course of the study;
- be willing and able to comply with study procedures and to return to the clinic for
scheduled follow-up visits; and
- colposcopy and microflora substudy only:
- be willing to avoid using tampons for 72 hours prior to clinic visits or any
intravaginal product other than those provided by the investigator for the
duration of participation; and
- be willing to comply with substudy procedures. Male Criteria
The male partner must be at least 18 years old and must not:
- have a known fertility problem or vasectomy;
- have known risks for STIs including HIV:
- have had more than one sexual partner in the past four months;
- have shared injection drug needles within the past six months;
- have had sex with a man within the past 12 months;
- have, or suspected to have, HIV infection; or
- have been diagnosed with or treated for any STI in the past six months;(with the
exception of recurrent genital herpes or condylomata)
- have a known sensitivity or allergy to silicone, nylon, and/or spermicide or product
containing N-9; and
- have taken an investigational drug or used an investigational device within 30 days
prior to enrollment or previously participated in this study.
Female Exclusion Criteria
In order to enroll into the clinical trial, potential subjects must not:
- have an allergy to silicone, nylon, latex or dry natural rubber products, and/or
spermicides or products containing N-9;
- have a history of toxic shock syndrome (TSS);
- have a suspected or diagnosed UTI or vaginitis, unless treated and symptoms resolved
prior to enrollment;
- have a history suggestive of infertility, defined as any of the following:
- known history of a fertility problem, sterilization, ectopic pregnancy,
hospitalization for pelvic inflammatory disease (PID), or endometriosis unless
participant has had a subsequent spontaneous intrauterine pregnancy; or
- abnormalities on pelvic examination at enrollment that may impair fertility;
- have contraindications to pregnancy (medical condition) or chronic use of class D or X
medications;
- have high risk for HIV or other sexually transmitted infections (STIs):
- have had more than one sexual partner in the past four months;
- have shared injection drug needles within the past six months;
- have, or suspected to have, HIV infection; or
- have been diagnosed or treated for any STI, including Trichomonas vaginalis,
(with the exception of recurrent genital herpes or condylomata) or PID within the
past six months prior to the enrollment visit;
- have signs or symptoms of current cervicitis, endometritis or PID or have clinical
evidence of HSV on exam;
- be lactating or breastfeeding;
- have any abnormal vaginal bleeding or spotting within the month prior to enrollment;
- have any abnormal finding on pelvic examination which precludes her from participating
in the trial;
- have had a vaginal or cervical biopsy within one week or vaginal surgery within the
three months prior to enrollment;
- have an abnormal Pap smear in the past 12 months defined as:
- ASC-US without a normal repeat Pap smear at least 6 months later;
- ASC-US with positive reflex high-risk HPV testing (ASC-US/HPV+) or LSIL except
when a colposcopy was performed (with or without biopsy) and found no evidence of
high-grade disease (CIN II or worse) unless treatment is indicated per local
standard of care;
- ASC-H, atypical glandular cells, or HSIL unless treatment was received and
follow-up at least 6 months after the treatment showed no evidence of disease;
- malignant cells;
- consume (on average) greater than 3 alcoholic beverages per day;
- have a past (within 12 months) or current history of drug abuse ;
- have previously participated in or completed this study;
- have a vaginal or cervical anatomic abnormality that would interfere with the proper
placement and retention of the device;
- have other conditions that would constitute contraindications to participation or
would compromise ability to comply with the study protocol;
- have taken an investigational drug or used an investigational device within the past
30 days; and
- have deep epithelial disruption on colposcopic exam (SUBSTUDY).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Contraceptive Effectiveness and Safety of the SILCS Diaphragm | NCT00578877 | Contradiction |
5,641 | 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:
- Age 25-45 years, male or female
- BMI 25.0-45.0 kg/m(2) for Overweight Subjects and 19.0-24.9 kg/m(2) for Non-Overweight
Controls
- Healthy, as determined by medical history and laboratory tests
- Written informed consent
EXCLUSION CRITERIA:
- BMI less than 19.0 or greater than 45.0 kg/m(2)
- History or symptoms compatible with cardiovascular disease, including arrhythmias and
syncopal episodes, or use of prescription medications for heart conditions, strokes,
or peripheral vascular disease
- Allergy to lidocaine
- Pregnancy or breastfeeding
- Menopause or peri-menopausal period (FSH greater than 15 mIU/ml)
- Use of hormonal contraceptives or estrogen replacement therapy
- Alcohol (more than 2 drinks per day or CAGE greater than 2 questions and/or
current/regular use of drugs such as amphetamines, cocaine, heroin, or marijuana
- Current use of tobacco products (smoking or chewing)
- History of Diabetes Mellitus, either type 1 or 2, or Fasting Glucose greater than 126
mg/dl
- Use of cholesterol- or lipid-lowering drugs, or fasting serum lipids in range
requiring medication per Adult Treatment Panel III recommendations of the National
Cholesterol Education Program
- Liver disease or ALT serum level greater than two-fold above the laboratory reference
standard
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 ml/min
- Current use of medications, dietary supplements (including fish oils), or alternative
therapies known to alter thyroid function with the exception of occasional use of
NSAIDs (3 tablets/week maximum) and Benzodiazepines; use of NSAIDs in the 10 days
preceding the hospital admissions
- Current history, symptoms, or behavior compatible with psychiatric disorders or
therapy with psychotropic medications that would be incompatible with safe and
successful participation in this study
- History of drug or alcohol abuse within the last 5 years; current use of drugs or
alcohol
- Keloid formation (relative to subcutaneous adipose tissue biopsies)
- Hypo- or hyperthyroidism (TSH greater than or equal to 10; less than or equal to 0.1
mIU/L)
- Blood pressure greater than 160/95 mm Hg or use of prescription medications for
treatment of hypertension
- Cushing Syndrome
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 45 Years | Gene Expression and Inflammation in Overweight Subjects | NCT00344266 | Contradiction |
4,905 | 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:
- HV aged between 18 - 60 years
Exclusion Criteria:
- history of psychiatric disease or a positive first degree psychiatric family history
- pregnancy or lactation
- concomitant administration of any centrally activating medication (anti-depressive
medication, hypnotics, sedatives, anxiolytics, …)
- medication affecting esophageal motility
- significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary,
endocrine, autoimmune, renal and hepatic)
- prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
- history of gastrointestinal disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers | NCT04355455 | Contradiction |
382 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Age 18-50 years
- Plan to stay in the Chiang Rai area for at least four months
- HIV-infected, confirmed by Elisa and Western Blot tests
- Either has 1) no current sex partner and is planning to be abstinent for the study
duration, or 2) has only one, HIV-infected sexual partner1 who is 18 years or older
and is willing to give informed consent for confirmatory HIV testing and for the
participant=s enrollment in the study. Women who have a steady partner/husband who she
will not see during the study period or with whom she is not sexually active will not
be required to bring their partner to the clinic for HIV testing and informed consent.
- Willing and able to give informed consent
- Willing and able to comply with the study protocol, including being tested for HIV and
undergoing repeated pelvic and colposcopic examinations
- Willing to have male partner asked for informed consent because he will be exposed to
study product
- Regular menstrual cycles (defined as occurring every 3-5 weeks, lasting 3-5 days) for
the prior 3 months; if have amenorrhea or if using depo-provera, participant must have
no reported history of vaginal bleeding for the previous 3 months
- CD4 count < 5002
- Not currently taking antiretroviral medications3
- Documented Class I or Class II ("atypical cells seen, usually caused by inflammation")
pap smear at screening for study participation
- In good health as determined by medical history, physical examination and results of
any laboratory screening test, and the discretion of the clinical staff
- Able to achieve a score of 80% or better on true-false test of key study concepts. If
women score less than 80% the first time they take the test, they may repeat the test
at least one day later
Exclusion Criteria:
- CD4 count <50
- Pregnancy or desire to become pregnant in the next 3-4 months
- Delivery, miscarriage, or abortion within six weeks prior to study enrollment
- History of surgery on external genitalia, vagina or cervix in the month prior to study
enrollment
- Existence of a clinically detectable genital abnormality, specifically warts or a
congenital abnormality
- History of nonmenstrual vaginal bleeding with intercourse in past one month
- Current use of tampons, diaphragms, sponges, douching, or other intravaginal products.
Women who are willing to abstain from using these products during the study will be
included in the study.
- Concurrent participation in another trial of a vaginal product
- History of sensitivity or allergy to latex products (including gloves)
- Presence of epithelial disruption of the labia or genital mucosa visible to the naked
eye at enrollment1
- Positive test for gonorrhea, chlamydial infection, trichomoniasis, or evidence of
untreated syphilis (see section 5.19). Participants with positive tests must be
treated and have a negative test of cure to be eligible for enrollment.1
- Positive tests for candidiasis or bacterial vaginosis (BV) and symptoms of vaginitis.
Women may be enrolled after treatment if they are asymptomatic or have negative tests.
Asymptomatic participants with positive tests for candidiasis or BV may be enrolled.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women | NCT00213044 | Contradiction |
1,645 | 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:
- 18-65 years of age
- BMI between 25- 49.9 kg/m2
- live in Columbia, South Carolina area
- be able to attend all assessment visits
- have access to the Internet, a computer, and a smartphone (iPhone, Android, etc.)
- have MD consent for participation if currently on blood pressure medications, have
issues with dizziness, or have bone or joint issues
- be free of an eating disorder as screened by the Eating disorder Screen for Primary
care. (If a participant has an eating disorder, they will be referred to their family
physician)
- no current participation in a weight loss program or taking weight loss medications
(although participants may be trying to lose weight on their own)
- able to prepare all their own meals (i.e. not living on-campus)
Exclusion Criteria:
- major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions,
or pregnancy
- pregnant (or have been pregnant in the last 6 months), anticipating on becoming
pregnant in the next 7 months, or currently breastfeeding o Women who are pregnant
should not be pursuing weight loss and should be under the direct care of a physician.
Therefore women who are pregnant or who are anticipating they might be pregnant should
not participate in this study. If a woman becomes pregnant during the study, she will
be advised to consult her care provider and will be dropped from the weight loss
study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using the Bite Counter | NCT02494674 | Entailment |
6,536 | 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
All of the following criteria must be fulfilled for inclusion:
- Patient must have willingness to read and sign a copy of the Informed Consent Form
Males and females, ≥25 years old.
- Patient in need of a single permanent tooth extraction with clinical and/or
radiographic evidence of unrestorable maxillary premolars, canines, or incisors with
at least one adjacent tooth present, and with periodontal attachment preserved at
least for 2/3rd of the root nor associated with acute periapical pathology.
- Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be
confirmed at Visit 2 after extraction. In case of >50% buccal bone loss, the
participant will be withdrawn.
- Patient in good general health as documented by self-assessment.
- Full mouth bleeding and plaque scores (FMBS <10% and FMPS <20%) recorded within the
previous 8 weeks.
Exclusion criteria
- Uncontrolled or untreated periodontal disease.
- History of local (head and neck) radiation therapy.
- Presence of oral lesions in the area of the extraction (such as ulceration,
malignancy).
- Severe bruxing or clenching habits.
- Acute endodontic lesion in the test tooth or in the neighbouring areas to the
extraction procedure (sites with presence of an asymptomatic chronic lesion are
eligible).
- Medical history that includes uncontrolled diabetes or hepatic or renal disease, or
other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid
arthritis, osteoporosis) or transmittable diseases (e.g. AIDS).
- History of alcohol or drug abuse.
- Smokers.
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes
related to pregnancy and nursing which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation of
trial results and, in the judgement of the investigator, would make the subject
inappropriate for entry into this trial.
- Malocclusion, or collapse of the occlusal vertical dimension leading to dentoalveolar
compensation which could interfere with ridge preservation dimensions and
measurements.
- Lack of adjacent sound restored or unrestored teeth.
- Any male participants with facial hair (such as moustache, beard or any other
variations of facial hair styles) and must keep their face shaven until after the
placement of the dental implant (Visit 10).
- Any individuals using Botox or fillers in the face region.
All patients to be enrolled who meet the inclusion / exclusion criteria will be asked if
they have participated in any other interventional periodontal studies within the last 3
months. If the patient did participate in such studies, then enrolment will be postponed
until after 3 months wash-out period has elapsed.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
| Alveolar Socket Healing With and Without PRGF | NCT04383158 | Contradiction |
3,726 | 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 who completed Study 17-007 or discontinued from Study 17-007 due to lack of
efficacy
- Patients who did not complete or discontinue from Study 17-007 must have
osteoarthritis of both knees for a minimum of six months
- Have moderate pain in the most involved knee when not taking non-steroidal
anti-inflammatory drugs (NSAIDs)
- Must have used an oral NSAID on at least three days per week for the last three
months, or 25 of the 30 days before screening
- Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last
six months
Exclusion Criteria:
- Any patient currently receiving physical therapy to either knee or having a history of
allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or
acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would
compromise the ability of the subject to complete the required assessments and visits
- For patients who did not participate in Study 17-007: having Grade 1 or Grade 4
severity of the most involved knee based on x-ray criteria
- Received intra-articular injections or arthroscopy of the most involved knee during
three months before screening visit
- Have a large bulging effusion, or have inflammation of the most involved knee that
could be related to gout, pseudogout-induced synovitis, or infection
- Have a history of partial or total knee replacement in either knee, or have a history
of gout, pseudo-gout induced synovitis, or infection of the more severe knee
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 Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee | NCT00265304 | Contradiction |
849 | 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:
- Pain at the base of the thumb 30 mm on VAS
- Patient aged 45 and < 75 years old
- At least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
- joint space narrowing
- subchondral bone sclerosis
- subchondral cysts
- At least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the
first web
Exclusion Criteria:
- Post traumatic osteoarthritis
- Cristal arthropathy
- Inflammatory arthritis
- Neurologic disorder involving upper limb
- Psychiatric disorder needing treatment adaptation in the last 3 months
- Hand or wrist trauma within the last 2 months
- Previous hand surgery
- Unable to speak or write French
- Pregnancy
- Collagen diseases (Dupuytren, Marfan, Ehlers Danlos syndromes)
- Hand or wrist infiltration within 2 months
- Skin disease interfering with the wearing of the orthoses
- Having already worn a BTOA orthoses
- Having bilateral BTOA without predominant symptomatic side
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 75 Years | Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA) | NCT00350896 | Entailment |
3,252 | 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 with pSS according to European-American Diagnostic Criteria
Exclusion criteria:
- Refusal to participate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Vaccine Coverage and Primary Sjögren'Syndrome | NCT04224454 | Entailment |
2,035 | 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:
- Over 18 years and below 75 years of age
- Plan to undergo MCCG examination in Changhai Hospital
Exclusion Criteria:
- dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal
stenosis, overt gastrointestinal bleeding, fistulas and strictures;
- history of gastrointestinal surgery or suspected delayed gastric emptying;
- Implanted metallic devices such aspacemakers, defibrillators, artificial heart valves
or joint prostheses;
- Allergic to high molecular materials such as simethicone and streptozyme;
- Pregnancy or mentally ill person;
- currently participating in another clinical study;
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy | NCT04479423 | Entailment |
1,899 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Histologically proven adenocarcinoma of the stomach
2. Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy
and abdominal computed tomography (CT) and MRI and laparoscopy.
