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2,634 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Male, age 25 years or older
- Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated
on before
Exclusion Criteria:
- The patient is not able or do not want to give written informed consent
- The patient is not suitable for an operation in local anesthesia
- Anticoagulant medication or a known coagulation disorder
Male
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
| The Significance of the Mesh Thickness in the Operation of Inguinal Hernia | NCT00451893 | Entailment |
2,767 | 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:
- unilateral hernia
- uncomplicated hernia
- medical fitness for general anesthesia
Exclusion Criteria:
- unfit for general anesthesia
- complicated hernia
- uncorrectable coagulopathy
- BMI > 35
- concomitant pathologies requiring simultaneous surgery
- bilateral hernia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Study of Laparoscopic Inguinal Hernia Repair | NCT02920307 | Entailment |
1,119 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Patients of either gender, aged 18-75 years, with HCM caused by sarcomeric gene mutations
determined by existing protocols.
LV wall thickness of greater than or equal to 20 mm measured in any LV segment by MRI.
Severe symptoms refractory to medical treatment (New York Heart Association functional
class III or IV).
No LV outflow tract obstruction at rest greater than 30 mm Hg as determined by cardiac
catheterization.
No coronary artery disease (greater than 50% arterial luminal narrowing of a major
epicardial vessel).
No chronic atrial fibrillation.
No bleeding disorder (PTT greater than 35 sec, pro time greater than 14 sec, platelet count
less than 154 k/mm(3).
No anemia (Hb less than 12.7 g/dl in males and less than 11.0 g/dl in females).
No renal impairment (serum creatinine greater than 1.3 mg/dl).
No hepatitis B or C; nor unexplained abnormal LFTs.
No inability to estimate LV wall thickness.
No positive urine pregnancy test.
No pregnant or lactating female patients.
No concurrent use of immunosuppressives or steroids.
No diabetes mellitus.
No history of malignancy other than skin tumors (squamous and basal cell) in the last 5
years.
No condition that excludes the patient from undergoing an MRI test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM) | NCT00001965 | Entailment |
2,218 | 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:
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of the American Rheumatism Association (ARA)
for the classification of the acute arthritis of primary gout;
- At least 2 gout flares in the year prior to the screening visit;
- Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit.
Exclusion Criteria:
- Acute gout flare within 2 weeks of the screening visit or during screening;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the screening visit;
- Previous exposure to Rilonacept;
- Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3
months prior to the screening visit.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2) | NCT00958438 | Contradiction |
6,004 | 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:
- Females of childbearing potential who are sexually active must agree to use adequate
contraception, and can neither be pregnant nor lactating from Screening throughout the
duration of the study.
- History of nocturnal heartburn and GERD associated sleep disturbances prior to
screening.
- Meets both of the following criteria: 1) nocturnal heartburn severity of moderate,
severe, or very severe on at least 3 of 7 nights and; 2) GERD related sleep
disturbances on at least 3 of 7 nights.
- Subjects must have history of symptomatic GERD prior to screening with GERD symptoms
that were responsive to acid-suppressive therapy.
Exclusion Criteria:
- Erosive esophagitis visualized during the screening endoscopy.
- Allergy to any proton pump inhibitor drug (lansoprazole, omeprazole, rabeprazole,
pantoprazole, esomeprazole), any component of Dexlansoprazole, or Gelusil/antacid.
- Active gastric or duodenal ulcers within 30 days prior to randomization.
- Upper gastrointestinal bleeding within 6 months prior to randomization.
- Co-existing diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal
varices, scleroderma, viral or fungal infection, and/or Barrett's esophagus).
- History of radiation therapy or cryotherapy to the esophagus, caustic or
physiochemical trauma such as sclerotherapy to the esophagus.
- Subject requiring dilation for esophageal strictures and/or strictures preventing
passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of
mucosal tissue near the lower esophageal sphincter) is acceptable.
- Has another condition that could be the primary cause of the subject's sleep
disturbance.
- Evidence of uncontrolled, clinically significant neurologic, cardiovascular,
pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
abnormality (other than the disease being studied) which may impact the ability of the
subject to participate or potentially confound the trial results.
- Diagnosis of cancer (except basal cell carcinoma) within 5 years of screening.
- Has a condition likely to require surgery during the study.
- Currently diagnosed with acquired immunodeficiency syndrome (AIDS).
- Abnormal clinical laboratory values.
- History of alcoholism or drug addiction.
- Subject who works the night shift.
- Subject who is planning to travel beyond 3 time zones during the study.
- Chronic use (more than 12 doses/month) of non-steroidal anti-inflammatory drugs
(NSAIDs), including cyclooxygenase-2 (COX 2) inhibitors within 30 days prior to
randomization or anticipated use during the study.
- Use of the following medications during the 14 days prior to randomization or
anticipated use during the study: proton pump inhibitors, sucralfate, misoprostol,
corticosteroids, prokinetics, anticoagulant therapy, antiseizure medications (other
than stable doses), psychotropic medications (other than stable doses), narcotic
medications (occasional use allowed), bisphosphonates.
- Use of sleep medications, first generation antihistamines, benzodiazepines, modified
cyclic antidepressants, antianxiety medications or drugs with significant
anticholinergic effects such as tricyclic antidepressants or drugs with central
nervous system effects that could mask perception of symptoms (eg, selective-serotonin
reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors). However,
subjects who remain on a stable regimen and dose of these medications during the 90
days prior to randomization and who agree to maintain the same regimen and dose during
the trial will qualify. Also, short term use of anticholinergics for trial related
procedures is not exclusionary. Second generation antihistamines are not excluded.
- Use of histamine (H2) receptor antagonists or antacids (except for trial supplied
Gelusil) during the screening period or anticipated use during the treatment 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 65 Years | A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn | NCT00627016 | Entailment |
5,784 | 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:
- Pemphigus vulgaris patients having bilateral erosions in the buccal mucosa.
Exclusion Criteria:
- Pemphigus vulgaris patients who do not have oral erosions.
- Pemphigus vulgaris patients who have received intralesional steroid injection in their
buccal mucosa.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris | NCT02828163 | Contradiction |
4,439 | 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:
- Applying to Dokuz Eylül University Medical Faculty Physical Medicine and
Rehabilitation Department outpatient clinic
- Having pain in the elbow for less than 12 weeks and having no similar attack history
for 1 year
- Diagnosing lateral epicondylitis with clinical and ultrasonographic evaluation
- Having pain of at least 3 in their VAS scores
- Agreeing to participate in the study
Exclusion Criteria:
- Having elbow pain for more than 12 weeks
- Having signs of lateral epicondylitis in the other extremity
- Having a history of injection for lateral epicondylitis
- In the last 3 months, who had physical therapy for lateral epicondylitis
- Having a history of elbow surgery and fracture in the elbow area.
- Having muscle weakness in the upper extremity due to cervical radiculopathy and/or
entrapment neuropathy
- Having malignancy or neurological, rheumatological, and psychiatric disease
comorbidities
- Pregnant
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 | Comparison of Two Different Splints in the Treatment of Lateral Epicondylitis | NCT04773249 | Contradiction |
1,760 | 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:
- aged greater than 20 years
- fulfill Rome III diagnostic criteria
Exclusion Criteria:
- children and teenagers aged less than 20 years
- Organic lesions such as ulcers, tumors, bleeding, vasculopathy or esophagitis as
demonstrated on upper endoscopy
- concurrent illness with malignancy, diabetes mellitus, liver cirrhosis, renal failure
or porphyria
- diagnosis of organic disease for dyspeptic symptoms by treating physicians
- history of abdominal surgery
- concurrent user of aspirin and NSAID
- history of allergy or severe side effects to lansoparzole
- pregnant or lactating women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome | NCT00673972 | Contradiction |
1,532 | 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:
- Eligible patients will include anyone >18 years old that presents to the participating
clinical institutions and requires an endosonographic evaluation for the presence of a
solid-appearing mass lesion amenable to EUS access, and no contraindication to FNA as
determined by standard clinical care
Exclusion Criteria:
1. Refusal to participate in the study
2. Solid-appearing mass lesion that in not amenable to EUS guided needle access for
tissue acquisition
3. Patients with incomplete medical records
4. Pregnant patients
5. Prisoners
6. INR > 1.5
7. Platelets < 50,000
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle | NCT02872831 | Contradiction |
6,815 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Patients of participating Hemophilia Treatment Centres with Hemophilia A or B
Exclusion Criteria:
- none
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| World Bleeding Disorders Registry | NCT03327779 | Entailment |
6,552 | 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:
- 12 to 65 years old;
- The activity of the coagulation factor VIII (FVIII:C) ≤5%, and was previously treated
with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
- Bleeding state need to be treated with FVIII;
- Negative assays for FVIII inhibitors (<0.6 BU/mL);
- The platelet count is normal；
- Normal prothrombin time or INR ≤1.5；
- Given informed consent
Exclusion Criteria:
- Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the
excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
- Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);
- Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days
prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII],
cryoprecipitate and whole blood);
- Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
- HIV seropositive;
- Abnormal hemostasis from causes other than hemophilia A；
- Patients with severe heart disease, including myocardial infarction, heart failure
(III or higher level);
- Patients who received any anticoagulant or antiplatelet therapy within one week
(including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during
the period of clinical trials;
- Alcoholism, drug abuse, mental disorders and mental retardation;
- Elective surgery planned during the process of study;
- Patients who previously participated in the other clinical trials prior to study
entry;
- The patient or parent/legal guardian is unable or unwilling to sign an informed
consent form or to comply with the requirements of clinical protocol;
- Other conditions confirmed by the researchers, resulting in that patients are unable
to benefit from clinical observation;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A | NCT02921945 | Contradiction |
793 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Age between 18 and 75 years old.
2. Patients with clinically verified OA, coming to see a physical therapist for the
Supported self-management of osteoarthritis program.
Exclusion Criteria:
1. Other serious disorders causing hip or knee pain (e.g. tumor, rheumatic arthritis,
sequel hip fracture).
2. Other symptoms more aggravating than the OA problem (e.g. chronic pain, fibromyalgia,
cardio-respiratory dysfunction, spinal condition).
3. Total joint replacement surgery within the past 12 months.
4. Other surgery of knee or hip within the past 3 months.
5. Unable to read and understand Swedish and follow verbal and visual instructions.
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 | The Effect of Structured Information and Individually Adapted Exercise on Levels of Physical Activity Measured by Accelerometer in Patients With Knee or Hip Osteoarthritis | NCT02022566 | Entailment |
2,227 | 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. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.
2. The participant or, when applicable, the participant's legally acceptable
representative signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedure.
3. Has a history or presence of gout defined as having one or more of the American
Rheumatism Association (ARA) criteria for the diagnosis of gout:
1. A tophus proven to contain urate crystals by chemical or polarized light
microscopic means, AND/OR;
2. Characteristic urate crystals in the joint fluid, AND/OR;
3. History of at least 6 of the following clinical, laboratory, and x-ray phenomena:
i. more than one attack of acute arthritis, ii. maximum inflammation developed within
1 day, iii. monoarticular arthritis, iv. redness observed over joints, v. first
metatarsophalangeal joint painful or swollen, vi. unilateral first metatarsophalangeal
joint attack, vii. unilateral tarsal joint attack, viii. tophus (proven or suspected),
ix. Hyperuricemia, x. asymmetric swelling within a joint on x-ray, xi. subcortical
cysts without erosions on x-ray; xii. joint fluid culture negative for organisms
during attack.
4. Is male or female at least 18 years of age, inclusive.
5. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from signing
of informed consent throughout the duration of the study.
6. Have a serum urate (sUA) level ≥8.0 mg/dL at the Day -4 Visit or at the retest visit.
7. Has an estimated Glomerular Filtration Rate (eGRF) ≥15 mL/min using the Modification
of Diet in Renal Disease (MDRD) formula at the Screening visit (Day -21 for
participants on urate lowering therapy (ULT) and Day -4 for participants not on ULT)
or at the retest visit.
8. Has at least one gout flare within 12 months prior to Screening visit.
Exclusion Criteria:
1. Has received any investigational compound within 30 days prior to Screening.
2. Is an immediate family member, study site employee, or is in a dependent relationship
with a study site employee who is involved in conduct of this study (eg, spouse,
parent, child, sibling) or may consent under duress.
3. Is breastfeeding or pregnant.
4. Has secondary hyperuricemia (eg, due to myeloproliferative disorder).
5. Has a history of xanthinuria.
6. Has received ULT (ie, allopurinol, probenecid, etc.) within 20 days prior to Day
1/Randomization Visit.
7. Has a known hypersensitivity to febuxostat or any components of their formulation; has
a known hypersensitivity to naproxen, any other nonsteroidal anti-inflammatory drug
(NSAID), aspirin, lansoprazole, colchicine or any components in their formulation.
8. Has active peptic ulcer disease.
9. Has a history of cancer (other than basal cell carcinoma of the skin) within 5 years
prior to the Screening Visit.
10. Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values >2 x
the upper limit of normal (ULN).
11. Has rheumatoid arthritis which requires treatment.
12. Has a significant medical condition and/or conditions that would interfere with the
treatment, safety, or compliance with the protocol.
13. Has experienced a myocardial infarction (MI), stroke, hospitalized unstable angina,
cardiac or cerebrovascular revascularization procedure or hospitalized transient
ischemic attack (TIA) - except in participants who have severe renal impairment.
14. Participants with severe renal impairment had a MI or stroke within 90 days prior to
initial screening visit or has a MI or stroke during the screening period prior to Day
1/Randomization Visit.
15. Participant consumes >14 alcoholic beverages/week. Has a history of alcoholism or
illicit drug abuse within 5 years.
16. Has participated in another investigational study within the 30 days prior to the
Screening Visit.
17. Has a known history of infection with hepatitis B, hepatitis C, or human
immunodeficiency virus.
