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944 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Male or female patient, older than 40 years of age, with knee osteoarthritis, based on
clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:
1. Pain on movement of the affected knee for more than 15 days in the previous month
with at least partial relief at rest;
2. Presence of osteophytes at least 1 mm in radiological imaging;
- Knee osteoarthritis symptoms for at least six months prior to randomization.
Exclusion Criteria:
- Concomitant arthropathy that may confuse or interfere with assessing the efficacy or
pain;
- Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the
absence of radiological findings already described;
- History of significant injury on collateral ligament, or anterior cruciate, or
meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;
- Arthroscopy of the affected knee in last 6 months;
- Serum creatinine ≥ 1.8 mg/dL;
- Diagnosis of diabetes mellitus;
- Presence of any serious disease that could compromise the study, at the investigator
discretion;
- History of adverse event or allergy to acetaminophen, glucosamine sulfate or
chondroitin sulfate;
- Inability to understand and report the study questionnaire and the Visual Analogic
Scale;
- Inability to understand and consent to participate in this clinical study, expressed
by signing the Informed Consent (IC);
- Woman in pregnancy.
- If female of childbearing potential, has a negative urine pregnancy test at Visit 0
and do not use, or do not agree to use, for the duration of the study, a medically
acceptable form of contraception as determined by the investigator;
- Alcohol intake ( > 3 doses/day);
- Oral or intramuscular corticosteroids four weeks prior to study entry;
- Intra-articular injections with corticosteroids, into the studied knee, within the
past three months;
- Intra-articular injections in any other joint within the past four weeks;
- NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less,
once daily) is allowed for cardio-protective benefit;
- Intra-articular injections of hyaluronic acid within the past 12 months;
- Use of topical analgesic in the joint studied or any other oral analgesic (with the
exception of acetaminophen and other NSAID) two weeks prior to randomization;
- Implementation of any other medical treatment for osteoarthritis one month prior to
study entry;
- Participation in last one year of clinical protocols, unless it can be direct benefit
to patient;
- Use of glucosamine and/or chondroitin sulfate three and six months prior the study
entry, respectively;
- Initiation of physical therapy two months prior to the study period;
- Use of tetracycline and oral anticoagulants;
- Use of vitamin D in doses in doses above the recommended;
- Patients in alternative therapies;
- Allergy to sulfonamides;
- Presence of psychiatric disorders that could compromise 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 40 Years old.
| Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis | NCT02010918 | Entailment |
3,576 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- solitary erythema migrans in patients > 15 years
Exclusion Criteria:
- a history of Lyme borreliosis in the past
- pregnancy or lactation
- immunocompromised status
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Duration of Antibiotic Treatment of Erythema Migrans | NCT00910715 | Entailment |
3,915 | 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:
- History of osteoarthritis (OA) of the knee joint and meeting American College of
Rheumatology (ACR) Clinical and Radiographic criteria,
- Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing
pain as per the protocol requirements.
- Willing to washout of analgesics and to follow treatment plan, visit schedules and
study procedures.
Exclusion Criteria:
- Diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than
osteoarthritis involving the study joint, or other painful syndrome that could
interfere with the assessment of pain at the study joint
- Any cardiac, respiratory, neurological, psychiatric disorder or any other medical
condition or illness that is not well controlled with treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee | NCT01444365 | Entailment |
1,434 | 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:
- Age: 40 to 70 years old.
- Untreated patients or those on monotherapy of antihypertensive drugs but with
uncontrolled blood pressure in the ranges of 140-160/90-100 mmHg.
- Patients on antihypertensive medication should discontinue their antihypertensive
treatment for at least 4 weeks. During the 4 weeks run-in period, all patients should
have 2 clinic visits. At each visit, blood pressure will be measured 3 times
consecutively. The average of these 6 readings from 2 clinic visits should be in the
range of 140-180 systolic or 90-110 diastolic mm Hg. 24-h mean blood pressure should
be equal to or higher than 130 mm Hg systolic and 80 mm Hg diastolic.
- The patients should sign the consent form prior to the participation in the trial,
adhere to the study design, and can visit the outpatient clinic on his/her own.
Exclusion Criteria:
- With life-threatening disease.
- With myocardial infarction or stroke in the last 2 years.
- With contraindications to a dihydropyridine calcium channel blocker.
- Current participation in another trial or trials.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Amlodipine Prevents Morning Blood Pressure Surge Study | NCT01030081 | Contradiction |
5,458 | 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. Regularly menstruating women before CIUD insertion.
2. Age between 18 and 35 years.
3. Hormonal treatment has not been taken at least two months before the study.
4. Non steroidal anti-inflammatory drugs has not been taken 24 hours before the
examination.
Exclusion Criteria:
1. Pregnancy.
2. The presence of pelvic pathology as ovarian cysts, pelvic endometriosis, endometrial
polyps or fibrosis.
3. Present or past history of pelvic inflammatory disease.
4. Patients on hormonal treatment in the last two months before the study.
5. Patients on non steroidal anti-inflammatory drugs last 24 hours before the
examination.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Study About Patients Using Copper Intrauterine Device | NCT01541241 | Entailment |
3,503 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Know history of pituitary or adrenal disease. Current or recent use of glucocorticoids,
and use of oral estrogen, 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 65 Years | Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers | NCT03752190 | Contradiction |
3,421 | 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. Subject is informed and has been given ample time and opportunity to think about
his/her participation and has given his/her written informed consent
2. Subject is ≥18 years of age
3. Subject's health status: individual is considered to be healthy (hypertension and
hypotension is permissible. Other stable diseases at the time of testing are also
permissible)
4. Subject is capable of undergoing controlled hypoxaemia to the levels called for the in
the protocol with minimal medical risk (unless only participating in the blood
pressure study).
Exclusion Criteria:
1. Subject cannot expose their face fully for a reading to be taken
2. Subject is unable to give informed consent
3. Subject is outside of the specified age range
4. Subject has already taken part in the study (all 4 sub studies)
5. Subject with significant irregular heart rhythm or any disease that might affect the
results of the study
6. Subject is not capable of undergoing controlled hypoxia and would be placed at undue
medical risk if this occurred
7. Subject has any contraindications identified that would deem them unsuitable to take
part
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application | NCT03998098 | Entailment |
2,171 | 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 patients, age between 18 to 60 years
- With the data of serum uric acid level more than 8.0 mg/dl within 2 weeks before the
initiation of study
- Signed informed consent obtained prior to inclusion into the study
Exclusion Criteria:
- Pregnant women.
- Acute onset of gouty arthritis or renal stone
- Significant liver or renal dysfunction, hematological disease, oncological disease, or
other life threatens disorders.
- Condition that need the management of diuretics or analgesics agent
- Have been administrated by anti-hyperuricemia agent or healthy food with in 4 weeks
before the initiation of study.
- The serum uric acid level could be decrease to lower than 8 mg/dl by diet 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 60 Years | A Clinical Double Blind, Randomized Study of the Efficacy of Hyperuricemia Treatment With Anserine Product. | NCT00208000 | Contradiction |
2,246 | 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:
- Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for
acute arthritis of primary gout;
- Onset of pain from an acute gouty arthritis attack within 48 hours prior to
Screening/Baseline (Visit 1);
- A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's
assessment of pain intensity in the index joint (5-point scale:0-4) at
Screening/Baseline.
Exclusion Criteria:
- Diagnosis of any other type of arthritis including those types suspected of being
infectious in origin in the index joint or presence of any acute trauma of the index
joint. Patients with osteoarthritis will be included as long as it is mild or moderate
(according to investigator's criteria) and it does not affect the index joint;
- Acute polyarticular gout involving greater than 4 joints or chronic gout.
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.
| Celebrex In Acute Gouty Arthritis Study | NCT00549549 | Entailment |
4,715 | 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:
- Volunteer,
- Between the Ages of 18-45,
- Least Primary School Graduate,
- Not Using Drugs That May Affect Cognitive Functions,
- Non-Alcohol Substance Use,
- Patients Without Psychiatric and Neurological Disease.
- Those with regular and predictable menstrual cycles
Exclusion Criteria:
- Those with known psychiatric disease and drugs,
- Those with an important cardiovascular or central nervous system disease,
- Patients with pain syndromes or routinely using opioid,
- Those whose menstrual cycles last less than 21 days and do not have an irregular and
predictable menstrual cycle
- Very urgent patients
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Mü-opioid Receptor Level and Postoperative Pain in Patients With Gynecological Laparoscopy | NCT04690491 | Entailment |
6,554 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion criteria:
1. Male and aged 18 to 80 years old
2. Patients who were enrolled and treated in one of the following clinical trials:
- AGT4HB (EudraCT No 2005-005711-17) - FIX AAV gene therapy trial (Sponsor: St Jude
Children's Research Hospital)
- GO-8 (EudraCT No 2016-000925-38) - FVIII AAV gene therapy trial (Sponsor: UCL)
3. Patients with endogenous FVIII:C/FIX:C expression at >1% after gene transfer that is
stably maintained for >6 months and associated with normal prothrombin (PT) and
thrombin times (TT) as determined in a coagulation assay
Exclusion Criteria:
1. Patients with a platelet count measured at <140 x109/L
2. Any condition that, in the opinion of the investigator or Sponsor would prevent the
patient from fully complying with the requirements of the study and/or would influence
or interfere with evaluation and interpretation of subject safety or efficacy result.
3. Patients with abnormal kidney function (estimated GFR <50ml/min)
4. Patients with a known allergy to iodine-based intravenous contrast agents
5. Patients with a known allergy to local or general anaesthetic
6. Patients with a known reaction to FVIII/FIX concentrate infusions
7. Presence of FVIII or FIX inhibitor (done within 14 weeks of biopsy)
8. Evidence of any bleeding disorder not related to haemophilia A or B
9. Patients unable and unwilling to provide and sign an informed consent.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Liver Biopsy In Haemophilia Gene Therapy | NCT04817462 | Contradiction |
3,502 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Primary adrenal insufficiency under stable glucocorticoid replacement therapy (15-30
mg of Hydrocortisone stable dose the last 3 months) due to autoimmune adrenalitis
(disease diagnosed at least 12 months before inclusion), age 20-60 years, BMI 20-30
kg/m2, and ability to comply with the protocol procedures.
Exclusion Criteria:
- Glucocorticoid replacement therapy for indication other than primary adrenal
treatment, any treatment with sex hormones inclusive contraceptive drugs, treatment
with levothyroxine, diabetes mellitus, renal or liver failure, significant and
symptomatic cardiovascular disease.
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 60 Years | Biomarker(s) for Glucocorticoids | NCT02152553 | Contradiction |
6,187 | 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:
- Ages 18-65, Male or Female
- Normal exercise tolerance without dyspnea or clinically important limitation of
exercise tolerance.
Exclusion Criteria:
- Complicated heart or lung disease
- Pregnancy
- Complex arrhythmias
- Severe Anemia
- Uncontrolled Diabetes, hypertension, or untreated thyroid disease
- Has any of the following symptoms in the last 21 days: sore throat, cough, chills,
body aches for unknown reasons, shortness of breath for unknown reasons, loss of
smell, loss of taste, fever at or greater than 100 degrees Fahrenheit.
- COVID-19 test positive within 21 days.
- Any Disease that the PI feels will markedly increase the risk of CPET testing
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | The Effects of Filter During CPET on WOB and Aerosol Particle Concentrations | NCT04526925 | Contradiction |
6,800 | 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:
- Hemophilia A
- Able and willing to comply with pharmacokinetic testing schedule
- Either overweight or obese BMI using CDC definitions by age
Exclusion Criteria:
- Inhibitor of > 0.6 BU twice in the past, or documented abnormal recovery of less than
66% (of expected) in the past
- Known other bleeding disorder
- Known other prolongation in aPTT (lupus anticoagulant, FXII deficiency)
- Female
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Comparison of Ideal vs. Actual Weight Base Factor Dosing | NCT03286153 | Entailment |
661 | 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:
- Male patients aged from 18 to 70 years
- Hepatic iron overload measured by magnetic resonance imaging [MRI] (> 36 µmol/g and <
200 µmol/L)
- Homozygosity for the C282Y mutation of the HFE or dysmetabolic iron overload syndrome
(DIOS) based on the presence of at least one of these following metabolic
abnormalities:
- Overweight: BMI > 25 kg/m2
- Waist/hip circumference (cm) > 0.90
- Diabetes mellitus (fasting blood glucose level >1.25g/L or blood glucose level after 2
hours > 2g/L) or glucose intolerance (fasting blood glucose level between 1.10 and
1.25g/L)
- Total cholesterolemia > 6.2 mmol/L or HDL-Cholesterol < 0.9 mmol/L
- TG>= 1.7 mmol
- Written informed consent
Non-Inclusion Criteria:
- Consumption of alcohol > 50 g/day and of any CYP2E1 inhibitor substances
- Smoker > 5 cigarets/day
- History of blood donation or venesection
- Other causes of iron overload: aceruloplasminaemia, haematological disorder (abnormal
blood counting), late cutaneous porphyria (cutaneous bullous disorders and
photosensibilisation) , martial treatment, repeated transfusions.