3. Receive neoadjuvant chemotherapy in clinical
Exclusion Criteria:
1. Contraindication for chemotherapy
2. Contraindication for surgery
3. Clinically apparent distant metastasis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making | NCT03413514 | Entailment |
1,868 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion criteria:
1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
3. Clinical stage tumor T1-4a (cT1-4a), N0/+, M0 at preoperative evaluation according to
the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition.
Preoperative staging was made by conducting mandatory computed tomography (CT) scans
and an optional endoscopic ultrasound
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby
in the preoperative examinations
5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
6. American Society of Anesthesiology score (ASA) class I, II, or III
7. Written informed consent
Exclusion criteria:
1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
dissection
5. Rejection of laparoscopic resection
6. History of allergy to iodine agents
7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
8. History of other malignant disease within past five years
9. History of previous neoadjuvant chemotherapy or radiotherapy
10. History of unstable angina or myocardial infarction within past six months
11. History of cerebrovascular accident within past six months
12. History of continuous systematic administration of corticosteroids within one month
13. Requirement of simultaneous surgery for other disease
14. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
15. Forced expiratory volume in 1 second (FEV1)<50% of predicted values
16. Linitis plastica, Widespread
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 | Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection | NCT04219332 | Entailment |
94 | 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
- no history of spontaneous puberty
- clinical hypogonadism
- infantile testes (< 3 ml)
- no reproductive hormone therapy except testosterone
- Complete absence of normal LH pulses during 12-hour baseline frequent blood sampling
and serum testosterone < 100 ng/dl
- Normal testing of the anterior pituitary gland
- Negative MRI of the hypothalamic-pituitary area
Exclusion Criteria
- Prior therapy with gonadotropins (FSH, hCG, or GnRH)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism | NCT00064987 | Contradiction |
2,578 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Adult patients who had developed a recurrent inguinal hernia and had undergone a
re-TREPP.
Exclusion Criteria:
- Children (age <18 years)
- Exclusion criterium for long term follow up: no informed consent obtained.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Feasibility of Re-TREPP in Patients With a Recurrent Inguinal Hernia After Previous TREPP Repair | NCT03411226 | Contradiction |
4,949 | 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. | Males and females, ages 18 and over.
Diverse racial groups.
Amputees and others with whom we will have no patient-care relationship may also be
considered to be volunteers.
Patients will be recruited from those referred to the Human Motor Control Section, NINDS
who have neurological syndromes that are of interest.
On rare occasions we may attempt to study children as young as 10 years with TES.
Individuals without indwelling cardiac lines and pacemakers.
Patients recruited for study would come from those referred to the EMG laboratory and to
the Human Motor Control Clinic who would have distinct neurologic syndromes from well
defined peripheral and central nervous system lesions including hemiplegia from stroke,
trauma, tumor or focal demyelination (most commonly patients would have hemiplegia from
stroke), peripheral nerve lesions, amputations, spinal cord injury.
Normal volunteers, including NIH employees, would be healthy adults without history of
physical examination evidence of neurologic disease and individuals with different types of
amputations involving upper and lower extremities.
Volunteers may also be participants in the electrophysiological protocol (84-N-0196).
No history of epilepsy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Non-Invasive Electrical Stimulation of the Human Brain | NCT00001216 | Entailment |
6,647 | 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:
- Confirmed diagnosis of Hemophilia A;
- Severe disease (FVIII <2%);
- Receiving ADVATE for prevention of bleeding (prophylaxis) or receiving ADVATE on
demand and a candidate for prophylaxis;
- Body weight ≤120 kg; and ≥12kg;
Exclusion Criteria:
- FVIII inhibitor positive (level of ≥0.6 Bethesda Units [BU] per mL using the Nijmegen
modification of the Bethesda assay). Inhibitor status to be documented as negative
prior to study enrollment according to the two most recent, consecutive inhibitor
assays on record. If patients have < 50 exposure days, an assay will be completed
centrally within a reasonable timeframe (approximately 8 weeks suggested) to make sure
that they are negative.
- Body weight >120 kg or <12kg;
- Human immunodeficiency virus (HIV) positivity with cluster of differentiation 4 (CD4)
count < 200 / microliter;
- Significant hepatic dysfunction, alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) >5 times upper limit of normal
- History of recent events that might affect FVIII half-life (e.g., infection, surgery
or an invasive procedure) within 2 weeks of blood sampling.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Evaluation of a Simple Pharmacokinetic Tool (myPKFiT™) to Guide Personalized Factor VIII Dosing in Patients With Hemophilia | NCT02750085 | Contradiction |
3,437 | 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:
- I1. Sufficiently conversant in the English language to satisfy I3.
- I2. Able and willing to comply with all study requirements.
- I3. Able and willing to provide written informed consent to participate (including by
parent or legal guardian if under 16 years old).
Exclusion Criteria:
- There are no exclusion criteria.
No condition on gender to be admitted to the trial.
Subject must be at least 3 Years old.
| Vital Sign Comparison Between Lifelight and Standard of Care - Development | NCT04003662 | Entailment |
610 | 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. According to the GCP regulations, obtain the informed consent of the subject,
volunteer for the test, and have signed the informed consent form.
2. Women aged 20-40 years with fertility requirements
3. Infertility patients who are treated in this hospital
4. After more than 2 times of hysteroscopic adhesion separation surgery, the uterine
cavity morphology has basically returned to normal. The patient has a normal menstrual
cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the
endometrium is 5.5 mm in 6 cycles by ultrasound.
5. or receive adjuvant reproductive treatment, the endometrial thickness is less than
5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor,
aspirin, sildenafil and other drugs up to 8mg / day is invalid.
6. HBVAg negative, HCV negative, HIV negative, syphilis negative
7. Normal bone marrow morphology, normal blood routine
8. Previously failed to receive relevant stem cell therapy
Exclusion Criteria:
1. Those who cannot accept the treatment observation process required by the test
2. There are contraindications for hysteroscopic surgery;
3. congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect
embryo implantation; the investigators judged that there are other uterine factors
that are not suitable for embryo implantation
4. Patients with chromosomal abnormalities
5. contraindications to estrogen therapy; systemic diseases such as thrombosis,
cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
6. Patients without fertility requirements
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium | NCT03724617 | Entailment |
5,684 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion criteria:
- Turner syndrome with homogeneous 45,X karyotype.
- Age between 8 and 18 years.
- Somatic state compatible with the evaluation.
- Functional language and IQ ≥ 80 for the transfer tests
- Informed consent signed by the holders of parental authority, the patient and the
mother for her own participation (DNA collection).
- Affiliation to Social Security (beneficiary or assignee).
Exclusion Criteria:
- Additional condition associated with an autism spectrum disorder
- Turner syndrome not related to an homogeneous 45,X karyotype
Female
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 18 Years | Social Cognition and Turner Syndrome | NCT01687842 | Entailment |
4,338 | 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:
- Individual with Marfan syndrome consented in to the Main Atenolol Vs. Losartan NIH
study.
Exclusion Criteria:
- Subjects in the main PHN Marfan trial who have not achieved the maintenance drug
dosing or who have stopped taking study drug.
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 24 Years | Circulating Transforming Growth Factor Beta (TGF-β) in Individuals With Marfan Syndrome | NCT01361087 | Entailment |
6,250 | 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:
The patients who were 18 years old or older, conscious, without communication issues,
volunteers, not diagnosed with otitis media, who did not have a fever.
Exclusion Criteria:
havin fever, Being under the age of 18, not volunteers.
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 70 Years | The Effect of Auricle Position on Tympanic Thermometry | NCT04463537 | Contradiction |
1,548 | 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:
- Adolescent must be English-speaking
- Adolescent must have a lifetime history of physical dating violence perpetration or
victimization
Exclusion Criteria:
- Current enrollment in an intervention for dating violence or HIV prevention
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 17 Years | Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions | NCT01326195 | Contradiction |
6,343 | 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:
- All patients between the ages of 18 and 65 included will suffer from COVID 19, and
specific treatment should not yet be initiated.
- COVID 19 diagnosis of patients will be based on full medical history, thorough
clinical examination, radiological imaging, laboratory assessment, and SARS-CoV-2
analysis by RT-PCR.
Exclusion Criteria:
- People with chronic lung disease or previous AC surgery
- People with immune deficiency or cancer patients
- Patients receiving immunosuppressive therapy for autoimmune disease
- People with neurological diseases affecting the respiratory muscles, such as
hypotonia.
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 | Epigenetic Tools as Prognostic Predictors in Covid19 | NCT04411563 | Entailment |
707 | 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:
- • 18 years and older
- first or second degree lateral ankle sprain within 48 h of administration of
study drug
- reported moderate (45 - 60 mm) to severe (>60 mm) ankle pain on full weight
bearing on the Patient's Assessment of Ankle Pain using a 100 mm VAS
- available for the duration of the study (90 days)
Exclusion Criteria:
- • Bilateral ankle sprain
- Ipsilateral knee injury
- Third-degree sprain
- Previous ankle sprain within 6 months
- Patients who had recently used anti-inflammatory medications, muscle relaxants
psychotropic medications that could confound the results
- Patients with a history of severe GI, renal, or hepatic disease
- Patients with rheumatic diseases
- History of drug or alcohol abuse
- Pregnant or lactating, or a woman of childbearing potential not willing to use an
acceptable method of contraception during the study
- Having received investigational product within 30 days of the Day 1 visit
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Management of Acute Ankle Sprain With Sodium Hyaluronate | NCT02091674 | Contradiction |
1,930 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients must have a histologic diagnosis of adenocarcinoma of the esophagus,
gastroesophageal junction or gastric cardia, based on biopsy material or adequate
cytologic exam.
- Patients must be clinically staged according to the AJCC 2002 staging system and must
have either T3-4, or N1 or M1a disease. Staging should include at least an upper
endoscopy with endoscopic ultrasound and an FDG-PET/CT scan.
- Patients must have an ECOG performance status of 0-1.
- Patients must have adequate bone marrow function as evidenced by: Absolute neutrophil
count > 1,500/uL Platelet count > 100,000/uL
- Patients must have adequate renal function as evidenced by serum creatinine < 1.6
mg/dL
- Patients must have adequate hepatic function as evidenced by:Serum total bilirubin <
1.5 mg/dL Alkaline phosphatase < 3X the institutional ULN AST/ALT < 3X the
institutional ULN
- Patients must have adequate pulmonary function as evidenced by an FEV1 > 50%
predicted.
- Patients or their legal representatives must be able to read, understand, provide and
sign informed consent to participate in the trial.
- Patients of childbearing potential agree to use an effective form of contraception
during the study and for 90 days following the last dose of study medication (an
effective form of contraception is an oral contraceptive or a double barrier method)
- Age > 18 years
Exclusion Criteria:
- Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma,
small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma etc,) will be ineligible.
- Patients with any evidence of distant hematogenous or distant nodal disease (M1b) will
be ineligible.
- No prior chemotherapy, radiation therapy or surgery for this malignancy will be
allowed. Prior endoscopic debulking, laser therapy or dilatation will not exclude a
patient.
- Patients with another active malignancy will not be eligible except for curatively
treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or
localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive
evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of
entry
- Patients with an active infection will not be eligible.
- Patients with known hypersensitivity to any of the components of oxaliplatin,
epirubicin, fluorouracil or cisplatin will not be eligible.
- Patients who are receiving any other concurrent investigational therapy, or who have
received investigational therapy within 30 days of the first scheduled day of protocol
treatment (investigational therapy is defined as treatment for which there is
currently no regulatory authority approved indication) will not be eligible.
- Patients with a baseline peripheral neuropathy greater than or equal Grade 2 will not
be eligible.
- Patients who are pregnant or lactating will not be eligible.
- Patients with any other medical condition, including mental illness or substance
abuse, deemed by the Investigator to be likely to interfere with a patient's ability
to sign informed consent, cooperate and participate in the study, or interfere with
the interpretation of the results, will not be eligible.
- Patients with any history of an allogeneic transplant will not be eligible.
- Patients with known infection with HIV, Hepatitis B or C (active, previously treated
or both) will not be eligible.
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.
| Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach | NCT00601705 | Entailment |
4,502 | 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 patient aged 30-45 years
- Diagnosed adenomyosis by transvaginal ultrasound or MRI or 3D ultrasound
- Patient complains of heavy menstrual bleeding or dysmenorrhea or both
- Living in a nearby area to make follow-up reasonably possible
- Planning for birth spacing for at least 2 years.
