id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
3,840 | 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:
- Clinical diagnosis and radiological evidence of symptomatic osteoarthritis of the knee
- Moderate to severe pain
Exclusion Criteria:
- Other conditions in the knee, e.g., crystal arthropathies, septic necrosis, joint
replacement, major injury within 12 months prior to screening, tense effusions
- Requires ongoing treatment with intra-articular pain medications or systemic
corticosteroids
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 85 Years | AP-004-A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee | NCT02024529 | Entailment |
5,110 | 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:
- Inclusion criteria include perimenopausal women,
- willingness to participate in the 6-month study, willingness to undergo testing of
bone turnover markers before and after the drug therapies and willingness to provide a
self-assessment on quality of life and sleep throughout the program.
- Subjects must be willing to take their treatments right before bed and to not to
consume alcohol with this medication.
Exclusion Criteria:
- Exclusion criteria will include women in whom osteopenia is a result of some other
known process such as hyperparathyroidism, metastatic bone disease, multiple myeloma
or chronic steroid use.
- Those individuals on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs,
fluvoxamine or those with severe sleep apnea, severe COPD and those with moderate or
severe hepatic impairment will also be excluded.
- Individuals who are lactose intolerant will also be excluded because the placebo and
melatonin capsules will contain lactose.
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 54 Years | Melatonin Osteoporosis Prevention Study | NCT01152580 | Contradiction |
6,722 | 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:
- Written informed consent from participant or their legal representative.
- Participants with acquired hemophilia with autoimmune inhibitors to human factor VIII.
- Has a serious bleeding episode, as documented by the investigator.
- Be willing and able to follow all instructions and attend all study visits.
- Participants taking anti-thrombotics may be included depending on the time elapsed
since taking such medications.
- Life expectancy of at least 90 days prior to the onset of the bleeding episode.
Exclusion Criteria:
- Hemodynamically unstable after blood transfusion, fluid resuscitation and
pharmacologic or volume replacement pressor therapy.
- Has an established reason for bleeding that is not correctable.
- Bleeding episode assessed likely to resolve on its own if left untreated.
- Anti-OBI-1 inhibitor that exceeds 20 BU (prospectively or retrospectively).
- Subsequent bleeding episode at the site of the initial qualifying bleeding episode
within 2 weeks following the final OBI-1 dose for the initial qualifying bleeding
episode, or subsequent bleeding episode at a different site than the initial
qualifying bleeding episode within 1 week following the final OBI-1 dose for the
initial qualifying bleeding episode will not be considered "new" qualifying bleeding
episodes.
- Prior history of bleeding disorder other than acquired hemophilia.
- Known major sensitivity (anaphylactoid reactions) to pig or hamster products.
- Use of hemophilia medication within 3 to 6 (depending on medication) hours prior to
OBI-1 administration.
- Participation in any other clinical study within 30 days of the first OBI 1 treatment.
- Anticipated need for treatment or device during the study that may interfere with the
evaluation.
- Abnormal baseline findings
- Inability or unwillingness to comply with the study design, protocol requirements, or
the follow-up procedures.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | NCT01968655 | Contradiction |
4,320 | 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. | No eligibility criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Determinants of Respiratory Health in Young Adults | NCT00005361 | Entailment |
1,410 | 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:
- Diagnosis of uncontrolled hypertension,
- prescribed a medication to lower blood pressure,
- have a regular primary care physician at Durham VA Medical Center, and
- be a veteran. For Sustainability portion the patient must have participated in an
intervention arm of primary study.
Exclusion Criteria:
- Hospitalized in past 3 months for stroke,
- heart attack,
- surgery for blocked arteries,
- diagnosed with metastatic cancer or treated with dialysis,
- have a diagnosis of dementia or a hearing impairment which prevents them from being
able to hear/speak on the telephone, and
- creatinine serum lab which exceed 2.5.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Hypertension Intervention Nurse Telemedicine Study (HINTS) | NCT00237692 | Contradiction |
2,918 | 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. | Main Inclusion Criteria:
1. El Escorial criteria for probable or definite ALS
2. Males and and non pregnant females between 18 and 70 years of age
3. Patients with an ALS-FRS-R score of at least 30 with an ALS diagnosis of two years or
less
4. No history of active psychiatric disorder. Patients receiving antidepressants as a
preventive treatment, with no history of active psychiatric disorder may be included.
5. Patient has a good understanding of the study and nature of the procedure
6. Patient provides written informed consent prior to any study procedure
7. Patients should either be on a stable dose of Riluzole and/or Radicava® (if
applicable) for at least 30 days, or not be treated with Riluzole and/or Radicava®
8. Patient is medically able to tolerate immunosuppression regimen
9. Presence of a willing and able caregiver who understands the need to attend all
follow-up visits, even if mobility declines
Main Exclusion Criteria:
1. Patient has a past infection or a positive test for HBV,HCV or HIV
2. Patient is in need of respiratory support
3. Patient has a lower than 10/12 in ALS-FRS-R respiratory parameters or below 70% of
predicted slow vital capacity (SVC)
4. Patient has renal failure
5. Patient has impaired hepatic function
6. Patient has a Body Mass Index (BMI) of <18.5 or > 30
7. Patient suffers from significant cardiac disease, diabetes, autoimmune diseases,
chronic severe infection, malignant disease or any other disease or condition that may
risk the patient or interfere with the ability to interpret the study results
8. Patient has systemic inflammation or active infections
9. Patient has been treated previously with any stem cell therapy
10. Current use of immunosuppressant medication or use of such medication within 6 weeks
of Screening visit (Visit 0)
11. Patient has participated in another clinical treatment trial or received other
experimental medications outside of a clinical trial within 1 month prior to start of
this study
12. Any known immunodeficiency syndrome
13. Any concomitant disease or condition limiting patient safety 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.
Subject must be at most 70 Years | A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT03482050 | Entailment |
5,998 | 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:
1. Male or female
2. Age of 20-60 years
3. Suffered from heartburn with or without acid regurgitation
Exclusion Criteria:
1. Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus
2. previously underwent the esophagus, stomach or duodenum surgery
3. Lactating women or pregnant women
4. patients with severe 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 | The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD) | NCT02255071 | Entailment |
96 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Men greater than or equal to 65 years old
- Total serum testosterone concentration < 275 and < 300 ng/dL at 7 -10 AM at each of
two screening visits
Exclusion Criteria:
- Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule
or, by the Prostate Cancer Risk Calculator, a >35% risk of having overall prostate
cancer or >7% risk of having high grade prostate cancer
- Severe lower urinary tract symptoms (score of > 19) by the International Prostate
Symptom Score questionnaire
- Hemoglobin <10 g/dL or >16.0 g/dL
- Sleep apnea, diagnosed but untreated
- Alcohol or substance abuse within the past year (based on self report)
- Angina not controlled by treatment
- NYHA class III or IV congestive heart failure
- Myocardial infarction within the previous 3 months before entry
- Stroke within the previous 3 months before entry
- Severe pulmonary disease that precludes physical function tests
- Serum creatinine >2.2 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c >8.5%, TSH >
7.5mIU/L
- Diagnosis or treatment for cancer within the past 3 years, with the exception of
nonmelanotic skin cancer
- Body mass index (BMI) >37 kg/m2
- Mini Mental State Exam (MMSE) Score <24
- Major psychiatric disorders, including major depression (PHQ-9 score > 14), mania,
hypomania, psychosis, schizophrenia or schizoaffective disorders, that are untreated,
unstable, have resulted in hospitalization or medication change within the previous
three months, or would result in inability to complete the trial efficacy instruments.
Subjects whose disorders have been stable while being treated for more than three
months are eligible.