18. Is required to take excluded medications.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout | NCT02139046 | Entailment |
3,148 | 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:
Group 1: Interstitial Lung Disease and Other Parenchymal Lung Diseases
- Known or suspected interstitial lung disease regardless of radiographic pattern
- Interstitial lung disease due to alternative autoimmune etiology
- Sarcoidosis
- Organizing pneumonia
- Hypersensitivity pneumonitis absent known or suspected trigger
- Primary pulmonary lymphoma
- Other idiopathic pulmonary conditions at discretion of study team
Group 2: Refractory Airway Symptoms
- Chronic cough despite treatment trials with albuterol, proton-pump inhibitors and
anti-histamine and intranasal corticosteroids
- Persistent bronchial hyperreactivity (defined as positive response to methacholine
challenge on spirometry or subjective worsening after exposure to airway irritants
such as tobacco, pollution, etc) or persistent asthma symptoms despite trial of
inhaled corticosteroid and long acting bronchodilator
- Unexplained persistent bronchial wall thickening on CT imaging
- Recurrent or chronic bronchiolitis (including but not limited to chronic
bronchiolitis, obliterative bronchiolitis, lymphocytic bronchiolitis, constrictive
bronchiolitis associated with bronchiolar destruction, and panbronchiolitis)
- Bronchiectasis
- Lymphocytic alveolitis on bronchoalveolar lavage absent hypersensitivity pneumonitis
with known trigger or HIV
- Recurrent bacterial pneumonia (greater than 2 episodes in 1 year, confirmed by focal
consolidative opacity on chest imaging and requiring antibiotic therapy)
Group 3: Other
•Select patients outside the protocol testing schema who have one of the above lung
diseases and are found to have Sjogren's syndrome through the course of their normal
clinical care will be invited to participate in the data collection portion of the study
for analyzing longitudinal outcomes.
Exclusion Criteria:
- Patients with interstitial lung disease due to a known or suspected trigger such as
drug-induced (including but not limited to nitrofurantoin, amiodarone, methotrexate
and other chemotherapies), inorganic dust exposure (including but not limited to
asbestos, silica, hard metals, coal dust) or organic exposure (including but not
limited to birds, hay, mold).
- Patients who have taken a muscarinic antagonist or agonists within 7 days of planned
testing
- Patients who are unable to consent for themselves
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.
| Sjogren's Lung Study | NCT04843345 | Contradiction |
4,310 | 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 greater than or equal to 18 years and less than or equal to 60 years
2. Body mass index (BMI) of 19-32 kg/m(2)
3. Estimated glomerular filtration rate greater than or equal to 70 mL/min at
screening, calculated using the CKD-EPI formula
4. Subjects must agree to:
- Not take any prescription or OTC medications with the exception of acetaminophen,
ibuprofen, vitamins, seasonal allergy medications, and/or contraceptive medications
for a period 7 days prior to study drug administration (i.e., Day 0)
5. One of the following in order to avoid pregnancy:
- Females who are able to become pregnant (i.e., are not postmenopausal, have not
undergone surgical sterilization, and are sexually active with men) must agree to use
at least 2 effective forms of contraception from the date of the subject s signing of
the informed consent form through 60 days after the last dose of study drug. At least
one of the methods of contraception should be a barrier method.
- Males who have not undergone surgical sterilization and are sexually active with women
must agree to use condoms plus have a partner use at least one additional effective
form of contraception from the date of the subject s signing of the informed consent
form through 60 days after the last dose of study drug.
EXCLUSION CRITERIA:
1. Any history of allergy, anaphylaxis, or severe reaction to beef products (including
milk and gelatin)
2. Any history of allergy, anaphylaxis, or severe reaction to IGIV or human blood
products
3. Any chronic medical problem that requires daily oral medications (except Tylenol,
ibuprofen, oral contraceptives, vitamins, and seasonal allergy medications).
4. History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained
syncope
5. Subjects that have had confirmed MERS
6. Women who are breast-feeding
7. Positive urine or serum pregnancy test
8. Abnormal chemistry panel
-defined as any clinically significant baseline Grade 1 or greater toxicity, or any
Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity
table
--evaluating only sodium (Na), potassium (K), serum bicarbonate (total CO2), blood
urea nitrogen (BUN), creatinine, glucose, asp (ALT), aspartate aminotransferase (AST),
total bilirubin, lactate dehydrogenase (LDH), and estimated glomerular filtration rate
(GFR) by the CKD-EPI equation.
9. Abnormal complete blood count (CBC)
-defined as any clinically significant baseline Grade 1 or greater toxicity, or any
Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity
table--evaluating only the WBC (to include absolute neutrophil, lymphocyte, and
eosinophil counts), hemoglobin, hematocrit, and platelets.
10. Abnormal urinalysis
-defined as any clinically significant baseline Grade 1 or greater
toxicity--evaluating only protein, and RBCs
11. Positive rheumatoid factor
12. IgA deficiency (defined as IgA < 7 mg/dL)
13. Participation in another research study with receipt of any investigational drug
within 5 half-lives or 30 days, whichever is longer, prior to study drug
administration (i.e., Day 0) and until completion of the study
14. Participation in any other research study for 30 days after study drug administration
15. Receipt of blood products within 2 months prior to study drug administration (i.e. Day
0)
16. Receipt of any vaccination within 30 days prior to study drug administration (i.e. Day
0)
17. Any acute or chronic condition that, in the opinion of the Investigator, would limit
the subject s ability to complete and/or participate in this 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 60 Years | Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults | NCT02788188 | Entailment |
5,710 | 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:
- obese or overweight 4th grade public school student in Starkville
Exclusion Criteria:
- unable to run or physical disease or disability
Female
Accepts Healthy Volunteers
Subject must be at least 9 Years old.
Subject must be at most 12 Years | Nutrition and Soccer for Pediatric Overweight and Obesity | NCT00365651 | Entailment |
7,006 | 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:
Group 1: Cognitively Normal (CN)
1. No subjective complaints of cognitive impairment
2. No cognitive impairment evident on formal testing interpreted by expert adjudication
committee (typically, performance not worse than 1 SD below demographically relevant
norms)
3. Clinical Dementia Rating (CDR) = 0 or 0.5
4. Normal glycemic control as indicated by American Diabetes Association (ADA) guidelines
for normal 2 hour glycemic response to a glucose tolerance test (< 140 mg/dL).
5. Reliable collateral or study partner available to attend Visit 1 at a minimum
Group 2: Mild Cognitive Impairment (MCI)
1. Objective evidence of memory and/or executive function deficits on neuropsychological
testing (typically 1.5 SD below demographically relevant norms)
2. CDR = 0 or 0.5
3. Reliable collateral or study partner
Group 3: Alzheimer's Disease (AD)
1. Diagnosis of probable mild AD, diagnosed with NIA-AA criteria, or mixed AD and
vascular pathology as long as there is not a large vessel territory stroke,
adjudicated by expert consensus panel.
2. Mini-Mental Status Exam (MMSE) score ≥ 10; CDR = ≥0.5
3. Normal glycemic control or prediabetes
4. Reliable collateral or study partner available to attend all visits
Exclusion Criteria:
1. Clinically significant abnormal labs
2. Significant neurologic disease that might affect cognition, other than AD, such as
stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury with
loss of consciousness for more than 30 minutes within the last year, or with permanent
neurologic sequelae
3. Clinically significant medical illness or organ failure as determined by study
clinicians, including severe, uncontrolled cardiovascular disease, oxygen-treated
chronic obstructive pulmonary disease, severe liver disease, Stage 4 chronic kidney
disease or impending dialysis, active cancer, or other life-limiting condition with
life expectancy less than 3 years
4. Current substance abuse or heavy alcohol consumption defined as >14 alcoholic drinks
per week; or history of alcoholism or substance abuse within previous 10 years
5. Current poorly controlled depression or other psychiatric illness as determined by
clinical judgement of study clinicians or neuropsychologists
6. Current use of anti-psychotic, benzodiazepines (PRN use <3 times per week is
acceptable), anti-coagulants (for participants who will receive a lumbar puncture),
strongly anticholinergic or sedative medications
7. Use of anticonvulsant for seizure disorder. (Use of anticonvulsant to treat other
illnesses will be reviewed by the study MD and eligibility will be determined on a
case by case basis.)
8. Current use of insulin
9. Brain MRI contraindications; including use of pacemakers, aneurysm clips, artificial
heart valves, ear implants or metal/foreign objects in the eyes will be excluded from
MRI
10. For participants completing any brain imaging protocol, inability to lie on the
scanner bed for 40 minutes, or claustrophobia
11. For ADCC-BIG, significant obesity or a lower back condition that is likely to impede
successful collection of CSF, as determined by study physician judgment
12. Other significant medical conditions at the investigators' discretion
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
| Wake Forest Alzheimer's Disease Clinical Core | NCT03140865 | Entailment |
5,175 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
1. Women, 50 to 80 years of age, both inclusive.
2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest
tenth.
3. Postmenopausal
4. Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as
assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA)
scan.
5. Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1
to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central
imaging vendor. Patients with unilateral metal in hips that would be allowed for the
other side of 1 evaluable hip are included.
6. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at
Screening.
Exclusion Criteria:
1. Patient with a hypersensitivity to any component of denosumab or dry natural rubber.
2. Patient with history and/or presence of one severe or > 2 moderate vertebral fractures
as determined by central reading of lateral spine X-ray
3. Patient with history and/or presence of hip fracture
4. Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism,
irrespective of current controlled or uncontrolled status
5. Patient with current hyperthyroidism (unless well controlled on stable antithyroid
therapy)
6. Patient with current hypothyroidism (unless well controlled on stable thyroid
replacement therapy)
7. Patient with history and/or presence of bone disease and metabolic disease (except for
osteoporosis) that may interfere with the interpretation of the results
8. Patient with history and/or concurrent use of any osteoporosis treatment (other than
calcium and vitamin D supplements), oral or parenteral glucocorticosteroids, any bone
active drugs, and any investigational drug
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 80 Years | A Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis | NCT04757376 | Entailment |
5,880 | 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 newly diagnosed as erosive esophagitis or history of erosive esophagitis
confirmed by endoscopy.
- Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity
and frequency and treatment satisfaction.
- During the past 1 week , patients who have either two days or more with heartburn or
acid taste in the mouth of any severity
Exclusion Criteria:
- Patients receiving treatment with proton pump inhibitors, which make stomach acid
decreased during the last 4 weeks prior to enrolment.
- Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom
severity and frequency and treatment satisfaction.
- Patients included previously in this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis | NCT00859287 | Contradiction |
5,828 | 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! | Diagnosis and main criteria for inclusion:
- Subjects diagnosed with GERD with symptomatic improvement on PPIs.
- Subjects who have demonstrated a baseline 24 Hour pH ≥ 4% time with pH ≤ 4.0.
- Subjects with a baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥ 20 off PPI.
Diagnosis and main criteria for exclusion:
- Extensive Barrett's Esophagus (> 2 cm).
- Esophagitis (LA Classification Grades C or D).
- Previous history of gastroesophageal surgery, anti-reflux procedures, or
gastroesophageal or gastric cancer.
- Large hiatal hernia (> 3 cm).
- Current complaints of clinical dysphagia evidenced by greater than one occurrence per
month.
- Esophageal strictures
- Esophageal or gastric varices
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.
| An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD) | NCT00200044 | Contradiction |
2,695 | 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 with inguinal hernia
Exclusion Criteria:
- patients with malignancies
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Inguinal Hernia and Arterial Disease | NCT04428138 | Entailment |
3,432 | 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:
- Hyperlipidemic
- On therapy for hyperlipidemia for >=3 months without achieving target lipid values
Exclusion criteria:
- Hypersensitivity or intolerance to hypolipemics
- Significant myopathy or rhabdomiolysis probably caused by hypolipemics
- Uncontrolled endocrine or metabolic disease which is known to affect lipid or
lipoprotein values (for example, hypothyroidism and hyperthyroidism)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
| Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179) | NCT01436253 | Entailment |
455 | 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. PCOS diagnosed by Roterdam criteria
2. Protocol used for ovulation induction either long procol with freeze all embryos vs
antagonist with fresh embryo transfer
3. BMI less than 30
4. ALL patients receiving adjuvant drugs for prevention of OHSS in the form of metformin,
cabergoline as well as prophylactic hysteril , low dose asprin and LMW heparin
following oocyte retrieval on a routine basis
Exclusion criteria;
1. PCOS on long protocol with fresh embryo transfer and those on antagonist protocol with
freezing all embryo
2. BMI more than 30
3. PCOS patients not given adjuvant drugs in prophylaxis of OHSS
4. Antagonist cases receiving agonist as trigger instead of HCG
5. PCOS receiving more than 5000 IU HCG as trigger
6. PCOS undergoing costing during ovulation induction
7. PCOS with known medial problems as diabetes or hypertension
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 39 Years | Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI | NCT03118830 | Contradiction |
2,293 | 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:
- no major complaints of muscle numbness, spasm, or atrophy, muscle-related physical
activity impairment or joint swelling and pain
- no obvious malformation in the lower limbs
- no disease history in the musculoskeletal system, nervous system, and peripheral
blood,
- no history of severe trauma in the lower limbs
- joint mobility and muscle tension met the thresholds of muscle strength assessments
- no severe osteoporosis
- no acute inflammation or acute bone fracture repair
- between 18-55 years of age
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A New Method of Muscle Strength Testing Using a Quantitative Ultrasonic Technique and a Convolutional Neural Network | NCT04043832 | Contradiction |
1,461 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- adults age 18 years and older with essential hypertension.
- who are treated with medication to lower their blood pressure.
- whose mean daytime blood pressure at enrolment is 135/85 mm Hg or greater.
- and who are not currently using HBPM.
Exclusion Criteria:
- a diagnosis of secondary hypertension.
- pregnancy.
- hypertension management primarily by a consultant.
- a disability that precludes use of a home blood pressure monitor.
- enrolled in another hypertension trial
- white coat hypertension
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.
| Home Blood Pressure Monitoring and Blood Pressure Control | NCT00202137 | Entailment |
4,920 | 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 for PD:
- Diagnosis of idiopathic Parkinson's disease where the diagnosis was made by a Movement
Disorder Specialist according to the MDS criteria of 2015, with a Hoehn and Yahr scale
(H&Y) of at least 2 (bilateral involvement).
- Onset of the symptoms more than five years ago.
- MDS-UPDRS-III score of ≥30 without medication or DBS.
- Electrodes are implanted in target area STN.
Inclusion Criteria for ET:
- Patient is diagnosed with essential tremor by a Movement Disorder Specialist.
- Diagnosis since more than 3 years.
- Patient has a disabling medical-refractory upper extremity tremor without medication
or DBS.
- Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the
extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for
Tremor without medication or DBS.
- Electrodes are implanted in target area VIM.
General Inclusion Criteria:
- Post-op the implanted electrodes pass an integrity check, i.e. no open or shorted
electrodes.
- Stable medications
- Lack of dementia or depression.
- Patient is willing and able to comply with all visits and study related procedures
- Patient understands the study requirements and the treatment procedures and provides
written informed consent before any study-specific tests or procedures are performed.
- Patient can tolerate at least 12 hours OFF medication and per clinical judgement be
able to perform all study related procedures
Exclusion Criteria:
- Any significant psychiatric problems, including unrelated clinically significant
depression.
- Any current drug or alcohol abuse.
- Any history of recurrent or unprovoked seizures.