Exclusion Criteria:
- Pregnancy or seeking fertility
- Severe underlying comorbidities (hepatic, oncological)
- Pelvic inflammatory disease
- Other cervical or uterine pathologies
- Deep venous thromboembolism
- Hormonal therapy contraindications
- Endometriosis or fibroid
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 45 Years | Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri | NCT03037944 | Contradiction |
377 | 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:
- We will recruit 30 poor ovarian responders and thin endometrium patients
Exclusion Criteria:
- women with underlying medical diseases, such as diabetes or hypertension
Female
Accepts Healthy Volunteers
Subject must be at most 45 Years | Intravenous Laser Irradiation Effect on Treatment Resistant Thin Endometrium | NCT03081130 | Contradiction |
6,335 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients over 18 years of age.
- With SARS-CoV-2 infection confirmed by specific PCR.
- With clinical manifestations of the infection, such as fever or cough, or
otolaryngologic (ORL) signs or respiratory difficulties, that started less than 7 days
ago.
- COVID-19 specific treatment-naive.
- Women of childbearing age should accept the use of mechanical contraception during the
study period.
- Informed consent signed by the patient.
Exclusion Criteria:
- Severe form of infection requiring oxygen therapy > 4l/min to achieve oxygen
saturation > 94%.
- Patient whose weight is < 35kg.
- Pharmacological investigation contraindicating the introduction of a CYP450 inhibitor,
in particular the CYP3A4 isoform.
- Known hypersensitivity to lopinavir, ritonavir, telmisartan, atorvastatin or their
excipients.
- Renal impairment (eGFR <30 mL/min, CKD-EPI formulation).
- Known cirrhosis.
- Transaminases > 3N.
- Bilirubin > 2.6N.
- Electrocardiogram showing QTc> 500 ms.
- HIV-infected patient without treatment or treated with protease inhibitors (lopinavir,
darunavir, atazanavir).
- Ongoing exposure to statins.
- Contraindications to the use of statin:
CPK > 5N, history of rhabdomyolysis or myopathies, increased risk when atorvastatin is
administered with strong CYP3A4 inhibitors or transport proteins (cyclosporin,
telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole,
itraconazole, posaconazole, letermovir, erythromycin, diltiazem, verapamil, fluconazole).
- Ongoing exposure to sartans.
- Contraindications to the use of telmisartan:
patient on angiotensin-converting enzyme (ACE) inhibitors, aliskiren or other angiotensin
receptor blockers (ARB).
- Curatorship or guardianship.
- Pregnancy or breastfeeding.
- Dementia or any other condition that prevents informed consent.
- Any reason that, at the discretion of the investigator, would compromise patient
safety and cooperation in the 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.
| Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial | NCT04466241 | Entailment |
6,962 | 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:
- Alzheimer's Disease, mild and moderate stage
Exclusion Criteria:
- Other neurological diseases or injuries
- Stroke
- Cancer
- Psychiatric disorders (moderate/ severe depression, psychosis)
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 | MR Guided tDCS in Alzheimer's Disease | NCT03325205 | Entailment |
5,599 | 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:
1 Segment 1 :Boys at the age range of 8-13 years 2. Segment 2: Boys at the age range of
12-17 years 3. Tanner stage 1 (segment 1 only) 4. more than 2 SD's (standard deviation)
below the average height
Exclusion Criteria:
1. Mental retardation,
2. Psychiatric illness,
3. Lack of informed consent\assent.
4. Health status that required chronic treatment with steroids
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 17 Years | Short Stature Related Distress | NCT01246219 | Contradiction |
931 | 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:
- Are male or female participants with osteoarthritis (OA), as determined by medical
history and physical examination. Males and females with stable medical problems that,
in the investigator's opinion, will not significantly alter the disposition of the
drug, will not place the participant at increased risk by participating in the study,
and will not interfere with interpretation of the data.
1. Male participants: agree to use a reliable method of birth control during the
study and for 3 months following the last dose of the investigational product
2. Female participants: women not of child-bearing potential due to surgical
sterilization (at least 6 weeks post surgical bilateral oophorectomy with or
without hysterectomy or tubal ligation) confirmed by medical history, or
menopause
- Body weight greater than 40 kilograms (kg) and less than 120 kilograms (kg) with a
body mass index (BMI) between 19-35 kilograms per square meter (kg/m^2) inclusive
- Participant with osteoarthritic knee based on disease diagnostic criteria as presented
in the Inclusion Disease Criteria, below
- Blood pressure and pulse rate in supine and standing positions, within normal
reference ranges for the population and investigator clinical research unit (CRU), or
results with acceptable deviations that are judged to be not clinically significant by
the investigator
- Have clinical laboratory test results within normal reference range for the population
or investigator clinical research unit (CRU), or results with acceptable deviations
that are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow for blood sampling
- Have agreed to maintain the same activity level throughout the course of the study
Inclusion Disease Criteria:
- Have a unilateral or bilateral osteoarthritis (OA) of the knee diagnosed according to
the American College of Rheumatology (ACR) criteria. The clinical diagnosis of
osteoarthritis (OA) will be confirmed by the American College of Rheumatology (ACR)
clinical and radiographic criteria for classification of idiopathic osteoarthritis
(OA) of the knee based upon the following criteria:
1. Knee pain for at least 14 days per month for the 3 months before screening
2. Osteophytes (with radiographic evidence)
3. At least 1 of the following 3 conditions: Age greater than 50, or Morning
stiffness less than 30 minutes, or Crepitus
- Have a Kellgren and Lawrence grade of I, II, III or IV
- Have a mean score of at least 4 (moderate) and less than or equal to 8
(moderate-severe) on the 24-hour average pain score (0-10) (question 1) in the
participant e-diary from screening to randomization for the knee joint during walking
- Discontinued use of all analgesic medications (including over-the-counter [OTC]
analgesics/Non-Steroidal Anti-Inflammatory Drug [NSAID]) at least 2 weeks prior to
randomization (participants are allowed limited use of analgesic medications)
Exclusion Criteria:
- Are currently enrolled in, have completed or discontinued within the last 3 months
from, a clinical trial involving an off-label investigational drug or device or are
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study
- Have known allergies to LY2828360, related compounds or any components of the
formulation
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the
opinion of the investigator, increases the risks associated with participation in the
study
- Have a recent or current history of cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs; of
constituting a risk when taking the study medication; or of interfering with the
interpretation of data
- Have current or previous (within the past year) Axis 1 diagnosis of major depressive
disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder,
alcohol or eating disorders according to the Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition Text Revision, criteria, as determined by the
investigator and confirmed by the Mini-International Neuropsychiatric Interview
- Are judged by the Principal Investigator to be clinically at suicidal risk based upon
clinical interview
- Have intercurrent illness or clinically significant adverse events
- Have increased risk of seizures as evidenced by a history of seizures, stroke, surgery
to the cerebral cortex, or head trauma with loss of consciousness
- Have an alanine aminotransaminase (ALT) greater than 2.5 times Upper Limit of Normal
(ULN) at Screening, based on reference ranges of the local laboratory. Moderate or
greater hepatic impairment
- Have prior renal transplant, current renal dialysis or severe renal insufficiency, or
serum creatinine laboratory value greater than 1.5 times Upper Limit of Normal, based
on the reference ranges of the local laboratory
- Have clinically significant abnormal neurological examination, especially any evidence
of tremor or nystagmus
- Have a history of or symptoms suggestive of sleep apnoea
- Use of any known strong inducers or inhibitors of Cytochrome P450 within 30 days prior
to enrolment.
- Regularly use known drugs of abuse and/or show positive findings on urinary drug
screening
- Have a positive alcohol breath test at Screening
- Show evidence of human immunodeficiency virus infection and/or positive human HIV
antibodies
- Have an active malignancy of any type or a history of malignancy (except basal cell
carcinoma of the skin that has been excised prior to study start)
- Are at a high risk of infection
- Have an autoimmune disorder
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Are women with a positive pregnancy test or women who are lactating or child bearing
- Use prescription and herbal medications that cannot safely be discontinued by end of
screening
- Have donated blood of more than 500 milliliters (mL) within the last 3 months
- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age
65) and 14 units per week (males over 65 and females), or are unwilling to refrain
alcohol consumption for the duration of the study
- Are persons who have previously received the investigational product in study, have
completed or withdrawn from this study or any other study investigation LY2828360
- Are taking any excluded medications (analgesic medications) and over-the- counter
medications that cannot be discontinued at screening
- Show evidence or have any prior history of significant active neurological or
psychiatric disease including depression
Exclusion Disease Criteria:
- Have secondary causes of arthritis of the knee including septic arthritis,
inflammatory joint disease, articular fracture, major dysplasias or congenital
abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, and primary
osteochondromatosis
- Have had lower extremity surgery (including arthroscopy of the index knee) within 6
months prior to Screening or have surgery planned of the index knee at anytime
- Have had significant prior injury to the index knee within 12 months prior to
Screening
- Use of lower extremity assistive devices other than a cane or knee brace (use of a
'shoe lift' is permitted). Are non-ambulatory or require the use of crutches or a
walker. Use of a cane in the hand opposite the index knee is acceptable
- Have a confounding painful condition that may interfere with assessment of the index
joint, that is, knee
- Have any other musculoskeletal or arthritic condition that may affect the
interpretation of clinical efficacy and/or safety data or otherwise contraindicates
participation in this clinical study
- Have used corticosteroid prior to baseline
- Have received hyaluronan injections into index knee within the previous 6 months prior
to Treatment Phase day 3
- Have initiated or have changed to an established physiotherapy program within 2 weeks
prior to Treatment Phase day 3 or during the study period An established physiotherapy
program may be continued throughout the study period if unchanged in frequency and
intensity
- Has had a prior synovial fluid analysis showing a White Blood Cell (WBC) greater than
or equal to 2000 cubic millimeters (mm^3) that is indicative of a diagnosis other than
OA
- Have started recently or changed dose regimen of any OA specific therapies (that is,
nutraceutical products)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | A Study of LY2828360 in Patients With Osteoarthritic Knee Pain | NCT01319929 | Entailment |
2,554 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- adults
- consultation during the early stages of care
- leaving after consultation
- agrees to participate in the study
Exclusion Criteria:
- minor patients
- permanently off care
- hospitalized patients
- refusal to participate in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| the Observance of Emergency Exit Treatments During the Stay of Care at the Exit of Reims Emergencies | NCT03836534 | Contradiction |
3,797 | 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:
- If female and of childbearing potential, must be using adequate contraception since
last menses and will use adequate contraception during the study,
- Diagnosed as having OA of the knee
- Functional Capacity Classification of I-II (FCC)
- If on active analgesic or anti-inflammatory pain medication, must have VAS pain
score>=30mm in signal knee related to walking on a flat surface within the previous 48
hours. Subjects who are not taking any pain medication must have a VAS pain
score>=40mm in the signal knee
- At baseline visit, must have a history of pain in the signal knee>=40mm when walking
on the flat within the previous 48 hours.
- In the Investigator's opinion, the patient requires and is eligible for therapy with
an anti-inflammatory analgesic.
- If on an NSAID or analgesic, patient must have completed a washout period prior to
baseline assessments that is a minium of five half lives.
- The patient has provided written informed consent before undergoing any study
procedures.
Exclusion Criteria:
- Diagnosed as having inflammatory arthritis or acute trauma at the index joint.
- Another painful condition that would interfere with his/her ability to walk or to make
reasonable assessments of their pain.
- Received an injection of corticosteroid into the signal knee within 3 months; or with
a hyaluronan produce in the signal knee within the previous 6 months.
- Requires the use of a cane or other assistive device to complete the walk.
- Known cardiovascular disease which has been symptomatic in the past 12 months
- History of blood clots or is at any increased risk for blood clotting.
- Asthma or any breathing condition which would preclude walking briskly for 20
consecutive minutes or 40 minutes total.
- Has taken any NSAIDs, COX-2 inhibitors, or any analgesic, with the exception of the
rescue acetaminophen, within two days prior to Visit 2
- Active malignancies or any type or a malignancy that has recurred within 5 years
before enrollment.
- Diagnosed as having or has been treated for esophageal, gastric, pyloric channel,
duodenal ulceration within 90 days
- Active GI disease, a chronic or acute renal or hepatic disorder, or a significant
coagulation defect.
- Any chronic illness or laboratory abnormalities considered to be clinically
significant.
- Received any investigational medication within 30 days
- Known hypersensitivity to celecoxib, NSAIDs, to sulfonamides
- Use of the following drugs:
1. NSAIDs or COX-2 specific inhibitors
2. Analgesics except rescue medication within 24 hours of a study visit
3. Anticoagulants
4. Lithium
5. Glucosamine or chondroitin sulfate are excluded unless on stable dose for at
least 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 45 Years old.
| Efficacy of Celecoxib 200mg in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee | NCT00597415 | Entailment |
3,540 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | - INCLUSION CRITERIA:
- Adult patients of all ages with endocrine-related conditions will be eligible for this
protocol.
- Both male and female subjects of all ethnic backgrounds are eligible.
EXCLUSION CRITERIA:
- Unstable patients and patients with severe organ failure that may affect/limit the
endocrine work-up and exhaust Clinical Center and/or NICHD resources will be excluded
if appropriate. Decisions will be made on a case by case basis by investigators.
- Subjects who are unable to provide informed consent will not be accrued; however, if
patients have previously given consent, they will continue to be seen for ongoing
clinical care. If they require medically-indicated procedures, we will follow NIH
policy regarding obtaining consent from next of kin if they have not indicated a
medical decision maker.
- Minor subjects will not be accrued; they will be referred to NICHD protocols or other
NIDDK protocols for evaluation of eligibility.