- Use of the following medications within the previous three months:
- drugs that affect serum testosterone concentration
- rhGH or megestrol acetate
- introduction of anti-depressant medication
- daily use of prednisone for more than two weeks
- Opiate use within the past three months
- Skin conditions at the testosterone gel application site, such as ulcer, erosion,
lichenification, inflammation, or crust, or generalized skin conditions such as
psoriasis or eczema that might affect testosterone absorption or tolerability of the
testosterone gel
- Known skin intolerance to alcohol or allergy to any of the ingredients of testosterone
gel
Participants in the T Trial may also enroll in the Cardiovascular and Bone Trials if it is
determined that they are eligible based on the specific exclusion criteria.
Male
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| The Testosterone Trials in Older Men | NCT00799617 | Contradiction |
4,324 | 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:
- Patients of either sex aged ≥ 6;
- Clinical diagnosis of cystic fibrosis defined as: (1)Patients preferably registered in
the National Registry of CF (or other documents depending on country legislation); (2)
Evidence of two or more typical pulmonary clinical features observed in CF, e.g.,
persistent colonization/infection with typical CF pathogens, chronic cough and sputum
production, persistent chest radiography abnormalities, airway obstruction, nasal
polyps and/or digital clubbing;
- Positive response in the standard sweat test (sweat chloride concentration ≥ 60 mmol/l
for the standard method or ≥ 80 mmol/L for a microduct technique) documented in the
clinical records and/or gene mutation documented in the clinical records;
- Chronic colonization of P. aeruginosa: presence in a sputum or throat culture of a
minimum of 2 positive samples for P. aeruginosa over the previous 12 months and/or
presence of more than two precipitating antibodies against P. aeruginosa;
- Sputum containing P. aeruginosa susceptible to tobramycin (defined as a zone diameter
≥ 16 mm after testing with 10 µg tobramycin disk or as a minimal inhibition
concentration based on microdilution testing system) as identified by local laboratory
at screening visit;
- Forced expiratory volume in 1 sec (FEV₁) ≥ 40% and ≤ 80% of the predicted normal
value;
- Written informed consent obtained by parents/legal representative according to local
regulations) and by the patient (when appropriate).
Exclusion Criteria:
- Administration of antipseudomonal antibiotic therapy by any route in the previous 4
weeks;
- Evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl);
- Evidence of impaired auditory function (auditory threshold in either ear above 20 dB
at frequencies between 250 and 8000Hz);
- Sputum culture containing Burkholderia cepacia;
- Patients with end-stage lung disease, candidates for heart-lung transplantation;
- History of other clinically significant cardiac, renal, neurological,
gastrointestinal, hepatic or endocrine disease related to cystic fibrosis, whose
sequelae and/or treatment can interfere with the results of the present study;
- Female subjects: pregnant or with active desire to be pregnant, lactating mother or
lack of efficient contraception in a subject with child-bearing potential (i.e.,
contraceptive methods other than rod containing a hormone that prevents user from
getting pregnant and that will be placed under the skin, syringes that contain a
contraceptive hormone, combined birth control pill, i.e., such that contains two
hormones, some intrauterine devices (IUDs) and sexual abstinence). A pregnancy test in
urine is to be carried out in women of a fertile age at screening and at the last
clinic visit;
- Known hypersensitivity to aminoglycosides;
- Patients with evidence of alcohol or drug abuse, likely to be not compliant with the
study protocol or likely to be not compliant with the study treatments;
- Participation in another clinical trial with an investigational drug in the four weeks
preceding the screening visit.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® | NCT00885365 | Entailment |
928 | 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:
- Symptomats of osteoarthritis of the hip or knee for a minimum of six months
- History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs,
acetaminophen, or another analgesic agent on a regular basis (>= three days per week)
for at least three months before the screening visit
- History of positive therapeutic benefit with acetaminophen use for osteoarthritis pain
- History of osteoarthritis pain (moderate, moderately severe, or severe) of the hip or
knee when not taking osteoarthritis analgesic medication
- Must have a pain level of moderate or moderately severe for 24 hours over the previous
24 hours prior to the baseline visit, and at baseline, demonstrate a 20% or greater
increase in the pain subscale score, relative to the score at screening
Exclusion Criteria:
- History of surgery, including arthroscopy, or major trauma to the study joint in the
previous six months before the screening visit
- Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence
radiographic criteria
- Maximum osteoarthritis pain intensity of none, mild or severe experienced over the
previous 24 hours of the baseline visit
- Signs of clinically important active inflammation of the study knee joint including
redness, warmth and/or a large, bulging effusion with the loss of normal contour at
the screening and/or baseline visits
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee | NCT00240786 | Entailment |
5,437 | 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:
- You must be between 18-45 years old
- You have Heavy Periods
Exclusion Criteria:
- You are pregnant
- You are currently using hormonal contraception or hormonal therapy
- You have a history of pelvic inflammatory disease (and have not had a normal pregnancy
since)
- You had an infected abortion within the last three months
- You have abnormal or cancerous cells of the cervix or uterus
- You have an actine infection in your genital organs
- Known or suspected breast cancer
- Active liver disease or tumors
- Allergy to levonorgestrel or norethindrone
- You currently have deep vein thrombosis, pulmonary embolism, or history of these
conditions
- you currently have active or recent (within the past year) arterial thromboembolic
disease (such as a stroke or myocardial infarction) these conditions
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding | NCT01391052 | Entailment |
6,689 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Participants with hemophilia A and FVIII activity <1% or hemophilia B with FIX
activity <2%
- Participants must be currently without inhibitors or with low titer inhibitors
(inhibitor titer < 5 Bethesda units) who are receiving current on demand treatment
with any FVIII or FIX (recombinant or plasma-derived; modified or unmodified)
Exclusion Criteria:
- History or at risk of developing diseases related to venous thromboembolic events
(e.g., pulmonary embolism, deep vein thrombosis or thrombophlebitis)
- History of any other clinically relevant coagulation disorder (particularly
disseminated intravascular coagulopathy or combined FVIII/Factor V deficiency) or
platelet disorder
- History or at risk of developing cardiac, coronary and/or arterial peripheral
atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial
infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive
heart failure, angina pectoris, treatment for angina pectoris or uncontrolled
hypertension
- History or at risk for thrombotic microangiopathy
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia | NCT03996486 | Contradiction |
2,230 | 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:
- Males or females at least 18 years of age who have acute 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.
| A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED) | NCT00142558 | Entailment |
2,084 | 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. | No eligibility criteria
Male
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Idiopathic Pulmonary Fibrosis--Pathogenesis and Staging - SCOR in Occupational and Immunological Lung Diseases | NCT00005317 | Entailment |
3,088 | 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:
- Aged between 10 et 45 years old
- BMI > 18.3
- Molecular diagnosis of FXS
- Accompanied by his legal tutor
Exclusion Criteria:
- Pregnancy/Breastfeeding
- Intolerance to metformin
- History of lactic acidosis
- Gastric/renal/hepatic pathology
- Acute medical condition
- Concomitant use of ACE inhibitors
- Modification of antipsychotic treatments in the last 6 weeks
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 45 Years | Metformin in Children and Adults With Fragile X Syndrome | NCT03722290 | Entailment |
5,376 | 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:
- Anybody suitable for novasure ablation
Exclusion Criteria:
- Mirena IUS is indicated as treatment
Female
Accepts Healthy Volunteers
| RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia | NCT01965587 | Entailment |
929 | 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 suffering from osteoarthritis of the hands according to the ACR criteria
Exclusion Criteria:
- Patients suffering from any other rheumatological disease other than osteoarthritis
- Patients that have been treated with mud-pack therapy and balneotherapy in the last 9
months
- Contraindications to mud-packs and balneotherapy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand | NCT00773682 | Entailment |
446 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Patients with history of previous one caesarean delivery
- Patients who refused trail of vaginal birth after caesarean section
- Patients with permanent indication for caesarean section like contracted pelvis
- Patient without any history of medical diseases
Exclusion Criteria:
- Patients with history of more than one previous caesarean delivery
- Patients with medical disorders complicating pregnancy kike preeclampsia and
gestational diabetes mellitus
- Patients with known uterine abnormalities eg (Bicornuate uterus, Adenomyosis,
Submucous fibroids and Myotonic dystrophy)
- Patients who are candidates for vaginal birth after caesarean section
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Risk Factors for Occurrence of Placenta Accrete Spectrum Following Primary Cesarean Delivery | NCT04264169 | Contradiction |
641 | 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:
- Stable idiopathic pulmonary arterial hypertension (stable disease for at least 3
months)
- iron deficiency (serum iron below 10 μmol/l, decreased transferrin saturation (< 15%
in females and < 20% in males) and serum ferritin < 100 μg/l) irrespective of the
coexistence of anaemia
Exclusion Criteria:
- Current iron therapy (oral or iv)
- Current other study medication for PAH
- History of anaemia or current treatment for anaemia
- Liver function impairment
- Chronic disease other than PAH (rheumatism, asthma, chronic infection)
- Acute infection
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.