- Have any significant medical condition that is likely to interfere with study
procedures or likely to confound evaluation of study endpoints, including any terminal
illness with survival <12 months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders | NCT04725045 | Entailment |
6,385 | 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:
- Are currently not hospitalized
- Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat,
malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with
exertion
- Must have sample taken for test confirming viral infection no more than 3 days prior
to starting the drug infusion
- Are men or non-pregnant women who agree to contraceptive requirements
- Understand and agree to comply with planned study procedures
- Agree to the collection of nasopharyngeal swabs and venous blood
- The participant or legally authorized representative give signed informed consent
Exclusion Criteria:
- Body mass index (BMI) greater than or equal to (≥)35
- Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at
sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of
mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate ≥30
per minute, heart rate ≥125 per minute
- Require mechanical ventilation or anticipated impending need for mechanical
ventilation
- Have known allergies to any of the components used in the formulation of the
interventions
- Have hemodynamic instability requiring use of pressors within 24 hours of
randomization
- Suspected or proven serious, active bacterial, fungal, viral, or other infection
(besides COVID-19) that in the opinion of the investigator could constitute a risk
when taking intervention
- Have any co-morbidity requiring surgery within <7 days, or that is considered
life-threatening within 29 days
- Have any serious concomitant systemic disease, condition or disorder that, in the
opinion of the investigator, should preclude participation in this study
- Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility
for this study
- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30
days before dosing
- Have received treatment with a SARS-CoV-2 specific monoclonal antibody
- Have a history of convalescent COVID-19 plasma treatment
- Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2
vaccine
- Have participated, within the last 30 days, in a clinical study involving an
investigational intervention. If the previous investigational intervention has a long
half-life, 5 half-lives or 30 days, whichever is longer, should have passed
- Are concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study
- Are pregnant or breast feeding
- Are investigator site personnel directly affiliated with this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 64 Years | A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness | NCT04634409 | Entailment |
5,728 | 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
- women age >18 years
- diagnosed with LD (VLS or LP histologically proven)
- Clinical LS score ≥ 4 based on the score of Günthert et al. [1]
- Normal Pap-smear within 24 months
- negative clinical and microscopic evaluation of vaginal fluid
- Negative test for STD (sexually transmitted diseases) pathogens (chlamydia, gonorrhea,
genital mycoplasma and trichomonas) if symptomic including abdominal pain or abnormal
vaginal fluid
- Good German language skills
- written informed consent
- preceding local corticoid therapy of at least 12 weeks according to the current
guideline for LD
Exclusion criteria:
- women with contraindications for the use of laser on the skin
- pregnancy
- presence of vulvar pathology (other than lichen)
- any vulvar/ vaginal infection
- immunocompromised women
- swollen lymph nodes
- genital malignant disease
- allergy to topical anaesthesia
- connective tissue disease
- keloid formation
- Patients with a legal guardian
- Body Mass Index > 35 kg/m²
- History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)
- Coagulopathy
- patients using anticoagulants
- patients with renal, hepatic or pulmonary-cardiovascular failure
- patients who have undergone any kind of organ transplantation in the last three years.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Laser Therapy in Women With Lichenoid Disorders | NCT04697563 | Contradiction |
2,464 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- sarcoidosis, subjects (18 - 45 years of age), including 30 sarcoidosis, 15 latent TB
and 15 healthy controls.
Exclusion Criteria:
- pregnant women
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Development of a Novel Human In Vitro Sarcoidosis Model | NCT01857401 | Entailment |
2,277 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Completed Study NS-065/NCNP-01-201 through Week 25.
2. Willing and able to comply with scheduled visits, investigational product
administration plan, and study procedures.
3. Stable dose of glucocorticoid (GC), and is expected to remain on the stable dose for
the duration of the study.
Exclusion Criteria:
1. Serious or severe adverse event in Study NS-065/NCNP-01-201 that precludes safe use of
NS-065/NCNP-01.
2. Patient had a treatment which was made for the purpose of dystrophin or its related
protein induction after completion of Study NS-065/NCNP-01-201.
3. Patient took any other investigational drugs after completion of Study
NS-065/NCNP-01-201.
4. Patient was judged by the investigator and/or the Sponsor that it was not appropriate
to participate in the extension study for other reasons.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 10 Years | Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD) | NCT03167255 | Contradiction |
5,310 | 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:
In osteoporotic patients:
- 50-80 years of age
- Established diagnosis of osteoporosis, based on prior dual energy x-ray absorptiometry
(DXA) scan with T-score <-2.0 at any site and/or history of fragility fracture
In healthy controls:
- 27-40 years of age
- Female
Exclusion Criteria:
In osteoporotic patients:
- Current or recent (within 2 years) use of osteoporosis medications including
bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators,
teriparatide, denosumab, calcitonin, or strontium
- Pregnancy or breastfeeding within the past 2 years
- Any medical or psychiatric condition or situation that would compromise subject
safety, informed consent/assent, or data quality
In healthy controls:
- History of significant cardiac, renal, pulmonary, hepatic, or malignant disease, or
current alcohol or illicit drug abuse
- Current diagnoses known to effect bone metabolism, including cystic fibrosis,
diabetes, osteoporosis, amenorrhea >3 months (in menstruating women who are not taking
oral contraceptives or have an IUD), hyperthyroidism, hyperparathyroidism, Paget's
disease, kidney stones, chronic inflammatory diseases, malabsorptive disorders,
malnutrition or eating disorder, endocrine disorders (growth disorder, Cushing
syndrome), prolonged immobility, and skeletal dysplasias
- History one or more pathologic fracture, or greater than four total lifetime
non-digital, non-facial fractures
- Cumulative lifetime use of oral glucocorticoids for greater than 2 months
- Current or previous use of medications known to affect bone metabolism including
hormone replacement therapy, anti-estrogens, bisphosphonates, calcitonin, lithium,
suppressive doses of levothyroxine, or anticonvulsants.
- Pregnancy or breastfeeding within the past 2 years
- BMI less than 18.5 or greater than 30 kg/m2.
- Any medical or psychiatric condition or situation that would compromise subject
safety, informed consent/assent, or data quality
Female
Accepts Healthy Volunteers
Subject must be at least 27 Years old.
Subject must be at most 80 Years | Radio-frequency Identification (RFID) Osteoporosis Pilot Study | NCT03385941 | Entailment |
2,947 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or
definite ALS as defined by revised El Escorial criteria.
2. Age 18 years or older.
3. Symptom onset of weakness or spasticity due to ALS ≤ 60 months prior to Screening
Visit.
4. Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the
screening visit.
5. Must be able to swallow capsules throughout the course of the study, according to Site
Investigator judgment.
6. Capable of providing informed consent and following trial procedures.
7. For TMS: a resting motor threshold defined as 50% of pulses eliciting a motor evoked
potential (MEP) of amplitude ≥ 50 µV.
8. For TTNCS: median Compound Muscle Action Potential (CMAP) ≥ 1.5 mV.
9. Subjects must not have taken riluzole for at least 30 days or be on a stable dose of
riluzole for at least 30 days prior to the Screening Visit and continue on the stable
dose throughout the course of the study (riluzole-naïve subjects are permitted in the
study).
10. Subjects must not have taken medication for muscle cramping such as cyclobenzaprine,
baclofen, carisoprodol, or methocarbamol, for at least 30 days prior to screening or
be on a stable dose for at least 60 days prior to screening.
11. Geographic accessibility to the site.
12. Women must not become pregnant for the duration of the study and must be willing to
use two contraceptive therapies and have a negative pregnancy test throughout the
course of the study.
13. Use of medications known to affect the neurophysiology measures in the study must be
scheduled, not as needed (pro re nata, PRN). A subject must have been on a fixed dose
for 30 days prior to the Screening Visit, and there must be no reason to believe that
a subsequent change would be necessary during the course of the study. These
medications include: benzodiazepines, muscle relaxants, tricyclic antidepressants,
selective serotonin reuptake inhibitors, non-selective serotonin reuptake inhibitors,
hypnotics (including anti-histamines) and anti-cholinergics.
Exclusion Criteria:
1. Invasive ventilator dependence, such as tracheostomy.
2. Creatinine level greater than 1.5 mg/dL at screening.
3. Serum Glutamic-Oxaloacetic (SGOT/AST) / Serum Glutamic-Pyruvic (SGPT/ALT) greater than
3 times the upper limit of normal at screening.
4. History of known sensitivity or intolerability to mexiletine or lidocaine.
5. Any history of either substance abuse within the past year, unstable psychiatric
disease, cognitive impairment, or dementia.
6. Clinically significant conduction abnormalities on electrocardiogram or a known
history of cardiac arrhythmia.
7. Known history of epilepsy.
8. Known history of congestive heart failure (CHF) or history of myocardial infarction
within the past 24 months.
9. Use of mexiletine for 30 days prior to Screening Visit.
10. Exposure to any other experimental agent (off-label use or investigational) including
high dose creatine (>10 grams a day) within 30 days prior to Screening Visit.
11. Metal in the head and neck region, cardiac pacemaker or brain stimulator, cochlear
implants, implanted infusion device or personal history of epilepsy.
12. Use of amiodarone, flecainide, duloxetine, tizanidine, or clozapine.
13. Pregnant women or women currently breastfeeding.
14. Placement of Diaphragm Pacing System (DPS) device < 60 days prior to Screening Visit.
15. Planned DPS device implantation during study participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Mexiletine in Sporadic Amyotrophic Lateral Sclerosis | NCT02781454 | Entailment |
6,691 | 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:
- Adults or adolescents older than 12 years
- Patients under Prophylactic treatment with Advate® for at least 1 year
- Written informed consent.
Exclusion Criteria:
- History of FVIII inhibitor (titre ≥ 0.6 BU [Bethesda unit]) or detectable FVIII
inhibitors at screening (titre ≥ 0.4 BU),
- Another haemostatic defect
- Need for major surgery.
- Withdrawal of 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 12 Years old.
| Personalized Prophylactic Treatment With Advate® in Severe or Moderate Haemophilia A Patients | NCT02622646 | Contradiction |
1,370 | 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:
- Hirschsprungs disease confirmed preoperative and postoperative specimen pathology
Exclusion Criteria:
- Other cases of Enterocolitis and constipation
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
Subject must be at most 12 Years | Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis | NCT02343562 | Contradiction |
1,922 | 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:
Main inclusion criteria :
- Digestive symptoms suggestive of GORD (heartburn, regurgitation, epigastric pain), or
dyspeptic syndrome (nausea, belch, bloating, epigastric discomfort).
- Need of upper GI endoscopy and pH monitoring.
- Normal propagation of oesophageal persitaltic waves (manometry < 6 months).
- Age 18 -70 yrs
- Signed informed consent
- Normal coagulation
Exclusion Criteria:
- Barrett's oesophagus
- Previous oesophageal bleeding
- Need of NSAID treatment.
- Previous sus mesocolic surgery
- Alcool consumption > 40g/d, smoking > 10 cig/j
- Pregnancy or lack of contraceptive disposal, breast feeding.
- Allergy to Xylocaïne
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux | NCT00231881 | Entailment |
32 | 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:
- Males with age 35-75 years inclusive.
- Evidence of hypogonadism: Hypogonadism will be defined as low total testosterone (<300
ng/dL) and low calculated free testosterone (below 6.5ng/dL; calculated using
testosterone and SHBG). Testosterone levels will be measured between 8 and 10 am.
Subjects who have normal total but low free testosterone levels (or vice versa) will
be asked to come again after one week to have their testosterone levels re-measured.
They will be included in the study in their free and total testosterone levels are low
on re-measurement.
- Type 2 diabetes
- Hemoglobin A1c <8.0 %
- Subjects on medications for diabetes will be allowed as long as they are on stable
doses of these compounds for at least 6 weeks. The dose of thiazolidinediones will
have to be stable for 3 months prior to the study. The dosage of diabetic medications
will not be changed during the study.
Exclusion Criteria:
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery
bypass, surgery or coronary angioplasty) in the previous four weeks
- Hepatic disease (transaminase > 3 times normal)
- Renal impairment (serum creatinine > 1.5)
- Chronic steroid therapy
- Use of testosterone or other androgens (such as DHEA) in the last 3 months
- Panhypopituitarism
- HIV or hepatitis C
- Subjects will be excluded from the study for history of prostate or breast cancer,
gonadal endocrine disorders
- Current or recent history of major psychiatric illness, significant uncontrolled
systemic illness
- Sleep apnea
- History of alcoholism or substance abuse within the past year
- History of taking other drugs that might interfere with the results of the study (ie,
Lupron, finasteride, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme
inducers, barbiturates)
- Abnormal prostate evidenced by prostatic symptoms, prostatic masses or induration on
rectal examination, elevated levels of prostate specific antigen (>4 ng/mL; subjects
with PSA levels between 2.5-4 ng/mL will be permitted if prostate biopsy is negative)
or positive biopsy, a urine flow rate of less than 12 mL/s, or an International
Prostate Symptom Score greater than 19
- Hematocrit greater than 50%
- Body weight >300 lbs (this is the maximum weight that can be accommodated on DEXA or
MRI machines.
- The subject has systolic blood pressure >170mmHg or diastolic blood pressure >100 mmHg
while on or off anti-hypertensive treatment.
- Generalized skin disease that could affect the absorption of testosterone gel (ie,
psoriasis);
- Morning prolactin level greater than 40 mg/mL
- Subjects with serum fasting triglyceride concentration > 500 mg/dL at screening or
with history of hypertriglyceridemia-induced pancreatitis.
- Participation in any other concurrent clinical trial
- Any other life-threatening, non-cardiac disease
- Use of an investigational agent or therapeutic regimen within 30 days or 5 half-lives
(which ever is longer) preceding the first dose of study medication.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 Years | Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism | NCT00440440 | Contradiction |
1,198 | 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:
- Subject provides informed consent
- Subject is >18 years of age
- Subject is deemed competent for making medical decisions
- Subject is scheduled to undergo radiation followed by extrapleural pneumonectomy.
- Subject is a surgical candidate
- A negative pregnancy test is required in women of child-bearing potential, as standard
of care.
Exclusion Criteria:
- Subject is <18 years old.