- Prisoners will not be recruited. If a subject becomes incarcerated during the study,
s/he may continue to participate so as to not compromise medical care.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Evaluation of Patients With Endocrine-Related Conditions | NCT00005664 | Entailment |
4,911 | 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:
- Adults
- Individuals who have undergone or are scheduled to undergo Deep Brain Stimulation
(DBS) placement
Exclusion Criteria:
- Individuals who have not had or are not scheduled for Deep Brain Stimulation (DBS)
placement
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.
| Electromagnetic Tracking to Measure Tremor | NCT02641366 | Contradiction |
4,415 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Patients aged 18 years and up
- Pain at the lateral side of the elbow
- Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the
elbow in full extension
- Pain for longer than 3 months
Exclusion Criteria:
- Previous operations (including previous steroid injections for the disorder)
- Nerve entrapment
- Pregnancy and while breast-feeding
- Presence of systemic neuromuscular disorders such as myasthenia gravis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Treatment of Tennis Elbow With Botulinum Toxin | NCT00119704 | Contradiction |
4,386 | 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:
People with Marfan syndrome.
- Age ≥ 18yrs
- Able and willing to provide informed consent
- Willing to sleep connected to research apparatus
Exclusion Criteria:
- Unstable cardiovascular disease (CHF, myocardial infarction or revascularization
procedures, and unstable arrhythmias)
- Uncontrolled hypertension (BP > 190/110)
- Underlying obstructive or other intrinsic lung disease
- Renal failure on dialysis
- Cirrhosis
- Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Hemodynamics Response to Upper Airway Obstruction in Marfan Syndrome | NCT03985657 | Entailment |
1,011 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Female patients evaluated to be relatively in good health
- 40 years old and above
- Negative pregnancy test
Additional inclusion criteria for OA patients:
- Frequent knee symptoms in the past year, defined as:
- pain, aching, or stiffness on most days of a month during the past year
- use od medication (all types) for treatment of knee pain on most days of a month
during the past year
- Kellgren & Lawrence Grades 2 or 3 of the study knee (with either the same or less
severe OA , or no OA in the contralateral knee)
- Body mass index (BMI) of 30 and above
- Medial joint space width of 2 mm and above
Additional inclusion criteria for age-matched controls:
- BMI of 28 and above
- No evidence of knee OA in either knee (i.e., Kellgren & Lawrence Grade 0 diagnosed by
x-ray on AP view; infrequent knee pain, aching, stiffness during the past year;
infrequent use of medication (all types) for treatment of knee pain during the past
year.
Exclusion Criteria:
- Anticipated need for knee surgery in the next 2 years
- OA predominantly in the lateral tibiofemoral compartment measured by PA x-ray view of
the study knee
- Intra-articular steroids to study joint (3 month washout), intra-articular hyaluronic
acid to the study joint (3 month-washout), doxycycline (3 month washout), or
arthroscopy within the last 6 months
- Medial joint space width less than 2 mm measured by PA view of knee x-ray
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty, or
meniscectomy of the study knee
- History of other diseases that may involve the study joint including inflammatory
joint diseases, crystalline disease, endocrinopathies, metabolic, diseases, knee
infection of the study knee, neuropathic disorders, avascular necrosis, Paget's
disease, or tumors (chondrocalcinosis is acceptable; treated thyroid disease is
acceptable)
- Systemic inflammatory diseases (e.g., Rheumatoid arthritis)
- Other pain that the principal investigator feels can not be distinguished from knee
pain (e.g., lumbar pain, hip pain, trochanteric bursitis)
- Musculoskeletal pain that may preclude the subject from remaining motionless for the
MRI acquisitions
- Unable to undergo an MRI exam of the knee because of contraindications
- Unable to receive gadopentate contrast agent injection because of contraindications. A
study subject who displays any sign of an allergic reaction to the contrast agent will
be withdrawn from the dGEMRIC part of the protocol and will not receive any subsequent
contrast agent injection. The subject may continue to complete the remainder fo the
study, which includes MR morphometry scan, collection of blood and urine sample for
biomarker assays, and completion of study questionnaires.
- Clinical chemistry laboratory values more than 2 times the upper limit of normal
- Participation in clinical trial with a study during in the past 14 days
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or may
interfere with the interpretation of trial results and, in the judgment of the
investigator, would make the subject inappropriate for entry in the this trial
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography | NCT00505297 | Entailment |
177 | 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:
- Testosterone level <350 ng/dL, 10 am [± 2 hour] sample.
- Body mass index (BMI) <35.0 kg/m2 and weight ≥50 kg
Exclusion Criteria:
- History of clinically significant renal, hepatic, neurologic, hematologic, endocrine,
oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other
condition.
- Significant gastrointestinal or malabsorption conditions.
- Any man in whom testosterone therapy is contraindicated including the following:
1. Known or suspected carcinoma (or history of carcinoma) of the prostate,
clinically significant symptoms of benign prostatic hyperplasia, and/or
clinically significant symptoms of lower urinary obstruction and International
Prostate Symptom Score (IPSS) ≥19. A clinically significant digital rectal
examination of the prostate or clinically significant elevated serum PSA levels
(>4.0 ng/mL).
2. Known or suspected carcinoma (or history of carcinoma) of the breast.
3. Liver disease defined as alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) >2 × upper limit of normal (ULN) or bilirubin >2 × ULN.
4. Active deep vein thrombosis or thromboembolic disorder, or a documented history
of these conditions.
5. Untreated sleep apnea.
6. Hematocrit >50%.
7. Untreated moderate to severe depression.
- Current use of long-acting testosterone or any of the testosterone esters injectables.
- Topical, oral, or injectable testosterone replacement therapy.
- Clinically significant changes in any medications (including dosages) or medical
conditions in the 28 days before screening.
- Suspected reversible hypogonadism (e.g., leuprolide injection).
- Taking concomitant medications that affect testosterone concentrations or metabolism
- Uncontrolled diabetes (screening glycated hemoglobin [HbA1c] ≥9%).
- Donated blood or blood products or experienced significant blood loss within 90 days
before dosing.
- Donated bone marrow within 6 months before dosing.
- History of drug or alcohol abuse in the last 6 months.
- Ingested St John's wort within 30 days of screening.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males | NCT03335254 | Entailment |
6,759 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Patients with Hemophilia A (congenital factor VIII deficiency) who will receive
Hemlibra SC inj. according to medical judgement of investigator (Severe for Hemophilia
A patients without FVIII inhibitors).
2. Signed informed consent form
Exclusion Criteria:
1. Subjects who are hypersensitive to Emicizumab
2. Subjects who are hypersensitive to mouse or hamster protein
3. Subjects with myocardial infarction or the history who are prohibited from
administering L-Arginine containing drug
4. Subjects who participated in other clinical trials within a month before enrollment
(or the first administration of Hemlibra SC inj.) (Unable to participate in other
clinical trials related to Hemophilia A treatment even after enrollment)
5. Subjects who the investigator deems inappropriate for the study.
Male
No healthy subjects accepted to join the trial.
| The Safety of Emicizumab SC Injection in Korean Patients With Hemophilia A | NCT04805801 | Entailment |
6,211 | 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:
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed)
- at least one of the following: radiation contactless body temperature ≥37.5, cough,
shortness of breath, nasal congestion/ discharge, myalgia/arthralgia,
diarrhea/vomiting, headache or fatigue on admission.
- Time of onset of the symptoms should be acute (Days ≤ 14)
- NEWS2 ≥ 1 on admission (National Early Warning Score 2)
Exclusion Criteria:
- Refusal to participate expressed by patient or legally authorized representative if
they are present
- Patients using drugs with potential interaction with Lopinavir/Ritonavir or
Interferon-β 1a
- Pregnant or lactating women.
- History of alcohol or drug addiction in the past 5 years.
- Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
- The patients who were intubated less than one hours after admission to the hospital
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 100 Years | the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19 | NCT04521400 | Contradiction |
5,527 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
1. Diagnosis of a systemic vasculitis: The V-PPRN includes patients with self-reported
Behçet's disease, central nervous system vasculitis, cryoglobulinemic vasculitis,
eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome, CSS), giant
cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's, GPA),
IgA vasculitis (Henoch-Schönlein Purpura), microscopic polyangiitis (MPA),
polyarteritis nodosa (PAN), Takayasu's arteritis (TAK), and urticarial vasculitis.
2. Language requirements: questionnaire will be in English only
Exclusion Criteria:
1. Inability to provide informed consent and complete survey in English
2. Patients with a diagnosis of "other" type of vasculitis
3. Patients with a "missing" diagnosis -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Journey of Patients With Vasculitis From First Symptom to Diagnosis | NCT03410290 | Entailment |
4,976 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Adult subjects aged between 18 and 75 years old, inclusive, with history of tremor
that fulfills the diagnostic criteria of ET according to Movement Disorder Society
(MDS) Consensus Statement on the classification of tremors from the task force on
tremor of the International Parkinson and Movement Disorder Society (Bhatia, 2018).
2. Duration of ET illness since the first symptoms were noticeable of at least 3 years or
more prior to screening, based on the subject's self-report, with onset prior to age
65 years old, per the Principal Investigator's assessment during screening.
3. Except for ET, subjects must be otherwise healthy as determined by the Investigator,
based upon a medical evaluation including medical history, physical examination,
laboratory tests, and 12-lead ECG.
4. Subjects are able to understand study activities required, can give written informed
consent, and are willing to comply with the requirements and restrictions of the
study.
5. Women of childbearing potential must undertake a pregnancy test with documented
negative serum pregnancy test at Screening and negative urine pregnancy test result at
Pre-dose, Days 7 and 14 before administration of the study drug, and then at the
Follow-up visit (Day 21).
6. Postmenopausal women must have had ≥365 days of spontaneous amenorrhea, with
documented follicle-stimulating hormone (FSH) ≥38 IU/mL, prior to screening. If
needed, per Investigator's judgment, FSH level can be performed at Screening.
7. Surgically sterile women must have documentation of a hysterectomy, bilateral
ovariectomy, or bilateral tubal ligation.
8. Female subjects with reproductive potential and male subjects with reproductive
potential or who have female partners of reproductive potential, must agree to use two
effective methods of contraception from signing informed consent until 90 days after
the last dose of study drug. Acceptable forms of contraception include double barrier
(ie, condom with spermicide); surgically sterilized partner (180-day minimum); or
abstinence.
Exclusion Criteria:
1. Prior or ongoing medical condition or any abnormal finding on the Screening visit
physical exam, ECG, laboratory testing that, in the Investigator's opinion, could
adversely affect the safety of the subject or the conduct of the study assessments.
2. Any neurological abnormality other than ET upon neurological exam, including dystonia,
ataxia, or any other neurodegenerative disease, including multiple sclerosis or
Parkinson's disease.
3. Significant cognitive impairment or dementia that, in the opinion of the Investigator,
would interfere with participation in the study.
4. An unstable thyroid condition that, per the Investigator's judgment, has not
stabilized over the past 90 days prior to screening. This includes current clinical
history of hypo- or hyperthyroidism, thyrotoxicosis or significant abnormality of
thyroid function testing at Screening.
5. History of, or evidence of psychogenic tremor at Screening.
6. History of anaphylaxis, hypersensitivity reactions (including to any of CAD-1883
excipients), or clinically significant drug allergies.
7. Alkaline phosphatase, aspartate aminotransferase (AST), and/or alanine
aminotransferase (ALT) level >2.0 x upper limit of normal (ULN) at Screening and/or at
Pre-dose.
8. Serum creatinine >120 μmol/L and/or creatinine clearance <60 mL/min (according to
Cockcroft-Gault formula) at Screening and/or at Pre-dose.
9. Total bilirubin >2.0 x ULN at Screening and/or at Pre-dose. Note: isolated bilirubin
>2.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%.
10. History of Long QT syndrome and/or QTcF (Fridericia's correction) interval >450 msec
(males) or >470 msec (females) per 12-lead ECG done at Screening.
11. History of Alcohol Use Disorder per Diagnostic Statistical Manual of Mental Disorders,
Fifth Edition (DSM-V) criteria.
12. History of human immunodeficiency virus (HIV) infection or positive screening result
for: HIV 1 or 2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis B core
antibody (HBcAb), or hepatitis C virus antibody (HCVAb).
13. Has a diagnosis of epilepsy or any history of seizure as an adult, head trauma,
stroke, transient ischemic attack within 1 year prior to Screening, unexplained loss
of consciousness within 1 year prior to Screening, or any lifetime history of
asymptomatic or symptomatic orthostatic hypotension (eg, postural syncope).
14. History of unstable angina, myocardial infarction, chronic heart failure (New York
Heart Association Class 3 or 4), or clinically significant conduction abnormalities
(eg, unstable atrial fibrillation) within 1 year prior to screening.
15. Any major psychiatric disorder that is uncontrolled (for the past 90 days) that, per
the Investigator's judgment, can interfere with any of the study procedures.
16. Subject has cancer, except for the following: basal cell carcinoma or successfully
treated squamous cell carcinoma of the skin; cervical carcinoma in situ; prostatic
carcinoma in situ; or other malignancies curatively treated and with no evidence of
disease recurrence for at least 3 years.