| Iron Deficiency In Pulmonary Hypertension | NCT01288651 | Contradiction |
4,329 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
1. Male subjects in the range of age from 18 to 55 years.
2. Body weight within ± 15% of ideal weight as related to height and body frame according
to Life Insurance Corporation (LIC) Chart. (Appendix A)
3. Subjects with normal findings as determined by baseline history, physical examination
and vital signs (blood pressure, pulse rate, respiration rate and axillary
temperature).
4. Subjects with normal findings as determined by Haemogram with ESR,
Biochemistry,Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and
Urinalysis, ECG, X-ray (X-ray if taken).
5. Willingness to follow the protocol requirement as evidenced by written, informed
consent.
6. Agreeing to, not using any medication prescription and over the counter medications
including vitamins and minerals for 14 days prior to study & during the course of the
study.
7. No history or presence of significant alcoholism or drug abuse in the past one year.
8. Non-smokers, ex smokers and moderate smokers will be included. "Moderate smokers are
defined as someone smoking 10 cigarettes or less per day, ex smokers are someone who
completely stopped smoking for at least 3 months."
Exclusion Criteria:
1. Requiring medication for any ailment including enzyme-modifying drugs in the previous
28 days, before day 1 of dosing.
2. Any medical or surgical conditions, which might significantly interfere with the
functioning of gastrointestinal tract, blood-forming organs etc.
3. History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary,
neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or
psychiatric diseases.
4. Participation in a clinical drug study or bioequivalence study 90 days prior to
present study.
5. History or presence of malignancy or other serious diseases.
6. Refusal to abstain from food for at least ten (10) hours prior to administration of
the study drug and for four (4) additional hours each, post dose during each study
period.
7. Any contraindication to blood sampling.
8. Refusal to abstain from water for at least one (1) hour prior to study drug
administration on dosing day of each study period and for at least two (2) additional
hours, post dosing except 240 mL administered during administration of the dose.
9. Use of xanthine-containing beverages or food and grapefruit or grapefruit products for
48 hours prior to each drug dose.
10. Blood donation 90 days prior to the commencement of the study.
11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
12. Subjects having contradiction or hypersensitivity to Tacrolimus or related group of
drugs or any excipients of the products.
13. Refusal to abstain from smoking or consumption of tobacco products 24 hours before
dosing until last sample collection of each period.
14. Found positive in Breath alcohol test done at the time of screening or on the day of
enrollment for each study period or for every ambulatory sample.
15. History or presence of problem in swallowing tablets or capsules.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fasting Condition | NCT01080482 | Contradiction |
639 | 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 between 20 and 35 yo
- BMI between 18 and 30
- Ferritin < 50ug/l
- Transferrin saturation < 20 if ferritin between 20 and 50ug/l
Exclusion Criteria:
- high level athlete
- blood donation within 6 months before the study
- liver disorder
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Impact of Iron Injection on Blood Donation | NCT03014921 | Contradiction |
6,796 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male or female
- Regardless of age
- No inhibitor (anti-FVIII alloantibodies) at the time of treatment.
- No objections expressed to participate in the study after having been informed of its
purposes and the data involved.
- No other inherited hemorrhagic disorders than HA
Exclusion Criteria:
In order to reflect the reality of daily practice, no criteria for non-inclusion are
provided for other than the refusal of the patient or his or her legal representative to
participate in the study or the existence in the patient of a contraindication to the use
of turoctocog alfa (NovoEight®) 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.
| Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery | NCT04808349 | Entailment |
2,138 | 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 greater than 18 years of age;
- Previously met the preliminary criteria of the American Rheumatism Association (ARA)
for the classification of the acute arthritis of primary gout;
- At least 2 gout flares in the year prior to the screening visit.
Exclusion Criteria:
- Acute gout flare within 2 weeks of the screening visit and during screening;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the screening visit.
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.
| Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares | NCT00610363 | Contradiction |
6,596 | 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 hemophilia A with inhibitors (Inhibitor titer; >0.5 Bethesda U/ml)
- Patients with agreement consents with the patients signatures
Exclusion Criteria:
- Patients that do not fill the conditions described above
Male
No healthy subjects accepted to join the trial.
| Basic Study of Combination Therapy Based on APCC-induced FVllI Activation in Hemophilia A Patients With Inhibitors | NCT02554526 | Contradiction |
3,981 | 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:
- Subjects aged 35 to 75, male or female
- Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee
according to the modified criteria of the American College of Rheumatology 17,18
- Subjects who present with osteoarthritis of the knee as judged by symptoms and
disabilities detectable through published, validated questionnaires or previous
diagnosis by a physician
- subjects who are symptomatic with daily or near daily pain and stiffness from
osteoarthritis
- subjects who are taking non-steroidal anti-inflammatory drugs (NSAIDs) prior to study
enrollment
- subjects who are willing to stop NSAIDS and use acetaminophen for pain management
during the trial
- subjects with screening WOMAC osteoarthritis index total score (transformed score) of
not more than 75
- subjects with ability to comprehend and complete the questionnaires and forms
- subjects whose schedules permit clinical evaluations every four weeks
- subjects who are willing to stop taking calcium supplements, if any and to restrict
consumption of high calcium food to 600mg (two dairy servings) per day
- subjects with a high probability of compliance with study procedures and test article
consumption
- subjects willing and able to follow protocol guidelines and schedules and complete
diaries
- subjects who are likely to abstain from taking unathorized supplements or
participating in any other clinical trial or experimental treatment during this trial
- subjects with normal gastrointestinal digestion and absorption
Exclusion Criteria:
- subjects who have a history of inflammatory arthritis, gout, pseudogout, Paget's
disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled
hypertension, unstable cardiovascular disease, active hepatic or renal disease, active
cancer and/or HIV infection
- subjects who are non-ambulatory or bedridden due to osteoarthritis
- subjects who are dependent on prescription drugs to control pain
- subjects on any other clinical trial or experimental treatment in the past 3 months
- subjects who are pregnant, lactating or at risk of becoming pregnant
- subjects who have received : intramuscular corticosteroid injection or systemic
corticosteroid administration within 4 weeks prior to study enrollment,
intra-articular corticosteroid injection within 2 months prior to study enrollment or
intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 75 Years | Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee | NCT00755482 | Entailment |
1,588 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. a FHT patient at one of the FHT sites selected and is 60 years or older;
2. physical capability to use a tablet and/or a caregiver who can use the tablet on their
behalf;
3. ability to read and write in English and/or the availability of a caregiver who can do
so on their behalf;
4. has complex care needs defined as two or more chronic conditions and 10 or more visits
to their primary health care provider within the last 12 months; and
5. be thinking about or ready to make changes to support their self-management.
In addition patients can self-identify and join the study, as well as providers can
identify other patients they feel fit our eligibility criteria that may not have been
pulled from the EMR system. This allows eligible patients to enroll into the study that may
have been missed when identifying patients through the EMR system.