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.
| Surgery for Mesothelioma After Radiation Therapy "SMART" for Resectable Malignant Pleural Mesothelioma | NCT02613299 | Entailment |
4,614 | 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, nonpregnant women with regular menstrual cycles
- sexually active and at risk of pregnancy
- acceptable body mass index (BMI)
- last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual
cycle since
- sitting BP<140mmHg/<90mmHg
- 1 normal menstrual cycle since removal of IUD or norplant
- agreement to use study drug for contraception for up to 13 cycles, except when backup
contraception is required for disease protection or patch detachment
- agree not to use other systemic steroid medication
Exclusion Criteria:
- Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or
thromboembolic disorders
- cerebral vascular or coronary artery disease, hypertension, or severe migraines
- liver tumor resulting from estrogen-containing products
- diabetes mellitus
- cholestatic jaundice, liver or renal disease
- abnormal PAP smear
- undiagnosed abnormal vaginal bleeding
- thyroid disorder
- dermal hypersensitivity
- carcinoma of breast, genital tract or other estrogen-dependent neoplasia
- received any depot hormone injection within prior 6 months
- 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 | A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil. | NCT00236795 | Entailment |
5,161 | 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:
- Confirmed diagnosis of osteoporosis or osteopenia examination of bone densitometry;
- Patients without severe neurological disease, vascular disorders, labyrinthitis and
blindness;
- No use of gait auxiliaries;
- No history of fractures of the lower limbs in the last year;
- Do not be an alcoholic inactive (0 to 5 points) or less active (6 to 11 points)
accordance with the usual physical activity questionnaire (QAFH).
Exclusion Criteria:
-Patients who submit to hypertensive peak, nausea and dizziness during the training
program.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 90 Years | Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia | NCT03448276 | Contradiction |
733 | 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:
- Radiographic evidence of at least moderate narrowing (joint space < 1mm) or the
presence of osteophytes or sclerosis at the Carpometacarpal joint
- Patient complaint of unacceptable pain despite modification of activity, a trial of
splinting and a therapeutic dose of NSAIDS
- If bilateral disease, only the most severely involved hand, (as defined by VAS for
pain), will be entered in the study.
- Proficiency in English.
Exclusion Criteria:
- Previous bad injury to the thumb
- Previous hand surgery on the study thumb
- Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc)
- Rheumatoid arthritis or lupus
- Bleeding problems
- Being on blood thinners (except aspirin)
- Known allergies to any of the medications being used
- Allergies to chicken products
- Current use of oral steroids
- Cancer that is not cured or in remission
- Severe diabetes
- A serious infection somewhere else in the subject's body
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 95 Years | An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study | NCT00198029 | Contradiction |
2,395 | 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:
DMD Subjects
- Eligible for the parent study
- Willing and able to comply with all protocol requirements and procedures, including
MRI without sedation
- Able to give informed assent and parent(s)/legal guardian to give informed consent in
writing signed by the subject and/or parent(s)/legal guardian
Healthy Volunteers
- Must be unaffected by a neuromuscular condition
- Willing and able to comply with all protocol requirements and procedures, including
MRI without sedation.
- Able to give informed assent and parent(s)/legal guardian to give informed consent in
writing signed by the subject and/or parent(s)/legal guardian.
EXCLUSION CRITERIA:
DMD Subjects and Healthy Volunteers
- Having metal objects in his body that are not MRI-safe. These include the following
objects: 1) pacemakers or other implanted electrical devices; 2) brain stimulators; 3)
some types of dental implants; 4) aneurysm clips (metal clips on the wall of a large
artery); 5) metallic prostheses (including metal pins and rods, heart valves, and
cochlear implants; 6) implanted delivery pump; 7) permanent eye liner; or 8) shrapnel
fragments.
- Having a fear of closed spaces
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 17 Years | Studying Skeletal Muscle, Heart, and Diaphragm Imaging in Boys With Duchenne Muscular Dystrophy | NCT01451281 | Entailment |
5,181 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual
cycles for at least one year)
Exclusion Criteria:
Morphological abnormalities or skeletal distortions
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women | NCT03798444 | Entailment |
6,805 | 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:
- subject of Hemophilia
- 20-65 years old
Exclusion Criteria:
- Any history of surgery
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 65 Years | The Effect of Functional Activities and Balance Ability With Taping in Subjects of Hemophilia | NCT02389205 | Entailment |
6,185 | 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 equal or more than 18;
- Symptoms suggestive of Covid-19 pneumonia. At least : fever > 38°C or influenza-like
illness (asthenia, myalgia, chills, muscular aches, …) AND cough or dyspnea;
- Hospitalization required on clinical criteria including: oxygen saturation <96%
without oxygen support, respiratory frequency > 25 per minute, hemodynamic
instability, medical history or comorbidities known at high risk for Covid-19 (chronic
heart disease, congestive heart failure, chronic bronchopulmonary disease, diabetes
mellitus, age>70, history of cancer, immunosuppression, …);
- Covid-19 confirmation test performed (RT-PCR).
Exclusion Criteria:
- Age < 18
- Refusal to participate in the study
- detainee or prisoner
- Protected adult uncapable to 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.
| Renin-Angiotensin-Aldosterone System Inhibitors, Hypertension, and COVID-19 | NCT04374695 | Contradiction |
4,065 | 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:
- medical diagnosis of Grade 3 or 4 knee OA
- have a prescribed knee brace for at least three months
- self-reported knee pain when standing, walking, climbing stairs, squatting, or other
mobility activities
- self-reported limitations to mobility and walking activities due to knee pain,
stiffness, loss of range of motion
Exclusion Criteria:
- neurological paralysis causing an inability to stand, weight bear or take stepping
movements
- fixed contractures resulting in limited range of motion in the hip, knees, or ankles
that prevent sitting, standing, walking, and/or squatting activities
- able to walk at a normal walking speed (>1.2 m/s) based on a 6-minute walk test (6MWT)
- anthropometric incompatibility with the device
- any medical complication or co-morbidity as judged by the study physician to be
contraindicated for wearing the device or walking (e.g., cardiovascular disorders,
pressure ulcers, open wounds, lower limb vascular disorders, or other medical
conditions)
- a score of <8/10 on the MacArthur Competence Assessment Tool for Treatment (MacCAT-T)
(as a proxy for cognitive competency screening); and 7) pregnancy or planning on
becoming pregnant
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 Powered Exoskeleton for Veterans With Knee OA | NCT04653896 | Entailment |
4,235 | 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:
- Ages 18 or older
- Self-report of general good health other than voice disorder
- Self-report of normal pulmonary function
- Non-smoker status for at least the last 5 years
- English as their primary language to avoid potential linguistically-based differences
in acoustic measures of voice
- Adequate visual acuity (with or without corrective lenses) to read basic graphs and
print, as determined with visual screening
- No evidence of current organic or neurologic laryngeal pathology, as assessed by
nasolaryngoscopy examination and reviewed by a laryngologist
- No prior surgery to the vocal folds
- Do not report difficulty with swallowing
- Not currently receiving voice therapy or other voice treatment that cannot be
discontinued
- Do not report a bilateral, severe to profound hearing loss
- Willingness to be recorded for data collection that is necessary for this study
- Have a confirming diagnosis of Muscle Tension Dysphonia from an otolaryngologist and
speech-language pathologist
- Demonstrate quantified auditory-perceptual dysphonia and acoustic dysphonia
(Cepstral/Spectral Index of Dysphonia) that exceed normative values for the
participant's age and sex
- Based on the nasolaryngoscopy examination and assessment performed by the
otolaryngologist, show one or more patterns of supraglottic activity that are
consistent with adducted vocal fold hyperfunction
- Show no evidence of abnormal, incomplete vocal fold closure patterns as determined on
the videostroboscopy assessment (patterns of posterior glottal gaps are normal and
expected)
- Show no evidence of additional neurological voice disorders such as spasmodic
dysphonia or vocal fold paralysis
- Show elevated hyolaryngeal position that exceeds normative expectations as determined
through quantitative analysis of ultrasonographic laryngeal images measuring change
from rest to phonation
- Demonstrate voice problems that have persisted for ≥2 months
- Demonstrate self-reported increase in speaking effort
- Show evidence of speech breathing abnormalities relative to accepted normative values
Exclusion Criteria:
- Ages 17 or younger
- Self-report of major health problems
- Self-report of pulmonary disease such as asthma, chronic obstructive pulmonary
disease, or emphysema
- Current smoker status or prior smoker status within the last 5 years
- English not the primary language
- Inadequate visual acuity (with corrective lenses if applicable) to read basic graphs
and print as determined by failing a visual screening
- Evidence of current organic or neurologic laryngeal pathology, as assessed by
nasolaryngoscopy examination and reviewed by a laryngologist
- Prior surgery to the vocal folds
- Self report of difficulty with swallowing
- Currently receiving voice therapy or other voice treatment that cannot be discontinued
- Self-report of a bilateral, severe to profound hearing loss
- Not willing to be recorded for data collection that is necessary for this study
- No confirming diagnosis of Muscle Tension Dysphonia from an otolaryngologist and
speech-language pathologist
- Do not demonstrate quantified auditory-perceptual dysphonia and acoustic dysphonia
(Cepstral/Spectral Index of Dysphonia) that exceed normative values for the
participant's age and sex
- Based on the nasolaryngoscopy examination and assessment performed by the
otolaryngologist, do not show one or more patterns of supraglottic activity that are
consistent with adducted vocal fold hyperfunction
- Show evidence of abnormal, incomplete vocal fold closure patterns as determined on the
videostroboscopy assessment (patterns of posterior glottal gaps are normal and
expected)
- Show evidence of additional neurological voice disorders such as spasmodic dysphonia
or vocal fold paralysis
- Do not show elevated hyolaryngeal position that exceeds normative expectations as
determined through quantitative analysis of ultrasonographic laryngeal images
measuring change from rest to phonation
- Demonstrate voice problems that have persisted for less than 2 months
- Do not demonstrate self-reported increase in speaking effort
- Do not show evidence of speech breathing abnormalities relative to accepted normative
values
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Effects of Respiratory Training on Voice | NCT04710862 | Contradiction |
3,792 | 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:
- Signature of the free, informed consent form
- Age over 18 years old
- Knee pain for more than six months without improvement with clinical treatment
- Clinical and imaging diagnosis (radiography) of knee osteoarthritis
- Moderate pain intensity (pain greater than 4, by the numerical scale).
Exclusion Criteria:
- Cognitive impairment or psychiatric disease
- Other causes of knee pain (trauma, complex regional pain syndrome)
- Puncture site infection
- Coagulopathy or use of anticoagulant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis | NCT03601533 | Entailment |
5,580 | 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:
- Previously randomized in study B9R-US-GDFG (NCT00406926)
- Karyotype-proven Turner syndrome
Exclusion Criteria:
- Immediate family members of study site personnel directly affiliated with the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 20 Years | Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome | NCT00266656 | Contradiction |
5,328 | 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:
- 12 to 65 years old;
- The activity of the coagulation factor VIII (FVIII:C) ≤2%, and was previously treated
with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
- Non-bleeding state (No clinical manifestations of active hemorrhage);
- Negative assays for FVIII inhibitors (<0.6 BU/mL);
- The platelet count is normal；
- Normal prothrombin time or INR ≤1.5；
- Given informed consent
Exclusion Criteria:
- Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the
excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
- Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);
- Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days
prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII],
cryoprecipitate and whole blood);
- Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
- HIV seropositive;
- Abnormal hemostasis from causes other than hemophilia A；
- Patients with severe heart disease, including myocardial infarction, heart failure
(III or higher level);
- Patients who received any anticoagulant or antiplatelet therapy within one week
(including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during
the period of clinical trials;
- Alcoholism, drug abuse, mental disorders and mental retardation;
- Elective surgery planned during the process of study;
- Patients who previously participated in the other clinical trials prior to study
entry;
- The patient or parent/legal guardian is unable or unwilling to sign an informed
consent form or to comply with the requirements of clinical protocol;
- Other conditions confirmed by the researchers, resulting in that patients are unable
to benefit from clinical observation;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A | NCT02888223 | Contradiction |
47 | 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:
- Women age 18-55
- Hypopituitarism with central adrenal and/or gonadal deficiencies. To qualify patients
will need to have either 1 or 2 and they need to have 3:
1. To diagnose central adrenal deficiency, patients not on glucocorticoid
replacement will have an insulin tolerance test (ITT) (patients with
cardiovascular disease will be excluded) in which 0.1U/kg of insulin will be
given by iv and a peak cortisol value of less than 20ug/dl, associated with a
glucose level of less than 40mg/dL will be considered consistent with central
adrenal insufficiency. Patients on glucocorticoid replacement will be evaluated
by examining their prior workup and if it is determined that they had evidence of
central adrenal deficiency, an ITT will not be required to document central
adrenal deficiency (an ITT will still be performed to determine GH deficiency).
2. To diagnose central gonadal deficiency, patients will be asked if they had
amenorrhea or oligomenorrhea prior to estrogen replacement. An FAH of less than 5
MIU/ML will be used to confirm that they have central and not primary gonadal
deficiency. In select patients in which the diagnosis of central gonadal
deficiency is unclear, we may perform an LHRH stimulation test, in which 100 ug
iv of LHRH (Factrel) will be given and a peak LH response of less than 15 MIU/ML
will be considered consistent with central gonadotropin insufficiency.
3. Serum testosterone level on transdermal estrogen replacement of less than 20
ng/dL or free testosterone of less than 1.5 pg/ml.
- No other significant medical condition
- Weight between 80 and 150% of ideal body weight
- Able to provide informed consent
- All races and ethnicities
- All patients regardless of marital status and relationship status.
Exclusion Criteria:
- Physical disabilities that would prevent them from participating in the study.
- Current use of testosterone or other androgenic steroids. Patients who are taking
testosterone, DHEA or other androgen precursors will discontinue these
medications/supplements three months prior to the study.
- Significant cardiopulmonary disease (prior myocardial infarction causing ventricular
dysfunction, angina, arrhythmias, congestive heart failure, valvular problem), venous
thrombotic event (pulmonary embolism or deep vein thrombosis), renal disease
(creatinine greater than 1.5 mg/dL), diabetes mellitus on insulin, uncontrolled
hypertension, malignancy (other than basal cell skin carcinoma) or major psychiatric
disease. Patients with depression or anxiety on a stable dose of medication will be
allowed to enroll.
- Current abuse of illicit drugs or heavy ethanol use.
- History of breast cancer or abnormal mammogram at entry. If patients with an abnormal
mammogram or PAP smear are appropriately evaluated and found not to have cancer, they
will be allowed to participate in the study.
- Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline
phosphatase value of greater than one and one-half the upper limit of normal in our
Clinical Pathology Laboratory or serum bilirubin levels of greater than 2 mg/dL will
be excluded.
- Those with history of hyperandrogenic disorders such as hirsutism and polycystic ovary
disease will be excluded. These conditions are rare in women with hypopituitarism.
Testosterone administration to these patients may exacerbate the underlying disorder.
- Women who are pregnant, seeking to become pregnant in the next 6 months, or
breast-feeding.