- Inflammatory syndrome (CRP > 3ng/ml)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Cytochrome P450 2E1 and Iron Overload | NCT00138684 | Contradiction |
3,841 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Age 45-75 years old, male or female;
2. Single / bilateral knee pain, duration of more than 6 months;
3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 6 months;
4. NRS ≥ 40mm;
5. Signed informed consent
Exclusion Criteria:
1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint
cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
3. History of arthroscopy within 1 year or intra-articular injection within 4 months;
4. History of receiving acupuncture treatment within 3 months;
5. Severe acute/chronic organic or mental diseases;
6. Pregnant women, pregnant and lactating women;
7. Coagulation disorders (such as hemophilia, etc.);
8. Participation in another clinical study in the past 3 months;
9. With a cardiac pacemaker, metal allergy or needle phobia.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 75 Years | Electro-acupuncture in Knee Osteoarthritis | NCT03359603 | Entailment |
2,288 | 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:
- Age 10-18 years
- Non-ambulatory (primary mode of transportation is via wheelchair for 3 years or less)
- Confirmed DMD diagnosis
- Steroid-naive for the 6 months prior to screening
- Stable dose of b-blocker or ACE inhibitor medication for the 6 months prior to
screening, if taking either of these medications
- Ability to provide reproducible repeat QMT grip score within 15% of first assessment
score
- Has not participated in other therapeutic research protocol within the last 6 months
prior to screening
- Ability to swallow tablets
Exclusion Criteria:
- Failure to achieve one or more of the diagnostic inclusion criteria cited above
- Symptomatic DMD carrier
- Use of carnitine, other amino acids, creatine, glutamine, CoQ10 or any herbal
medicines (this would not include herbal teas unless they are consumed daily with
intended medicinal effect) within the last 3 months
- History of significant concomitant illness or significant impairment of renal or
hepatic function, or other contraindication to steroid therapy
- Positive PPD
- No prior exposure to chickenpox and no immunization against chicken pox
- Baseline serum CoQ10 level of 5.0mg/ml or greater
Male
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 18 Years | CoQ10 and Prednisone in Non-Ambulatory DMD | NCT00308113 | Contradiction |
7,001 | 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 early-onset Alzheimer's disease based on the NIA-AA diagnostic criteria
as determined by the clinician. (Those patients with severe dementia due to
Alzheimer's disease or who have impaired decisional capacity, may participate only if
their legally authorized representative gives their consent.)
- Male and female patients ≥40 and ≤65 years of age.
- Parents and siblings of the participant with Alzheimer's disease.
Exclusion Criteria:
- Family history of early or late-onset Alzheimer's disease.
- Uncontrolled concurrent illness including psychiatric illness or situations that would
limit compliance with the study requirements or the ability to willingly give written
or verbal informed consent
No condition on gender to be admitted to the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years | Early Onset Alzheimer's Disease Genomic Study | NCT03645993 | Entailment |
1,167 | 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:
- To have a diagnosis of lung cancer
- Complete chemotherapy
- Complete radiotherapy
- Coopere,
- Accepts participation in the study will be included in the study
Exclusion Criteria:
- Neurological, cognitive or orthopedic diseases that affect the measurements
- Acute infection
- Individuals with other chronic diseases that may affect their walking will not be
included in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
| Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer Patients | NCT03881046 | Contradiction |
359 | 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) Less than 6mm endometrial thickness before, (2) at least two failed implantations
before
Exclusion Criteria:
- Abnormal uterine cavity in Hysteroscopy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 50 Years | HCG (Human Chorionic Gonadotropin) Priming for Thin Endometrium in IVF (in Vitro Fertilization) | NCT01768247 | Contradiction |
2,846 | 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:
- Definite/probable ALS according to El Escorial criteria
- Aged > 40, < 85 years
- Progression from onset
- Disease duration ≤3 years
- Treatment with Riluzole
Exclusion Criteria:
- Rapid disease progression in the first 6 months after diagnosis
- Patients with tracheostomy and/or Gastrostomy
- Disease duration > 3 years
- Patient with exclusive bulbar or 2° motorneuron involvement
- Hepatic/renal failure
- Pregnant or breastfeeding
- Signs of active neoplasia
- Complicated Diabetes
- Severe hypertension
- Unable to undergo MRI exams
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Growth Hormone in Amyotrophic Lateral Sclerosis | NCT00635960 | Entailment |
3,748 | 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:
- Community-dwelling older adults aged 65 years and above with primary knee OA diagnosed
according to the ACR criteria for diagnosis of primary OA of the knee
Exclusion Criteria:
- Any inflammatory or serious medical condition
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Prednisolone for Pain Reduction in Knee OA | NCT01619163 | Contradiction |
2,140 | 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:
- Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within
the previous 12 months
- Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
- Onset of current acute gouty arthritis flare within 3 days prior to randomization
Exclusion criteria:
- Hemodialysis CKD Stage 5 Organ transplantation
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis
- Live vaccinations within 3 months prior to randomization Other protocol-defined
inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease | NCT01593527 | Contradiction |
396 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women undergoing embryo transfer in either fresh or frozen cycles.
- Women whose endometrial cavity can be visualised adequately via US
Exclusion Criteria:
- Women aged >42 years
- Women whose endometrial cavity cannot be visualised adequately via US, such as large
fibroids, adenomyosis, BMI>35, significant uterine retroflexion/retroversion
Female
No healthy subjects accepted to join the trial.
Subject must be at least 24 Years old.
Subject must be at most 42 Years | Three-dimensional Versus Two-dimensional Ultrasound Guided Embryo Transfer in Women Undergoing ART Treatment | NCT02413697 | Contradiction |
973 | 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:
- Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic
classification
- Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due
to degenerative cartilage
Exclusion Criteria:
- Has systemic bone or cartilage disorders
- Has significant vascular impairment proximal to implant site
- Has substantial joint destabilization including extensive osteophyte formation
- Has substantial surface erosion of the weight-bearing articular cartilage
- Evidence of infection or fractures in or around the joint
- Contraindication to bone marrow aspiration
- Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Any past history of neoplasia and primary hematological disease
- Renal impairment indicated by serum creatinine greater than 200mM
- Liver impairment indicated by serum aspartate transaminase and serum alanine
transaminase greater than 120 IU
- Any other co-morbidity which the physician deems as a contraindication to stem cell
transplantation and bone marrow biopsy
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 | Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis | NCT01459640 | Entailment |
5,408 | 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:
- the patients who had undergone tooth extraction within the previous 3 months
Exclusion Criteria:
- those who required bone augmentation simultaneously with implant insertion, and
patients with any systemic disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Evaluation of the Related Factors Influencing the Stability of Dental Implants | NCT02733861 | Entailment |
4,760 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted.
Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz)
of ≤ 55 dB sensorineural hearing loss.
OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery.
Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤
20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air
Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not
use an AC CROS.
- Adult subjects (18 years or older).
- Previous experience from amplified sound through properly fitted amplification (for
example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device,
Bone conduction hearing device on softband).
- Candidate is a fluent speaker in the language used to assess speech perception
performance.
- Willing and able to provide written informed consent
Exclusion Criteria:
- Uncontrolled diabetes as judged by the investigator.
- Condition that could jeopardise osseointegration and/or wound healing (e.g.
osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that
may have an impact on the outcome of the investigation as judged by the investigator.
- Insufficient bone quality and quantity to support successful implant placement.
- Previous surgery and/or implantation with any bone conduction/active device on the
side to be implanted, which may jeopardise the implantation and use of the Osia 2
system, as judged by the investigator.
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the
investigator.
- Unable to follow investigational procedures, e.g. to complete quality of life scales,
or unwilling to comply with the requirements of the clinical investigation as
determined by the investigator.
- Condition with a likely negative progression and/or with expected relapses
jeopardising general wellbeing and health-related quality of life as judged by the
investigator.
- Subject that has received radiotherapy in the area of implantation or is planned for
such radiotherapy during the study period.
- Investigator site personnel directly affiliated with this study and/or their immediate
families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors
engaged by Cochlear for the purposes of this investigation
- Currently participating, or participated within the last 30 days, in another
interventional clinical investigation involving an investigational drug or device.
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.
| Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System | NCT04041700 | Entailment |
6,769 | 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 with severe or moderately severe hemophilia A (HA) who have since birth been
treated with only a single Factor VIII product (i.e., FVIII protein molecules
containing only one primary amino acid sequence).
Exclusion Criteria:
- HA patients with severities other than severe or moderately severe.
- Hemophilia B patients.
- HA patients who have been treated with more than one FVIII product.
- HA patients who have been treated with more than one FVIII product.
- HA patients who do not have verifiable infusion histories.
- HA patients who lack documentable inhibitor testing & infusion histories.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
| Personalized Prediction of Tolerance and Immunogenicity in Hemophilia | NCT01626105 | Entailment |
1,892 | 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:
- Histological diagnosis of gastric adenocarcinoma;
- Early stage GC without lymph node and distal metastasis;
- Availability of frozen, fresh GC and corresponding surgical margin samples;
- Available of methylation status of gene CpG island in the extracted DNA sample.
Exclusion Criteria:
- GC with lymph node or distal metastasis;
- Quality of the prepared DNA is not good enough for detection of gene methylation;
- GC cases were subjected to the neoadjuvant chemotherapy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| DNA Methylation Biomarkers and Metastasis of Gastric Carcinoma | NCT02159339 | Entailment |
1,387 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Patients from 0 to 16 years ;
- With rectosigmoid Hirschsprung's disease confirmed by rectal biopsies and at surgery;
- Already operated on, whatever the surgical technique was ;
- With a health care insurance;
- Clear information and signed consent form
Exclusion Criteria:
- Long segment Hirschsprung disease ;
- Syndromic Hirschsprung disease ;
- Down syndrome.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 16 Years | MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis | NCT02857205 | Entailment |
6,900 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Willingness to participate, as indicated by written informed consent of the patient.
The competence of the participating patient has to be assessed by a physician who is
not involved in this trial.
2. Male or postmenopausal female outpatients.
3. Age of > 50 years at time of randomization.
4. Diagnosis of probable Alzheimer's Disease (according to NINCDS-ADRDA criteria).
5. Clinical and psychometric rating cut-off score (valid at randomisation): MMSE range of
15 to 26 points.
6. MRI brain scan not older than 12 months (before randomization) compatible with the
diagnosis of Alzheimer's Disease. (The MRI brain scan must be repeated if older than
12 months or if clinically indicated).
7. Patient being ambulatory having adequate vision and hearing abilities to allow
neuropsychological testing.
8. Patient with a knowledgeable, cooperative, reliable caregiver/informant who is willing
to follow the study procedure as indicated by written informed consent.
Exclusion Criteria:
1. Dementia of any other type than AD:
1. vascular dementia
- HIS Score (modified acc. to Rosen) > 5 or
- evidence for VD acc. to NINCDS-AIREN criteria.
2. depressive pseudodementia defined acc. to DSM-IV criteria for major depression.
3. other non-AD dementia.
2. Significant neurological disease other than AD, such as cerebral tumor, Huntington's
disease, Parkinson's disease, normal pressure hydrocephalus, subdural hematoma, mental
retardation, history of brain surgery or serious head trauma with residual deficits.
3. Diagnosis of psychosis (requiring hospitalization or antipsychotic therapy for more
than two weeks) within the past 10 years not associated with AD or a diagnosis of
alcoholism or drug dependence within the past 10 years.
4. History of epileptic seizures or patient receiving antiepileptic drugs.
5. Abnormal laboratory test results considered clinically relevant for dementia: e.g.,
electrolyte changes, folate deficiency, vitamin B12 deficiency, pathological thyroid
function (T3 and TSH levels), positive syphilis serology.
6. Patient who, in the opinion of the investigator, is suffering from an acute or poorly
controlled illness, such as:
1. Presently uncontrolled hypertension (> 180 mmHg systolic or > 100 mmHg
diastolic).
2. Myocardial infarction within the last six months.
3. Patient with uncompensated congestive heart failure (NYHA Class III or IV)
4. Severe renal, hepatic or gastrointestinal disease, which could alter absorption,
metabolism or excretion of the trial drug.
5. Serum creatinine > 130 μmol/l or 1.5 mg/dl, transaminases (ALAT, ASAT) or GGT >
twice the upper limit of normal range.
6. Uncontrolled diabetes on entry into the double-blind phase of the research
project (fasting blood glucose > 10.0 mmol/l or 180 mg/dl in repeated tests) or
patient requiring insulin treatment.
7. Patient taking any inadmissible medication, such as:
- Any investigational drug.
- Anticonvulsants (incl. barbiturates).
- Anti-Parkinson agents.
- Dopaminergic agents.
- Amantadine.
- Antimuscarinic agents (i. e., anticholinergics).
- Selegiline, MAOI.
8. Any condition that precludes cooperation with the tests or other investigations during
the study (e.g., seeing or hearing loss, relevant confusion or agitation,
musculoskeletal disorders, contraindication for magnetic resonance imaging, i.e.,
presence of pacemaker, metallic implants in high risk areas, presence of metallic
material in high risk areas, history of claustrophobia. Hip implants are not
contraindicated).
9. Patient has participated in an investigational clinical trial during the last 2
months.
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.
| The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease | NCT01921972 | Entailment |
2,684 | 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:
- Clinical diagnose of a primary groin hernia that requires surgical intervention.
- Eligible for procedure performed under general anesthesia
Exclusion Criteria:
- Not able to understand Danish, written and spoken.
- Emergency procedures
- Previous inguinal hernia on ipsilateral side.
- ASA score more than 3.
- Incarcerated or irreducible hernia.