Exclusion Criteria:
1. Absence of Inclusion Criteria
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
| Electronic Patient Reported Outcome (ePRO) Mobile Application Pragmatic Trial | NCT02917954 | Contradiction |
265 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Age 18-35
- BMI > 30kg/m2
- Proof of a normal breast and pelvic exam within last 9 months
- Self reported normal menstrual periods (24-35 days)
- Good general health
- In the investigator's opinion, are subject's veins suitable the repeat blood draws
dictated by study protocol
- Single progesterone level during screening visit ≥ 3ng/mL
- Hematocrit ≥ 36%
Exclusion Criteria:
- Contradictions to COCs (history of deep vein thrombosis,myocardial infection,
uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke,
migraines with neurologic changes, breast cancer, impaired liver function,
uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
- Smoker (must smoke 0 cigarettes)
- Actively seeking/involved in a weight loss program
- Currently pregnant/seeking pregnancy in the next 6 months
- Currently breast-feeding
- Past or current diagnosis of polycystic ovarian disease
- Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants:
6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6
months)
- Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St.
John's Wort)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Oral Contraceptives and Body Mass Index | NCT01170390 | Contradiction |
4,337 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Documented stable refraction for at least 1 year(within 0.5D)
- Best spectacle-corrected visual acuity (BCVA) of 20/40 or better
- Clear central cornea
- -0.5D to -18.0D of myopic refractive error
- Normal anterior chamber depth at least 2.8 mm to endothelium
- Endothelial cell density (ECD) more than 2000 cell/mm2
- Pupil diameter smaller than 7.0 mm under mesopic condition
- Discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear
Exclusion Criteria:
- Preexisting ocular diseases or conditions other than myopia, evidence of progressive
or acute ocular disease
- Evidence of connective tissue disease or other systemic diseases that may confound the
results of the study;
- Narrow angle of anterior chamber
- Pregnant, lactating, or planning to become pregnant during the course of the trial
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation | NCT03059043 | Contradiction |
6,093 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Under 7 months of age
- Trisomy 21
- Live in recruitment Area-i.e. London inside M25, in West Midlands or SW England.
- One parent speaks English
Exclusion Criteria:
- No life threatening cardiac disease
No condition on gender to be admitted to the trial.
Subject must be at most 7 Months | Vitamins and Minerals for Children With Downs Syndrome | NCT00378456 | Entailment |
1,365 | 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:
- Male or female subjects at lest 18 years or older with pain.
- Subjects must report constipation caused or aggravated by opioids.
Exclusion Criteria:
- Females who are pregnant or lactating.
- Subjects with evidence of significant structural abnormalities of the gastrointestinal
(GI) tract (e.g. bowel obstruction, strictures).
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.
| Oxycodone-naloxone in Relieving Opioid-related Constipation | NCT00412152 | Contradiction |
1,553 | 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 who have suffered ligamentous injuries to their wrists and have been referred
to the principal investigator
- subject selected to undergo surgery
- The ethnicity and racial makeup of the group is similar to the demographics of the
surrounding referral base
- There will be no exclusion of any gender, racial or ethnic group
Exclusion Criteria:
- Pregnant women will not be included because of increased anesthetic risks at surgery.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
Subject must be at most 50 Years | Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability | NCT00657072 | Contradiction |
4,082 | 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: all Atahualpa residents aged 40 years or more -
Exclusion Criteria: persons not signing the informed consent form
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Sleep Disorders and Their Cardiovascular Correlates in Atahualpa. | NCT01877616 | Entailment |
3,550 | 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:
- Previously diagnosed (e.g. more than 6 months ago) primary or secondary adrenal
insufficiency with a stable daily glucocorticoid substitution dose for at least 3
months prior to study entry
- Signed informed consent to participate in the study
Exclusion Criteria:
- acute primary or secondary adrenal insufficiency
- clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,
hepatobiliary, pancreatic disease
- clinically significant renal dysfunction
- any medication with agents which could interfere with glucocorticoid kinetics
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM) | NCT02277587 | Entailment |
5,779 | 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:
- Speak English
- Have a symptomatic form of the disease.
- Are at least 18 years of age.
Exclusion Criteria:
- Known or suspected sensitivity to non-steroidal anti-inflammatory medication
- History of asthma
- History of gastrointestinal ulceration
- History of bleeding disorders
- Use of anti-inflammatory agents in the last 24 hours
- Use of systemic steroid medication in the last 14 days.
- Pregnancy
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.
| Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions. | NCT03509675 | Contradiction |
4,730 | 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:
- Receiving an injection with a needle
- Able to score the pain on a scale of 0-10 using the universal pain assessment tool,
preferably 7 years of age or older
Exclusion Criteria:
- Current pregnancy
- Inability to understand and carry out instruction
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Pain Blocking During Drug Administration or Blood Collection With Needles | NCT01166906 | Entailment |
6,668 | 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 patients with liver cirrhosis caused by HIV/HCV co-infection that fall under
the following 1) and 2).
1. HIV-RNA positive in serum or HIV antibody positive patients (the amount of HIV-RNA in
the blood at the time of screening is less than 200 copies/mL, and the number of CD4
positive T lymphocytes can be maintained at 200/micro L or more).
2. HCV-RNA positive in serum or HCV antibody positive patients (regardless of the amount
of viral and treatment).
2. Patients with Child-Pugh class A or B.
3. Patients who meet at least one of 1) to 3) for diagnosis of liver cirrhosis.
1. FIB-4 index value is 3.25 or higher.
2. Liver hardness value by FibroScan is 11.8 kPa or more.
3. Abdominal CT scan shows changes in liver shape and/or portal hypertension symptoms.
4. Patients who meet any of 1) to 3) for anti-HCV therapy.
1. Patients who have not reached the sustained virological response (SVR) * with the
direct acting antivirals (DAA) therapy. * SVR shall be as SVR12 (persistent virus
negative at 12 weeks after the end of administration).
2. Patients who have difficulty in performing DAA therapy.
3. Patients who have passed 24 weeks or more after achieving SVR* with DAA therapy or IFN
therapy.
5. Patients with Performance Status 0-2.
6. Male patients aged 20 to under 75 at the time of obtaining written consent.
7. Patients who provided voluntary written consent to participate in this clinical trial.
Exclusion Criteria:
1. Patients who have cirrhosis due to causes other than HCV, and patients whose cause of
cirrhosis is unknown.
2. Patients with esophagogastric varices who are judged to require treatment by endoscopy
at the time of screening.
3. Patients with complication or with previous history of primary liver cancer (excluding
patients who have been for more than 1 year after hepatoma removing operation or
radiofrequency ablation etc.).
4. Patients with complication or with previous history of malignant tumor (within 3 years
before screening).However, except for the following diseases: treated basal cell
carcinoma, treated lung carcinoma in situ, or well-controlled superficial
(non-invasive) bladder cancer.
5. Patients with active AIDS index disease requiring treatment.
6. Patients for whom HBV, HTLV-1 active viral infection or syphilis infection cannot be
ruled out.
7. Serum creatinine level: Patients over 1.5 times the upper limit of the facility
reference value.
8. Patients with complications with uncontrolled diabetes, hypertension or heart failure.
9. Patients with psychiatric disorders that may affect the conduct of clinical trial.
10. Patients with or have a history of serious allergies to contrast agent.
11. Patients who have not passed the following period at the time of registration and
after the end of anti-HCV therapy.
- IFN preparation 12 weeks after the last administration
- Ribavirin preparation 16 weeks after the last administration
- 16 weeks after the last administration of DAA
12. Patients whose dosage and administration have been changed within 12 weeks prior to
registration if the following treatments have been given.
- Liver cirrhosis
- HIV
13. Patients with a history of drug or alcohol intoxication within 5 years prior to
obtaining written consent, or patients with a history of drug or alcohol abuse within
the last 1 year.
14. Patients who participated in other clinical trials within 30 days before obtaining
written consent and used or had used investigational drugs or investigational medical
devices.
15. Patients who have undergone liver transplantation or other organ transplantation
(including bone marrow transplantation) and patients who have difficulty in
intravenous administration.