17. Subjects with scheduled surgeries during the study period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Clinical Study to Evaluate CAD-1883 in Essential Tremor | NCT03688685 | Entailment |
4,788 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
1. Adults age 22.0-90 with bilateral vestibular deficiency not responsive to vestibular
rehabilitation as determined by pre-inclusion history, vestibular testing and clinical
examination
2. Hearing status: (1) Hearing in the candidate ear for implantation is equivalent to or
worse than that in the contralateral ear; and (2) hearing in the contralateral ear is
good enough to allow functional communication in case hearing in the implanted ear is
lost after implantation. Specifically, the contralateral ear must satisfy all of the
following criteria:
1. 0.5/1/2/4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less
than) 70 dB HL; and
2. ear-specific sentence recognition score using the recorded AzBio Sentence Test
presented at 60 dB SPL-A in quiet must be >60% when tested under either the
unaided condition or, if 0.5/1/2/4 kHz PTA>50 dB, the best-aided condition; and
3. ear-specific word recognition score using the recorded
Consonant-Nucleus-Consonant (CNC) Word Recognition Test presented at 60 dBHL in
quiet must be >60% when tested under either the unaided condition or, if
0.5/1/2/4 kHz PTA>50 dB, the best-aided condition
3. Caloric responses consistent with severe or profound bilateral loss of labyrinthine
function, as indicated by one or more of the following: (a) summed speed of caloric
responses to warm and cool supine caloric stimuli totaling <10°/sec per ear for each
of both ears; (b) summed speed of ice water caloric responses during supine and prone
head orientation tests totaling <10°/sec per ear for each of both ears; or (c) speed
of ice water caloric responses during supine head orientation tests <5°/sec per ear
for each of both ears, with a lack of nystagmus reversal on quickly flipping from
supine to prone
4. Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP)
angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present
cochlear nerve, and absence of internal auditory canal/cerebellopontine angle tumors
or other central causes of vestibulo-ocular reflex dysfunction or sensorineural
hearing loss
5. Prior CT imaging of the temporal bones showing a facial nerve canal with normal
caliber and course, middle ear without evidence of chronic otitis media or tympani
membrane perforation or cholesteatoma, a mastoid cavity with adequate aeration for
surgical access to each semicircular canal, skull thickness ≥3 mm at the planned well
site, and scalp soft tissue thickness ≤7 mm. This criterion may be satisfied without
additional imaging if an existing head CT or MRI already demonstrates those findings
6. Vaccinations as recommended per Johns Hopkins Listening Center protocols to reduce the
risk of meningitis in subjects undergoing cochlear implantation, as described at this
site:
http://www.hopkinsmedicine.org/otolaryngology/specialty_areas/listencenter/vaccine.htm
l
7. Motivated to travel to the study center, to undergo testing and examinations required
for the investigational study, and to participate actively in a vestibular
rehabilitation exercise regimen
8. The participant must agree not to swim or to use or operate vehicles, heavy machinery,
powered tools or other devices that could pose a threat to the participant, to others,
or to property throughout the duration of participation in the study and until at
least 1 month after final deactivation of the MVI Implant
Exclusion Criteria:
1. Inability to understand the procedures and the potential risks involved as determined
by study staff
2. Inability to participate in study procedures due to blindness, ≤ ±10° neck range of
motion, cervical spine instability, ear canal stenosis or malformation sufficient to
prevent caloric testing
3. Diagnosis of acoustic neuroma/vestibular schwannoma, chronic middle ear disease,
cholesteatoma, or central nervous system causes of vestibulo-ocular reflex
dysfunction, including chronic and continuing use of medications, drugs or alcohol at
doses sufficiently great to interfere with vestibular compensation
4. Vestibular dysfunction known to be caused by reasons other than labyrinthine injury
due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic defects
known to act on hair cells
5. Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with
attention to the internal acoustic meatus
6. Any contraindication to the planned surgery, anesthesia, device activation and
deactivation, or participation in study assessments, as determined by the surgeon,
anesthesiologist, or designee, including known intolerance of any materials used in
any component of the investigational devices that will come in contact with the
subject
7. History of myocardial infarction, coronary bypass surgery, or any percutaneous
coronary intervention (PCI) within 6 months prior to screening
8. Orthopedic, neurologic or other nonvestibular pathologic conditions of sufficient
severity to confound posture and gait testing or other tests used in the study to
assay vestibular function.
9. Subjects with estimated glomerular filtration rate (GFR) < 30 ml/min (MDRD formula) at
screening
10. Subjects with heart failure NYHA class III or IV
11. Subjects with Child-Pugh class C cirrhosis
12. A psychiatric disease or substance abuse history likely to interfere with protocol
compliance
13. Contraindications to scleral coil eye movement testing, including monocular blindness
and a history of fainting vagal reactions to prior eye manipulations would exclude
subjects from eye coil testing
14. Inability to tolerate baseline testing protocols
15. Recent corneal injury
16. A history of cervical spine disease preventing head rotation
17. A history of fainting or vagal reactions prior to eye manipulations that would
preclude 3D eye movement coil testing
18. Pregnancy, positive urine or serum pregnancy test at any time during study
participation,
19. Ability to become pregnant combined with failure or refusal to consistently use a
highly effective method of contraception from at least 1 month prior to implantation
to not before 1 month after both device deactivation and conclusion of study
participation. Highly effective contraception methods include:
Total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post
ovulation methods) and withdrawal are not acceptable methods of contraception for
purposes of defining exclusion criteria for this study
Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or
tubal ligation at least six weeks before entering the study. A woman who has undergone
oophorectomy without hysterectomy may participate in the study only after her
reproductive status has been confirmed by subsequent hormone level assessment
For female subjects of child-bearing potential, study participation is not excluded if
the study candidate's male partner is the sole partner of the study candidate and has
been vasectomized.
Combination of any two of the following:
Use of oral, injected or implanted hormonal methods of contraception or other forms of
hormonal contraception that have comparable efficacy (failure rate <1%), for example,
hormone vaginal ring or transdermal hormone contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral
contraception, women should have been stabile on the same pill for a minimum of 3
months before taking study treatment.
20. Women who are nursing/lactating
21. Any medical condition, judged by the investigator team, that is likely to interfere
with a study candidate's participation in the study or likely to cause serious adverse
events during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 90 Years | Multichannel Vestibular Implant Early Feasibility Study | NCT02725463 | Entailment |
5,432 | 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:
- Informed consent
- Validated coagulation disorder
Exclusion Criteria:
- Not consenting to participate
- Multiple coagulopathies and comorbidities
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 90 Years | Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders | NCT02324517 | Entailment |
6,548 | 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:
- patient with proven spinal lipoma
Exclusion Criteria:
- complex spinal lipomas related to other developmental abnormalities
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 16 Years | Developing a Biomarker for Monitoring Clinical Outcomes in Children With Spinal Lipoma. | NCT02722681 | Contradiction |
4,734 | 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:
- Regular menstrual cycles
- sexually active and at risk of pregnancy
- nonpregnant
- normal Pap smear
Exclusion Criteria:
- Presently have or at risk of venous thrombosis or arterial thrombosis
- migraines with focal aura
- severe hypertension
- diabetes mellitus
- hereditary dyslipoproteinemia
- carcinoma of breast, endometrium or other estrogen-dependent neoplasia
- substance abuse
- skin conditions
- concurrent use of hormone-containing medication
- smoking women over 35 years of age.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception. | NCT00261482 | Entailment |
4,109 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Age 18-45 of both genders
2. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
3. History of episodic wheezing, chest tightness, or shortness of breath consistent with
asthma, or physician diagnosed asthma.
4. Positive methacholine test. A positive test is defined as a provocative concentration
of methacholine of 10 mg/ml or less producing a 15% fall in forced expiratory volume
in 1 second (FEV1) (PC20 methacholine) by the method used in a separate screening
protocol or a pre and post bronchodilator challenge used to determine reversible lung
function. Reversibility is confirmed with a 10-12% increase in FEV1 15 minutes after
inhaling 4 puffs of albuterol with a spacer. Reversibility is used in the same
separate screening protocol; or a clinical history of asthma after the age of 6.
5. FEV1 of at least 80% of predicted and FEV1/Forced Vital Capacity (FVC) ratio of at
least .70 (without use of bronchodilating medications for 12 hours or long acting beta
agonists for 24 hours), consistent with lung function of persons with no more than
mild episodic or mild persistent asthma.
6. Allergic sensitization to at least one of the following allergen preparations: (House
Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1,
Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive
immediate skin test response; or a clinical history consistent with seasonal or
perennial allergy symptoms.
7. Symptom Score (this will be submitted as an attachment) no greater than 20 (out of a
possible 60) for total symptom score with a value no greater than 3 for any one score.
No more than one score may be greater or equal than 3.
8. subjects must be willing to avoid caffeine for 12 hours prior to all visits.
Methacholine challenge and allergy skin testing are performed as part of IRB 98-0799,
which a subject must complete in order to be considered for this protocol.
9. for subjects who are prescribed inhaled corticosteroids (ICS). These volunteers must
be able to come off of the ICS for 2 weeks without increased symptoms or increased
need for beta agonist rescue medication prior to screening and throughout the course
of the study.
-
Exclusion Criteria:
1. Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic renal
disease, chronic thyroid disease, history of chronic infections/immunodeficiency,
history of tuberculosis
2. Physician directed emergency treatment for an asthma exacerbation within the preceding
3 months
3. Moderate or Severe asthma
4. Exacerbation of asthma more than 2x/week which would be characteristic of a person of
moderate or severe persistent asthma as outlined in the current NHLBI guidelines for
diagnosis and management of asthma.
5. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
tightness) which would be characteristic of a person of moderate or severe persistent
asthma as outlined in the current NHLBI guidelines for diagnosis and management of
asthma. (Not to include prophylactic use of albuterol prior to exercise).
6. Viral upper respiratory tract infection within 4 weeks of challenge.
7. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
8. Severe asthma
9. Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
10. Medications which may impact the results of the O3 exposure, interfere with any other
medications potentially used in the study (to include systemic steroids, beta
antagonists, non-steroidal anti-inflammatory agents)
11. Any history of smoking in the year prior to study enrollment; lifetime smoking history
> 10 pack years
12. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a
clearly recognized viral induced asthma exacerbation) which would be characteristic of
a person of moderate or severe persistent asthma as outlined in the current NHLBI
guidelines for diagnosis and management of asthma
13. Allergy/sensitivity to study drugs, or their formulations.
14. Known hypersensitivity to methacholine or to other parasympathomimetic agents
15. History of intubation for asthma
16. Unwillingness to use reliable contraception if sexually active (IUD, birth control
pills/patch, condoms).
17. Abnormal Prothrombin Time (PT) or activated Partial Thromboplastin Time (aPTT) values
at screening or during the treatment period. Normal values will be those published by
the clinical lab (Labcorp, INC).
18. Any bleeding disorder
19. Orthopedic conditions which would prevent the volunteer from performing moderate
exercise on a treadmill.
20. Radiation exposure history will be collected. Subjects whose exposure history within
the past twelve months would cause them to exceed their annual limits will be
excluded.
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure | NCT02911688 | Contradiction |
6,165 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Confirmed patient COVID19 positive with clinical signs of acute lower respiratory
infection with signs of pneumonia or bronchitis: fever and / or cough and / or
difficulty breathing in the absence of acute respiratory failure (PaO2> 60 mmHg) with
Plus or less :
- Chills
- Asthenia, fatigability
- Headache
- Arthromas myalgia
- Dry throat
- Rhinorrhea
- An anosmia
- chest pain
- Diarrhea
- Nausea and vomiting
- Absence of rhythm disturbance (Qt interval <500ms)
- Patients hospitalized in the medical service
- 18 years old <Age <80 years old
- Having given written consent for their participation in the study
Exclusion Criteria:
- Allergy to macrolides, local anesthetics such as lidocaine or amide type and
betalactamines
- Take hydroxychloquine in the previous month
- Severe / severe liver failure
- Kidney failure (GFR <30 ml / min / 1.73 m2)
- Ongoing treatments with colchicine, ergot, rye, pimozide, mizolastine, simvastatin,
lomitapide, alfuzosin, dapoxetine, avanafil, ivabradine, eplerenone, dronedarone,
quetiapine, ticagrelor, cisapride, astemizole, terfenadine, ranolazine, domperidone.
- Complete branch block
- Hypovolemia
- Retinopathy including vitreous involvement
- Psoriasis
- Pregnant or breastfeeding woman
- hypersensitivity to chloroquine or hydroxychloroquine or to any of the other
ingredients of this medication
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 | Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia | NCT04528927 | Contradiction |
2,369 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Diagnosis of DMD confirmed by 1) clinical history with features before the age of
five, 2) physical examination, 3) elevated serum creatine kinase level and 4) absence
of dystrophin expression, as determined by immunostain or Western blot (<2%) and/or
DNA confirmation of dystrophin mutation.
- Age 5.0 to 8 years: a lower age limit of 5.0 years is selected as children younger
than that are likely unable to cooperate and comply with all of the exercise measures
as needed. An upper age limit of 8 years has been set as boys with DMD tend to reach a
rapid progression into a late ambulatory phase soon after this age.
- Ambulatory at the time of the first visit, defined as the ability to walk for at least
100 m without an external assistive device and able to climb four stairs.
- Aim 1 only: GC-naïve at baseline (and prior 6 months)
- Aim 2 only: on stable daily GC regimen for 6 months prior to baseline
Exclusion Criteria:
- Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia,
magnetic implants)
- Presence of unstable medical problems, significant concomitant illness including
cardiomyopathy or cardiac conduction abnormalities
- Presence of a secondary condition that impacts muscle function or muscle metabolism
(e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
- Presence of a secondary condition leading to developmental delay or impaired motor
control (e.g. cerebral palsy)
- Presence of an unstable medical condition (e.g. uncontrolled seizure disorder)
- Behavioral problems causing an inability to cooperate during testing or understand
exercise instruction
- Participation in other forms of drug or gene therapy during the period of the study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 8 Years | Weekend Steroids and Exercise as Therapy for DMD | NCT04322357 | Entailment |
2,081 | 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. | For cases
Inclusion Criteria:
- New diagnosis of IPF between February 2017 and October 2019
Exclusion Criteria:
- Unable to give informed consent
- Ever worked outside of the UK
For controls
Inclusion Criteria:
- New outpatient department attendee between February 2017 and October 2019
Exclusion Criteria:
- Unable to give informed consent
- Ever worked outside of the UK (does not include work outside the UK by members of the
armed forces or merchant navy)
- Diagnosis of IPF
Male
No healthy subjects accepted to join the trial.
| Idiopathic Pulmonary Fibrosis Job Exposures Study | NCT03211507 | Entailment |
2,741 | 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:
- age ≥18 years
- unilateral primary reducible inguinal hernia
- elective operation
- consent to participate in the study.