- Local (site of surgery) or systemic infection.
- Contralateral hernia being operated at the same time or planned operated during
follow-up.
- Other abdominal hernias being operated at the same time or planned operated during
follow-up.
- Previous surgery that has impaired the sensation in the groin area.
- BMI > 40 or < 20.
- Daily intake of alcohol >5 units, 1 unit = 12g pure alcohol.
- Known disease that impairs central or peripheral nerve function.
- Concurrent malignant disease.
- Impairment of cognitive function (e.g. dementia).
- Chronic pain that requires daily medication.
- Mental disorder that requires medication.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Onstep Versus Lichtenstein, the Onli Trial. | NCT01753219 | Entailment |
1,635 | 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. | General: Age equal to or greater than 18.
Access to a primary medical care provider outside of the NIH.
Able to give informed consent.
No history of malignancy or autoimmune disease such as rheumatoid arthritis, vasculitis,
pyoderma gangrenosum, psoriasis.
No use of systemic corticosteroids within the past month.
No use of local corticosteroids at the proposed blistering site within the past month.
No evidence of current acute infection.
INR less than or equal to 1.5, PTT less than or equal to 40, platelet count greater than or
equal to 100,000/mm(3).
No personal or family history of keloid formation.
Blood glucose less than or equal to 160.
No use of any investigative drugs within the past month.
No allergy to lidocaine.
Healthy volunteers must not have a history of atopic dermatitis, mastocytosis or chronic
urticaria.
Mastocytosis: Histologic evidence of mast cell hyperplasia in at least one organ system.
Atopic Dermatitis: Must have at least 3 major and 3 minor criteria.
No history of mastocytosis.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Cytokine Production Patterns in Patients With Systemic Mastocytosis Compared With Atopic Dermatitis and Healthy Individuals | NCT00001760 | Entailment |
1,741 | 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:
- healthy subjects
- sporadic cigarette smoking (<9 cigarettes per month)
Exclusion Criteria:
- Any form of cardiovascular disease
- Any form of pulmonary disease like asthma or COPD
- Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
- Active allergy within 4 weeks of the study
- Symptoms of infection or inflammation within 4 weeks of the study
- 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 35 Years | Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers | NCT02532894 | Entailment |
2,428 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- (1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic
granuloma and negative staining of fungi and atypical mycobacterium; (2)No
corticosteroids and immunosuppressants were used for nearly 1 months.
Exclusion Criteria:
- 1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ;
(2)with mental disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Clinical Study of Tranilast in the Treatment of Sarcoidosis | NCT03528070 | Contradiction |
208 | 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:
- Low T males 18 - 80 years of age
Exclusion Criteria:
- Normal T levels
- Elevated Prostatic Specific Antigen (PSA)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Testosterone Treatment for Hypogonadal Men | NCT00433199 | Entailment |
5,698 | 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:
- Must be able to donate at least 10 mL of whole blood
- Must be able to provide consent, or parental consent and patient assent (if
applicable)
- Must be currently followed as a patient of a genetic clinic or counselor at one of the
recruiting sites
- Must have at least one chromosomal change that is detectable by the GeneTrait CGH
Microarray System DX as determined by karyotype and/or fluorescence in situ
hybridization (FISH) analysis (within any of the 73 critical regions)
Exclusion Criteria:
- Unable to donate at least 10 mL of whole blood
- Unable to provide consent, or parental consent and patient assent (if applicable)
- Not currently followed as a patient of a genetic clinic or counselor at one of the
recruiting sites
- Does not have at least one chromosomal change that is detectable by the GeneTrait CGH
Microarray System DX as determined by karyotype and/or FISH analysis (within any of
the 73 critical regions)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples | NCT00214448 | Entailment |
3,433 | 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:
- adults 18-50 years of age
- have unilateral or bilateral holes in the eardrums/patent tympanostomy tubes
- otherwise healthy
- ability to read and comprehend English
Exclusion Criteria:
- drainage through either tube or hole in the eardrum
- cold or allergic rhinitis on presentation
- syndrome predisposing to otitis media
- history of ossicular reconstruction
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 50 Years | Gas Supply, Demand and Middle Ear Gas Balance -- Preliminary Protocol | NCT01955486 | Entailment |
5,861 | 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:
- Male and female GERD patients aged 18-70 years with GERD symptoms.
- Prior long-term treatment with PPI with minimum duration of 1 year with expected
future duration of at least 2 more years.
- Controlled on 20-40mg/day maintenance PPI therapy prior to study, defined as GERD
symptom score<18 and score of 70 or more on 1-100 Global Rating Scale at screening (on
medication).
- Increase in GERD symptom score>=15 points at baseline (off omeprazole).
- GERD symptom score>=18 at baseline (off omeprazole).
- Percent acid reflux in 24hr 4% at baseline (off omeprazole).
- Positive Bernstein test at baseline.
- Willingness to adhere to randomized treatment with availability for 3 years of
follow-up.
- Ability to answer self and interviewer-administered questions in English.
- Signed informed consent.
Exclusion Criteria:
- Aperistaltic esophagus.
- Severe cardiac, respiratory, hematologic or other disease constituting an unacceptable
surgical risk in the investigator's opinion.
- Previous gastric, esophageal or anti-reflux surgery.
- History of malignancy within the last year with the exception of basal cell carcinoma.
- Pregnancy or an intention to become pregnant in the following year.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Treatment of Patients With Chronic GERD | NCT00182260 | Contradiction |
1,737 | 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:
- ASA-Status 1
- Complete permanent dentition
- Bitewing radiography already existing (< 4 months)
- Minimum of one cavitation-free approximal surface, symptomless, interproximal enamel
or dentin caries lesion in the posterior teeth without restorations and/or sound tooth
surface.
Exclusion Criteria:
- Children younger than 15 Years
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection | NCT02657538 | Entailment |
4,074 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- Idiopathic REM sleep behavior disorder
Exclusion Criteria:
- REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia,
Parkinson's Disease, etc)
- Other neurological disorder
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.
| North American Prodromal Synucleinopathy Consortium | NCT03623672 | Contradiction |
1,307 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- adult medical or surgical ICU patients who have preexisting central venous
(jugular/subclavian only) catheters.
Exclusion Criteria:
- subjects with only a femoral venous catheter.
- subjects whose CVP measurement by the indwelling catheter exceeds 20cm of water.
- subjects younger than 18 years old.
- inability to obtain informed consent from the subject or the subjects authorized
representative.
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.
| Central Venous Pressure (CVP) Assessment by Ultrasound and Physical Examination | NCT01099241 | Contradiction |
807 | 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. Patients ≥40 and ≤ 80years of age.
2. Patients who meet the American College of Rheumatology clinical plus radiographic
classification criteria for idiopathic osteoarthritis of the knee, which are defined
as follow:
a patient who had knee pain and radiographically diagnosed osteophytes and met at
least one of the followings.
- Age> 50 years.
- Morning stiffness for less than 30 minutes.
- Crepitus during movement of the weight-bearing knee.
3. Patients with symptomatic primary osteoarthritis of the knee at least in the last 3
months prior to screening.
4. Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2
inhibitor for the treatment of arthritis of the knee for at least 5 days a week during
4 weeks prior to screening.
5. Patients who had a score of 100mm pain VAS ≤80 mm at screening.
6. Patients who had a score of 100mm pain VAS ≥50 mm at baseline.
7. Patients should be able and willing to provide the written informed consent.
Exclusion Criteria:
1. Patients with a history of surgery or arthroscopy of the study joint within the
previous 6 months.
2. Patients with trauma of study joint within the previous 12 months.
3. Patients with symptomatic hip osteoarthritis, other condition that would interfere
with study assessments.
4. Patients with any other type of arthritis, active malignancies or any active GI,
cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
5. Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory
drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
6. Patients with uncontrollable hypertension.
7. Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate
aminotransferase > 1.5 times the Upper Lange of normal at screening.
8. Patients with a history of drug or alcohol abuse.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients | NCT01576419 | Entailment |
527 | 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 age < 45years
- BMI < 35 kg/m2
- at least one of good quality embryo in embryo transfer cycle by Istanbul consensus
workshop morphologic grading Day3 : Grade 1-2, Day4 : Grade 1-2 , Day5 : stage of
development grade 2-4
Exclusion Criteria:
- structural intrauterine cavity distortion
- leiomyoma FIGO subclassification 3
- adenomyosis
- recurrent pregnancy loss
- recurrent implantation failure
- urerine relaxant drugs
- difficult embryo transfer
Female
Accepts Healthy Volunteers
Subject must be at most 45 Years | Comparison of Uterine Peristaltic Wave Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles | NCT03587246 | Contradiction |
5,616 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
1. Pre-pubertal child aged ≥ 3 years old, and not yet 10 years for girls (9 years and 364
days) or not yet 11 years for boys (10 years and 364 days), on the date of ICF
signature, with either isolated GHD, or GH insufficiency as part of multiple pituitary
hormone deficiency.
2. Confirmed diagnosis of GHD by 2 different types of GH provocation tests (standardized
on growth foundation data): defined as a peak serum GH level of ≤ 6.0 ng/mL or ≤ 16
ng/mL when conducting GHRP-2 provocation test.
Prior local laboratory results will be accepted subject to pre-approval by the study
medical monitor and if the tests were conducted as specified in the protocol.
3. Bone age (BA) is not older than chronological age and should be less than 10 for girls
and less than 11 for boys.
4. Without prior exposure to any r-hGH therapy.
5. Height SD score ≤ -2.0 at screening
6. Impaired height velocity defined as:
- Annualized height velocity (HV) below the 25th percentile for CA (HV < -0.7 SDS)
and gender according to the local primary care provider standard.
- The interval between two height measurements should be at least 6 months, but
should not exceed 18 months prior to inclusion.
7. BMI must be within ±2 SDS of mean BMI for the chronological age and sex.
8. Baseline IGF-1 level of at least 1 SDS below the mean IGF-1 level standardized for age
and sex (IGF-1 SDS ≤ -1) according to the central laboratory reference values. A
single re-test will be allowed (subject to discussion with the study medical monitor)
if all other criteria are met.
9. Normal creatinine levels according to common practice reference ranges per age.
10. Children with multiple hormonal deficiencies must be on stable replacement therapies
(no change in dose) for other hypothalamo-pituitary organ axes for at least 3 months
prior to ICF signing
11. Normal 46 XX karyotype for girls.
12. Willing and able to provide written informed consent of the parent or legal guardian
of the patient and written assent from pediatric patients (when applicable based on
age and Japan regulation).
Exclusion Criteria:
1. Children with prior history of leukemia, lymphoma, sarcoma or any other forms of
cancer.
2. History of radiation therapy or chemotherapy
3. Malnourished children defined as BMI < -2 SDS for age and sex
4. Children with suspected psychosocial dwarfism by the discretion of the investigator
5. Children born small for gestational age (SGA - birth weight and/or birth length < -2
SDS for gestational age)
6. Presence of anti-hGH antibodies at screening
7. Any clinically significant abnormality likely to affect growth or the ability to
evaluate growth, such as, but not limited to, chronic diseases like renal
insufficiency, spinal cord irradiation, etc.
8. Children with diabetes mellitus
9. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan
syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX (short stature
homeobox) mutations/deletions and skeletal dysplasia's, with the exception of
septo-optic dysplasia.
10. Concomitant administration of other treatments that may have an effect on growth such
as anabolic steroids, sex steroids, with the exception of ADHD drugs or hormone
replacement therapies (thyroxin, hydrocortisone, desmopressin [DDAVP])
11. Children requiring glucocorticoid therapy (e.g. for asthma) that are taking
chronically a dose greater than 400 µg/d of inhaled budesonide or equivalent as
provided in Appendix J.
12. Major medical conditions and/or presence of contraindication to r-hGH treatment.
13. Known or suspected HIV-positive patient, or patient with advanced diseases such as
AIDS or tuberculosis.
14. Drug substance or alcohol abuse.
15. Known hypersensitivity to the components of study medication.
16. Other causes of short stature such as celiac disease, uncontrolled primary
hypothyroidism and rickets.
17. The patient and/or the parent/legal guardian are likely to be non-compliant in respect
to study conduct.
18. Participation in any other clinical trial within 30 days prior to screening and
throughout the entire study period (including administration of investigational
agent).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 11 Years | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | NCT03874013 | Contradiction |
2,552 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
1. Children with a diagnosis of atopic dermatitis that meet Hanifin and Rajka criteria
2. SCORAD ( SCORing Atopic Dermatitis) index 15- 50 at the time of enrollment
Exclusion Criteria:
1. SCORAD (SCORing Atopic Dermatitis) index <15 or >50.
2. Children treated with systemic corticosteroids, methotrexate, or cyclosporine in the
previous 3 months and antibiotics in the previous 2 weeks.
3. Immunocompromised children.
4. Concomitant diagnosis of intolerance to gluten and/ or lactose.
5. Pre-existing hypersensitivity to components contained in the probiotics.
6. Children suffering from chronic infectious diseases.
7. A child with other known systemic diseases (heart, liver or kidney diseases).
8. Known case of short gut syndrome.
9. Refusal of children's parents to participate 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 4 Years old.
Subject must be at most 17 Years | Efficacy of Oral Supplementation of Probiotics in Children With Atopic Dermatitis | NCT04706559 | Entailment |
1,470 | 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:
- Osteoarthritis of the hand, hip, knee or spine
- High blood pressure (<140/ 90 mmHg) which is controlled by antihypertensive
medication(s).