16. Male patients who do not consent to contraception from the time of consent acquisition
to 12 weeks after the end of study drug administration.
17. In addition, patients who are judged by the investigator or sub-investigator to be
ineligible for this study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 74 Years | Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV With Hemophilia. | NCT04688034 | Contradiction |
6,654 | 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. Severe hemophilia A (<1% FVIII:C) as documented in medical records
2. Males ≥18 years of age
3. Subjects who have had ≥150 exposure days (EDs) with a FVIII product
4. Written informed consent for study participation obtained before undergoing any study
specific procedures
Exclusion Criteria:
1. Previous participation in this trial
2. Use of an Investigational Medicinal Product within 30 days prior to the first OCTA101
injection
3. History of FVIII inhibitors titre ≥0.6 BU/mL defined by medical records
4. Inhibitors to FVIII (≥0.6 BU/mL) at screening measured by Nijmegen modified Bethesda
method at central laboratory
5. Human immunodeficiency virus (HIV) positive subjects with a CD4+ count <200/mL
6. Clinically significant anemia at screening (hemoglobin <8 g/dL)
7. Presence of any significant comorbidity (at the discretion of the investigator) that
might confound the interpretation of the study data and/or that might put the patient
at undue risk by participating in the trial
8. Any coagulation disorder other than hemophilia A
9. AST or ALT levels >3 times the upper limit of normal
10. Creatinine >120 μmol/L
11. Platelet count <100,000 μL
12. BMI ≥30 kg/m²
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A | NCT04046848 | Contradiction |
6,833 | 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:
- Males with severe congenital Hemophilia A or B defined as <1% FVIII or Factor IX (FIX)
concentration by measurement at the time of screening or from reliable prior
documentation
- For subjects in Cohorts I-IV, I-SC1 and I-SC2; If history of inhibitors is evident,
inhibitor titer of ≥5 Bethesda Units (BU) at screening or prior to screening at any
time from medical records.
- Age: 18 to 65 years of age at screening
- Body mass index (BMI): 18 to 29.9 kg/m²
Exclusion Criteria:
- Subjects with known bleeding disorders (such as von Willebrand factor [vWF]
deficiency, FXI deficiency, platelet disorders, or known acquired or inherited
thrombophilia etc.) other than congenital Hemophilia A or B with or without inhibitors
- History of angina pectoris or treatment for angina pectoris
- History of coronary and/or peripheral atherosclerotic disease, congestive heart
failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as
systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg
even if controlled
- History of thrombophlebitis, venous / arterial thromboembolic diseases (particularly
deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction,
cerebrovascular accident, ischemic heart disease, transient ischemic attack)
- Known or suspected hypersensitivity of the immune system, history of anaphylactic
reaction, known (clinically relevant) allergies, non-allergic drug reactions, or
multiple drug allergies
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors | NCT02571569 | Entailment |
3,006 | 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
- Mental retardation
- Medically stable resident of either Western Carolina Center, Morganton, NC or
Tacachale Community, Gainesville, FL
- Free of sensory deficits
- Ambulatory
- High rate of stereotyped behavior that may co-occur with self-injurious or compulsive
behaviors
Exclusion Criteria
- Poor general health
- Cardiac, hepatic, or renal abnormalities
- Seizure within 4 months prior to study entry (patients on seizure medication who have
not had a seizure within 4 months prior to study entry may participate)
- Tardive dyskinesia
- Akathisia
- Neuroleptic use within 6 months of study entry
- History of sensitivity to ergot alkaloids
- Hypertension
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Repetitive Behavior Disorders in People With Severe Mental Retardation | NCT00491478 | Contradiction |
5,693 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- age 6-12 years
- child is attending one of the selected classrooms
Exclusion Criteria:
- age below 6 or above 12 years
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Years old.
Subject must be at most 12 Years | Body Weight Assessment in Swiss Primary School Children: Trend Analysis Over 10 Years | NCT01572935 | Entailment |
5,763 | 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:
- Diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy, on the basis of physical examination and medical history, vital
signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
Exclusion Criteria:
- Diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within the
3 months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety
disorders
- Currently seeking treatment for nicotine disorders
- On parole or probation
- History of seizures or head trauma with loss of consciousness, brain contusion, or
fracture
- History of significant recent violent behavior
- Blood pressure greater than 150/90
- History of eating disorders
- Pregnant
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 45 Years | Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2 | NCT00136838 | Contradiction |
1,454 | 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:
Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any
other NIH institute protocol can be included for study as well as patients who are admitted
specifically for this protocol.
Those patients at risk for oropharyngeal dysfunction will be screened initially by
completing a self-assessment swallowing questionnaire, and by an interview with staff
and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia
and oral motor impairment on the screening assessment will be considered for the protocol:
Difficulty swallowing food or pills.
Changed swallowing ability.
Coughing or choking when eating.
Shortness of breath during swallowing.
Food backing up into the mouth or nasal passage.
Fever or voice changes after swallowing.
Pain when swallowing.
Unexplained loss of weight.
EXCLUSION CRITERIA:
Patients who are severely demented or severely compromised will be excluded if they do not
have sufficient cognitive ability to follow directions.
Patients who are non-ambulatory will be excluded if they can not be braced or supported
within the fluoroscopy unit.
Highly agitated individuals will also be excluded if they are unable to remain confined in
the equipment.
Infants and children under age 3 will be excluded due to radiation risk on the developing
visual system.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders | NCT00001220 | Entailment |
5,296 | 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 for a minimum of 13 months
- Lumbar spine T-score of 0 to -2.5 (0 to -2.0 if over 60 years old) by Dual Energy
X-ray Absorptiometry (DEXA) (i.e., evidence of normal bone mass or osteopenia)
- Body Mass Index (BMI) between 18 and 32
- Planning to live in the greater New Brunswick, NJ, area for at least 3 years
Exclusion Criteria:
- Radiographically or DEXA-morphometrically proven vertebral or hip fracture
- Conditions requiring routine use of sublingual, transdermal, or oral nitrates
- Significant postmenopausal symptoms that require estrogen therapy
- Metabolic bone diseases other than postmenopausal bone loss (e.g., active
hyperthyroidism, hyperparathyroidism, Paget's disease of bone, etc.)
- Insulin-dependent diabetes mellitus
- Significant migraine headaches
- History of renal calculi
- Cancer within 5 years prior to study entry
- Any condition causing an anticipated life expectancy of less than 3 years
- Failure to maintain 75% to 125% compliance with open-label calcium with vitamin D
regimen during the screening period
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 65 Years | Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women | NCT00043719 | Entailment |
5,258 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
1. Cluster site (hospital) level: Hospitals with no dedicated osteoporosis coordinator
that treat more than 60 patients/year in their Emergency Department and who have a
Telehealth studio.
2. Patient level: Patients 40 years old and over (men and women) presenting with a low
trauma fracture of the hip, forearm and wrist, rib(s), sternum, thoracic and lumbar
spine, shoulder and upper arm, pelvis, lower leg and ankle. Subjects without previous
medication as well as subjects on osteoporosis medication and presenting with a
fracture will be included.
Exclusion Criteria:
1. Hospitals that have an Osteoporosis Strategy fracture clinic coordinator
2. Fractures associated with major trauma; fractures due to malignancy
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.
| Osteoporosis Coordinator for Low Volume Community Hospitals | NCT00511693 | Entailment |
6,931 | 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:
For all groups:
- Female and male subjects aged 40 to 85 years.
- Dated and signed informed consent by the subject (or its legal representative if
applicable in accordance with the local regulations).
- AD, NAD patients and control subjects will be age-matched and mean age similar in the
three groups.
- Able to comply with all study procedures.
For AD group:
- Diagnosis of AD: typical and atypical AD.
- MMSE score (measured in the last 3 months): < 21 for patients with moderate to severe
AD. MMSE score > 21 in subjects with mild AD with sporadic or a familial form of AD
due to mutation in APP or PSEN1 or PSEN2 genes.