Exclusion Criteria:
- age <18 years
- irreducible
- strangulated
- recurrent hernia
- inability to understand the questionnaire
- unwillingness to participate in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty | NCT02500056 | Entailment |
4,621 | 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. | Volunteers must meet all of the following criteria prior to genital sampling at Visit 2:
- Age 18 to 50 years, inclusive
- General good health (by volunteer history and per investigator judgment) without any
clinically significant systemic disease (including, but not limited to significant
liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease,
osteoporosis or bone disease, and diabetes)
- History of Pap smears and follow-up consistent with standard medical practice as
outlined in the Study Manual or willing to undergo a Pap smear at V1
- Willing to give voluntary consent and sign an informed consent form
- Willing and able to comply with protocol requirements
- Protected from pregnancy by:
- hysterectomy
- reliable methods of contraception other than male or female condoms,
contraceptive IVR or male partner's vasectomy
- abstinence (IVR group only)
- or in a same sex relationship (IVR group only)
- For gel, insert or film assigned participants: Willing to engage in intercourse with a
male sexual partner without the use of male or female condoms as required in the
protocol
- For gel, insert or film assigned participants: In a mutually monogamous relationship
with a male partner who:
- Is at least 18 years old
- Is not known to be HIV positive
- Has no known risk for STIs
- Has not undergone a vasectomy
- Is not known to have azoospermia
- Is willing and able to comply with protocol requirements regarding sexual
activity/ abstinence
- Can engage with the participant in vaginal intercourse without condoms, as
specified in the protocol 8.2. Exclusion Criteria
Volunteers must not meet any of the following criteria prior to genital sampling at Visit
2:
- Currently pregnant
- Currently breastfeeding or planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the vaginal products for either the
volunteer or her sexual partner, as applicable
- Use of vaginal douches, creams or gels, other than the study product, at any time
during the study, beginning 7 days prior to V2
- In the last six months, either the volunteer or her sexual partner (as applicable)
diagnosed with or treated for any STI. Note: Women with a history of genital herpes
who have been asymptomatic for at least six months may be considered for eligibility
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis or
HIV
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding,
discharge, etc.)
- Known current drug or alcohol abuse which could impact study compliance
- Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
- Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or her sexual partner (as applicable) which, in the
opinion of the investigator, would make participation in the study unsafe or would
complicate interpretation of data
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms | NCT02569697 | Entailment |
1,799 | 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:
- long-lasting upper gastrointestinal symptoms (>15 years)
- atrophic gastritis or GIM identified at surveillance endoscopy
Exclusion Criteria:
- presence of advanced adenocarcinoma in the stomach
- presence of acute gastrointestinal bleeding
- presence of coagulopathy, uncontrolled impaired renal or liver disease
- presence of pregnancy or lactation
- presence of allergy to acetic acid
- age younger than 18 years or older than 80 years
- inability to provide written informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia | NCT02806115 | Contradiction |
4,964 | 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:
- Essential Tremor diagnosed by criteria listed in the Consensus statement of the
Movement Disorders Society on Tremor
- Age 18 - 85 years of age
- Motor skills allowing for capability to complete evaluations
- Medically cleared for undergoing anesthesia and DBS surgery
Exclusion Criteria:
- Dementia per DSM-V criteria
- Medical or other condition precluding MRI
- History of supraspinal CNS disease other than Essential Tremor
- Alcohol use of more than 4 drinks per day
- Pregnancy
- History of suicide attempt
- Currently uncontrolled clinically significant depression (BDI>20)
- History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
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 85 Years | Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Essential Tremor | NCT02418858 | Entailment |
18 | 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. Age ≥ 18, ≤ 45 years old;
2. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner
score ﹤ 5;
3. Serum FSH and LH levels are low or in normal low value, testosterone was lower than
normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference
range of Tongji Hospital affiliated to Tongji Medical College, Huazhong University of
Science and Technology);
4. With or without olfactory loss/reduction;
5. Other pituitary hormone levels are normal;
6. Head MRI examination is normal;
7. Fertility is desired currently or will be desired in the future;
8. Understand and sign the informed consent form.
Exclusion Criteria:
1. Primary hypogonadism;
2. Acquired hypogonadotrophic hypogonadism;
3. A history of treatment with pulsed GnRH, hCG and FSH related hormones;
4. Receive testosterone replacement therapy for more than 6 months;
5. History of cryptorchidism or cryptorchidism;
6. The sperm density before treatment ≥1×10^6/ml;
7. Moderate or severe liver and kidney dysfunction (ALT>120IU/L, AST>80IU/L,
CR>115μmol/L);
8. The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes;
9. True hermaphroditism and pseudohermaphroditism;
10. Sex hormone abnormalities caused by adrenal lesions;
11. Hypogonadism secondary to other systemic diseases;
12. Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors);
13. There are other hormone abnormalities in the pituitary;
14. There are contraindications for the treatment with hCG or hMG.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in the Treatment of Male Patients With Isolated Hypogonadotropic Hypogonadism: an Open, Randomized Controlled Study | NCT03687606 | Contradiction |
6,986 | 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:
- Alzheimers Disease
Exclusion Criteria:
- Inability to understand English
- No telephone
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Care Management for Patients With Alzheimer Disease and Their Family Caregivers | NCT00246896 | Entailment |
2,739 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery | NCT02782832 | Entailment |
5,498 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria: Subjects must meet the following criteria
1. Able and willing to provide written informed consent and to comply with the study
protocol
2. Diagnosis of GCA classified according to the following criteria:
- Age 50 years or older
- History of erythrosedimentation rate (ESR) ≥ 50 mm/hour or C-reactive protein
(CRP) ≥ 10 mg/L
AND at least one of the following:
- Cranial symptoms of GCA
- Symptoms of polymyalgia rheumatica (PMR)
AND at least one of the following:
- Temporal artery biopsy revealing features of GCA
- Evidence of large-vessel vasculitis by angiography or cross-sectional imaging
3. Active new-onset or relapsing active disease
Exclusion Criteria:
1. Allergies: Subjects who have history of previous severe allergic or anaphylactic
reaction associated with the administration of monoclonal antibodies or antibody
fragments.
2. Systemic infection: Subjects who have an active systemic infection.
3. Serious infection: Subjects who have had serious infections, or any major episode of
infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of
enrollment.
4. Chronic or recurrent infection: Subjects who have chronic or recurrent bacterial,
viral, fungal, mycobacterial, or protozoan infection.
5. Opportunistic infection: Subjects who have, or have had, an opportunistic infection
within 6 months prior to enrollment.
6. Subjects who have active hepatitis B or active hepatitis C or a documented history of
HIV
7. Latent tuberculosis infection
8. Malignancy
9. Subjects with evidence of serious uncontrolled concomitant cardiovascular, nervous
system, pulmonary, renal, hepatic, endocrine, immunologic, psychiatric or
gastrointestinal disease that could interfere with participation in the trial
according to the protocol.
10. Subjects with transplanted organs (with the exception of a corneal transplant > 3
months prior to screening)
11. Major surgery within 8 weeks prior to Screening or planned major surgery within 12
months after Baseline
12. Pregnancy
13. The following laboratory abnormalities
- Hemoglobin < 8 gr/dL
- Platelets < 100/mm3
- White blood cell count (WBC) < 3000/mm3
- Absolute neutrophil count < 2000/mm3
- Absolute lymphocyte count < 500/mm3
- Serum creatinine > 1.4 mg/dL in female subjects and > 1.6 mg/dL in male subjects
- Total bilirubin > 2 mg/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 X upper
limit of normal
- Positive hepatitis B surface antigen, hepatitis B core antibody or hepatitis C
antibody
14. Prohibited medications:
- Subjects who received methotrexate (MTX) > 30 mg weekly, azathioprine,
mycophenolate mofetil, cyclophosphamide, chlorambucil, tacrolimus, leflunomide,
canakinumab, belimumab, abatacept, tocilizumab, secukinumab, infliximab,
etanercept, adalimumab, golimumab, or certolizumab within the 3-month period
prior to enrollment.
- Subjects who had treatment with any anti-cluster designation antigen (CD)20 agent
(e.g., rituximab) within the 9-month period prior to enrolment
- Subjects who used any investigational drug within 1 month prior to enrollment or
within 5 half-lives of the investigational agent, whichever is longer.
- Low dose MTX: Patients on < 30 mg of MTX weekly will be eligible for enrollment
after a 2-week washout interval before receiving ustekinumab
- Vaccines: Subjects who received any live virus or bacterial vaccinations other
than bacille Calmette-Guerin (BCG) within the 3 months before the first
administration of the study agent, or are expected to receive any live virus or
live bacterial vaccinations during the study, or up to 3 month after the last
administration of ustekinumab are not eligible. Subjects who received BCG
vaccines within the 12 months before the first administration of the study agent,
or are expected to receive BCG vaccines during the study, or up to 12 month after
the last administration of ustekinumab are also not eligible.
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.
| Ustekinumab for the Treatment of Giant Cell Arteritis | NCT02955147 | Entailment |
5,466 | 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:
- Signed and dated informed consent
- Women, 18 to 35 years of age at the time of screening (visit 1) who are currently
using Mirena for contraception or for contraception and heavy menstrual bleeding. The
duration of use of the current Mirena has to be at least 4 years 6 months at the start
of screening phase but not more than 5 years at visit 2 and the woman is willing to
continue with its use and has a continuing need for contraception.
- Normal or clinically insignificant cervical smear not requiring further follow up
Exclusion Criteria:
- Menopausal symptoms with Follicle-stimulating hormone>30 mIU/ml
- Pregnancy or suspicion of pregnancy
- Uterine bleeding of unknown etiology
- Untreated acute cervicitis or vaginitis or other lower genital tract infections
- Increased susceptibility to pelvic infection
- Acute pelvic inflammatory disease (PID) or a history of PID unless successfully
treated and which, in the investigator's opinion, has not negatively affected
subject's fertility
- Congenital or acquired uterine anomaly if it distorts the uterine cavity
- History of, diagnosed or suspected genital or other malignancy and untreated cervical
dysplasia
- Any active acute liver disease or liver tumor (benign or malignant)
- Clinically significant endometrial polyp(s)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Mirena Extension Trial | NCT02985541 | Entailment |
2,815 | 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:
- ALS diagnosed as possible, laboratory-supported probable, probable, or definite as
defined by revised El Escorial criteria.
- Having onset of ALS disease symptoms, including limb weakness within 24 months at the
Screening Visit.
- ALSFRS-R ≥ 25 at the screening Visit.
- Upright slow vital capacity (SVC) measure ≥ 65% of predicted for gender, height, and
age at the screening Visit.
- Rapid progressors
- Participants taking a stable dose of Riluzole are permitted in the study
- Citizen or permanent resident of the United States or Canadian citizen able to travel
to a US site for all follow-up study visits
Exclusion Criteria:
- Prior stem cell therapy of any kind
- History of autoimmune or other serious disease (including malignancy and immune
deficiency) that may confound study results
- Current use of immunosuppressant medication or anticoagulants (per Investigator
discretion)
- Exposure to any other experimental agent or participation in an ALS clinical trial
within 30 days prior to Screening Visit
- Use of RADICAVA (edaravone injection) within 30 days of screening or intent to use
edaravone at any time during the course of the study including the follow up period
- Use of non-invasive ventilation (BIPAP), diaphragm pacing system or invasive
ventilation (tracheostomy)
- Feeding tube
- Pregnant women or women currently breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients | NCT03280056 | Entailment |
5,606 | 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:
- child between the ages of 8 & 12
- an moderately overweight child with a BMI% between 85-97%
- child has a parent willing to participate
- child has a parent who can read English at a minimum of a 6th grade level
- family who is willing to commit to treatment attendance and attendance at all
assessments.
Exclusion Criteria:
- Child psychiatric disorder diagnoses (based on parent report)
- Child diagnoses of a serious current physical disease (such as diabetes)
- Child who is taking medications that may impact their weight
- Child with physical difficulties that limit the ability to exercise
- Child with an active eating disorder
- Child and parent will be moving out of the San Diego County before study completion
- Child and/or parent has a modified diet due to religious or socially conscious reasons
(such as Vegan, vegetarian)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 12 Years | Guided Self-help for Families With an Overweight Child | NCT01145833 | Contradiction |
4,781 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Eighteen years of age or older at the time of the study.
- Preoperative aided CNC word score in quiet of greater than or equal to 10% and less
than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in
the contralateral ear
- Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and
profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above)
- Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a
hearing aid on the contralateral ear) through at least 6-months postactivation.
- English spoken as the primary language.
Exclusion Criteria:
- Congenital hearing loss (for the purpose of this study, onset prior to 2
years-of-age).
- Preoperative aided HINT sentence score less than or equal to 50% in the ear to be
implanted
- Ossification, absence of cochlear development or any other cochlear anomaly that might
prevent complete insertion of the electrode array.
- Hearing loss of neural or central origin (e.g., deafness due to lesions on the
acoustic nerve or central auditory pathway).
- Active middle-ear infection.
- Unwillingness and/or inability of the candidate to comply with all investigational
requirements including, but not limited to, study protocol and surgical procedure.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy | NCT01337076 | Entailment |
6,999 | 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:
- Written informed consent obtained from participant or legal guardian prior to any
study-related procedures.
- Aged 18 (inclusive) or older.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
(DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and
Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders
Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's
Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is
assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by
β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up
to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE,
CDR and other cognitive function scales.
- Follow up 5 years and collect the information.
Exclusion Criteria:
- Under age 18.
- Medical or psychiatric illness that would interfere in completing initial and
follow-up visits.
- No one can serve as a study informant.
- With current or past neurological or psychiatric illnesses such as schizophrenia,
epilepsy, brain tumors, severe head trauma and other diseases which can induce
dementia.
- Refused to complete a cognitive test and provide biospecimen.