Exclusion criteria
• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or
events
Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
Subject must be at least 50 Years old.
| Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension | NCT00267176 | Entailment |
2,488 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Healthy female subjects of non childbearing potential and male subjects.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 (32 kg/m2 for healthy elderly); and a
total body weight >50 kg (110 lbs) at Screening.
- Evidence of a personally signed and dated informed consent document indicating that
the subject or a legally acceptable representative has been informed of all pertinent
aspects of the study.
- Additional criterion for subjects of Japanese descent who may be enrolled in Part B
(multiple ascending dose cohorts in healthy subjects): Japanese subjects who have four
Japanese grandparents born in Japan.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).
- Male subjects with partners currently pregnant; male subjects able to father children
who are unwilling or unable to use a highly effective method of contraception as
outlined in this protocol for the duration of the study and for at least 28 days after
the last dose of investigational product.
- Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.
- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.
- Any severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and,
in the judgment of the Investigator, would make the subject inappropriate for entry
into this 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 85 Years | Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979. | NCT02793232 | Entailment |
5,485 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria: for the cohort study
1. A clinical suspicion of new diagnosis of GCA e.g. patients with a new onset of
headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue
claudication with or without visual loss.
2. The clinician decides that the patient requires an urgent temporal artery biopsy to
determine whether or not the diagnosis is GCA.
3. The patient agrees and provides NHS consent to undergo a temporal artery biopsy as
part of standard care.
4. Patients have been started on high dose glucocorticoids or will be started on high
dose glucocorticoids.
5. Patients must be willing to attend for an ultrasound scan of their temporal and
axillary arteries.
6. Participants must be willing to give informed written consent or willing to give
permission for a nominated friend or relative to provide written informed assent if
they are unable to do so because of physical disabilities e.g. sudden onset of
blindness/vision loss which can be caused by GCA (this will be made clear in the
ethics approval application).
7. Must be 18 years of age or over.
For the training cases
1. Patients attending hospital outpatient or in patient departments for assessment for
any condition (apart from giant cell arteritis or polymyalgia rheumatica) or healthy
staff volunteers.
2. Above the age of 50 years.
3. Willing to attend for an ultrasound scan of their temporal and axillary arteries.
4. Willing and able to give written informed consent.
Exclusion criteria: for the cohort study
1. Previous diagnosis of GCA.
2. Use of high dose glucocorticoid (>20mg prednisolone/day) for management of current
suspected GCA for more than 7 days prior to the dates of the ultrasound and biopsy.
3. Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions
other than PMR, within three months prior to study entry.
4. Inability to give informed consent (either written consent or verbal assent from a
relative or carer)
5. Inability to undergo an ultrasound scans of the temporal and axillary arteries.
6. Patients with a known cause of headache (not due to GCA), or any condition which would
preclude the need for a temporal artery biopsy.
7. Patients who are unable to undergo an ultrasound scan and a temporal artery biopsy
within 7 days of starting glucocorticoids.
For the training cases
1. Diagnosis of suspected GCA or a previous history of diagnosed or suspected GCA.
2. Inability to give written informed consent.
3. Inability to undergo an ultrasound scans of the temporal and axillary arteries
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Temporal Artery Biopsy vs ULtrasound in Diagnosis of GCA (TABUL) | NCT00974883 | Contradiction |
5,808 | 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:
- All patients over 18 years old
- All non pregnant women
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Comparison of Triamcinolone Acetonide Mucoadhesive Film and Licorice Mucoadhesive Film Effect on Lichen Planus | NCT02453503 | Entailment |
4,675 | 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:
- Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
- American Society of Anesthesiologists (ASA) physical status of patient: classification
I-II
Exclusion Criteria:
- The procedure will be required to conversion to laparotomy.
- Cancer
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Single-port Access Laparoscopic-assisted Vaginal Hysterectomy | NCT01048931 | Entailment |
2,671 | 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 scheduled for laparoscopic primary inguinal hernia repair
- uni- or bilateral patients with recurrent hernias after anterior surgical technique
- written informed consent
Exclusion Criteria:
- general contradictions for laparoscopy
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.
| Stapler Versus Glue for Laparoscopic Groin Hernia Repair | NCT00793286 | Entailment |
2,946 | 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. | Key Inclusion Criteria:
- Diagnosis of clinically possible, clinically probable (with or without laboratory
support), or clinically definite ALS (using the revised El Escorial Criteria)
- Forced vital capacity greater than or equal to 65% of that predicted for age and
height
- Onset of ALS-related weakness less than 3 years prior to first dose of study drug
- Plasma high sensitivity C-reactive protein (hs-CRP) concentration of greater than or
equal to 0.113 mg/dL at pre-screening/screening
- Stable dose (greater than 30 days) of riluzole if undergoing treatment with this agent
- For females: Not be of childbearing potential or agree to use adequate birth control
during the study
Key Exclusion Criteria:
- Life expectancy of less than 6 months
- Tracheotomy or be using ventilatory assistance, including Bi-level Positive Airway
Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)
- Active pulmonary disease
- Gastrostomy
- Stem cell therapy
- Immune modulator therapy or participation in studies of other agents within 12 weeks
of pre-screening/screening
- Unstable medical condition other than ALS
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation | NCT02794857 | Entailment |
2,063 | 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:
Individuals who are 18 years of age or older with any of the following:
1. Idiopathic pulmonary fibrosis [defined by the American Thoracic Society/European
Respiratory Society guidelines],
2. Familial pulmonary fibrosis [defined as idiopathic pulmonary fibrosis in two or more
first-degree relatives],
3. Relatives of patients with hereditary pulmonary fibrosis,
4. Hermansky-Pudlak syndrome (diagnosed by paucity or deficiency of platelet dense bodies
on whole mount electron microscopy or by genetic testing),
5. Pulmonary fibrosis associated with collagen vascular diseases or autoinflammatory
disorders,
6. Pulmonary fibrosis post-COVID-19 [i.e., pulmonary fibrosis in an individual recovering
from SARS-CoV-2 infection], or
7. Healthy research volunteers by history and indicated tests (individuals without
history of chronic pulmonary disorder, collagen vascular disease, or bleeding
disorder).
EXCLUSION CRITERIA:
Individuals with any of the following:
1. Significant inhalational exposure to fibrogenic fibers or dusts or exposure to drugs
associated with pulmonary fibrosis,
2. Uncontrolled ischemic heart disease,
3. Uncorrectable bleeding diathesis,
4. Pregnancy or lactation, or
5. Inability to give informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Analysis of Specimens From Individuals With Pulmonary Fibrosis | NCT00084305 | Entailment |
3,226 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion criteria:
1. Positive diagnosis of Sjogrens syndrome, defined by meeting two or more of the
following three criteria:
- Positive serum anti-SS-A/Ro and/or anti-SS-B/La (or positive rheumatoid factor
and ANA ≥ 1:320)
- Labial salivary gland biopsy exhibiting focal lymphocytic sialadenitis with a
focus score ≥ focus/4 mm2
- Keratoconjunctivitis sicca with ocular staining score ≥ 3 (assuming that
individual is not currently using daily eye drops for glaucoma, and has not had
corneal surgery or cosmetic eyelid surgery in the last 5 years)
Or by both of the following:
Positive antibodies to one of the early markers of Sjogrens Syndrome:
- Anti-salivary gland protein 1 (SP1)
- Anti-carbonic anhydrase 6 (CA6)
- Parotid secretory protein (PSP) Ocular staining score ≥ 3
2. Age ≥ 18 years at time of enrollment
3. Able to provide signed and dated informed consent
4. Women of child childbearing potential in sexual relationships with men must use an
acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks
after completing study treatment.
5. Males must agree to avoid impregnation of women during and for four weeks after
completing study treatment through use of an acceptable method of contraception*.
- Includes, but is not limited to, barrier with additional spermicidal foam or
jelly, intrauterine device, hormonal contraception (started at least 30 days
prior to study enrollment), intercourse with men who underwent vasectomy.
- Includes, but is not limited to, barrier with additional spermicidal foam or
jelly and vasectomy.
Participant exclusion criteria
Exclusion Criteria:
1. Inability to provide informed consent and/or unable or unwilling to comply with
protocol requirements.
2. Antibiotics for at least 2 weeks prior to FMT.
3. Active infection for >15 days: bacteremia, urinary tract infection, pneumonia or
abdominal collection.
4. Known or suspected toxic megacolon and/or known small bowel ileus.
5. Previous FMT
6. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months
before enrollment. This does not include appendectomy or cholecystectomy.
7. History of total colectomy or bariatric surgery.
8. Antibiotics for the treatment of an active infection or anticipated antibiotic use
during trial duration.
9. Concurrent intensive induction chemotherapy, radiation therapy or biological treatment
for active malignancy.
10. Expected life expectancy < 6 months
11. Patients with a history of severe anaphylactic or anaphylactoid food allergy.
12. Solid organ transplant patients ≤ 90 days post-transplant or on active treatment for
rejection.
13. Neutropenia (<500 neutrophils/mL) or other severe immunosuppression. Patients on
monoclonal antibodies to B and T cells, anti-tumor necrosis factor, glucocorticoids,
antimetabolites, calcineurin inhibitors may be enrolled after consultation with their
medical doctor.
14. Renal failure (GFR <30 or dialysis)
15. Human immunodeficiency virus+ controlled or not well controlled on antiretroviral
therapy
16. Regular probiotic supplement use within prior 2 weeks to enrollment
17. Pregnancy or inability/unwillingness to use contraceptives.
18. A condition that would jeopardize the safety or rights of the subject, would make it
unlikely for the subject to complete the study, or would confound the results of the
study.
19. Exclusion on the discretion of the PI.
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.
| Fecal Microbial Transplant (FMT) for Sjogrens Syndrome | NCT03926286 | Entailment |
2,040 | 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 with radically resected adenocarcinoma of the stomach and/or gastroesophageal
junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N,
M0
- No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any
reason
- Patients must have a life expectancy of at least 16 weeks and a performance status of
< 2 ECOG scale
- Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen.
Patients who relapse within the first 6 months after the completion of adjuvant
treatment are not eligible for the study.
- Patients must have adequate bone marrow function (defined as peripheral absolute
granulocyte count of > 2.000/µL, and platelet count of > 100.000/µL), adequate liver
function (bilirubin < 1,5 mg/dl), and adequate renal function (creatinine < 1,5 mg/dl
- Patients must be able to understand the nature of this study and give written informed
consent
Exclusion Criteria:
- Patients with T1N0 carcinoma
- Positive cytology of pleural, or pericardial effusion or patients with any peritoneal
disease diagnosed intra-operatively)
- Biopsy proof of lymph node metastases outside the study field such as supraclavicular,
mediastinal, or para-aortic nodes
- Evidence of metastatic disease to distant organs
- Patients with cardiac disease graded as New York Heart Association Class III or IV,
severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection
- Patients with diabetic neuropathy
- Abnormalities of mental status such that either the patient cannot fully comprehend
the therapeutic implications of the protocol or comply with the requirements
- Presence of concurrent or previous malignancies in the past 5 years (except for
resected squamous or basal cell carcinoma of the skin)
- Pregnant women are excluded from study entry due to the teratogenic effects of the
study treatment
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.
| Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer | NCT00718913 | Entailment |
4,226 | 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:
- age 20-50 years
- idiopathic male factor infertility for at least one year;
- homozygous FSHR allele at codon 680 (wild type: Asn/Asn or Ser/Ser);
- sperm DFI > 15%;
- normal serum FSH levels (< 8 IU/L)
- normal serum LH, testosterone, prolactin and estradiol levels
- normal ovulatory female partner These men might have impaired ejaculate parameters
(decreased sperm count and/or decreased proportion of sperm with progressive motility
and/or decreased proportion of sperm with normal morphology) of unknown aetiology.
Exclusion Criteria:
- azoospermia
- all known aetiologies of male infertility (endocrine disorders, genetic disorders,
chromosome abnormalities, congenital bilateral absence of the vas deferens,
microdeletions within the AZF regions of the Y chromosome, varicocele, cryptorchidism,
infections, immunological infertility, and obstructive infertility)
- all known aetiologies of female infertility in the partner (tubal blockage, endocrine
abnormalities including anovulation and PCO, anatomical abnormalities, infections)
- heterozygous FSHR allele at codon 680
- drug abuse and major systemic diseases
- testicular insufficiency
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 50 Years | FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy | NCT02349945 | Contradiction |
2,633 | 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:
- Primary, unilateral or bilateral, inguinal hernia patients
- Informed consent
Exclusion Criteria:
- Sterilized patients
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects | NCT00925067 | Entailment |
844 | 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 with either a pragmatic diagnosis of osteoarthritis of the knee, with no
other known rheumatological condition and who report the following clinical features
(based on the ACR classification for knee OA1):
- knee pain on most days of the previous month
- morning stiffness of less than 30 minutes duration
- "stiffness" in resting the joint and and are aged over 40 years
- osteoarthritis of the hip, with no other known rheumatological condition and who
report the following clinical features (based on the ACR classification for hip OA2):
- hip pain on most days of the previous month and at least two of the following 3
features:
- ESR < 20mm/hour
- Radiographic femoral or acetabular osteophytes
- Radiographic joint space narrowing (superior, axial and/or medial)
- And are aged over 45 years of age
- The diagnosis of osteoarthritis will be confirmed by X-ray. Only patients who have
grade 2 to 4 of the Kellgren and Lawrence scale will be recruited. (The Kellgren and
Lawrence scale ranges from grade 0 to grade 4 where grades 0 and 1 represent doubtful
osteoarthritic changes and therefore a doubtful diagnosis.)