- FCSRT, MoCA tests (MoCA measured in the last 3 months).
- Neuroimaging compatible with a diagnosis of AD:
- At least quantitative volumetric structural MRI: volumes of hippocampus and
cortical areas.
- Visual semi-quantitative MRI if practiced shall show medial temporal lobe atrophy
(MTA) and parietal atrophy with visual rating (semi-quantitative) on the
MTA-score (e.g. Scheltens' scores 0-4). MTA score must be ≥ 2 in patients aged
40-75 years and ≥ 3 in patients aged above 75 years. For patients younger than 60
years, and with familial form of AD, who may have normal MTA-scores, Koedam score
(0-3) for Parietal Atrophy showing atrophy of the precuneus characteristic of AD
may be used with a Koedam score from 1 to 3.
Other neuroimaging data (retrospectively available) including PET Amyloid scan and FDG PET
are desired if practiced by clinical centres and if available.
- Cerebrospinal fluid biomarker data (retrospectively available) showing positive levels of
at least 2 out of 3 biomarkers: i.e. Aβ1-42 and tau (phosphorylated-Tau and/or total-Tau).
Note: If retrospective CSF data are not available, retrospective Aβ PET and Tau PET data
can be used.
For NAD group:
For all patients of the group NAD, except PSP subgroup (when PSP has a clear-cut typical
phenotype, sometimes called Steele-Richardson phenotype), the CSF biomarker data must show
levels for CSF biomarkers Aβ1-42, phosphorylated-Tau and total-Tau, compatible with the
respective NAD subgroup. If retrospective CSF data are not available, retrospective Aβ PET
and Tau PET data can be used.
Fronto-temporal dementia (FTD)
- Diagnosis of probable behavioural FTD (bvFTD) for all subjects of this FTD subgroup,
whether with familial or non-familial forms. If with familial form, the subject must
be a member of family with a known mutation in one of the FTD related genes: MAPT,
PGRN. The predominant phenotype in the kindred must be cognitive/behavioural (i.e.
kindred in whom Parkinsonism or Amyotrophic Lateral Sclerosis is the predominant
clinical phenotype among affected relatives is excluded).
- Centrally rated frontal and/or anterior temporal atrophy score of 2 or greater on
brain MRI.
- MMSE score compatible. If currently taking an acetylcholinesterase inhibitor and/or
memantine, the subject must have been taking such medication(s) for ≥3 months.
Dementia Lewy body (DLB)
- DLB should be diagnosed when dementia occurs before or concurrently with Parkinsonism.
- Patients diagnosed with probable DLB. Probable DLB can be made with the presence of
two core features out of the following:
- Fluctuating cognition with pronounced variations in attention and alertness,
- Recurrent visual hallucinations that are typically well formed and detailed,
- Spontaneous features of Parkinsonism.
Probable DLB is diagnosed with the presence of one or more of the above core features and
one or more of the following suggestive features. Probable DLB should not be diagnosed on
the basis of suggestive features alone:
- REM sleep behaviour disorder,
- Severe neuroleptic sensitivity,
- Low dopamine transporter uptake in basal ganglia demonstrated by SPECT or PET imaging
(if data retrospectively available).
Supportive diagnosis:
- Generalized low uptake on SPECT/PET perfusion scan with reduced occipital activity (if
data retrospectively available),
- Abnormal (low uptake) MIBG myocardial scintigraphy,
- Prominent slow wave activity on EEG with temporal lobe transient sharp waves.
- MRI: Relative preservation of medial temporal lobe structures on CT/MRI scan.
- Clinical Dementia Rating (CDR) score is greater than or equal to 0.5.
- MMSE score compatible.
- Patients with familial forms caused by mutation in genes SNCA, SNCB.
Parkinson's disease dementia (PDD)
- Subjects with Parkinson's Disease Dementia (PDD) must have dementia after (not before)
developing Parkinson's disease (PD).
- PD is diagnosed by the 3 typical PD symptomatic findings:
- tremor,
- rigidity, and
- slowed movement (bradykinesia).
- Subjects with dementia and with LRRK2 gene mutation (or with mutation in one of the
following genes: PARK2 or SNCA, VPS35, PINK1, DJ1, ATP13A2, FBX07, SLC6A3, TAF1 are
also included.
- L-DOPA responsive (a good response to levodopa as practiced by clinical investigator,
retrospectively to the study).
- MMSE score < 21 for moderate to severe PDD and > 21 for mild PDD.
- MRI: evidence of relevant structural abnormality (i.e. basal ganglia for Parkinsonism
and potentially medio-temporal or cortical findings that may be related to dementia).
Functional imaging techniques such as fluoro-dopa PET, FDG PET or SPECT to document
the presence of dopaminergic dysfunction if retrospectively available.
Progressive Supranuclear Palsy (PSP)
- Diagnosis of probable or possible PSP as defined by the National Institute of
Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy
(NINDS-SPSP) diagnostic criteria, and as summarized by Armstrong et al. (2013) for the
conclusions on CBD criteria from an international consortium of behavioural neurology,
neuropsychology, and movement disorders specialists):
- Gradually progressive disorder,
- Onset at age 40 or later,
- Vertical (upward or downward gaze) supranuclear palsy and prominent postural
instability with tendency to fall in the first year of disease onset,
- No evidence of other diseases that could explain the foregoing features, as
indicated by mandatory exclusion criteria.
- Brain MRI at Screening consistent with PSP: neuroradiologic evidence of relevant
structural abnormality in the midbrain and frontal lobes (i.e. basal ganglia, lobar
atrophy).
- MMSE score compatible.
- Be able to ambulate and stand unassisted for 5 minutes.
- Be able to cooperate with gait and balance testing.
Corticobasal degeneration (CBD)
• Diagnosis of possible CBD. Inclusion clinical criteria for possible CBD, with features of
Cortico-Basal Syndrome (CBS); familial forms related to MAPT included, Progressive
Supranuclear Palsy Syndrome (PSPS) phenotype included.
- Features of CBS: a) limb rigidity or akinesia, b) limb dystonia, c) limb myoclonus
plus 1 of: d) orobuccal or limb apraxia, e) cortical sensory deficit, f) alien limb
phenomena (more than simple levitation).
- Features of PSPS: Three of: a) axial or symmetric limb rigidity or akinesia, b)
postural instability or falls, c) urinary incontinence, d) behavioural changes, e)
supranuclear vertical gaze palsy or decreased velocity of vertical saccades.
Note: subjects with probable sporadic CBD (no familial form) are excluded.
- MRI findings: parietal cortical atrophy (asymmetric).
- MMSE score compatible.
Controls
- Normal cognitive performance with normal scores of neuropsychological tests for their
age.
- MMSE >26 (performed in less than 3 months).
- At least volumetric structural MRI with normal findings. Normal retrospective finding
in β-amyloid PET scan, FDG PET scan if practiced by clinical centres.
- If retrospectively available, normal CSF biomarkers concentrations: negative levels
for all three CSF biomarkers Aβ1-42, phosphorylated-Tau and total-Tau.
- If retrospectively available, Aβ PET and/or Tau PET scan(s) shall be negative.
- Able to comply with the study procedures.
EXCLUSION CRITERIA for all subjects:
The following exclusion criteria apply to all subjects:
- Neutropenia (Neutrophils: < 1,500/mm3 according to ethnic group).
- Thrombocytopenia (platelets: < 100,000/mm3, rule out EDTA-induced
pseudo-thrombocytopenia).
- Subjects with less than an elementary education are excluded.
- Subject with no medical insurance are excluded in the countries where medical
insurance is mandatory such as in France. In the countries where medical insurance is
not mandatory, subjects with no medical insurance may not be excluded.
- Psychiatric history: schizophrenia, psychosis.
- Vascular dementia.
- Infection diseases, chronic inflammatory diseases that affect blood cells, patients
with an active infection/ immunosuppressive disorders/ treatment with
immunosuppressive or immunomodulatory medication.