- With history of alcohol or drug abuse.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study on Biomarkers for Early Diagnosis of Alzheimer's Disease | NCT04575337 | Entailment |
3,984 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Male or female aged 18 years or above
- Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or
knee.
The diagnosis must be based on
- clinical signs and symptoms or
- x-ray diagnosis plus clinical signs and symptoms
- Assessment of pain on active movement (by the patient) must exceed 40 mm on a 100
mm visual analogue scale (VAS)
- Symptoms of OA requiring administration of NSAIDs
- Willingness and ability to provide written informed consent.
Exclusion Criteria:
- Known or suspected hypersensitivity to the trial drugs or their excipients,
analgesics, antipyretics or NSAIDs
- Any clinical evidence of active peptic ulceration during the last six months
- Pregnancy or breastfeeding (precaution : attention should be drawn to reports that
NSAIDs were reported to decrease the effectivity of intrauterine devices)
- Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration
of aspirin or NSAIDs
- Concomitant treatment with anti-coagulants (including heparin), lithium
- Concomitant administration of other NSAIDs or analgesic agents (except paracetamol up
to 4g/day)
- Administration of any NSAID during the last 2 days (3 days for any oxicam) prior to
the first administration of the trial drug
- Concomitant treatment with an oral corticosteroid initiated or with an altered dose
over the previous month
- Parenteral or intraarticular administration of corticosteroids in the previous month
- Any i.m. injection during the previous 7 days
- Any contra-indication to i.m. injections
- Clinical evidence of or known severe cardiac, hepatic, renal, metabolic,
haematological disease, mental disturbance, ulcerative colitis
- Any other rheumatological or non-rheumatological disease that could interfere with the
evaluation of efficacy and safety
- Serum creatinine 125 % of the upper limit of normal range ; aspartate transferase
(AST/SGOT) and/or alkaline transferase (ALT/SGPT) 200 % of the upper limit of normal
range
- Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3
- Synovectomy in the previous month or during the trial
- Participation in another clinical trial during this study or during the previous month
- Previous participation in this trial
- Patient unable to comply with the protocol
- Concomitant therapy with specific symptomatic drug of OA, such as chondroitin
sulphate, diacerhein, initiated or with an altered dose over the previous 3 months.
- Intraarticular administration of hyaluronic acid in the previous month
- Patients where physiotherapy will be changed throughout the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis | NCT00239395 | Entailment |
6,837 | 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:
- Aged ≥12 years old and ≤65 years old;
- Male patients who are clinically diagnosed with severe (laboratory tested FVIII:C <1%)
hemophilia A, including historical FVIII:C <1%;
- Previously received FVIII treatment (prophylactic or bleeding treatment), have the
relevant records and are verified to have accumulated exposures days( EDs) ≥150 days;
- The bleeding treatment records of at least 3 months before screening can be obtained;
- Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay
result <0.6 BU(Bethesda unit)/mL);
- The prothrombin time is normal or international normalized ratio (INR) ≤1.5; 7.
Platelet count ≥100 × 109/L;
Exclusion Criteria:
- Known allergy to recombinant coagulation factor VIII concentrate or any excipient;
known allergy to bovine, rodent or hamster bovine;
- Has a history or family history of blood coagulation factor VIII inhibitor;
- Clinical liver function test (glutamic-pyruvic transaminase, glutamic-pyruvic
transaminase) ≥ three times the upper limit of normal (ULN) or clinical kidney
function test (blood urea nitrogen, creatinine) ≥ three times the ULN;
- Patients clinically diagnosed with active Hepatitis B or Hepatitis C;
- Patients with other coagulation dysfunction diseases in addition to hemophilia A;
- Patients with severe heart disease, including myocardial infarction and cardiac
dysfunction of class III or above;
- Patients who previously experienced intracranial bleeding;
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A | NCT03815318 | Entailment |
1,730 | 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:
- The entire population of Manitoba is considered for inclusion.
Exclusion Criteria:
- Individuals less than or equal to 6 months of age;
- Having less than one year of insurance coverage before the enrolment period;
- Not registered with MH during the enrolment period;
- Physician or hospitalization records indicating a diagnosis of any demyelinating
condition between 1971 (earliest year for which information is available) and the
index date.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
| A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada | NCT02367222 | Entailment |
1,571 | 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:
- patients age 18 and over
- consulting their general practitioner for one of the 8 conditions below
Exclusion Criteria:
- patients who have already received an imagery exam for the acute episode justifying
the consult
- opposition to participate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of Ultra-portable Ultrasound in General Practice | NCT04127149 | Contradiction |
138 | 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:
- a minimum follow-up of 6 months under DA therapy with normal serum prolactin or with
maximum DA dose (3.5 mg/week of cabergoline or 10 mg/day of bromocriptine for at least
2 months)
- serum total testosterone less than 300ng/dl with normal or low LH and FSH levels after
discontinuing testosterone replacement for at least 2 months.
Exclusion Criteria:
- impossibility to attend scheduled visits and irregular compliance to DA treatment.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Clomiphene in Males With Prolactinomas and Persistent Hypogonadism | NCT00697814 | Contradiction |
4,837 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Patients will be eligible for inclusion if: they are males and over 18, lack clinical
features classically associated with Cushing's syndrome; have evidence of excess
circulating cortisol
Exclusion Criteria:
- Evidence of local or systemic malignancy; overt Cushing's syndrome; severe
uncontrolled diabetes mellitus or hypertension; pregnancy; clinically significantly
impaired cardiovascular function (e.g. stage IV cardiac failure); severe liver disease
(liver enzymes ≥ 3 x the institutional upper limit of normal range); significantly
impaired renal function (eGFR <30/min); uncontrolled severe active infection;
treatment with approved or experimental steroidogenesis inhibitors, adrenolytic
agents, within four weeks of admission; In women, known endometrial cancer, history of
endometrial hyperplasia or vaginal bleeding of unknown cause; requirement for inhaled
or systemic glucocorticoids for existing disease; impaired mental capacity or markedly
abnormal psychiatric evaluation that precludes informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Glucocorticoid Receptor Antagonism in Subclinical Cushings | NCT00721201 | Contradiction |
714 | 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:
- Hypertension.
- Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2).
- Aged between 18-75 years.
- Being a participant of the program 5 years ago.
Exclusion Criteria:
- Not having access to the Internet or lack of information about it.
- Treatment with more than 3 antihypertensive drugs.
- Meet the criteria of the DSM-IV-TR of a Food Disorder.
- Presenting some type of severe psychiatric disorder.
- Disability that prevents or hinders physical exercise.
- Receiving some treatment for weight loss.
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 | Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients | NCT04580264 | Contradiction |
5,293 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria
- women not more than 80 years of age on date of randomization
- ≥ 1 year postmenopausal on date of randomization
- ambulatory
- if ≤ 60 years of age, or had or would require a bilateral oophorectomy, serum follicle
stimulating hormone (FSH) > 50 mU/mL or serum estradiol < 20 pg/mL
- low BMD (BMD T-score ≤ -1.8 at any 1 of the following sites: lumbar spine, femoral
neck, or total hip; BMD T-scores must not have been < -4.0 at the lumbar spine or -
3.5 at the femoral neck or total hip)
- before any study-specific procedure, including the screening dual X-ray absorptiometry
(DXA) scan, gave informed consent for participation in the study.
Exclusion Criteria
- fluoride treatment for osteoporosis within the 2 years before the enrollment date
- bisphosphonate use within the 12 months before the enrollment date
- administration of the following medications within the 6 months before the enrollment
date
- tibolone
- Parathyroid hormone (PTH) (or any derivative)
- systemic glucocorticosteroids (> 5 mg oral prednisone equivalent per day for > 10
days)
- inhaled corticosteroids (> 2000 μg per day for > 10 days)
- anabolic steroids or testosterone
- administration of the following medications within the 3 months before the enrollment
date
- systemic hormone replacement therapy
- selective estrogen receptor modulators
- calcitonin
- calcitriol
- current hyper- or hypothyroidism (allowed if stable on thyroid replacement therapy and
thyroid-stimulating hormone was within the normal range)
- current hyper- or hypoparathyroidism
- albumin-adjusted serum calcium < 8.5 mg/dL (< 2.125 mol/L)
- osteomalacia
- rheumatoid arthritis
- Paget's disease
- malignancy within the 5 years before enrollment (except cervical carcinoma in situ or
basal cell carcinoma, which were acceptable)
- renal disease; ie, creatinine clearance ≤ 35 mL/min
- any bone disease, other than osteoporosis, which could interfere with the
interpretation of the findings (eg, osteogenesis imperfecta or osteopetrosis)
- malabsorption syndrome
- weight, height, or girth that could preclude accurate DXA measurements
- < 2 lumbar vertebrae (L1 through L4) evaluable by DXA
- recent long bone fracture (within 6 months)
- osteoporotic-related fracture (ie, crush or wedge vertebral fracture or hip fracture)
known or suspected to have occurred within 2 years of randomization
- > 1 single, grade 1 vertebral fracture
- currently enrolled in or had participated within the previous 30 days in other
investigational device or drug trial(s) (For some trials, this may have been allowed
after discussion and written approval from Amgen.)
- known sensitivity to mammalian-derived drug preparations (eg, Herceptin®)
- any organic or psychiatric disorder, serum chemistry, or hematology that, in the
opinion of the investigator, could have prevented the subject from completing the
study or have interfered with the interpretation of the study results
- self-reported alcohol or drug abuse within the previous 12 months
- any disorder that compromised the ability to give truly informed consent for
participation in the study
- previous administration of denosumab
- known sensitivity or contraindication to alendronate
- known sensitivity or contraindication to tetracycline derivatives (subjects in the
biopsy substudy only).
Female
No healthy subjects accepted to join the trial.
Subject must be at most 80 Years | Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density | NCT00043186 | Entailment |
5,569 | 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:
- Informed consent obtained
- Child population - treatment näive:
- Confirmed diagnosis of Growth Hormone Deficiency (GHD) prior to enrolment as
determined by a Growth Hormone (GH) stimulation test, defined as a peak GH level of
7.0 ng/ml or less. The GH stimulation test will be according to local clinical
standards
- Pre pubertal children age 9 to less than 13 years at enrolment
- No prior exposure to GH therapy (GH-treatment naïve)
- Annualized height velocity (HV) below the 25th percentile for Chronological Age (CA)
(HV less than -0.7 SD scores) and sex according to the standards of Prader et al
(1989)
- Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according
to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts
- Child population - maintenance patients:
- Confirmed diagnosis of GHD prior to enrolment as determined by a GH stimulation test,
defined as a peak GH level of 10.0 ng/ml or less. The GH stimulation test will be
according to local clinical standards
- Pre pubertal children age 9 to less than 13 years at enrolment
- Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according
to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts
- Parent/Guardian population - treatment näive:
- Parent/Guardian of child with a confirmed diagnosis of GHD prior to enrolment as
determined by a GH stimulation test, defined as a peak GH level of 7.0 ng/ml or less.
The GH stimulation test will be according to local clinical standards
- Parent/Guardian of pre pubertal child age 4 to less than 9 years at enrolment
- Parent/Guardian of child with no prior exposure to GH therapy (GH-treatment naïve)
- Parent/Guardian of child with annualized height velocity (HV) below the 25th
percentile for CA (HV less than -0.7 SD scores) and sex according to the standards of
Prader et al (1989)
- Parent/Guardian of child with Body Mass Index (BMI) percentile greater than 5th and
below 95th percentile according to Centers for Disease Control and Prevention (CDC)
BMI-for-age growth charts
- Parent/Guardian living in the same residence as the child at least 50% of the time
- Parent/Guardian population - maintenance patients:
- Parent/Guardian of child with confirmed diagnosis of GHD prior to enrolment as
determined by a GH stimulation test, defined as a peak GH level of 10.0 ng/ml or less.
The GH stimulation test will be according to local clinical standards
- Parent/Guardian of pre pubertal child age 4 to less than 9 years at enrolment
- Parent/Guardian of child with Body Mass Index (BMI) percentile greater than 5th and
below 95th percentile according to Centers for Disease Control and Prevention (CDC)
BMI-for-age growth charts
- Parent/Guardian living in the same residence as the child at least 50% of the time
Exclusion Criteria:
- Child population - treatment näive and maintenance patients:
- Any clinically significant abnormality likely to affect growth or the ability to
evaluate growth:
- a) Chromosomal abnormalities and medical "syndromes", e.g. but not limited to Turner's
syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors
- b) Congenital abnormalities (causing skeletal abnormalities), e.g. but not limited to
Russell-Silver Syndrome, skeletal dysplasia's
- c) Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
variants - Children born small for gestational age (SGA - birth weight and/or birth
length less than -2 SD for gestational age)
- Children diagnosed with diabetes mellitus or fasting blood glucose greater than or
equal to 126 mg/dl (7.0 mmol/L), or HbA1c greater than or equal to 6.5% at enrolment
- Current inflammatory diseases (e.g. but not limited to arthritis, inflammatory bowel
diseases) requiring systemic corticosteroid treatment or glucocorticoids treatment for
longer than 2 weeks within the last 3 months prior to enrolment
- Children requiring glucocorticoid therapy (e.g. asthma) who are taking a dose of
greater than 400 µg/day of inhaled budesonide or equivalents for longer than 1 month
the year prior to enrolment
- Concomitant administration of other treatments that may have an effect on growth, e.g.
but not limited to anabolic steroids and methylphenidate for attention deficit
hyperactivity disorder (ADHD). Hormone replacement therapies (thyroxin,
hydrocortisone, desmopressin) are allowed for inclusion
- Any disorder which, in the opinion of the investigator, might jeopardise subject's
safety or compliance with the protocol
- The subject and/or the parent/Legally Acceptable Representative (LAR) are likely to be
non-compliant in respect to trial conduct, as judged by the investigator
- Parent/Guardian population - treatment näive and maintenance patients:
- Parent/Guardian of child with any clinically significant abnormality likely to affect
growth or the ability to evaluate growth:
- a) Chromosomal abnormalities and medical "syndromes", e.g. but not limited to Turner's
syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors
- b) Congenital abnormalities (causing skeletal abnormalities), e.g. but not limited to
Russell-Silver Syndrome, skeletal dysplasia's
- c) Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
variants - Parent/Guardian of child born small for gestational age (SGA - birth weight
and/or birth length less than -2 SD for gestational age)
- Parent/Guardian of child diagnosed with diabetes mellitus or fasting blood glucose
greater than or equal to 126 mg/dl (7.0 mmol/L), or HbA1c greater than or equal to
6.5% at enrolment
- Parent/Guardian of child with current inflammatory diseases (e.g. but not limited to
arthritis, inflammatory bowel diseases) requiring systemic corticosteroid treatment or
glucocorticoids treatment for longer than 2 weeks within the last 3 months prior to
enrolment
- Parent/Guardian of children requiring glucocorticoid therapy (e.g. asthma) who are
taking a dose of greater than 400 µg/day of inhaled budesonide or equivalents for
longer than 1 month the year prior to enrolment
- Parent/Guardian of child with concomitant administration of other treatments that may
have an effect on growth, e.g. but not limited to anabolic steroids and
methylphenidate for attention deficit hyperactivity disorder (ADHD). Hormone
replacement therapies (thyroxin, hydrocortisone, desmopressin) are allowed for
inclusion
- Parent/Guardian of child with any disorder which, in the opinion of the investigator,
might jeopardise subject's safety or compliance with the protocol
- The subject and/or the parent/LAR are likely to be non-compliant in respect to trial
conduct, as judged by 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 4 Years old.