- Patients who have been on stable medication (conventional or complementary, including
nutritional medicine) for the past three months, but are still getting symptoms
(incomplete responders)
- Only those patients who record baseline pain scores on the WOMAC scale of at least 20
mm on the VAS for a minimum of 6 out of 7 days monitored during the period from Clinic
Visit 1 (screening) and Clinic Visit 2 (baseline)
- Ability to comply with the requirements of the study and to give informed consent
- For women of child-bearing potential: negative pregnancy test
Exclusion Criteria:
- Participation in an investigational trial within 30 days prior to enrollment
- Previous treatment with Devil' s Claw within 90 days prior to enrollment
- Patients awaiting a replacement knee or hip joint
- Patients with other conditions that cause pain
- Patients with congenital dislocation of the hip
- Patients who have had operations on their hip due to previous trauma
- Patients with severe co-morbidities - including severe cardiac or pulmonary disease
and cancer
- Dementia, psychoses, or other significant impairment of mental status that would
prohibit sufficient comprehension, provision of informed consent and to allow
undertaking of the necessary self-care or toxicity reporting
- Patients taking corticosteroid medication
- Known allergies against any of the ingredients of the treatments
- Patients who would be unable to complete the self assessment forms, or to attend for
X-ray and clinical examination
- Patients with other known rheumatic disease such as rheumatoid arthritis
- Patients with the diagnosis gout
- Patients who report a red or hot swollen joint (which is unlikely to be due to OA),
and would require further rheumatological assessment
- Patients with conditions known to be contraindicated to the study medication i.e.
patients with gastric or duodenal ulcers; gallstones; patients taking drugs for
arrhythmias; patients with heart failure
- Patients who are pregnant, trying to become pregnant or breastfeeding
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.
| Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis | NCT00295490 | Entailment |
4,273 | 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:
- Men with azoospermia at reproductive age .
Exclusion Criteria:
- Pyospermia.
- Previous trial of cryopreservation.
- Systemic diseases.
- Cryptorchidism history.
- Smoking
Male
Subject must be at least 14 Years old.
Subject must be at most 80 Years | Oxidative Stress in Testicular Tissue Before and After Cryopreservation | NCT03621995 | Entailment |
5,168 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
- Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more
consecutive months prior to screening.
- BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
- At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by
DXA.
- Other inclusion criteria may apply.
Exclusion Criteria:
- Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
- History of hip fracture.
- Bone disease other than osteoporosis/ or evidence of any other clinically significant
disorder, condition/ or disease or significant laboratory abnormalities.
- Known sensitivity or intolerance calcium and vitamin D products.
- Other exclusion criteria may apply.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 Years | A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis | NCT02791516 | Contradiction |
6,820 | 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 between the ages of 18 and 60 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Superficial subcutaneous lipoma excision surgery (sized from 5 to 7 cm)
- Able to provide informed consent
- Consent to participates
- Single procedure
Exclusion Criteria:
- Unable to consent
- Do not consent to participate
- Patients with local infections in the skin over lipoma
- Patients with history of allergy to local anesthetics
- More than one procedure is being performed at the same setting
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Ultra-sounded Guided Regional Blockade for Lipoma Excision | NCT02753361 | Entailment |
1,549 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Patients presenting to the emergency outpatient unit of Geneva University Hospital
- Patients suffering from symptoms localized to the superior or inferior member, the
back, hand the chest wall.
Exclusion Criteria:
- Strictly dermatologic concerns
- Toes and inversion ankle trauma (because the diagnosis of those conditions is
generally obvious)
- Medical condition considered as urgent
- Inability to complete de digilatized Diaana form (sight problems, language, inability
to use a tablet computer)
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 | DD Assessment With Diaana #2 | NCT03901495 | Contradiction |
5,843 | 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:
- long history of GERD symptoms
- persistent or recurrent symptoms despite optimal medical treatment
- persistent or recurrent complications of GERD
- reduced quality of life owing to increasing esophageal exposure to gastric juice
- pathological values in the preoperative evaluated functional parameters.
Exclusion Criteria:
- any distinct hiatal hernia detectable by gastroscopy or barium radiography
- dysphagia
- esophageal strictures
- poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)
and pregnancy.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD) | NCT01324791 | Contradiction |
6,803 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Hemophilia A.
2. FVIII:C <1%. 3）12 and 65 years old.
4）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding
treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay
results is negative. 7） Subjects should agree to use an adequate method of contraception
during the study.
8）Understood and Signed an informed consent form.
Exclusion Criteria:
1. Has a history or family history of blood coagulation factor VIII inhibitor.
2. Has other coagulation dysfunction diseases in addition to hemophilia A.
3. HIV positive.
4. Plan to receive surgery during the trial.
5. Has used immunomodulator within one weeks before the first dose，and less than 7
half-life periods.
6. Known to be allergic to experimental drugs or any excipients.
7. Severe anemia and need blood transfusion.
8. Serious liver or kidney damage.
9. Serious heart disease.
10. Uncontrollable hypertension.
11. Has participated in other clinical studies within one month before the first dose.
12. The researchers believe that it is not suitable for participants.
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 | Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A. | NCT04061109 | Entailment |
1,633 | 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:
- healthy and non-smokers
Exclusion Criteria:
- unhealthy smokers
- subjects unable to understand/sign informed consent unable to understand/perform
spirometric measurements
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Spirometric Predicted Values in Bolivia | NCT03660111 | Entailment |
5,204 | 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 with osteoporosis, defined as low bone mineral density (BMD T-score
at the total hip or femoral neck of ≤ -2.50)
Exclusion Criteria:
- BMD T-score of ≤ -3.50 at the total hip or femoral neck
- History of hip fracture
- Any severe or more than 2 moderate vertebral fractures, as assessed by the central
imaging based on lateral spine x-rays
- Use of agents affecting bone metabolism
- History of metabolic or bone disease (except osteoporosis)
- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 Years | Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis | NCT01575834 | Entailment |
3,135 | 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:
- Aged 30 years-old or over;
- Both sexes
- Affiliated to a social security scheme
Exclusion Criteria:
- severe disease compromising life expectancy at 5 years;
- Deprived of their liberty by administrative or judicial decision, or under
guardianship
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
| The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform | NCT04224038 | Contradiction |
693 | 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:
- Hereditary haemochromatosis patients
Exclusion Criteria:
- Malignancies, severe arrhythmias, congestive heart failure and/or recent angina,
severe liver disease, epileptic seizures preceding in last 3 months before planned
treatment
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.
| Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy | NCT00202436 | Entailment |
2,659 | 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:
- primary inguinal hernia
- male adults
- signed informed consent
- god condition of external oblique aponeurosis (assessed during the operation)
Exclusion Criteria:
- age < 18
- recurrent hernia
- incarcerated hernia
- diagnosed mental disorder
- manual reduction of hernia on inpatient
- infection at groin area
- wound or scar at the groin
- no consent
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment. | NCT01237470 | Entailment |
5,520 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of giant cell arteritis (GCA) by at least one of the following:
- Temporal artery biopsy confirming GCA Symptoms of GCA (including new onset (within 6
months) symptoms of headaches, tenderness of the scalp or the temporal arteries,
visual loss due to retinal ischemic optic neuropathy or otherwise unexplained tongue
or jaw pain) and an aortic angiogram that revealed stenotic and/or aneurysmal disease
of the aorta and its principal branches
- Symptoms of polymyalgia rheumatica plus ischemic optic neuropathy, newly identified
tenderness over a temporal artery, or new onset of tongue or jaw pain
Westergren erythrocyte sedimentation rate of at least 40 nm in one hour
--Prior/Concurrent Therapy--
Endocrine therapy: No greater than 20 days since initiation of prednisone therapy
Other: No concurrent sulfa drugs or nonsteroidal antiinflammatory drugs
--Patient Characteristics--
Hematopoietic:
- WBC at least 4,000/mm3
- Platelet count at least 120,000/mm3
- No acute or chronic liver disease
Hepatic:
- Alkaline phosphatase no greater than 2 times upper limit of normal
- No other reproducible abnormal liver function test
Renal: Creatinine less than 2.0 mg/dL
Other:
- HIV negative
- No symptomatic peptic ulcer disease within the last 3 months
- Hepatitis B or C antigen negative
- No alcohol use in excess of 2 ounces of 100 proof liquor or 1 beer or its equivalent
per week
- No insulin dependent diabetes mellitus plus morbid obesity (greater than 33% over
ideal body weight)
- No recently (less than 6 months) diagnosed malignancy
- Not pregnant or nursing
- Adequate contraception required of all fertile patients
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.
| Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis | NCT00004686 | Entailment |
5,870 | 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 (between 18 to 60 years of age) with PPI dependent GERD and pathologic
esophageal acid exposure as documented by percentage time esophageal PH less than 4 of
more than 4.2% on PH-metry during 24-hrs period while off PPI
- Patients who are willing to pay the expenses of the ARMA procedure
Exclusion Criteria:
- • Large Hiatal hernia >3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
- Esophageal dysmotility
- ASA physical status >II
- Previous esophageal or gastric surgery
- 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 | ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) | NCT04243668 | Contradiction |
2,183 | 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
- History of gout - crystal proven or historical as defined by ACR criteria listed above
- Serum urate level 6.8 mg/dl
Exclusion Criteria:
- Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR of <30 ml/min
- Women less than 50 years of age
- Patients with a history of prior solid organ / hematopoietic transplantation
- Previous allergy or intolerance to allopurinol or febuxostat
- Patients who are not candidates for any of the recommended prophylactic medications
(colchicine, naprosyn or glucocorticoids)
- Patients who in the opinion of the investigator have a high genetic risk for
allopurinol hypersensitivity syndrome (AHS*) unless they have been found to be
negative for HLA B5801.
- Previous history of failure to reach target uric acid levels despite therapy with
allopurinol at dose > 300 mg/day
- Prior febuxostat use
- Patients with malignancies that are currently active with exception of non-melanoma
skin cancer
- Patients with serum uric acid levels >15 mg/dl
- Patients with myelodysplasia and hemoglobin of < 8.5 g/dL
- Patients with chronic liver disease with more than one of the following:
- INR 1.7, not on Warfarin therapy
- Bilirubin 2 mg/dL
- Serum albumin <3.5 g/dL
- Ascites
- Encephalopathy
- Current use of azathioprine, mercaptopurine, didanosine, cyclophosphamide, or
probenecid
- Patient who are unable to give informed consent
- Enrollment in another randomized interventional clinical trial
- Any severe medical condition that, in the enrollee's opinion, is likely to compromise
the participant's ability to complete the trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat | NCT02579096 | Contradiction |
4,069 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Key Inclusion Criteria:
Healthy Subjects:
- With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600
to 0800
- Who report typical sleep latency of </= 30 minutes
- With typical total sleep time (TST) >/= 420 minutes
Primary Insomnia Subjects:
- Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia
(as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text
Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months
- With a score of > 15 on the Insomnia Severity Index (ISI) at Screening
- Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the
past month
- Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
- With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes
with neither night < 15 minutes
- With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with
neither night < 15 minutes or mean TST > 420 minutes
Key Exclusion Criteria:
- With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg
syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia
(for Part B)
- Subjects with any clinically abnormal symptom or organ impairment found in medical
history, symptoms/signs, vital signs, ECG finding, or laboratory test results which
require medical treatment
- All females must be of non-childbearing potential
- With a known history of significant neurological or serious psychiatric illness
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 64 Years | A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 | NCT01463098 | Contradiction |
6,829 | 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:To be eligible for this study, patients must meet all of the following
inclusion criteria:
1. Hereditary bleeding disorder:
- Congenital hemophilia A without inhibitors with a prophylactic treatment regime
- Heterozygous carriers of hemophilia A with subnormal FVIII levels
- VWD Type 1, "Vicenza" type
- VWD Type 2b
2. Male or female, age ≥18-70 years old at Screening
3. If female, must be post-menopausal or surgically sterilized
4. Able to comprehend and to give informed consent
5. Able to cooperate with the Investigator, to comply with the requirements of the study,
and to complete the full sequence of protocol-related procedures -
Exclusion Criteria: Patients meeting any of the following criteria will be excluded from
the study:
1. Clinically significant medical history or ongoing chronic illness that would
jeopardize the safety of the patient or compromise the quality of the data derived
from his/her participation in this study
2. Medical History of spontaneous (not FVIII or FEIBA-associated) venous or arterial
thromboembolic events
3. History of significant drug allergy or anaphylactic reactions
4. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment
of the Investigator for the patient to be able to comply fully with study procedures
5. Use of medication during 2 weeks before the start of the study, which in the judgment
of the Investigator may adversely affect the patient's welfare or the integrity of the
study's results
6. Concurrent treatment with other experimental drugs or participation in another
clinical trial with any investigational drug within 30 days or 5 elimination
half-lives (whichever is longer) prior to treatment start -
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 | BT200 in Hereditary Bleeding Disorders | NCT04677803 | Entailment |
498 | 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. Women ≥18 to ≤ 40 years of age, with one or more years infertility history, desirous
of conceiving, regularly ovulating (defined as 9 or more menses per year), at
initiation of participation.