- Those who have previously experienced intolerance to other transdermal systems or gels
- Drugs known to alter testosterone production such as megace or ketoconazole.
- Patients with untreated hyperprolactinemia or active Cushing's disease. Patients with
treated prolactinoma or Cushing's disease will be allowed to participate in the study.
- Hematocrit of greater than 50%
- Male sex
- Not willing to answer all questions on surveys
- EKG showing ischemia or prior myocardial infarction
- Patients with extensive brain surgery, severe head injury, brain tumors or other
conditions that profoundly affect CNS function.
- Patients not willing to be placed on a standardized hormonal replacement regimen
including transdermal estrogen and growth hormone.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Testosterone Gel Applied to Women With Pituitary Gland Problems | NCT00144391 | Contradiction |
1,754 | 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 cytologically or pathologically verified diagnosis of gastric
cancer; patients must have locally advanced or distant metastatic disease (either
recurrent or at primary diagnosis) that is not surgically curable
- The pathologic confirmation of gastric cancer may be made from the metastatic
site; biopsy of the primary tumor is not necessary; patients with pathologic
confirmation of cancer from a metastatic site, along with clinical documentation
of gastric involvement and no evidence of another primary are also eligible
- Eligible pathologic type: patients may have any histological subtype including
adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, intestinal type, clear
cell adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma,
undifferentiated carcinoma, carcinoma NOS; patients must not have carcinoid
tumors or sarcomas
- Patients must have measurable disease; x-rays, scans, or physical examinations for
measurable disease must have been completed within 28 days prior to registration;
x-rays, scans or physical examinations for non-measurable disease must have been
completed within 42 days prior to registration,; all disease must be assessed
- Patients must be willing to have specimens submitted; the paraffin embedded specimens
must be available for submission
- Patients may have had prior surgery for their gastric cancer; patients must be at
least 2 weeks beyond surgery, and recovered from all effects of surgery
- Patients may have received prior chemotherapy, hormonal therapy, immunotherapy,
radiation or chemoradiotherapy as neoadjuvant or adjuvant treatment but this must have
been completed at least 6 months prior to documented recurrence or metastatic disease;
patients must not have received previous treatment for metastatic disease
- If patient received radiation therapy, the site of measurable disease must be
outside of the radiation field
- Patients must not have had prior therapy with EGFR targeting therapies
- Patients must have a Zubrod performance status of 0-1
- Leukocytes >= 3,000/mcl
- Platelets >= 100,000/mcl
- AGC >= 1,500/mcl
- Serum transaminase (SGOT or SGPT) =< 2.5 x IULN; patients with liver metastases must
have SGOT/SGPT =< 5 x IULN
- Bilirubin =< IULN
- Serum creatinine =< IULN OR measured creatinine clearance > 60 mL/min OR estimated
creatinine clearance> 60 mL/min
- Patients must have cardiac ejection fraction within the institutional range of normal
as measured by echocardiogram or MUGA scan; note that baseline and on treatment scans
should be performed using the same modality and preferably at the same institution
- Patients must either be able to swallow and/or receive enteral medications via
gastrostomy feeding tube; patients with intractable nausea or vomiting are not
eligible; patients with GI tract disease resulting in an inability to take oral
medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical
procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g.,
Crohn's, ulcerative colitis) are not eligible
- Patients must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to GW572016
- There must be no plans for the patient to receive concurrent chemotherapy, hormonal
therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of
their cancer while on this protocol
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with GW572016
- Pregnant or nursing women are not eligible because of the risk of fetal harm; nursing
women may participate only if nursing is discontinued, due to the possibility of harm
to nursing infants from this treatment regimen; women/men of reproductive potential
must have agreed to use an effective contraceptive method
- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in remission or any other
cancer from which the patient has been disease-free for 5 years
- If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next
working day
- In calculating days of tests and measurements, the day a test or measurement is
done is considered day 0; therefore, if a test is done on a Monday, the Monday
four weeks later would be considered day 28; this allows for efficient patient
scheduling without exceeding the guidelines
- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines
- At the time of patient registration, the treating institution's name and ID number
must be provided to the Statistical Center in order to ensure that the current (within
365 days) date of institutional review board approval for this study has been entered
into the data base
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.
| S0413 Lapatinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer | NCT00103324 | Contradiction |
5,957 | 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:
- Female subject is not pregnant or lactating, Females of childbearing potential must
use reliable means of contraception during the course of the study
- Subject is in good health
- Subject is able to abstain from smoking during the 24-hour periods before and during
each treatment day
Exclusion Criteria:
- Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI
surgery
- Subject has a history of asthma or severe allergies to drugs or foods
- Subject currently uses prescribed or nonprescribed drugs on a regular basis
- Subject has a recent history of drug/alcohol abuse
- Subject consumes more than 6 cups of coffee per day
- Subject has unconventional or extreme dietary habits
- Subject has donated blood or has been in a clinical trial in which they received an
investigational drug during the past 30 days
- Subject has a history of allergy or intolerance to antacids
- Female subject is known to be pregnant or is not using reliable means of contraception
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED) | NCT00944671 | Contradiction |
6,225 | 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 years.
- Fever ≥ 38º C with upper respiratory tract manifestations, generalized bone ache with
or without gastrointestinal symptoms as diarrhea.
- Chest CT with signs suggestive of COVID-19.
- Mild and moderate cases of COVID-19 pneumonia with respiratory and hemodynamic
stability. - High C reactive protein (CRP).- With or without history of contact with
index case who is isolated in a governmental hospital assigned for treatment of
patients proved to have RT-PCR positive test for COVID-19
- With or without abnormalities in the total or differential white cell count.
- Welling to sign a fully informed consent.
Exclusion Criteria:
- Severe and critical illness with respiratory failure and/ or hemodynamic instability.
- CT with pleural effusion with or without lung cavitation.
- Other organ failure.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia | NCT04374591 | Contradiction |
5,155 | 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. | Experimental group:
Inclusion Criteria:
- patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis,
compression fracture, back pain treated at National Taiwan University Hospital
- received rehabilitation at the Physical Therapy Center in recent ten years.
Control group:
Inclusion Criteria:
- patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis,
compression fracture, back pain treated at National Taiwan University Hospital
- not received rehabilitation at the Physical Therapy Center in recent ten years.
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 | Physical Therapy Management in Degenerative Lumbar Diseases and Osteoporosis | NCT01703403 | Contradiction |
3,681 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
Patient group
- Radiating leg pain due to nerve root compression verified by MRI
- Clinical findings in accordance with MRI findings
- Average leg pain ≥ 3/10 on a numeric pain rating scale Controls
- No current or previous history of ongoing musculoskeletal pain
Exclusion Criteria:
Applies for both groups.
- Other specific medical conditions e.g. rheumatologic disease, diabetes or vascular
diseases.
- Pregnancy
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 | Changes in Radicular Pain and Pain Modulation | NCT04193969 | Entailment |
6,511 | 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:
- Participants with severe hemophilia A (baseline FVIII activity FVIII:C <1%),
determined by measurement at the time of screening (following a washout period of at
least 72 h after their last FVIII treatment for standard half-life FVIII products or
of 120 h for extended half-life FVIII products) or from reliable prior documentation
(e.g. measurement in other clinical studies, result from approved clinical laboratory
or diagnostic genetic testing).
- ≥150 exposure days with FVIII concentrate(s) (plasma-derived or recombinant) as
supported by medical records.
- Body mass index (BMI) within the range 18 kg/m2 to 29.9 kg/m2 (inclusive).
Exclusion Criteria:
- Inability to stop FVIII treatment to complete a minimum of 72 h washout for standard
half-life FVIII product or 120 h washout for extended half-life FVIII product
- Evidence of current or past inhibitor antibody
- History of any congenital or acquired coagulation disorders other than hemophilia A
- Platelet count <75,000/mm3
- Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4
(CD4+) lymphocyte count of <200/mm3
- Abnormal renal function (serum creatinine >2x the upper limit of the normal range
[ULN])
- Active liver disease verified by medical history or persistently elevated alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) >5x ULN or severe liver
disease as evidenced by, but not limited to any of the following: International
Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of
otherwise unexplained splenomegaly and history of esophageal varices
- Requirement of any pre-medication to tolerate FVIII treatment (e.g. anti-histamines)
- Prior treatment with immunomodulatory agents or chemotherapy within the last 3 months
prior to study entry or requirement of treatment during the study. The following drugs
are allowed: α interferon, PEG interferon, highly active anti-retroviral therapy for
HIV, and/or a total of two courses of pulse treatment with steroid for a maximum of 7
days at 1 mg/kg or less
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII) | NCT04015492 | Contradiction |
2,186 | 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:
- Male or female, aged 18 to 80
- Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the
presence of at least one gout tophus or gouty arthritis
- Hyperuricemia with a sUA ≥8.0 mg/dL
Exclusion Criteria:
- Pregnant or nursing
- Known hypersensitivity to any of the components of tranilast or allopurinol
- Known history of xanthinuria or kidney stones
- Use of an investigational drug within 30 days
- Presence of, or history of, cancer with the exception of completely excised,
non-metastatic squamous cell and basal cell carcinomas of the skin
- Subject is planning or likely to require a surgical procedure 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 18 Years old.
Subject must be at most 80 Years | Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO) | NCT01109121 | Contradiction |
1,597 | 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:
- Signed informed consent form and participated in all stages of the study
- Being in the age range of 18-25
- Being right-handed
Exclusion Criteria:
- Having physical, mental disability (vision, hearing, etc.) which may affect
participation in the study
- Presence of a history of congenital or acquired orthopedic, neurological, or rheumatic
disease that may impair joint range and / or function of the hand and wrist
- Having a history of trauma requiring medical, conservative and surgical treatment for
the application area in the last 6 months
- Presence of skin lesions (burns, cellulite, vesicles, bulla, pisoriasis, open / closed
wound, scar, active infection, malignancy, etc.) in the application area.
- Excessive skin reaction to applications
- The problem of hirsutism to the extent of preventing the kinesiotaping in the
application area.
- Dart sports experience as amateur or professional
- To have consumed alcohol, pharmaceutical substance until 24 hours before the
evaluation
- Using anabolic substance
- To have theoretical and practical experience in Kinesio taping
- Being obese
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 25 Years | Effect of Kinesiotaping on Wrist Kinematics and Functional Performance | NCT03788954 | Contradiction |
683 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
1. HFE C282Y homozygous.
2. Aged 18 - 70 years .
3. SF above the upper limit of the normal range of 300µg/L but less than 1000µg/L with a
currently or previously raised TS (>greater than the upper limit of normal for the
testing laboratory).
Exclusion Criteria:
1. HH due to genotypes other than HFE C282Y homozygosity.
2. Normal SF, SF > 1000µg/L.
3. Other major risk factor(s) for liver toxicity or other significant co-morbidities
including positivity for hepatitis B or C, excess alcohol consumption (> 60g/day in
males and 40g/day in females) or body mass index > 35.
4. Has had venesection therapy for HH in the last two years.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Mi-iron - Moderately Increased Iron - is Reducing Iron Overload Necessary? | NCT01631708 | Entailment |
3,293 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- alteration of the foveal contour not classifiable as lamellar or pseudo macular hole
- focal, well-defined increased autofluorescence signal at the fovea
Exclusion Criteria:
- intraretinal cysts not associated with break of the inner retina
- juxtafoveal telangiectasia
- ring of increased B-FAF
- vitelliform and pseudovitelliform lesions
- history of diabetes, retinal vein occlusion, uveitis, CSR, AMD or any other retinal
-disease potentially associated with intra or subretinal fluid
- macular drusen
- history of submacular hemorrhage
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 90 Years | Simultaneous OCT and B-FAF in Eyes With Alteration of the Foveal Contour | NCT03287648 | Contradiction |
2,658 | 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:
- 18 years of age or older (19 years in Nebraska)
- Male
- Diagnosis of inguinal hernia (patients with bilateral and recurrent hernias are
eligible)
- Inguinal hernia that is either completely asymptomatic or minimally symptomatic (does
not interfere with normal activities
- Informed consent for randomization
Exclusion Criteria:
- A hernia that could not detected on physical examination
- American Society of Anesthesia (ASA) Class IV or V
- Evidence was present of an acute hernia complication such as bowel obstruction,
strangulation, peritonitis, or perforation
- Local or systemic infection
- Presence of pain and discomfort associated with the hernia that limits usual
activities
- A history of recent (within six weeks of visit) onset of difficulty in reducing a
hernia that was previously easily reduced
- Participation in another clinical trial
- Female
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Inguinal Hernia Management: Watchful Waiting vs. Tension-Free Open Repair | NCT01922674 | Entailment |
1,487 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Mean screening systolic blood pressure of 110 to < 160 mm Hg at most recent visit
- Mean screening diastolic blood pressure of 70 to <100 mm Hg at most recent visit
Exclusion Criteria:
- Currently taking antihypertensive medications
- Known to be currently pregnant
- History of sleep apnea
- History of heart attack, stroke, or any cardiovascular disease
- History of arrhythmia (e.g. - atrial fibrillation or ventricular tachycardia)
- Completed ambulatory blood pressure monitoring in the past year
- Second shift, overnight, or jobs that will not allow ambulatory blood pressure device
to measure every 30 minutes for 24 hours.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 87 Years | Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure | NCT04307004 | Entailment |
4,161 | 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:
- Male or female healthy volunteers, 18 to 55 years of age, inclusive. A female
participant is eligible to participate if she is of non-childbearing potential defined
as postmenopausal or surgically sterile
- Healthy status is defined by absence of evidence of any active or chronic disease
following a detailed medical and surgical history, a complete physical examination
including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry,
serology and urinalysis
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive
- Nonsmokers
- Healthy male volunteers with female partners of childbearing potential must use
adequate contraception methods
Exclusion Criteria:
- Evidence of active chronic disease
- Regular consumption of drugs of abuse
- Infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C
(HCV)
- History of clinically significant hypersensitivity or allergic drug reactions
- Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
- Abnormal blood pressure or vital signs
- Contraindications to bronchoalveolar lavage (BAL)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers | NCT02165293 | Contradiction |
5,401 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Women with menorrhagia
- 18-49 years of age
- Regularly occuring menstrual periods
Exclusion Criteria:
- History or presence of clinically significant disease or abnormalities that might
confound the study
- History of bilateral oophorectomy or hysterectomy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Safety Study of XP12B in Women With Menorrhagia | NCT00113568 | Entailment |
2,182 | 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:
- Self-reported doctor-diagnosed arthritis
- No physical limitations precluding exercise participation
- Negative screen for CVD (PAR-Q)
- Age 20+
- English or Spanish speaking
Exclusion Criteria:
- Presence of any condition for which exercise is contraindicated
- Physical inability to complete exercise program
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 85 Years | Fitness and Exercise for People With Arthritis | NCT00252070 | Contradiction |
221 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
men with
- hypergonadotropic hypogonadism
- hypogonadotropic hypogonadism
- late-onset hypogonadism
combined with an initial Testosterone serum level of < 11 nmol/l
Exclusion Criteria:
- known or suspected carcinoma of the prostate
- clinically relevant abnormalities in clinical chemistry or haematology
- any severe medical conditions at the opinion of the investigator
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Three-Year Trial on a New Testosterone Gel | NCT00204269 | Entailment |
101 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male
- 18 years to 65 years
- Low testosterone as defined by criteria (serum total testosterone <350 ng/dl in men
<55 years, <300 ng/dl in men 55-65 years)
- EITHER taking opioid pain medication (see A below) OR planning to start new pain
medication regimen (see B below)
- A) EITHER continuous opioid treatment for chronic nonmalignant pain for >=6 months
receiving one of several specified opioid regimens for the past 1 month (including
>=20 mg/day of oral methadone, >=30 mg/day of oral sustained release oxycodone, >=30
mg/day of oral morphine sulfate, >=6 mg/day of oral dilaudid or >= 8 mg/day of
dilaudid ER, or >=25 mcg/hr of transdermal fentanyl or buprenorphine, or intrathecal
morphine pump)
- B) OR the pain management physician is planning to start pain medication (opioid or
non-opioid pain therapy) but you have not received it yet. If this is the case, your
testosterone will be checked before starting and during 1 month of pain therapy to
determine if you have low testosterone to qualify to begin medication (clomiphene or
placebo) treatment in this study.