Subject must be at most 13 Years | Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD) | NCT02580032 | Contradiction |
238 | 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:
- Inclusion Criteria:
To enroll in the clinical study, potential subjects must:
1. Be healthy women, who are sexually active, at risk of pregnancy, and desiring
contraception.
2. Be within the age range of 18 to 35 years old (inclusive) at enrollment.
3. In the opinion of the Investigator, be at low risk for both human immunodeficiency
virus (HIV) and sexually transmitted infections (STIs) based on review of high-risk
behaviors and exposures according to the Centers for Disease Control STI Guideline.
4. At the time of enrollment, have a single male sex partner for ≥3 months.
5. Have a negative urine pregnancy test at enrollment.
6. Have normal, cyclic menses with a usual length of 21 to 35 days over the last two
cycles or at least two consecutive spontaneous menses (21 to 35 days in length) since
delivery, abortion, or after discontinuing hormonal contraception or hormonal therapy
prior to the date of consent. In addition:
1. If the subject recently discontinued breastfeeding, she must have demonstrated
return to regular cycling and have had at least three consecutive, spontaneous
menses post-lactation prior to the date of consent.
2. If the subject received prior administration of injectable contraceptives (e.g.,
depot-medroxyprogesterone acetate [DMPA], Depo Provera), there must be at least
10 months since the last injection and the subject must have had at least two
consecutive, spontaneous menses prior to the date of consent.
3. If a contraceptive implant was recently removed, the subject must have had at
least two consecutive, spontaneous menses prior to the date of consent.
4. If an intrauterine device (IUD) was recently removed, the subject must have had
at least one spontaneous menses following removal and prior to the date of
consent.
7. Be willing to engage in at least three acts of heterosexual vaginal intercourse per
cycle.
8. Be willing to use the study drug as the only method of contraception over the course
of the study (with the exception of emergency contraception [EC] in the event a
subject engages in vaginal intercourse but believes that the study drug was not used
properly or she is at risk for pregnancy for any other reason).
9. Be capable of using the study drug properly and agree to comply with all study
directions and requirements, including retaining the wrappers and returning them to
the clinical site at the next study visit.
10. Be willing to keep a daily electronic diary (eDiary) to record coital information,
study drug use information, use of concomitant medications including other vaginal
products and other contraceptives, menses, and sign and symptom data for the subject
or as reported to her by her partner.
11. Agree not to participate in any other clinical studies during the course of the study.
12. Be capable and willing to give written informed consent to participate in the study.
Exclusion Criteria:
Exclusion Criteria:
To enroll in the clinical study, potential subjects must not:
1. Have had three or more urinary tract infections (UTIs) in the past year from the date
of consent.
2. Have a UTI by urine culture, chlamydia, gonorrhea, or symptomatic yeast vaginitis or
symptomatic bacterial vaginosis (BV) diagnosed by wet mount, or trichomoniasis, unless
treated and proof of cure is documented within the screening period.
3. Have used vaginal or systemic antibiotics or antifungals within 14 days prior to
enrollment, with the exception of vaginal or systemic antibiotics or antifungals
completed for the treatment of a UTI, BV, or yeast vaginitis diagnosed at screening
within seven days of the Enrollment Visit.
4. Have a history of any recurrent vaginal infections/disorders (either greater than or
equal to four times in the past year or greater than or equal to three times in the
previous six months from the date of consent).
5. Be pregnant, have a suspected pregnancy, or desire to become pregnant during the
course of the study.
6. Have a history of diagnosed infertility or of conditions that may lead to infertility,
without subsequent non-assisted reproductive technology intrauterine pregnancy.
7. Have any maternal contraindications to pregnancy (medical condition) or chronic use of
medications for which significant evidence of fetal risk exists.
8. Have known or screen test positive for HIV infection.
9. Have three or more outbreaks of genital herpes simplex virus (HSV) within the last
year from the date of consent or be receiving suppressive therapy.
10. Have visible genital condylomata (warts).
11. Be lactating or breastfeeding.
12. Have any clinically significant abnormal finding on physical examination including
pelvic examination or baseline laboratory assessments which in the opinion of the
Investigator, precludes study participation.
13. Have clinically significant signs of vaginal or cervical irritation on pelvic
examination.
14. Be planning to have any (e.g., diagnostic or therapeutic) vaginal or cervical
procedures during the period of the study.
15. Have an abnormal Papanicolaou test (Pap test) based on the following criteria:
a. Pap test in the past 12 months from the date of screening with atypical squamous
cells of undetermined significance (ASC-US) unless at least one of the following
criteria is met: i. Less than 21 years of age. ii. A repeat Pap test at least six
months later was normal. iii. Reflex human papillomavirus (HPV) testing was performed
and was negative for high-risk HPV.
iv. A colposcopy (with or without biopsy) found no evidence of dysplasia requiring
treatment or treatment was performed and follow up at least six months after the
treatment showed no evidence of disease.
b. Pap test in the past 12 months from the date of screening with low grade squamous
intraepithelial lesion (LSIL) unless at least one of the following criteria is met: i.
Less than 21 years of age. ii. A colposcopy (with or without biopsy) found no evidence
of dysplasia requiring treatment or treatment was performed and follow up at least six
months after the treatment showed no evidence of disease.
c. Pap test in the past 12 months from the date of screening with atypical squamous
cells in which high grade squamous intraepithelial lesion cannot be excluded (ASC-H),
atypical glandular cells, high grade squamous intraepithelial lesion (HSIL), or ≥30
years old who are cytology negative and HPV 16- or HPV 18-positive unless colposcopy
and/or treatment was performed and follow up at least six months after the colposcopy
and/or treatment showed no evidence of disease.
d. Pap test in the past 12 months with malignant cells.
16. Consume (on average) more than three drinks of an alcoholic beverage per day.
17. In the opinion of the Investigator, have a history of substance abuse in the last 12
months.
18. Have taken an investigational drug or used an investigational device within the past
30 days from the date of consent.
19. In the opinion of the Investigator, have issues or concerns that may compromise the
safety of the subject, impact the subject's compliance with the protocol requirements,
or confound the reliability of the data acquired.
20. Be an Evofem, PAREXEL, or clinical site employee regardless of direct involvement in
research activities, or their close relative.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | AMP002 Phase III Contraceptive Study | NCT03243305 | Contradiction |
1,363 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion criteria:
Patients :
- surgical treatment of an HD confirmed on histopathologic exam.
Controls :
- appendicetomy for acute appendicitis without history of HD, ano rectal malformation or
any other colic disease
Exclusion criteria:
- patients with HD but not yet operated
- patient with a stoma at the time of the study
- patient with chronic intestinal pseudo obstruction without HD
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children | NCT04837963 | Contradiction |
2,912 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Patients with sporadic or familial Amyotrophic Lateral Sclerosis
- Patients with a clinical diagnosis of laboratory-supported probable, probable, or
definite ALS according to the modified El Escorial criteria8.
- Have signed an Informed Consent to participate to the trial before any study related
procedure has taken place.
- Be of age >18 (exclusive) and < 80 years (inclusive).
- If a female, not lactating, has a negative pregnancy test and agrees to use an
effective method of birth control.
- Onset of ALS Symptoms (weakness) for more than 6 months (inclusive) and less than 36
months(inclusive).
- Slow vital capacity (SVC), measured three times, one of the measure being >/= 70% of
that predicted.
- Treated with riluzole at the stable dose of 50 mg bid for at least 30 days before
enrolment.
Exclusion Criteria:
- Tracheostomy, invasive ventilation, or non invasive positive pressure ventilation
(NIPPV).
- Gastrostomy.
- Evidence of major psychiatric disorder or clinically evident dementia.
- Diagnosis of a neurodegenerative disease in addition to ALS.
- Have a current medication that could interfere with TRO19622 pharmacokinetics:
tamoxifene.
- Have current medications that could interfere with TRO19622 absorption such as
ezetimibe, bile salts chelators (cholesteramine), fibrates, phytosterols, niacin
(vitamin B3),fish oils. Have a current medication of lipid lowering agents other than
statins.
- Known hypersensitivity to any component of the study drug.
- Patients with known intolerance or contra-indication to riluzole.
- Have a recent history (within the previous 6 months) or current evidence of alcohol or
drug abuse.
- Have concurrent unstable disease involving any system eg, carcinoma other than basal
cell carcinoma, any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs
of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of
Coronary Artery Disease, or any other condition that in the opinion of the
Investigator would make the patient unsuitable for study participation.
. In Germany: Have any cardiac dysrhythmia, myocardial infarction, clinical or ECG
signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms
of Coronary Artery Disease or any cardiovascular illness known or identified at the
screening or inclusion visits, or have concurrent unstable disease involving any
system eg, carcinoma other than basal cell carcinoma or any other condition that in
the opinion of the Investigator would make the patient unsuitable for study
participation.
- Having a baseline QTc (Bazett) > 450 msec for males and > 470 msec for females.
- Patients with known hepatitis B/C or HIV positive serology.
- Be pregnant female or lactating.
- Have renal impairment defined as blood creatinine > 1:5 X upper limit of normal.
- Have hepatic impairment and/or liver enzymes (ALAT or ASAT) > 3 X ULN.
- Hemostasis disorders or current treatment with oral anticoagulants.
- Be possibly dependent on the Investigator or the Sponsor (eg, including, but not
limited to, affiliated employee).
- Participated in any other investigational drug or therapy study with a non approved
medication, within the previous 3 months.
- Patients without Social Security Insurance (France).
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 | Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS | NCT00868166 | Entailment |
6,282 | 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. | Cohort 1)
- Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical
assay) for SARS-CoV-2
- Less than 48 hours since time of hospital admission OR if hospital-acquired COVID-19
is suspected, less than 48 hrs since onset of symptoms
- Adolescents and adults age >=18 years
- Subject or legally authorized representative able to give informed consent
- Admitted to hospital
Cohort 2)
- Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical
assay) for SARS-CoV-2
- One or more of the following symptoms of COVID-19 infection: fever, cough,
expectoration, shortness of breath, myalgia, fatigue, or head ache
- No more than 5 days since the beginning of symptom onset
- Adolescents and adults age >=18 years
- Subject (or legally authorized representative, for Cohort 1 only) able to give
informed consent
- Do not require immediate hospitalization (newly diagnosed COVID-19 patients who are
discharged within 24 hrs of hospital admission are eligible for enrollment)
- Must be willing to fill out a daily symptom diary
- Must be available for a daily phone call
- Must be willing to take their own temperature at least once a day
Exclusion criteria
- Any condition that, in the Investigator's opinion, will prevent adequate compliance
with study therapy (e.g. the patient is considered to be moribund within the next 72
hrs or has uncontrolled substance abuse that prevents adherence to study medication).
Patients needing ventilator treatment are eligible to be enrolled if they fulfill the
other in/exclusion criteria.
- The following laboratory values at baseline (Day 0):
- Serum total bilirubin ≥3 ULN
- Estimated glomerular filtration rate (eGFR) ≤30 mL/min (based on serum
creatinine)
- Known hypersensitivity to Camostat Mesilate
- Women who are pregnant or breastfeeding, or with a positive pregnancy test as
determined by a positive urine or blood beta- human chorionic gonadotropin test during
screening or women of child bearing potential* who are unwilling or unable to use an
acceptable method of contraception (combined estrogen and progestogen hormonal
contraception (oral, intravaginal or transdermal), progesteron-only hormonal
contraception (oral, injectable or implantable), intrauterine device or intrauterine
hormone-releasing system) to avoid pregnancy during the study. Sexual abstinence will
only be accepted in cases where this reflect the usual lifestyle.
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 110 Years | The Impact of Camostat Mesilate on COVID-19 Infection | NCT04321096 | Entailment |
6,660 | 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:
- Age ≥ 6 years
- Male previously treated patients (≥150 Exposure Days) with moderate or severe
hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is
anticipated to require at least 6 consecutive days of daily factor VIII (FVIII)
infusions (surgical and post-surgical prophylaxis)
- Ability to adhere to the protocol requirements
Exclusion Criteria:
- Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII
inhibitor or current inhibitor, defined as > 0.6 BU
- Prior participation in this study
- Any concomitant bleeding disorder other than hemophilia A
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery | NCT00092976 | Contradiction |
Subsets and Splits