2. BMI ≥ 30 kg/m2.
3. Normal uterine cavity and at least one open fallopian tube confirmed by
hysterosalpingography (HSG), sonohysterography (SHG), or laparoscopy/hysteroscopy in
the last three years preceding enrollment into the study. An uncomplicated
intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course
resulting in live birth within the last three years will also serve as sufficient
evidence of a patent tube and normal uterine cavity as long as the subject did not
have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or
serious pelvic infection or other disorder leading to an increased suspicion for
intrauterine abnormality or tubal occlusion.
4. Evidence of ovarian function/reserve as assessed by menstrual cycle day 3 (+/-2 days)
FSH ≤10 IU/L with estradiol ≤ 70 pg/mL OR AMH ≥ 1 ng/mL within one year prior to study
initiation.
5. Normal or corrected thyroid function within one year of study initiation.
6. Normal or corrected prolactin level within one year of study initiation.
7. In general good health, not taking any medications which could interfere with the
study (e.g., FSH, insulin sensitizers).
8. Ability to have inseminations following hCG administration.
9. Male partner with total motile sperm in the ejaculate of at least 5 million sperm,
within one year of study initiation.
10. Able to comply with intercourse instructions and collection of semen for insemination.
Exclusion Criteria:
1. Currently pregnant or successful pregnancies within 12 months of initiating
participation. Clinical intrauterine miscarriages prior to initiating participation,
within ASRM guidelines: subjects over 35 must wait six months, while subjects under 35
must wait 12 months. No exclusion for biochemical pregnancies.
2. Undiagnosed abnormal uterine bleeding.
3. Suspicious ovarian mass.
4. Subjects on oral contraceptives, depo-progestins, or hormonal implants (including
Implanon). A two month washout period will be required prior to screening for patients
on these agents. Longer washouts may be necessary for certain depot contraceptive
methods or implants, especially when the implants are still in place. A one-month
washout will be required for patients taking oral cyclic progestins.
5. Known 21-hydroxylase deficiency or other enzyme defect causing congenital adrenal
hyperplasia.
6. Type I or Type II diabetes mellitus, or if receiving antidiabetic medications.
7. Known significant anemia (Hemoglobin <10 g/dL).
8. History of deep venous thrombosis, pulmonary embolus, or cerebrovascular event.
9. Known heart disease (New York Heart Association Class II or higher).
10. Known Liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5
mg/dL).
11. Known Renal disease (defined as BUN >30 mg/dL or serum creatinine > 1.4 mg/dL).
12. History of, or suspected cervical carcinoma, endometrial carcinoma or breast
carcinoma.
13. History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks
at one time).
14. Known Cushing's disease.
15. Known or suspected adrenal or ovarian androgen secreting tumors.
16. Allergy or contraindication to the treatment medications: CC or hCG.
17. Couples with previous sterilization procedures (e.g. vasectomy, tubal ligation)
whether or not it has been reversed.
18. Subjects with untreated poorly controlled hypertension defined as a systolic blood
pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures at least 60
minutes apart.
19. Subjects who have undergone a bariatric surgery procedure in the past or are in a
period of acute weight loss (defined as a weight loss of greater than 5 kgs in the
last 6 months).
20. Known moderate or severe endometriosis.
21. Anovulation or oligo-ovulation including hypothalamic amenorrhea, polycystic ovary
syndrome, etc.
22. Donated semen.
23. Couples in which either partner is legally married to someone else.
24. Medical conditions that are contraindications to pregnancy.
25. Presence of severe, untreated psychiatric illness (major depression, substance abuse,
eating disorder, etc.) that would, in the opinion of the site investigator, interfere
with the patient's ability to successfully complete the study.
26. Any additional medical conditions that would be a contraindication to orlistat. (This
includes patients with chronic malabsorption syndrome or cholestasis or known
hypersensitivity to any of the drugs used in this study.)
27. Any contraindication to study requirements including diet recommendations and activity
requirements.
28. Currently participating in a lifestyle intervention program (such as Weight Watchers,
Atkins Diet, Curves) or lost more than 5% body weight within the last 6 months.
29. History of Gout.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility | NCT02432209 | Contradiction |
2,305 | 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:
- 4 to 10 years of age
- Ambulant
- Confirmed DMD Diagnosis
- Steroid naive
- Evidence of muscle weakness by MRC score or clinical functional evaluation
- Ability to provide reproducible QMT bicep score
Exclusion Criteria:
- History of significant concomitant illness or significant impairment of renal or
hepatic function, or other contraindication to steroid therapy
- Symptomatic DMD carrier
- Positive PPD
- Lack of prior exposure to chickenpox or immunization
- Use of carnitine, glutamine, Coenzyme Q10, other amino acids or any herbal medications
within the last 3 months
- History of symptomatic cardiomyopathy
- Prior attainment of quota for the age group in which the patient belongs
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 10 Years | High-dose Prednisone in Duchenne Muscular Dystrophy | NCT00110669 | Entailment |
3,195 | 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:
- Dry eye patients with Sjögren's syndrome finished KCT1301 study
Exclusion Criteria:
- Patients with poor adherence to medication of study drug in KCT1301 study
No condition on gender to be admitted to the trial.
Subject must be at least 20 Years old.
| An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome | NCT02503176 | Entailment |
1,587 | 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:
Smokers: Subjects who smoked commercial cigarettes exclusively (less than or equal to 10 mg
ISO tar yield in Germany and the UK; less than or equal to 12 mg ISO tar yield in
Switzerland) with a regular consumption of at least 1 cigarette per day over the last 12
months without change in brand over the previous 3 months.
or
Non-smokers: Subjects who did not smoke commercial cigarettes, hand-rolled cigarettes,
cigars, pipes, bidis, and did not use other nicotine-containing products (patch, gum,
lozenges etc.) within 1 year prior to Visit 1 and throughout the study duration.
Exclusion Criteria:
- Female subjects with child-bearing potential were to be excluded if
1. Subject was pregnant (or did not have negative pregnancy tests) or breast-feeding
2. Subject did not agree to use an acceptable method of contraception
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 85 Years | European Exposure Study | NCT01237912 | Contradiction |
888 | 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. Male or female patients at least 19 years of age
2. Patients diagnosed with degenerative arthritis
3. Patients with IKDC(Knee Documentation Committee subjective score) score of 60 or below
4. Patients with 100 mm VAS(Visual Analog Scale) score of 40 or above
5. With Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and
Lawrence
6. With an International Cartilage Repair Society(ICRS) Grade III or IV cartilage damage
in the major lesions, as confirmed through an MRI scan
7. With a Body Mass Index(BMI) of higher than18.5 and lower than 30
8. Patients who satisfies the clinical/radiational criteria by the American College of
Rheumatology (ACR) guidelines, and applies to one of the following.
- Older than 50
- Morning stiffness for less than 30 minutes
- Crepitus and Osteophytes
9. With major lesions concentrated in one section of the knee, and with the major lesions
considered the main cause of the clinical symptoms
10. With no alleviation of the symptoms even after at least three months of non-surgical
treatment
11. Healthy, with no major findings from the physical examination, hematology, serum
chemistry, and urine tests, and no significant medical history
12. Agreed to use an effective contraceptive method during the study period
13. Voluntarily agreed to participate in this study, and signed the informed consent form
Exclusion Criteria:
1. Showed clinically significant hematology, serum chemistry, and urine test results at
the screening visit
2. Regarding inclusion criteria 6. following patients should not be included
- patients with a major lesion of ICRS grade 4 which is larger than 6cm2(for
patient with ICRS grade 4)
- patients with a major lesion of ICRS grade 3 which is larger than 6cm2(for
patient without a ICRS grade 4),
3. Patient who had skin disease around target knee
4. patients who have a positive skin reaction to CS-10
5. Patients who had been administered with drugs such as oriental medicine, glucosamine
and chondroitin within 14 days of baseline visit
6. Patients taking steroidal anti-inflammatory medications within 14 days of baseline
visit
7. Patients with severe pain in other areas that could effect the diagnosis of the
symptoms of the
8. History of surgery like arthroendoscopy within the past 6 months on the target knee
9. Patients who had been administered with immunosuppressants, including antirheumatic
drugs (including methotrexate or antimetabolite), within the past 3 months
10. Patients who had been treated with physical therapy or herbal remedy (acupuncture,
heat etc.) within 2 weeks of baseline visit
11. History of injection within the past 3 months on the target knee
12. Pregnant or breastfeeding female
13. With another joint disease apart from degenerative arthritis (e.g., systemic rheumatic
inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis,
inflammatory arthritis, necrosis of the trochanter, Paget's disease adjacent to a
joint in the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis,
Charcot's disease in the knee joint, villonodular synovitis, synovial chondromas)
14. With an infectious disease, including HIV or hepatitis
15. With any of the following clinically significant diseases:
- heart disease (e.g., myocardial infarction, arrhythmia, other serious heart
diseases, coronary artery bypass graft)
- kidney disease (e.g., chronic renal failure, glomerulonephritis)
- liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver
disease)
- endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes
insipidus, Cushing's disease)
- insulin-dependent diabetes mellitus
- medical history of past or current malignant tumor
- In particular, the tumors that TissueGene-C may aggravate can be screened using
the following tests:
- Leukemia (White Blood Cell level in the hematology)
- Osteochondroma, Chondromas, Chondroblastoma, Chondromyxoid fibroma,
Chondrosarcoma (Alkaline phosphatase level in the hematology)
16. Participated in another clinical trial (using the investigational drug or a medical
device) within 30 days before enrollment in this study
17. Patients who administered the TissueGene-C from past clinical trial
18. Considered inappropriate by the investigator for participation in this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis | NCT02072070 | Entailment |
3,498 | 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:
- Aged 18 years or older and able to understand and sign the informed consent form.
- Patients diagnosed with hyperlipidemia and a very high risk developing
cardiovascular disease prescribed statin treatment according to clinical praxis
and the recommendations set forth in the MPA national guideline for treatment of
hyperlipidemia.
Exclusion Criteria:
- Patients contraindicated for statin treatment according to market authorization for
these drugs should be excluded from the study.
- Patients participating in other clinical trials or non-interventional studies.
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 | Compliance With Treatment For Patients With Hyperlipidemia | NCT00828945 | Entailment |
1,396 | 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:
- 18 years of age or older
- have diagnosed but uncontrolled hypertension
- Most recent measurement and one other measurement of the 3 most recent blood pressure
measurements in the past 2 years have a systolic pressure >140mmHg or a diastolic
pressure >90mmHg. For patients with a diagnosis of diabetes or chronic kidney disease
the blood pressure cut-offs will be systolic >130 mm Hg or a diastolic pressure > 80
mm Hg
- not on organizational "do not call" lists or deceased lists
- have been approved for invitation into the study by their physician
- do not have a life-threatening illness
- are not on more than 4 antihypertensive medications
- can use a telephone
- speak either English or Spanish
Exclusion Criteria:
- on organizational "Do Not Call" list or deceased list
- physician does not give permission for them to be included in the study
- younger than 18 years of age
- has a life-threatening illness
- currently takes more than 4 anti-hypertension medications
- does not have or cannot use a phone
- does not speak English or Spanish (languages available in IVR)
- does not want to participate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Improving Blood Pressure in Colorado | NCT00520988 | Contradiction |
4,856 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- an endogenous hypercortisolism (group 1)
- a disease justifying the next start of glucocorticoid therapy (group 2)
- chronic adrenal insufficiency (group 3)
- subjects with either diabetes, hypertension or osteoporosis, but without
glucocorticoid excess (control group)
- patients will have to be affiliated to a social security scheme
- patients should be able to understand the study and able to express their consent
Exclusion Criteria:
- patients with reduced life expectancy, less than 2 years
- pregnant or lactating women
- patients refusing the protocol
- patients under state medical assistance
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.
| Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism (CUSHINGOMICS) | NCT04840693 | Entailment |
2,068 | 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:
- more than 18 years-old
- diagnosis of IPF validated in a multidisciplinary consultation meeting (RCP) according
to French recommendations
Exclusion Criteria:
- pregnant or lactating women
- exacerbation of fibrosis on inclusion
- right or left heart aggravation on inclusion
- evolutive pulmonary infectious disease
- other forms of diffuse interstitial lung disease
- opposition to the data collection
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.
| ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution | NCT03944928 | Entailment |
5,320 | 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:
- Bleeding patients.
Exclusion Criteria:
- Coagulation defects, and those on anti-platelet drugs.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Platelet Glycoproteins in Inherited Thrombocytopathy: Association With Aggregation Studies and Bleeding Severity | NCT03648190 | Contradiction |
3,868 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Primary knee Osteoarthritis
- Stage 2 -3 according to Kellgren - Lawrence Classification
Exclusion Criteria:
- Previous surgery in the lower extremity
- Neuromuscular disease
- Vestibular pathology
- Physiotherapy intervention or intra-articular injection within the last 6 months
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 70 Years | Effects of Body Awareness Therapy in Knee Osteoarthritis | NCT04165187 | Entailment |
2,747 | 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: inguinal hernia repair -
Exclusion Criteria: uncontrolled diabetes mellitus,
-
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 | Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias | NCT01264003 | Entailment |
3,036 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1. Boys diagnosed with fragile X syndrome
2. Boys with intellectual disability who do not have FXS or other known genetic disorder
associated with intellectual disability
3. Age 8 to 18 years inclusive
4. Ability to travel to Stanford
5. Vineland Adaptive Behavior Scales standard score between 50 and 75 points
Exclusion Criteria:
1. Sensory impairments, or any other serious medical or neurological condition that
affects growth or development (e.g., seizure disorder, diabetes, congenital heart
disease).