- Current malignancy or past diagnosis of malignancy affecting blood cells under
treatment or with treatment stopped only during last 3 months.
- Medication interfering with cognitive functions and ADDIA biomarkers (i.e. kinase
inhibitors and beta-amyloid and tau passive and active immunizations).
- Major sensory deficits that could interfere with cognitive assessment (visual and
auditory).
- Epilepsy.
- Patients with known contraindication for MRI imaging such as MRI-incompatible stent or
MRI-incompatible endoprosthesis.
EXCLUSION CRITERIA for AD group
- Mixed dementia.
- Vascular dementia.
- Other dementia type.
- Other neurodegenerative disease.
- Absence of CSF biomarker data and/or amyloid PET data is an exclusive criterion for
all subjects with sporadic forms of AD, but it is not an exclusive criterion for
subjects with a familial form of AD that is due to a mutation of a gene among APP,
PSEN1, PSEN2.
EXCLUSION CRITERIA for NAD group
- AD diagnosis.
- Mixed dementia.
- Vascular dementia.
- Absence of either CSF biomarker data or amyloid PET data is an exclusive criterion for
all subjects in sporadic DLB, PDD, FTD and CBD (but not for subjects with PSP when PSP
has a clear-cut typical phenotype, sometimes called Steele-Richardson phenotype).
However, absence of CSF biomarker and/or amyloid PET data is not an exclusive
criterion for subjects with a familial form of NAD that is due to a mutation of a gene
among MAPT, PGRN, SNCA, SNCB, PARK2 or SNCA, VPS35, PINK1, DJ1, ATP13A2, FBX07, SLC6A3
or TAF1, TREM2.
EXCLUSION CRITERIA for Control group
- AD patients.
- Dementia patients.
- Cognitive impairments.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 85 Years | ADDIA Proof-of-Performance Clinical Study | NCT03030586 | Entailment |
5,494 | 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:
- Written consent
- Patient with GCA, defined by the following criteria (collected at the time of
diagnosis of GCA):
- Age ≥ 50 years old
- AND sedimentation rate VS ≥ 50 mm/h or C-reactive protein CRP ≥ 20 mg/L (optional
if the temporal artery biopsy (TAB) is positive)
- AND clinical signs of GCA or signs of rhisomelic pseudopolyarthritis (RPP)
- AND positive TAB (granulomatous vasculitis lesions) OR evidence of vasculitis of
large vessels (aorta or supra-aortic trunks) by angio-TDM, PET-scanner and/or
angio-MRI.
- CRP elevation >10 mg/L on at least one occasion during the 6 weeks prior to inclusion
- Relapse treatment initiated less than 4 weeks ago
- Patient with GCA relapse at a dose of prednisone ≤ 20 mg/d and who has received at
least 12 consecutive weeks of corticosteroid therapy since the diagnosis of GCA.
Relapse is defined as the reappearance of clinical or radiological sign(s) of GCA
after a remission phase of at least 1 month AND despite well followed treatment:
- headache (> 1 day, not relieved by paracetamol and not identical to headache that
the patient may have had in the past and that is not related to GCA)
- hyperesthesia of the scalp, claudication of the jaws or tongue, anomaly of the
temporal artery
- visual signs related to GCA
- signs of RPP
- non-infectious fever of more than one week
- aggravation, recurrence or appearance of signs of vasculitis of large vessels
with angioscanner, angio-MRI or PET scanner
- any other sign related to the activity of the GCA as determined by the
investigator
Exclusion Criteria:
- Person not affiliated to or not benefiting from a health insurance system
- Weight < 40kg or > 100kg (at inclusion)
- Non-compliant patient
- Adult unable to express consent
- Patient with a psychotic state not controlled by treatment
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person subject to judicial control
- Women who have not gone through menopause
- Hypersensitivity to ustekinumab, to any of its excipients or to any other murine or
human monoclonal antibody
- Latex hypersensitivity (because the packaging of ustekinumab contains latex, which is
only present in syringes)
- Relapse with the presence of obvious ophthalmological signs requiring high-dose
corticotherapy (1 mg/kg and/or methylprednisolone bolus)
- Surgery scheduled within 12 months (excluding low-risk surgery: endoscopy,
bronchoscopy, hysteroscopy, cystoscopy, biopsy or breast surgery, dental care, dental
extractions, eye surgery, outpatient surgery, skin surgery)
- Patient with other autoimmune or auto-inflammatory disease (except RPP, autoimmune
thyroiditis, Addison's disease, type 1 diabetes, Biermer's disease and presence of
autoantibodies without clinical manifestation)
- Neoplasia < 5 years (excluding in situ cervical cancer and skin carcinomas, excluding
melanomas, with healthy margin resections [R0]).
- Patient who has received an organ transplant (apart from a corneal transplant)
- Patient who has received an autograft or hematopoietic marrow allograft
- Unstable or poorly controlled disease, acute or chronic, not related to GCA and
considered by the investigator as a contraindication to ustekinumab treatment
(examples: recurrent infections, ulcers of the lower limbs poorly controlled, unstable
ischemic cardiovascular disease, terminal renal failure, liver failure, heart failure
≥ stage III/IV NYHA, diabetes poorly controlled...).
- Other treatments :
- Patient who has received at least 3 systemic corticoid cures for a condition
other than GCA within the last 6 months (dermocorticoids and inhaled corticoids
are allowed)
- Patient receiving long-term corticosteroid treatment (excluding dermocorticoids
and inhaled corticosteroids) for a condition other than GCA
- Patient currently treated or having received, within 4 weeks, cytotoxic,
immunosuppressive (except methotrexate and azathioprine which should however be
stopped before inclusion), immunomodulatory (except dapsone which should however
be stopped before inclusion) or biotherapic treatment.
- Live vaccine injected within 30 days of inclusion
Infections :
- Chronic (or acute) viral hepatitis B or C
- HIV infection
- Persistent infection or severe infection requiring hospitalization or intravenous
antibiotic treatment within 30 days of inclusion (trial antibiotics, regardless of
duration and route of administration, are not an exclusion criterion).
- Infection requiring oral antibiotic treatment within 14 days of inclusion (trial
antibiotics, regardless of duration and route of administration, are not an exclusion
criterion).
- History of histoplasmosis or listeriosis
- Active tuberculosis
- Sign of latent tuberculosis (based on a history of untreated contagion, an opacity
greater than 1 cm in diameter on chest X-ray, or a positive in vitro test
[QuantiferonR or T-spot-TBR]). A history of tuberculosis disease or latent
tuberculosis whose treatment has been completed and which has been properly conducted
does not constitute an exclusion criterion, regardless of the outcome of the
QuantiferonR or T-spot-TBR.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis | NCT03711448 | Contradiction |
5,499 | 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:
- positive artery biopsy between january 1st 2000 and july 25th 2019
Exclusion Criteria:
- orther vascular biopsy than temporal artery biospy
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.
| Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy | NCT04554290 | Entailment |
4,647 | 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: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two
sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of
the last two menstruations before randomization (baseline observation phase)
- Patients with dysmenorrheic pain during the 2 baseline cycles before randomization.
Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with
possible radiation towards back or thighs recorded in the Patient Diary in
correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start
up to 2 days before the onset of the bleeding episode the bleeding and terminates on
the last day of bleeding of before
- Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two
menses before randomization (baseline observation phase)
- Willingness to use a barrier method (i.e., non-hormonal method) for contraception
during the study. Acceptable methods of contraception include (i) condoms (male or
female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with
spermicide; (iii) intra-uterine device.
Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is
prioritized by the investigator
- Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in
size of the longest diameters
- Patients with ovarian chocolate cysts having solid part in the cyst
- Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese
Labeling)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea | NCT01892904 | Entailment |
6,928 | 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. | Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and
neuropsychological testing. Live at home or in the community and a caregiver capable of
accompanying the patient on all clinic visits and visiting the patient at least 5 times per
week.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease | NCT00021723 | Entailment |
5,078 | 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:
- Adults over 18 years old
- Patients diagnosed with low energy osteoporotic hip fracture, and was treated under
surgery.