- BMI (20-35 kg/m2)
- Presence of clear secondary hypogonadism with hypogonadal symptoms and low total
testosterone level (confirmed with morning testosterone level <= 350 ng/dL for men age
>= 55 and <= 300ng/dl for men age 55-65) or total testosterone <=200 ng/dl (regardless
of symptoms). Additionally luteinizing hormone (LH) should be <15 mIU
(milli-International unit )/mL (at baseline only). Symptoms of hypogonadism include
fatigue, decreased energy level/endurance, depressed mood, decreased libido, erectile
dysfunction.
- Chronic nonmalignant pain etiology includes rheumatoid arthritis, osteoarthritis,
spinal stenosis, polymyalgia, complex region pain syndrome I and II, neurinoma,
phantom limb pain, neuropathic pain of other origin, scoliosis, neck pain, failed back
surgery, or chronic pancreatitis.
- All patients must have ability to complete the study in compliance with the protocol,
and the ability to understand and provide written informed consent.
Exclusion Criteria:
- Chronic pain of malignant etiology (cancer-related)
- Preexisting testosterone deficiency
- Concomitant use of medication that could interfere with testosterone levels including
antidepressant medication, spironolactone, cimetidine, clomiphene (use in the past 1
year), human chorionic gonadotropin (hCG), androgen, estrogen, anabolic steroid,
5-alpha-reductase inhibitors such as finasteride, dehydroepiandrosterone (DHEA),
testosterone therapy (topical testosterone within 7 days of study, injectable
testosterone within 6 months of study),
- Uncontrolled hypertension
- Clinically significant abnormal findings on screening examination based on the
Investigator's assessment
- Known hypersensitivity to clomiphene
- Symptomatic cataracts
- Presence or history of known hyperprolactinemia with or without a tumor
- End-stage renal disease
- Any contraindication to testosterone supplementation therapy
- Absolute contraindications to hormone supplementation therapy which include active
prostate cancer (or suspicion of prostate disease unless ruled out by biopsy),
prostatic specific antigen (PSA)>=3.6, breast cancer, hematocrit>=51% (hemoglobin>=17
g/dL), uncontrolled congestive heart failure (CHF), myocardial infarction, acute
coronary event, unstable angina, coronary revascularization procedure in the preceding
6 months, untreated obstructive sleep apnea, high risk of prostate cancer (ethnicity
or family history), or severe lower urinary tract symptoms (AUA symptom score>19).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration | NCT01880086 | Contradiction |
6,970 | 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:
- Diagnosis of Alzheimer's type dementia, rated as severe
- progressive worsening of memory and other cognitive functions
- brain imaging (CTor MRI scan) within last 3 years
- ability to be mobile (aided or unaided) with sufficient vision and hearing to comply
with testing.
Exclusion Criteria:
- Dementia caused by cerebrovascular disease
- disturbances of consciousness, delirium, psychosis
- severe aphasia
- or major sensorimotor impairment
- cognitive impairment due to acute cerebral trauma, hypoxic cerebral damage, vitamin
deficiency, infections, primary of metastatic cerebral neoplasia, endocrine or
metabolic disease or mental retardation, pregnant or nursing women or those without
adequate contraception.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Treatment of Severe Alzheimer's Disease: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study | NCT00216593 | Entailment |
12 | 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:
- Women age 18-55
- Hypopituitarism with central adrenal and/or gonadal deficiencies. To qualify patients
will need to have either 1 or 2 and they need to have 3:
1. To diagnose central adrenal deficiency, patients not on glucocorticoid
replacement will have an insulin tolerance test (ITT) (patients with
cardiovascular disease will be excluded) in which 0.1U/kg of insulin will be
given by iv and a peak cortisol value of less than 20ug/dl, associated with a
glucose level of less than 40mg/dL will be considered consistent with central
adrenal insufficiency. Patients on glucocorticoid replacement will be evaluated
by examining their prior workup and if it is determined that they had evidence of
central adrenal deficiency, an ITT will not be required to document central
adrenal deficiency (an ITT will still be performed to determine GH deficiency).
2. To diagnose central gonadal deficiency, patients will be asked if they had
amenorrhea or oligomenorrhea prior to estrogen replacement. An FAH of less than 5
MIU/ML will be used to confirm that they have central and not primary gonadal
deficiency. In select patients in which the diagnosis of central gonadal
deficiency is unclear, we may perform an LHRH stimulation test, in which 100 ug
iv of LHRH (Factrel) will be given and a peak LH response of less than 15 MIU/ML
will be considered consistent with central gonadotropin insufficiency.
3. Serum testosterone level on transdermal estrogen replacement of less than 20
ng/dL or free testosterone of less than 1.5 pg/ml.
- No other significant medical condition
- Weight between 80 and 150% of ideal body weight
- Able to provide informed consent
- All races and ethnicities
- All patients regardless of marital status and relationship status.
Exclusion Criteria:
- Physical disabilities that would prevent them from participating in the study.
- Current use of testosterone or other androgenic steroids. Patients who are taking
testosterone, DHEA or other androgen precursors will discontinue these
medications/supplements three months prior to the study.
- Significant cardiopulmonary disease (prior myocardial infarction causing ventricular
dysfunction, angina, arrhythmias, congestive heart failure, valvular problem), venous
thrombotic event (pulmonary embolism or deep vein thrombosis), renal disease
(creatinine greater than 1.5 mg/dL), diabetes mellitus on insulin, uncontrolled
hypertension, malignancy (other than basal cell skin carcinoma) or major psychiatric
disease. Patients with depression or anxiety on a stable dose of medication will be
allowed to enroll.
- Current abuse of illicit drugs or heavy ethanol use.
- History of breast cancer or abnormal mammogram at entry. If patients with an abnormal
mammogram or PAP smear are appropriately evaluated and found not to have cancer, they
will be allowed to participate in the study.
- Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline
phosphatase value of greater than one and one-half the upper limit of normal in our
Clinical Pathology Laboratory or serum bilirubin levels of greater than 2 mg/dL will
be excluded.
- Those with history of hyperandrogenic disorders such as hirsutism and polycystic ovary
disease will be excluded. These conditions are rare in women with hypopituitarism.
Testosterone administration to these patients may exacerbate the underlying disorder.
- Women who are pregnant, seeking to become pregnant in the next 6 months, or
breast-feeding.
- Those who have previously experienced intolerance to other transdermal systems or gels
- Drugs known to alter testosterone production such as megace or ketoconazole.
- Patients with untreated hyperprolactinemia or active Cushing's disease. Patients with
treated prolactinoma or Cushing's disease will be allowed to participate in the study.
- Hematocrit of greater than 50%
- Male sex
- Not willing to answer all questions on surveys
- EKG showing ischemia or prior myocardial infarction
- Patients with extensive brain surgery, severe head injury, brain tumors or other
conditions that profoundly affect CNS function.
- Patients not willing to be placed on a standardized hormonal replacement regimen
including transdermal estrogen and growth hormone.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Physiologic Testosterone Replacement in Women With Hypopituitarism | NCT00144391 | Contradiction |
2,197 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Age > 18 years
- Mono or oligo arthritis (2-3 swollen joints)
- Indication for diagnostic aspiration of an inflamed joint in which gout is one of the
possibilities
Exclusion Criteria:
- Polyarthritis ( up to 4 swollen joint);
- Chrystal proven gout in history
- Patient is on uric acid lowering therapy (Allopurinol, Benzbromaron, Febuxostat)
- Hip arthritis*
- Metal or prosthesis of the inflamed joint
- Highly suspicion of infectious arthritis
- Pregnancy
- Contra indication of joint aspiration (skin infection, hemophilia)
- No 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.
| Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration | NCT03038386 | Contradiction |
3,725 | 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. | Phase I
Inclusion Criteria:
• All current or retired professional male footballers (Registered with the Professional
Footballer Association (age range 40 -80)
Phase II
Inclusion Criteria:
- Professional footballers both with and without a history of knee pain knee OA or knee
surgical history
- No contraindications of the affected joint such as gout or rheumatoid arthritis
- Willingness to participate in a clinical assessment of the knee and provision of blood
samples.
Phase III
Inclusion Criteria for controls:
- Over the age of 40 (age range 40 - 80)
- Both with and without a history of knee pain over at least the last 1 year
- No history of significant trauma, injury or surgery to the lower limb
- American College of Rheumatology (ACR) classification of OA based on physical
examination and clinical presentation: Pain in the knee and three of the following;
over the age of 50, less than 30 minutes of morning stiffness, crepitus on active
motion, bony tenderness, bony enlargement and no palpable warmth of synovium.
Phase I
Exclusion Criteria:
- Not a registered professional footballer (current or past)
- Inaccurate information (discrepancy with questionnaire information compared to other
football records. This will be verified by the co-investigator, Dr Fernandes and Mr
Sanjay Parekh)
- Incomplete questionnaire or duplicate questionnaire.
Phase II
Exclusion Criteria:
- Not a registered professional footballer
- No written informed consent to participate
Phase III
Exclusion Criteria:
- Aged 39 and under
- Comorbidities such as rheumatoid arthritis, gout, osteoporosis
- History of injury, trauma or surgery to the lower limb.
Male
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Knee Osteoarthritis Risk in Retired Professional Footballers | NCT02098044 | Contradiction |
3,823 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Patients with osteoarthritis of the hip or knee who use current approved medication
(nonsteroidal anti-inflammatory drugs (NSAIDs)) or tylenol to treat the symptoms of
their osteoarthritis. Patients taking NSAIDs are required to discontinue using these
drugs and their symptoms must become worse.
Exclusion Criteria:
- Patients with certain medical conditions may not be allowed to participate. These
conditions will be reviewed with the study physician.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| An Investigational Drug in Patients With Osteoarthritis (0663-073) | NCT00092755 | Entailment |
1,388 | 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:
- Clinical diagnosis of Hirschsprung Disease
Exclusion Criteria:
- with other disease
- receive emergency surgery
- need to do the ostomy
- full colonic Hirschsprung Disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 14 Years | Enhanced Recovery After Surgery In Hirschsprung Disease | NCT02776176 | Entailment |
2,091 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Diagnosis of IPF
- Ability ot provide informed consent
Exclusion Criteria:
- History of fundoplication or other gastroesophageal surgery
- Too ill to undergo bronchoscopy in the opinion of the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Microaspiration in Pulmonary Fibrosis | NCT01150591 | Entailment |
1,224 | 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 years
2. Symptomatic pleural effusion requiring intervention
3. Expected survival > 3 months
4. Written informed consent to trial participation
Exclusion Criteria:
1. Females who are pregnant or lactating
2. Inability to obtain consent from the patient or patient's designated representative.
3. Inability of the patient to comply with the protocol.
4. Previously documented adverse reaction to talc or cathflo activase.
5. Oral or intravenous steroid therapy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis | NCT04806373 | Entailment |
2,821 | 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:
- age between 18 and 75 years
- diagnosis of ALS according to revised El Escorial criteria and Awaji-Shima criteria
- disease duration < 24 months
- ALSFRS-R > 30 at the recruitment
- ALSFRS-R decline > 1 in the at least 3-months period before the intervention
- normal respiratory functionality (FVC > 80% and ALSFRS-R items 10,11,12 > 4) at the
recruitment
- treatment with riluzole 50 mg x 2/die
Exclusion Criteria:
- inclusion in other clinical trials
- presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
- contraindications to magnetic fields exposure
- pregnancy or breast-feeding
- history of epilepsy or seizures
- assumption of drugs acting on central nervous system, except for antidepressive drugs
and benzodiazepines.
- cognitive impairment
- lack of 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 75 Years | Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS). | NCT04393467 | Entailment |
6,557 | 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:
- Have given their agreement to take part in the observational registry after being
informed in writing of the purposes of the study and after their data have been
recorded (parent's agreement for minor patients);
- Be suffering from haemophilia A and being treated or having been treated with Afstyla®
long term prophylactically, on demand or preventatively for a surgical procedure;
- Absence of inhibitor and/or treatment for immune tolerance at the time of inclusion
Exclusion Criteria:
- Refusal of the patient or the patient's legal representative to take part in the
study;
- Existence of a contraindication to the use of Afstyla® treatment (known
hypersensitivity to FVIII or hamster proteins);
- Simultaneous participation in an interventional clinical study.
- Presence of an inhibitor and/or ongoing immune tolerance.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Register of Patients With haEmophilia A tReated With Afstyla® | NCT04675541 | Contradiction |
2,954 | 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 over 18 years old
- ALS sporadic or familial or unknown
Exclusion Criteria:
- known cutaneous disease not allowing the biopsy
- platelets less than 10 000/m3
- suspected or known xylocain allergy
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.
| Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study | NCT01639391 | Entailment |
338 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Woman of more than 18 years, presenting vulvo-vaginal symptoms to type(chap) of smell
or abnormal vaginal losses the day of the inclusion and having an imbalance of the
vaginal flora objectivized by:
- The presence of at least 3 clinical criteria of Amsel ( 41 ) is a score of Nugent > 4
( 42 )
- Woman in genital encircled period of activity (negative pregnancy test in the
inclusion) and under effective contraception, including an intra-uterine device
(mechanical, hormonal).