2. Materials in body that would preclude an MRI scan (e.g., dental braces).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 18 Years | Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome | NCT02616796 | Entailment |
3,362 | 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:
- HV aged between 18 - 60 years
Exclusion Criteria:
- history of psychiatric disease or a positive first degree psychiatric family history
- pregnancy or lactation
- concomitant administration of any centrally activating medication (anti-depressive
medication, hypnotics, sedatives, anxiolytics, …)
- medication affecting esophageal motility
- significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary,
endocrine, autoimmune, renal and hepatic)
- prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
- history of gastrointestinal disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers | NCT04355455 | Contradiction |
5,326 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- • Age ≥ 18 and < 49 years. We are including a wide range of ages because women of all
ages request TCu380A. While we recognize that some women approaching menopause (median
age = 51.4 years) may have changes in their baseline menstruation, we trust that
clinicians enrolling the patients into the study will ensure that these women meet all
inclusion (i.e., regular cycles) and exclusion criteria (i.e., do not have diagnosis
of menorrhagia).
- Requesting to have TCu380A IUD inserted as contraceptive method.
- English-speaking.
- Regular menstrual cycles ranging 21-35 days apart.
- Generally healthy.
- Willing to attend a 4- to 6-week follow-up visit and complete surveys.
Exclusion Criteria:
- Known or suspected pregnancy.
- Contraindications to NSAID use. This includes underlying heart failure, chronic
renal disease, chronic liver disease, peptic ulcer disease, or history of upper
gastrointestinal bleed, and allergy to NSAIDs.
- Current regular use of a NSAID.
- Unwilling to avoid use of NSAIDs (except for study medication) for the duration
of the study.
- Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or
endometrial polyps.
- Use of depot medroxyprogesterone acetate (DMPA) or levonorgestrel-releasing
intrauterine device (LNG IUD) within the previous 3 months.
- Postpartum in the past 4 weeks. The average day in which non-breastfeeding
postpartum women ovulate is 25 days after birth, indicating that menstrual cycles
can resume after the 4th postpartum week.
- Existing medical condition for which placement of TCu380A IUD is a
contraindication according to the Centers for Disease Control and Prevention
Medical Eligibility Criteria (MEC 4 medical conditions; see Appendix A).
- Currently breastfeeding.
- Previous use of the TCu380A.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Copper IUD Treatment Observation Study | NCT02519231 | Contradiction |
670 | 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:
- Male or female subjects ≥ to 18 years of age and able to give informed consent.
- Diagnosis of Iron Deficiency Anemia (IDA).
- Hemoglobin (Hgb) ≤ to 11 g/dL.
- Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
- Must demonstrate an unsatisfactory response or intolerance to oral iron.
Exclusion Criteria:
- Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous
sulfate.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease.
- No evidence of iron deficiency.
- Any non-viral infection.
- AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the
upper limit of normal.
- Known positive hepatitis with evidence of active disease.
- Received an investigational drug within 30 days of screening.
- Alcohol or drug abuse within the past 6 months.
- Hemochromatosis or other iron storage disorders.
- Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG
Performance Status greater than 1.
- Any other laboratory abnormality, medical condition, or psychiatric disorders which in
the opinion of the investigator would put the subject's disease management at risk or
may result in the subject being unable to comply with study requirements.
- Pregnant or sexually-active females who are of childbearing potential and who are not
willing to use an acceptable form of contraception.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA) | NCT00982007 | Contradiction |
40 | 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:
- Adult male subject aged 18 to 65 years inclusive
- BMI > 30 kg/m2 and < 50 kg/m2
- Serum total testosterone concentration below the normal range
- LH levels below the upper limit of normal
- Oestradiol levels within or above the normal range of approved assay
- At least two symptoms of androgen deficiency present for at least 2 months prior to
the first Screening Visit, with at least one of these being a sexual dysfunction
Exclusion Criteria:
- Evidence of clinically significant endocrinopathy at screening that may interfere with
the study assessments
- Other types of hypogonadotropic hypogonadism or primary hypogonadism
- Any other pituitary or hypothalamic disease
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism | NCT02730169 | Contradiction |
562 | 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 must meet all the following criteria to be eligible for inclusion in the study:
1. Age 18 through 45 years (inclusive) at screening
2. Able and willing to provide written informed consent to be screened for and to take
part in the study.
3. Able and willing to provide adequate locator information
4. HIV-uninfected based on testing performed by study staff at screening (per algorithm
in Appendix II)
5. In general good health as determined by the site clinician
6. Agree to be sexually abstinent for 48 hours prior to each visit and from Visit 2 to
Visit 3
7. At screening, agrees to abstain from any other intravaginal product or penetration
(including sex toys, excluding tampons) for 48 hours prior to each visit and between
Visit 2 and 3.
8. Willingness to undergo all study-related assessments and follow all study-related
procedures
9. At screening and enrollment, agrees not to participate in other research studies
involving drugs, medical devices, or vaginal products while enrolled in this trial
Exclusion Criteria:
Women who meet any of the following criteria by participant report will be excluded from
the study. Of note, the study is limited to premenopausal women with an intact uterus
because the mucosal immune environment differs substantially between pre- and post-
menopausal women. Therefore, inclusion of post-menopausal women would introduce
heterogeneity into the population.
1. Menopause (as defined as amenorrhea for one year or more without an alternative
etiology)
2. Hysterectomy
3. Participant report of any of the following:
1. Known adverse reaction to any of the study products (ever)
2. Known adverse reaction to latex (ever)
3. Non- therapeutic injection drug use in the 12 months prior to Screening
4. Surgical procedure involving the pelvis in the 90 days prior to enrollment
(includes dilation and curettage or evacuation, and cryosurgery; does not include
cervical biopsy for evaluation of an abnormal pap smear)
5. Participation in a drug, spermicide and/or microbicide study in the 30 days prior
to enrollment or anticipated participation in an investigational drug study until
completion of the study
6. Currently pregnant or pregnancy within 42 days prior to enrollment
7. Currently lactating
8. Use of a diaphragm, NuvaRing®, or spermicide for contraception
9. Internal vaginal use of any device or product (except tampons) in the 48 hours
prior to enrollment
4. Urogenital infection or suspected infection within 14 days of enrollment including:
symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis;
or cervical infection, including N. gonorrhoeae, C. trachomatis, or mucopurulent
cervicitis; syphilis; herpes simplex virus lesions, or other sores (Note: seropositive
Herpes simplex virus without active lesions will not be excluded); acute pelvic
inflammatory disease; urinary tract infection; recent exposure to a partner with N.
gonorrhoeae, C. trachomatis, Trichomonas, syphilis, or nongonococcal urethritis.
5. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
6. As determined by the PI, has any significant uncontrolled active or chronic
cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric,
endocrine, respiratory, immunologic disorder or infectious disease
7. Menses-like bleeding at the time of the Enrollment visit* or expected menses-like
bleeding within 14 days of the Enrollment visit (*Women who have vaginal bleeding at
the scheduled Enrollment Visit may return at a different date to be re-examined and
possibly enrolled provided they are still within the screening window and meet all
criteria.)
8. Any condition that, in the opinion of the Investigator, would preclude provision of
consent, make participation in the study unsafe, complicate interpretation of study
outcome data, or otherwise interfere with achieving the study objectives
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101 | NCT03537092 | Contradiction |
3,767 | 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:
- Knee pain and osteophytes on radiographs OR
- Knee pain plus patient age of 40 years or older, morning stiffness lasting 30 minutes
or less, and crepitus (cracking sound) during motion
- Experiences chronic pain for 6 months or longer
- Average pain rating of worse knee is equal to 4 or greater on a 0-10 scale
- If female, is not pregnant or breast feeding, and not currently attempting to
conceive; if of childbearing potential, use of a highly effective method of birth
control (as determined by Pl)
- Able to walk at least ½ a city block a day, and agrees to try and slowly increase that
over the course of study
- Able to read and speak English and provide informed consent
- Able to understand and comply with all data collection methodology including
electronic diary
- Subject agrees to 1) continue their stable drug regimen with no changes during the
course of study, 2) only use Tylenol 325 mg of tablets (a maximum of 8 tablets a day)
for breakthrough pain, and 3) not use Tylenol or any other pain medicines 12 hours
before testing.
Exclusion Criteria:
- Subject takes SNRIs (Savella, Cymbalta, Venlafaxine) or other neuroamine re-uptake
blockers for mood disorders
- Subject is allergic to SSRIs, SNRIs, or milnacipran
- Subject has severe or untreated psychiatric disturbance (e.g. mania, depression,
anxiety, substance dependence)
- Subject is medicated with 'triptans, MAOIs, SSRIs, other SNRIs, tricyclic or
heterocyclic antidepressants, lithium, epinephrine, norepinephrine, clonidine or
digoxin during the trial
- Subject has a clinical diagnosis of fibromyalgia
- Subject has severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic
disease [creatinine>1.5 ml/dl; AST or ALT> 3x normal limit], uncontrolled
hypertension, severe cardiac rate or rhythm disorders, rheumatologic disease (e.g.
polymyalgia rheumatica), narrow angle glaucoma, hyponatremia, clotting disorders,
uncontrolled seizure disorder or urinary retention)
- Subject has cardiac implants
- Subject has a knee replacement
- Subject plans to start new pain treatments or therapies during the study (e.g. new
pain medication, injections, PT, surgery)
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 90 Years | Milnacipran for Chronic Pain in Knee Osteoarthritis | NCT01510457 | Entailment |
674 | 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:
- Male or female subjects > or = to 18 years of age.
- Chronically impaired renal function.
- Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
- Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation
(TSAT) is < or = to 30%.
- If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks
prior to randomization.
Exclusion Criteria:
- Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or
Venofer.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease OR is being considered for
initiation of dialysis during the time period of this trial.
- No evidence of iron deficiency.
- Any non-viral infection.
- AST or ALT at screening as determined by central labs greater than 1.5 times the upper
limit of normal.
- Known positive hepatitis with evidence of active disease.
- Received an investigational drug within 30 days of screening.
- Alcohol or drug abuse within the past 6 months.
- Hemochromatosis or other iron storage disorders.
- Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG
Performance Status greater than 1.
- Any other laboratory abnormality, medical condition or psychiatric disorder which in
the opinion of the investigator would put the subject's disease management at risk or
may result in the subject being unable to comply with study requirements.
- Pregnant or sexually-active female subjects who are not willing to use an acceptable
form of contraception.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function | NCT00981045 | Contradiction |
6,463 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Healthy male or non-pregnant female ≥18 years-of-age with a clinical diagnosis of
moderate facial rosacea.
- Patient must have at least eight and not more than fifty inflammatory facial lesions
(i.e., papules/pustules) and ≤2 nodules on the face. For the purposes of study
treatment and evaluation, these lesions should be limited to the facial treatment area
including those present on the nose. Lesions involving the eyes, and scalp should be
excluded from the count.
- Patients must have persistent erythema on the face with moderate (Definite redness,
easily recognized) to Severe (Marked erythema; fiery red).
- Patients must have a mild to moderate score for telangiectasia on the face - Patients
must have a definite clinical diagnosis of moderate facial rosacea as per the IGE
- Patient must be willing to minimize external factors that might trigger rosacea
flare-ups (e.g., spicy foods, thermally hot foods and drinks, hot environments,
prolonged sun exposure, strong winds and alcoholic beverages).
- Patient must be in general good health and free from any clinically significant
disease other than rosacea, that might interfere with the study evaluations.
- Patient must be willing and able to understand and comply with the requirements of the
study, apply the medication as instructed, return for the required treatment period
visits, comply with therapy prohibitions, and be able to complete the study.
- Female Subjects of childbearing potential (excluding women who are
surgicallysterilized or postmenopausal for at least 1 year), in addition to having a
negative urine pregnancy test, must be willing to use an acceptable form of birth
control during the study from the day of the first dose administration to 30 days
after the last administration of study drug For the purpose of this study the
following are considered acceptable methods of birth control: oral contraceptives,
contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier
methods (e.g., condom and spermicide), contraceptive injection (Depo-provera®),
intrauterine device (IUD), hormonal IUD (Mirena®) and abstinence with a documented
second acceptable method of birth control, should the patient become sexually active.
Patients on hormonal contraception must be stabilized on the same type for at least
three months prior to enrollment in the study and must not change the hormonal
contraception during the study. Patients who had used hormonal contraception and
stopped must have stopped no less than three months prior to the study. A sterile
sexual partner is NOT considered an adequate form of birth control.
- All male patients must agree to use accepted methods of birth control with their
partners, from the day of the first dose administration to 30 days after the last
administration of study drug. Abstinence is an acceptable method of birth control.
Female partners should use an acceptable method of birth control as described in the
above Item Number 10.
- Patients who use make-up must have used the same brands/types of make-up for a minimum
period of 14 days prior to study entry and must agree to use the same make-up,
brand/type, or frequency of use, throughout the study.