- Woman ménopausée with or without hormonal treatment (by way oral, transcutaneous, sous
cutaneous, vaginal).
- Woman encircled at the time of the inclusion.
- Having Woman was treated(handled) for a vaginal infection or one imbalance of the
vaginal flora more than 7 days ago.
- Woman having understood(included) the progress and the objectives of the study and
having agreed to sign a lit(enlightened) consent.
- Only the profitable women of a national insurance scheme will be included
Exclusion Criteria:
- Woman presenting a sexually transmitted infection (infection with gonococcus, with
Chlamydia trachomatis, with Trichomonas vaginalis) revealing on the takings realized
during the consultation of inclusion but the bacteriological results(profits) of which
will be known only secondarily.
- Pregnant Woman presenting to the consultation of inclusion of métrorragies either a
break of the pocket of waters or an infectious complication of the pregnancy.
- Woman removing her consent during the study.
- Lost sight Woman.
- Woman deprived of freedom, judicial or administrative;
- Woman hospitalized for quite other reason that looks for her(it);
- Woman hospitalized in a sanitary establishment or social in the other purposes that
the research;
- Major Woman except state to express its consent
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy | NCT01287728 | Contradiction |
3,458 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion criteria
1. Diagnosis of type 2 diabetes mellitus.
2. Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or
metformin plus 1 other antidiabetic drug. Metformin must be administered in twice
daily dosing regimen. Patients taking metformin three times daily can be included if
posology is switched to twice daily and total daily dose is maintained.
3. Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
4. Body Mass Index (BMI) </=45 kg/m2.
Exclusion criteria
1. Treatment with extended release metformin.
2. Uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dL or 13.3 mmol/L).
3. Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months
prior to informed consent.
4. Impaired hepatic or renal function, or gastric bypass surgery.
5. Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics,
antiobesity agents, or insulin within 3 months of informed consent.
6. Current treatment with systemic steroids or change in dosage of thyroid hormones.
7. Alcohol or drug abuse within 3 months of informed consent.
8. Participation in another trial with investigational drug within 2 months prior to
informed consent.
9. Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method
of birth control.
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 | Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes | NCT01012037 | Entailment |
5,634 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | - INCLUSION CRITERIA:
- Girls without a chronic medical condition
- Normal weight (BMI 5th-85th%) or overweight/obese (BMI > 85th%)
- 8-14 years old
- Some breast development
- Pre-menarchal
EXCLUSION CRITERIA:
- Treated with medications that may affect reproductive hormones (e.g. birth control
pills).
- Pregnancy
During the study, the PI s discretion may be used to determine final eligibility. The PI s
discretion may be used at any point in the study (pre-screening, clinical/lab assessments,
etc.) to ensure participants are not subjected to unnecessary procedures or visits.
Female
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 14 Years | Investigating the Impact of Obesity on Pubertal Development in Girls | NCT02583646 | Contradiction |
4,178 | 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:
- Subjects ≥ 18 years of age.
- Signature of the written informed consent
Exclusion Criteria:
Subjects will be excluded if they meet at least one of the following conditions:
- Abnormal spirometry defined as FEV1, FEV1/VC and VC below the LLN as established by
the Global Lung function (GLI) 2012 reference equations.
- Smokers or ex-smokers
- BMI >30 kg/cm2
- History of respiratory symptoms using the ECRHS II screening questionnaire
(www.ecrhs.org)
- Wheezing
- Cough
- Phlegm production
- Dyspnea
- Feeling of chest tightness
- Night awakening due to a cough attack
- Have a history of pulmonary or cardiac disease
- Had a recent (e.g., in the last 4 weeks) respiratory tract infection
- Have a neurological or neuromuscular disorder
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects | NCT04140825 | Contradiction |
4,726 | 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:
- Confirmed adenomyosis and/or endometriosis
- Signed an approved informed consents
- Feasible for biopsy
Exclusion Criteria:
- Not meeting all of the inclusion criteria
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Multi-omics Study of Adenomyosis | NCT03742843 | Entailment |
6,562 | 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%. | Eligibility criteria for person with congenital bleeding disorder(PWCBD, men with
congenital hemophilia):
- Known diagnosis of congenital hemophilia A or B with or without inhibitor (defined by
a plasma factor VIII or factor IX level below lower limits of normal and medical
history consistent with diagnosis).
- Male age 21 years or older
- Willing to indicate if they have a spouse or significant other.
- Able to read, write and participate in interview on site.
Exclusion Criteria for PWCBD:
- Other bleeding disorder besides congenital hemophilia A or B
Eligibility criteria for spouses/significant other (SSO) participants in the study:
- A person in a relationship for a minimum of 9 months with the PWCBD participating in
the study.
- PWCBD partner must be participating in the study.
- Willing to participate in questionnaire and interview on site.
Exclusion criteria for SSO:
- Biologically related to PWCBD participant (that is, not a parent, sibling, child or other
biologically-related caregiver).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Socialization of Adult Men With Congenital Hemophilia A or B | NCT01510418 | Contradiction |
605 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Patients with unexplained RPL.
- Patients with abnormal immunological profile, including ANA, RF, anti-DNA,
antilymphocyte, anticardiolipin, antithyroid and lupus anticoagulant antibodies that
have no other clinical manifestation.
- Women with three or more pregnancy losses (before 24 weeks of gestation) who referred
to the RPL clinic in Soroka hospital.
- An age above 25 years.
- The women agreed to participate in the study and signed on a consent form.
- women with index pregnancy.
Exclusion Criteria:
- Presence of any genetic impairment, Mullerian anomaly, endocrine or metabolic
disorders, or a luteal-phase defect (as determined by a timed endometrial biopsy).
- Diabetes mellitus diagnosed by symptoms of diabetes plus random glucose concentration≥
200mg/dL or fasting plasma glucose≥ 126mg/dL or hemoglobin A1C≥5.8% or 2-h plasma
glucose≥ 200mg/dL during an oral glucose tolerance test.
- Previously untreated tuberculosis, as determined by an abnormal chest film in the
previous year or a positive tuberculin skin test.
- Prednisone therapy during pregnancy for other reasons.
- Sensitivity to prednisone.
Female
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 40 Years | Low Dose Prednisone Therapy in Women With Recurrent Pregnancy Loss | NCT04558268 | Entailment |
6,115 | 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:
- Healthy persons aged ≥ 18, and able to give informed consent
- Patient is admitted to hospital
- Primary reason for hospital admission is clinical suspicion of a new episode of ARI
- Onset of the following symptoms within the last 7 days: i. Sudden onset of
self-reported fever OR temperature of ≥ 38°C at presentation AND ii. At least one
respiratory symptom (cough, sore throat, runny or congested nose, dyspnoea) AND iii.
At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness).
Exclusion Criteria:
- Patient lacks capacity to provide informed consent
- Patient has been transferred from another hospital
- Patient has been previously enrolled in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19) | NCT04664075 | Contradiction |
444 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women with PCOS aged 20-30 years and 40-49 years. Subject is considered to have PCOS
if she has current or verifiable history of: a) clinical and/or biochemical evidence
of hyperandrogenism plus b) oligomenorrhea (average menstrual cycle length >45 days or
fewer than 9 menses/year) or irregular menstruation (substantially inconsistent
menstrual cycle length). Note: For subjects aged 40-49 years, they will be allowed to
participate if they have fewer than 10 menses/year (average menstrual cycle length >35
days) as long as they have a compelling past history of oligomenorrhea or irregular
menstruation.
- Screening safety labs within normal reference ranges although mild abnormalities that
are common in obesity and/or hyperandrogenism will not be grounds for exclusion (see
exclusion criteria).
- Subjects must be willing and able to provide written informed consent.
- Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time
of the study
- Willingness and ability to comply with scheduled visits and study procedures
Exclusion Criteria:
- Postmenopausal status (i.e., absence of periods for previous year plus elevated
follicle stimulating hormone [FSH] level)
- Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone <0.5
ng/mL. As an alternative, cycle day 3 FSH > 9 IU/L (with concomitant estradiol level
>80 pg/mL), if this testing is available, will serve as evidence of perimenopause
status. NOTE: If FSH >9 IU/L on screening (but it is not cycle day 3), FSH and
estradiol will be repeated on cycle day 3.
- History of hysterectomy and/or bilateral oophorectomy
- BMI ≥ 40 kg/m2
- Inability to comprehend what will be done during the study or why it will be done.
- Being a study of older women with PCOS, children and men will be excluded.
- Pregnancy or lactation within the past 6 months. Subjects with a positive pregnancy
test will be informed of the result by the screening physician.
- Prisoners.
- History of (or clinical evidence for) Cushing's syndrome or adrenal insufficiency.
- History of congenital adrenal hyperplasia or 17-hydroxyprogesterone (17-OHP) >200
ng/dL, which suggest the possibility of congenital adrenal hyperplasia. 17-OHP will be
collected during follicular phase. NOTE: if a 17-OHP >200 ng/dL and is confirmed on
repeat testing, an ACTH-stimulated 17-OHP <1000 ng/dL will be required for study
participation.
- Total testosterone >150 ng/dL, which suggests the possibility of virilizing neoplasm.
- DHEA-S greater than 1.5 times the upper limit of normal range (mild elevations may be
seen in PCOS, so elevations < 1.5 times the upper limit of normal will be accepted in
these groups).
- Virilization
- Diagnosis of diabetes mellitus (DM), fasting glucose ≥ 126 mg/dL, or a hemoglobin A1c
of ≥ 6.5%.
- Abnormal thyroid stimulating hormone (TSH). Subjects with stable and
adequately-treated hypothyroidism, reflected by normal TSH values, will not be
excluded.
- Moderate to severe hyperprolactinemia. Mild prolactin elevations may be seen in PCOS,
and elevations < 1.5 times the upper limit of normal will be accepted in this group.
- Persistent liver abnormalities, with the exception that mild bilirubin elevations will
be accepted in the setting of known Gilbert's syndrome. Mild transaminase elevations
may be seen in women with obesity, so elevations <1.5 times the upper limit of normal
will be accepted in this group.
- Hemoglobin level is less than 11 g/dL.
- Persistent hematocrit <36% and hemoglobin <12 g/dL.
- Subjects who remain anemic after two sequential months of ferrous gluconate (325 mg
twice daily) will be excluded from study participation.
- Abnormal sodium, potassium, or bicarbonate concentrations or elevated creatinine
concentration.
- Significant history of pulmonary dysfunction (e.g., asthma or COPD requiring
intermittent systemic corticosteroid, pulmonary hypertension, etc.).
- History of known or suspected congestive heart failure.
- History of known or suspected ischemic heart disease or cerebrovascular disease.
- History of moderate to severe hypertriglyceridemia (triglyceride level > 500 mg/dL).
Subjects with stable and adequately treated hypertriglyceridemia reflected by normal
triglyceride values will not be excluded.
- History of breast, ovarian, or endometrial cancer.
- The cut off threshold for estimated dominant ovarian cyst size on the day of r-hCG
injection will be 18 mm. Since the ultrasound will be assessed 3-4 days prior to r-hCG
administration, we will estimate the size of the dominant follicle (at the time of
r-hCG administration) using the typical rate of ovarian follicle growth of 1.4 mm per
day. If the dominant follicle size exceeds the cut off threshold, the subject will be
asked to repeat the transvaginal ultrasound: if menses begin within 3 weeks of the
prior ultrasound, the ultrasound would be repeated during the new menstrual cycle. If
menses do not occur within 3 weeks of the prior ultrasound, the ultrasound will then
be scheduled at the subject's earliest convenience.
- Ovarian enlargement, defined by ovarian volume greater than 15 mm on transvaginal
ultrasound. If the ovarian volume exceeds the cut off threshold, the participant will
be given an option to repeat the transvaginal ultrasound in 2-3 months.
- History of venous thromboembolism (e.g. deep venous thrombosis (DVT), pulmonary
embolism (PE)).
- History of blood clotting disorders (e.g., protein C, protein S, positive
antiphospholipid antibodies).
- First-degree relative history of blood clotting disorder, unless the same disorder has
been formally excluded for the study subject. Note: any abnormal labs may be repeated
to exclude a lab error.
- No medications known to affect the reproductive system can be taken in the 2 months
prior to screening and 3 months prior to the study. Such medications include oral
contraceptive pills, metformin, progestins, glucocorticoids, anti-psychotics and/or
mood stabilizers that are known to cause hormone abnormalities.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 49 Years | Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS | NCT03905603 | Contradiction |
936 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Patients > 18 years with diagnosis of OA or RA according to the criteria of the
American College of Rheumatology (ACR).
Exclusion Criteria:
- Patients with precedents of fractures; carrying patients of chronic diseases who limit
them in the functional capacity.
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.
| Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR) | NCT02124031 | Entailment |
5,772 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
1. Clinically and histopathologically proven cases of erosive and atrophic OLP.
2. Patients who are willing to participate in the study.
Exclusion Criteria:
1. Patients with reticular form of OLP and OLP with muco-cutaneous involvement.
2. Patients consuming drugs for the treatment of OLP in the past 6 months.
3. Suspected lichenoid reaction associated with drugs and restorations.
4. Patients whose histopathological findings indicate moderate to severe dysplasia.
5. Patients with acquired and congenital immuno-deficiency disorders like AIDS,
chemotherapy, addiction to injectable opioids like hemophilia and blood dialysis.
These patients are excluded because of difficulty in their biopsy procedure, control
of infection, possible interaction with clinical findings of OLP, and their potential
doubtful cooperation.
6. Patients with systemic diseases involving the gastro-intestinal tract.
7. Known cases of Acrodermatitis enteropathica where difficulty in zinc absorption
persists.
8. Presence of factors that can alter the absorption of zinc like consumption of calcium
tablets, iron supplements and high protein diet.
9. Pregnancy and lactation phase
10. Alcoholic patients, since alcoholism results in intracellular zinc deficiency.
11. Recorded allergy to zinc and/or corticosteroids.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients | NCT04278599 | Contradiction |
528 | 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 for women:
- Age 18-50 years old
- Regular menses
- HIV-1 seronegative at screening
- Normal Pap smear at screening or documented normal Pap smear within six months prior
to screening
- No evidence of reproductive tract infection (RTI)
- Willing and able to comply with study procedures, including pelvic exams, colposcopy,
maintaining a study coital and symptom log, and applying assigned study gel per
protocol
- Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit
- Agree to abstain from the following activities from at least 48 hours prior to
enrollment through the Day 14 visit:
- Insertion of fingers and other objects into the vagina
- Receiving oral sex
- Receiving anal sex
- Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
- Using vaginal products other than the study gels, including douches, lubricants,
or feminine hygiene products
- In a monogamous sexually active relationship with one male partner
- Report having vaginal intercourse only with that partner at least two times per week
- No other reported partner in the prior six months and no plan to have another partner
for the duration of the study
- Agree to use condoms for each act of vaginal intercourse during participation in the
study
- Their male partner is informed and also consents to participate in the study
- Willing to have male partner informed and treated if an STD is diagnosed at screening
or during the study
Inclusion Criteria for men:
- Age 18 years or older
- HIV-seronegative and free of other STI at screening exam
- One female sexual partner; no other reported partner in the prior six months and no
plan to have another partner for the duration of the study
- Willing and able to comply with study procedures, including clinic visits, interviews
and acceptability evaluation, and consistent use of condoms during enrollment in the
study
- Willing to have female partner informed and treated if an STD is diagnosed at
screening or during the study
Exclusion Criteria for women:
- Pregnancy or desire to become pregnant at time of study participation
- Currently breastfeeding
- Delivery or abortion within last eight weeks
- History of any male sexual partner other than current partner in past six months
- No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including
hematology, liver and kidney function
- History of post-coital vaginal bleeding in the past three months
- History of surgery to remove uterus or cervix
- History of surgery on the external genitalia, vaginal, or cervix in the past month
- Clinically significant chronic medical condition that is considered progressive,
including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.
- History of sensitivity/allergy to latex
- Existence of a clinically detectable genital abnormality at screening (e.g. ulcer,
congenital abnormality, any lesion with mucosal disruption)
- Concurrent participation in another trial of a vaginal product
- Have any other condition that in the opinion of the investigator might interfere with
the evaluation of the study objectives
Exclusion Criteria for men:
- History of genital surgery in the past month
- Clinical or laboratory evidence of an STI.
- History of sensitivity/allergy to latex
- History of any sexual partner other than their current partner in the past six months
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Safety Study of UC-781 Vaginal Microbicide | NCT00446979 | Contradiction |
2,306 | 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:
- Ages 2-17 years old with a confirmed diagnosis of DMD. Has an appointment in MDA
clinic at the Ann & Robert H. Lurie Children's Hospital of Chicago.
Exclusion Criteria:
- Is less than two years old and does not have a confirmed diagnosis of DMD.
Male
Subject must be at least 2 Years old.
Subject must be at most 17 Years | Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD) | NCT03319030 | Entailment |
4,572 | 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
- Regular menstrual cycles (23 -35 days cycle length)
- No systemic or intrauterine steroid hormone use
Exclusion Criteria:
- Psychiatric disorder (DSM IV Axis I or WHO ICD-10 diagnostic classification).
- Prior or present neurological or other severe medical condition including substance
abuse.
- No drug intake suspected to influence results
- Conditions that may increase risk by participating in the study program including
ovarian cysts
- Pregnancy during the last year
- Delivery during the last 2 years
- Presently wishing to obtain pregnancy
- Breast feeding
- Not fluent in Danish or severe visual or hearing impairments
- Earlier or present learning disabilities
- Claustrophobia (due to MRI scans)
- Metal implants (excludes MRI)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Neuropsychobiological Correlates of Sex-steroid Hormone Manipulation in Healthy Women: a Risk Model for Depression | NCT02661789 | Contradiction |
5,318 | 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:
1. Pregnant females >= 18 years of age
2. Confirmed VWD, as defined by VWF:RCo < 0.50 IU/dL and previous history of bleeding
3. Willingness to have blood drawn
4. Willing to be randomized to one of two treatments at delivery and for 2 days
postpartum.
5. Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment
chart (PBAC) and any blood products, transfusion, or medications taken.
6. Willing to return at 21 days for final blood draw and review of diary.
Exclusion Criteria:
1. Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding
disorders.
2. Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension,
MI, or stroke.
3. Platelet count < 100,000/ ul.
4. Past allergic reaction to VWF or tranexamic acid.
5. Surgery within the past 8 weeks.
6. Inability to comply with study protocol requirements.
7. Concomitant use of antiplatelet drugs, anticoagulants, aspirin or NSAIDs.
8. Treatment with DDAVP, cryoprecipitate, whole blood, plasma or plasma derivatives
containing substantial quantities of VWF within 5 days of study.
9. History of renal disease.
10. Inability to comply with study requirements.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial | NCT04344860 | Contradiction |
1,654 | 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:
- Males and Females who meet the inclusion/exclusion criteria; females must not be
pregnant or nursing, and must agree to use a double-barrier method of birth control
(condoms or diaphragm, plus spermicide) throughout the trial (alone or in addition to
other methods of birth control such as oral contraceptives)
- Age ≥18 and <60 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Ability to give signed and dated written informed consent prior to admission to the
study in accordance with good clinical practice (GCP) and the local regulations
Exclusion Criteria:
- Current (symptomatic within the last 30 days) and medically relevant gastrointestinal,
hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal
disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Currently active (symptomatic within the last 30 days) diseases of the central nervous
system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant
to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within one month prior to
administration of study drug or during the trial (review with clinical monitor if
questionable)
- Use of drugs within 10 days prior to administration or during the trial, which might
reasonably influence the results of the trial based on the knowledge at the time of
protocol preparation (review with clinical monitor if questionable)
- Participation in another trial with an investigational drug within one month prior to
administration or during the trial
- Current smoker
- Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit
prescription or non-prescription drugs or drugs of abuse)
- Recent blood donation (more than 100 mL within 4 weeks prior to administration or
during the trial)
- Excessive physical activities (within 1 week prior to study drug administration or
during the trial)
- Any laboratory value outside the normal reference range that is of clinical relevance
at screening, according to the judgment of the investigator
- Inability to comply with dietary regimen required by the protocol
- Chronic or relevant acute infections
- Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B
surface antigen, or hepatitis C antibody positive)
- HIV-1 infected as defined by a positive HIV ELISA test
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 59 Years | Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir in Healthy Volunteers | NCT02253901 | Entailment |
1,004 | 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:
- Diagnosis of primary knee osteoarthritis, based upon the following:
- X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint
space narrowing and osteophyte formation
- Patients will be Kellgren and Lawrence classification II/III, and total Western
Ontario McMaster (WOMAC) score 24 -72.
- Patients fulfilling the American College of Rheumatology Clinical and Radiographic
criteria for Osteoarthritis.
Exclusion criteria:
- Patients younger than 40 years
- Women of child bearing potential.
- Women either sterilized for more than 3 months, or post-menopausal for more than 12
months. Menopause is defined as over age of 60 years or being amenorrheic for at least
2 years with plasma FSH level >30 IU/L.
- Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic
osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease,
Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium
pyrophosphate deposition disease, or neuropathic arthropathy.
- Presence of local skin abnormality at the affected knee joint.
- Intra-articular injection within 3 months.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I | NCT01463488 | Entailment |
2,885 | 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:
- Diagnosis of definite or possible ALS by the El Escorial Criteria
- No previously known gastrointestinal problems
Exclusion Criteria:
- Patients or controls who have evidence of previous gastrointestinal disease
- Patients unable to give informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 85 Years | Quantitative Measurement of Nutritional Substrate Utilization in Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT00714220 | Entailment |
667 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- All adult patients (age 19 or greater) with hereditary anemias requiring chronic blood
transfusion at St. Paul's Hospital will be invited to participate in this study. The
majority of patients will be β-Thalassemia Major.
Exclusion Criteria:
- Known Hepatitis B positive
- Known Hepatitis C positive
- Known HIV positive
- Known liver cirrhosis
- Known primary liver disease such as Wilson's disease and hereditary hemochromatosis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Utility of Fibroscan in Estimating Hepatic Iron Concentration | NCT02067130 | Contradiction |
373 | 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. | - ELIGIBILITY CRITERIA:
- Females, age 15-44.
- Since bacterial vaginosis is primarily a condition of reproductive-age women, this
study will be restricted to women regarded by demographers as reproductive age.
- Non-pregnant women whose last menstrual period is later than expected will undergo a
urine pregnancy test. Women who become pregnant while on study will complete their
next regularly scheduled study visit, following which their participation will
terminate.
EXCLUSION CRITERIA:
1. Immunocompromised status
Receiving or expected to receive in the next 12 months cytotoxic or immunosuppressive
drugs.
Receiving or expected to receive in the next 12 months one or more 30-day courses of
corticosteroids.
Congenital or acquired immune deficiency; known HIV positivity.
2. Primary or secondary affective disorder, psychosis, emotional or intellectual
limitations that preclude informed consent.
3. Non-fluency in English.
4. Post-menopausal (natural or surgical).
5. Status post hysterectomy or expected to undergo hysterectomy in the next 12 months.
6. Status post pelvic radiotherapy, or expected to undergo pelvic radiotherapy in the
next 12 months.
7. Receiving or expected to receive chronic (daily for at least 30 days) antibiotics in
the next 12 months.
8. Planning to move out of the area in the next 12 months.
9. Participating or expected to participate during the next 12 months in a clinical trial
in which antibiotics or topical microbicides will be administered in a blinded manner.
10. Women who unexpectedly develop one of these conditions during their participation will
continue to be followed, unless a specific contraindication arises.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 44 Years | Longitudinal Study of Vaginal Flora | NCT00340275 | Contradiction |
1,180 | 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:
- recurrent symptomatic malignant pleural effusion, with subjective improvement of
dyspnea following thoracentesis
Exclusion Criteria:
- history of any allergy to iodine or doxycycline
- history of thyroid disorders
- failure of lung expansion after insertion of intercostal tube (trapped lung)
- presence of air leaks
- advanced malignancy with limited predicted life expectancy (<30 days)
- failure to provide informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | A Study to Compare the Efficacy and Safety of Intrapleural Doxycycline Versus Iodopovidone for Performing Pleurodesis in Malignant Pleural Effusion | NCT02583282 | Entailment |
1,018 | 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:
- Men/Women aged over 20
- Subjects who are diagnosed with one- or both-sided knee osteoarthritis according to
the standards of clinical diagnosis from American College of Rheumatology(ACR)have
knee osteoarthritis pain and meet over three of the following conditions.
1. Older than 50
2. Morning stiffness for less than 30 minutes
3. Crepitus on active motion
4. Bony tenderness
5. Bony enlargement
6. Not have heat-generating site
- Subjects who are diagnosed with degenerative osteoarthritis and have its pain at least
for over 3 months before the screening visit.
- Subjects who are uncontrolled with pain after administration of Celecoxib at least for
over 2 weeks before the randomization and have more than 40mm out of 100mm VAS at
randomization.
- Subjects who voluntarily agree to participate in this clinical trial in writing.
Exclusion Criteria:
- Subjects with rheumatoid arthritis or inflammatory, infectiousand metabolic arthritis.
- Subjects with ochronosis, hemochromatosis, secondary knee osteoarthritis by systemic
disease.
- Subjects who have severe pain such as Sudek's atrophy, Paget's disease and spinal disc
herniation.
- Subjects with poly-articular affected by severe pain of knee osteoarthritis.
- Subjects who take psychtrophic medicine and narcotic analgesics for over 3 months that
might affect on pain sensory system.
- Subjects who had Tramadol but there was no improvement in pain.
- Subjects who got the follwing treatment and medicine before the screening;
1. Subjects who had surgery on knee ligaments within a year, cartilage transplant
and scarf osteotomy.
2. Subjects who had arthroscopy within 6 months.
3. Subjects with intra-articular knee joint steroid injection within 3 months.
4. Subjects with HA injection in knee joint within 2 months.
5. Subjects with systemic steroid injection within a month(but inhaled steroids)
6. Subjects with knee replacement surgery.
- Subjects who hot the following treatment and medicine before the randomization;
1. Subjects who had Celecoxib, acetaminophen or steroidal/non-steroidal
anti-inflammatory drugs except low dose aspirin(before 300mg/day) But,
acetaminophen and low dose aspirin (before 300mg/day) are prohibited within 24
hours)
2. Nutritional supplements, physical therapy and Korean herbal medicine for knee
osteoarthritis and it pain within 2 weeks.
- Subjects who have to take anticoagulant drugs such as warfarin and coumarin during
this clinical trial.
- Subjects who took MAO inhibitors within 14 days before the screening or needed to take
these drugs during this clinical trials.
- Subjects with drug and opioid hypersensitivity and who have history.
- Subjects with sulfanilamide allergy and who have history.
- Subjects with asthmma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic
reaction to aspirin or any oher NSAIDs(incluing COX-2 inhibitors)
- Subjects with significant investigations - Hyperkalemia(Exceeded 5.5mmol/L)
- Subjects with severe liver dysfunction (ALT or AST of more than 3.0 times the upper
limit of ULN and 1.5 tmines the upper limit of ULN)
- Subjects with severe renal impairment (Serum Creatine > 3x ULN).
- Subjects with active peptic ulcer and gastrointestinal bleeding.
- Severe blood disease (Agranulocytosis, aplastic anemia, hemolytic anemia,
Thrombocytopenia, etc.).
- Subjects with Crohn's disease or inflammatory bowel disease such as ulcerative clitis.
- Subjects with congestive heart failure(NYHA 2-4)
- Subjects with severe ischaemic heart disease, peripheral artery disease and/or
cerebrovascular disease.
- Subjects with genetic problesa such as galactose intolerance), lapp lactase deficiency
or glucose-galactose malabsorption).
- Subjects with acute alcohol intoxification.
- Subjects who are addicted with took central nervous system drugs such as painkillers,
sleeping pills, anti-anxiety medications, etc.
- Subjects with severe bronchopulmonary dysplasia.
- Subjects with head injury history of brain structure lesions which may be in danger of
mental confusion.
- Subjects with epilepsy who are treated properly.
- Subjects who use Tramadol to cure for narcotic withdrawal.
- Subjects who took other clinical drugs more than once within 30 days before the
clinical trial.
- Subjects suspected to be pregnant who don't agree with the clinical method which is
permitted medically during clinical trial(Method of hormone contraception,
IUD(Intrauterine device) or IUS(Intrauterine system)), tubal ligation, bilateral tubal
ligation(condom, Diaphragm, etc).
- Pregnant woman and breastfeeding woman.
- Subjects who can increase risk due to clinical test and administraion of drugs or have
severe grade / chronic medical, mental condition or abnormal laboratory result that
may interfere with the analysis of thest results.
- Any other ineligible condition at the direction of investigator that would be
ineligible to participate 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 20 Years old.
| Clinical Trial of YYC301 for Treatment of Osteoarthritis of the Knee | NCT03850587 | Entailment |
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