Exclusion Criteria:
- Pregnant or lactating or planning to become pregnant during the study period.
- Presence of any skin condition on the face that would interfere with the diagnosis or
assessment of rosacea.
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
with diagnosis or assessment of rosacea.
- History of hypersensitivity or allergy to azelaic acid, propylene glycol or any other
component of the formulation.
- The use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or
therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are
allowed).
- The use of estrogens or oral contraceptives for less than 3 months prior to baseline.
- The use within 1 month prior to baseline of:
1. topical retinoids to the face;
2. systemic antibiotics known to have an impact on the severity of facial rosacea
(e.g., containing tetracycline and its derivatives, erythromycin and its
derivatives, sulfamethoxazole, or trimethoprim);
3. systemic corticosteroids (Note: intranasal and inhalational corticosteroids do
not require a washout and maybe used throughout the trial if the subject is on a
stable dose).
- Use within 2 weeks prior to baseline of:
1. topical corticosteroids;
2. topical antibiotics;
3. topical medications for rosacea (e.g., metronidazole).
- Patients with moderate or severe rhinophyma, dense telangiectases (score 3, severe),
or plaque-like facial edema.
- Patients with a severe irritation grade for erythema, dryness, scaling, pruritus,
stinging/burning, and edema.
- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient
severity to require topical or systemic antibiotics.
- A patient who has used a sauna during the 2 weeks prior to study entry and during the
study.
- Patients who have performed wax epilation of the face within 14 days prior to baseline
- A patient who has a history of being unresponsive to topical azelaic acid therapy.
- A patient with bacterial folliculitis.
- A patient who consumes excessive alcohol, abuses licit or illicit drugs, or has a
condition that could compromise the patient's ability to comply with study
requirements.
- Patients who engage in activities that involve excessive or prolonged exposure to
sunlight or weather extremes, such as wind or cold.
- A patient who has any clinically significant condition or situation, other than the
condition being studied that, in the opinion of the Investigator, would interfere with
the study evaluations or optimal participation in the study.
- A patient who has used any topical azelaic acid therapy within 30 days of baseline
visit.
- Patients who have participated in an investigational drug study (i.e., patients have
been treated with an Investigational Drug) within 30 days prior to baseline will be
excluded from study participation. Patients who are participating in non-treatment
studies such as observational studies or registry studies can be considered for
inclusion.
- Patients who have been previously enrolled in this study.
- Patients who have had laser therapy (for telangiectasia or other conditions),
electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 180
days prior to study entry.
- Patients who have had cosmetic procedures (e.g., facials) which may affect the
efficacy and safety profile of the Investigational Product within 14 days prior to
study entry.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea | NCT02120924 | Entailment |
3,617 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- All adult (18 years or older) patients presenting to the ED
- All adult (18 years or older) patients transferred from the ward to ED for upgrading
of care
Exclusion Criteria:
- All patients who died on arrival in the ED
- Patients transferred from another acute care facility
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.
| Emergency Department Crowding in Relation to In-hospital Adverse Medical Events | NCT01116323 | Entailment |
6,925 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- 1. Male or female subject aged 55 to 85 y at Screening (V1). 2. Has mild to moderate
AD as defined by all of the following criteria:
1. Meets the National Institute on Aging and Alzheimer's Association (NIA-AA, 2011)
criteria of all cause dementia and probable AD.
2. Has a Clinical Dementia Rating (CDR) total score of 1 to 2, inclusive (mild to
moderate).
3. Has an MMSE score of ≥14 and ≤24 (score is an average from Screening [V1] and
Baseline [V2]) with no more than a 3 point change between visits.
4. Has an MRI of the brain that is generally supportive of AD upon local reading. A
CT scan can be substituted only if the subject has an absolute contraindication
for MRI.
5. Has evidence of Aβ pathology based on Aβ PET scan conducted coincident with
diagnosis of AD or use of APTUS™ Aβ42/40 assay during the Screening Period. Scan
must be completed prior to randomization at V2.
3. Has a modified Hachinski Ischemic Scale score of ≤4 at Screening (V1). 4. If
taking an anticholinesterase inhibitor (AChEI) (e.g., donepezil, galantamine,
rivastigmine) and/or memantine at Screening (V1):
1. Must have been taking the medication(s) for ≥3 mo and
2. Current dose regimen and form must have remained stable for ≥6 wk prior to
randomization and must remain stable throughout participation in the study.
NOTE: Subjects not being treated with an AChEI and/or memantine at Screening (V1)
may also be enrolled if initiation of an AChEI and/or memantine is not planned
for the time period during which the subject will be participating in this study.
NOTE: Dosage changes during the study due to clinical deterioration should be
discussed with the Medical Monitor prior to being implemented.
5. If taking medications for glycemic control at the time of Screening (V1), must
be stable on the current dose regimen and form for ≥3 mo prior to randomization
and must remain stable throughout participation in the study.
6. Must meet one of the following criteria:
1. Females: Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or
tubal ligation) for at least 6 mo prior to Screening (V1) or postmenopausal
(postmenopausal females must have no menstrual bleeding for at least 1 y). If
needed, the Investigator may confirm postmenopausal status through an FSH
assessment at Screening [(V1]). If not surgically sterilized or postmenopausal,
subject must agree to use a highly effective method of contraception that can
achieve a failure rate of less than 1% per year when used consistently and
correctly, such as hormonal contraception or a double barrier method (e.g.,
intrauterine device plus condom or true abstinence defined as in line with the
preferred and usual lifestyle of the subject) while enrolled in the study.
Methods of periodic abstinence (e.g., calendar, ovulation, symptothermal, post
ovulation) are not acceptable as noted in Section 6.8.1 of the protocol.
2. Males: Vasectomized. If not vasectomized, must use an appropriate contraception
methods (e.g., double barrier or true abstinence defined as in line with the
preferred and usual lifestyle of the subject) while enrolled in the study.
Partner methods of periodic abstinence (e.g., calendar, ovulation, symptothermal,
post ovulation) are not acceptable as noted in Section 6.8.1 of the protocol.
7. Must provide voluntary written informed consent prior to Screening (V1). If
the subject is unable to provide informed consent due to cognitive status, the
subject must provide assent, and a legally authorized representative provides
full written informed consent on behalf of the subject.
8. Willing to allow collection of blood for ApoE genotyping. 9. Able to comply
with the study procedures, in the opinion of the Investigator.
10. Has a primary caregiver/study partner that has face to face contact with the
subject for a minimum of approximately 10 hours (h) per week spread over 2 to 5 d
during the week (e.g., 2 h per day for 5 d a week, or 5 h per day for 2 d a week)
and is willing to accept responsibility for supervising the treatment (e.g.,
administering study drug), accompanying the subject to clinic visits and
assessing the condition of the subject throughout the study in accordance with
all protocol requirements. The primary caregiver/study partner must be willing to
sign the caregiver ICF.
Exclusion Criteria:
- 1. Has imaging consistent with other differential dementia diagnoses other than the
diagnosis of AD. For example, any suggestion of vascular disease including multiple
infarction involving large blood vessels or localized single infarction (angular
gyrus, thalamus, anterior cerebral artery, and posterior cerebral artery region),
multiple lacunae of the basal nuclei or white matter, or extensive lesions of the
periventricular white matter or combination of several lesions. Additionally, any
single lacunae in an area known to impact cognition, such as the hippocampus, will
also be exclusionary.
a. Should there be any evidence of neurologic symptoms between the date of the scan
confirming diagnosis and Screening (V1), rescanning is necessary.
2. Has abnormal laboratory tests that suggest an alternate etiology for dementia, such
as history of uncorrected serum vitamin B12 deficiency, thyroid function abnormality,
severe anemia, electrolyte abnormality, or history of positive syphilis serology. In
these cases, the subject should be re evaluated to determine if these potential causes
of dementia have been addressed. Only if these causes have been ruled out as the cause
of the dementia, can the subject be enrolled.
3. Diagnosis of type 1 diabetes or type 2 diabetes requiring insulin treatment.
Subjects who become insulin dependent during the study may not continue to participate
in the study.
4. History of epilepsy or seizure disorder requiring ongoing treatment, or any seizure
or loss of consciousness within 12 mo prior to Screening (V1).
5. Has any of the following laboratory findings at Screening (V1):
1. Alanine aminotransferase >3 × upper limit of normal (ULN), aspartate
aminotransferase >3 × ULN, or history of clinically significant liver disease in
the Investigator's medical judgment.
2. Hemoglobin ≤10 g/dL.
3. International normalized ratio >1.5 if not on anticoagulant medication; if the
subject is on anticoagulant medication, the anticoagulant medication should be
optimized and on a stable dose for ≥4 wk prior to Screening (V1).
4. Creatinine clearance (Cockcroft Gault formula) of <45 mL/min.
5. Known to be seropositive for human immunodeficiency virus (1 and 2), hepatitis B,
or hepatitis C. Subjects with hepatitis C who had spontaneous resolution or
received successful curative treatment (e.g., HARVONI® [ledipasvir/sofosbuvir])
with a documentation of undetectable viral load for at least 3 mo may be allowed.
Serological testing will not be performed as part of this study.
6. Female subjects who are pregnant or breastfeeding. 7. History of any medical
illness such as cancer requiring systemic therapy in the last 5 y, except for
localized basal cell carcinoma of the skin, in situ cervical cancer successfully
treated with surgical excision, and stable (for ≥90 d prior to Screening [V1])
prostate cancer.
8. History of severe heart failure (Grade 2 or higher on the New York Heart
Association scale), major stroke, uncontrolled seizure disorder, or other medical
illness that, in the Investigator's opinion, will increase the subject's risk of
participation in the study or confound study assessments.
9. Any surgery requiring general anesthesia that is planned to occur during the
study. Local anesthesia during outpatient surgery is permitted if, in the opinion
of the Investigator, the operation will not interfere with study procedures and
subject safety.
10. History or current evidence of major psychiatric illness such as
schizophrenia, bipolar disorder, or major depressive disorder that may interfere
with the subject's ability to perform the study and all assessments.
a. Geriatric Depression Scale Short Form (GDS SF) score >5 at Screening (V1). NOTE:
Mild depression or depressive mood arising in the context of AD are not criteria for
exclusion. The use of anti epileptic medication for non seizure related treatment or
the use of antidepressants is allowed if the dose has remained stable for ≥60 d prior
Screening (V1).
11. History of violent or aggressive behavior requiring medication or a formal program
of psychosocial intervention.
12. History of active suicidal thoughts (Type 4 or 5 on the C SSRS) in the 6 mo prior
to Screening (V1) or at Baseline (V2), history of a suicide attempt in the previous 2
y or >1 lifetime suicide attempt, or are at serious suicide risk, in the
Investigator's clinical judgment.
13. History of alcohol or drug abuse or dependence within 24 mo of Screening (V1) as
defined by the Diagnostic and Statistical Manual of Mental Disorders 5.
1. Positive urine screen for drugs of abuse that include methadone, cocaine, and
amphetamines; positive urine screen for opiates, barbiturates, or benzodiazepines
without a prescription.
14. Has participated in another Investigational New Drug research study involving
small molecule drugs within 60 d or biological drugs within 90 d prior to the
first dose of study drug in this study (Baseline [V2]) or within 5 half lives of
the other investigational medicinal product, whichever is longer.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | A Phase 3 Study of NE3107 in Alzheimer's Disease | NCT04669028 | Entailment |
985 | 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:
- Being diagnosed with knee osteoarthritis
- To be in the age range of 40-70
- No lower extremity surgery in the last 6 months.
- Agree to participate in the study
Exclusion Criteria:
- Having had hip-knee replacement surgery
- Surgery planned in the last 6 months
- Having received physical therapy in the last 6 months
- Having uncontrollable hypertension and cardiac problems
- Having been diagnosed with rheumatoid arthritis
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercise With Knee Osteoarthritis | NCT04540341 | Entailment |
4,217 | 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:
All volunteer subjects, employees and non-employees, must 18 to 40 years of age and must be
able to provide informed, written consent for participation in this study. We will not
directly advertise the study to employees to avoid the potential for coercion. Eligibility
in the study is determined prior to enrollment on the basis of the following inclusion and
exclusion criteria.
Normal screening examination including:
1. medical history and physical examination, nonsmoker, no concurrent medications
including aspirin or nonsteroidal anti-inflammatory drugs, no active medical problems
2. complete blood count with differential and platelet counts
3. serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes
and function tests, electrolytes, prothrombin time, partial thromboplastin time,
carboxyhemoglobin measured by venous co-oxymetry.
4. urinalysis
5. female subjects must have negative urine pregnancy test within one week of
participation (this will be repeated immediately prior to beginning the screening
procedures due to radiation exposure from the chest x-ray)
6. electrocardiogram
7. chest radiograph
Sexually active females not using contraceptive methods will be instructed to abstain from
sexual activity or use barrier contraception methods from the time of last negative
pregnancy test to 24 hours after completion of the study.
EXCLUSION CRITERIA:
1. active tobacco use
2. baseline caroxyhemoglobin greater than 2%
3. pregnancy
4. lactation
5. medical history of recent clinically significant asthma allergy to both sulfa- and
penicillin-based drugs
6. Allergy to both sulfa- and penicillin-based drugs.
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 40 Years | Carbon Monoxide to Prevent Lung Inflammation | NCT00094406 | Contradiction |
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