Exclusion Criteria:
- Patients not diagnosed with osteoporosis.
- Patients diagnosed with high energy osteoporotic hip fracture.
- Patients that suffered from Multiple Trauma.
- Patients diagnosed with Metabolic diseases or Genetic diseases.
- Pregnant women
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.
| Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture | NCT02223572 | Contradiction |
5,605 | 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:
- Before starting treatment, according to the medical history, clinical symptoms and
signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
- According to the height statistical data of Chinese children's physique
development in nine cities in 2005,height is lower than the third percentile of
growth curve of normal children with the same age and gender.
- Height velocity (HV) ≤5.0 cm/yr.
- GH stimulation test with two different mechanisms affirms that GH peak
concentration of patients' plasma<10.0ng/ml.
- Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than
his/her chronological age (CA).
- Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
- Receive no prior GH treatment within 6 months.
- Sign informed consent.
Exclusion Criteria:
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal
value, Cr> the upper limit of normal value).
- Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen
(HBsAg) or hepatitis Be antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug of the study.
- People with severe cardiopulmonary, hematological and malignant tumors diseases or
general infection and immune deficiency.
- Diabetic.
- Potential tumor patients (family history).
- Abnormal growth and development, such as Turner syndrome, constitutional delay of
growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth
retardation without excluding abnormal chromosome.
- Subjects took part in other clinical trial study within 3 months.
- Other conditions which in the opinion of the investigator preclude enrollment into 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 3 Years old.
Subject must be at most 18 Years | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I) | NCT02380235 | Contradiction |
5,305 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
1. The participant is able and willing to provide informed consent
2. The participant is male or female, 18+
3. The participant has received a diagnosis, from a physician, of primary osteopenia or
osteoporosis (T < - 1.0)
4. The participant can read and write English
Exclusion Criteria:
1. The participant has been diagnosed with secondary osteopenia or osteoporosis
2. The participant has a history of smoking, alcoholism, gastrointestinal disease,
hypercalciuria and/or steroid use.
3. The participant is diagnosed with a reading disability or dyslexia
4. The participant has a cognitive impairment of some severity as to adversely affect the
validity of the data
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Validation, Reliability and Pilot Test of the Personalized Exercise Questionnaire (PEQ) | NCT03125590 | Entailment |
3,471 | 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. | Overweight or Obese subjects with BMI> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin,
receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on
treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological,
neurological, endocrine (other than T2DM) and unstable psychiatric disease.
Men or women. Women of childbearing potential will have a negative pregnancy test before
initiation of medication.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin | NCT02033876 | Entailment |
4,053 | 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:
- Age 45 to 80 years old, inclusive
- Clinical diagnosis of osteoarthritis in one target knee based on the following
American College of Rheumatology (ACR) criteria:
1. Knee Pain
2. At least 1 of 3:
- Age > 50 years
- Morning stiffness lasting < 30 minutes
- Crepitus on motion
3. Osteophytes on radiograph
- Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months
prior to Screening
- Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥
15 days during the preceding month
- Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a
rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as
confirmed by the Sponsor's designated rheumatologist through radiographic review of
x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the
tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional
details)
- Meets pain assessment entry criteria as defined by Sponsor's pain eligibility
algorithm and calculated by the study Interactive Web Response System
- No clinically significant change in physical activity and/or therapy for the past 3
months
- Able to provide written informed consent prior to initiation of any clinical
trial-related procedures; and willing and able, in the opinion of the Investigator, to
comply with all requirements of the clinical trial for the duration of the trial (such
requirements include, but are not limited to: attending all study visits, refraining
from elective surgery or extensive travel during participation)
Exclusion Criteria:
General
- Women of childbearing potential, or men whose sexual partner(s) is a woman of
childbearing potential may not be entered into the study if:
1. They are or intend to become pregnant (including use of fertility drugs) during
the study
2. They are nursing
3. They are not using an acceptable, highly effective method of contraception until
all follow-up procedures are complete. (Acceptable, highly effective forms of
contraception are defined as: oral contraception, intrauterine device, systemic
[injectable or patch] contraception, double barrier methods, naturally or
surgically sterile, strict abstinence or partner has been sterilized. If
hormonal-based birth control is being used, subject or subject's sexual
partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit
and maintained at the same dosing level throughout the 9-week clinical trial.)
- Body Mass Index (BMI) over 40
- A history of osteoarthritis symptoms that are completely non-responsive to
non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator
- Planned change (increase or decrease) in subject's level of physical activity (e.g.,
aerobic or anaerobic exercise) during the 6-week Treatment Period following
randomization
- Enrollment in any trial and/or use of any Investigational Drug or device within the
immediate 30-day period prior to the Baseline visit
- Enrollment in any study previously sponsored by Olatec Industries LLC, specifically
Study OLT1177-01 or OLT1177-02
Pain Related
- Does not meet pain assessment entry criteria as defined by Sponsor's pain eligibility
algorithm and calculated by the study Interactive Web Response System
- Clinically significant joint (other than the knee) or general pain at Baseline, at the
discretion of the Investigator
Musculoskeletal Related
- Clinically significant, excessive effusion heat and/or redness in the target knee as
determined by the Investigator
- Knock-kneed or bow-legged, as defined by a valgus or varus deformity of ≥ 15 degrees
- Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a
rating of Grade 0, 1 or 4 in the target knee, as confirmed by the Sponsor's designated
rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior
to the Screening visit (sharpening of the tibial spine is not considered to be an
osteophyte)
- Documented history of clinically significant pain associated with osteoarthritis of
the spine or hips, at the discretion of the Investigator
- Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or
chondromalacia
- Clinically significant medio-lateral and/or anterior-posterior instability, at the
discretion of the Investigator
- Open surgery of the target knee within the prior year or surgery to the contralateral
knee or other weight-bearing joint within the prior year, if at the discretion of the
Investigator it would interfere with the study. If subject had open surgery more than
one-year prior, Sponsor's designated rheumatologist must confirm that such surgery did
not have any negative impact or consequence to the target knee (e.g., deformity of
angle to the bone, bone on bone, locking joints, etc.)
- Arthroscopic surgery of the target knee within the prior six months
- Any acute or chronic injury, other than osteoarthritis in the target knee, that will
be treated during the trial with any medication not allowed during the Treatment
Period
- Prior surgery of the target knee requiring insertion of a medical device or surgical
hardware (e.g., screws)
- Any major trauma or injury (including sports injuries) to the target knee in the past
12 months
- Documented history of inflammatory joint disease, including but not limited to:
rheumatoid arthritis, gout, pseudogout, Paget's disease, psoriatic arthritis,
ankylosing spondylitis, chronic inflammatory disease (e.g., colitis), fibromyalgia
(diagnosed in accordance with ACR criteria, as applicable), articular fracture,
ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary
osteochondromatosis, heritable disorders (e.g., hypermobility) or collagen gene
mutations
- Any planned interventional and/or surgical procedure during the 6-week Treatment
Period following randomization
Concomitant Conditions, Diseases, Medications/Therapies and Medical History Related
- Any use of Rescue Medication within 24 hours prior to the Baseline visit or use of any
other pain medication within 7 days prior to Baseline visit
- Uncontrolled hypertension, defined as blood pressure ≥ 150/95 mmHg
- A history of uncontrolled and untreated diabetes mellitus with an HbA1c level > 8; or
blood sugar levels that are outside of the normal range and HbA1c level > 8 is
subsequently confirmed
- Any inflammatory skin condition over the target knee application area
- Use of any prohibited concomitant medications/therapies during the 7-day Washout
Period or planned use of any prohibited concomitant medications/therapies during the 6
week Treatment Period
- Use of intraarticular or intramuscular steroids in the target knee within the previous
3 months or in any other joint within the previous 30 days
- Use of intraarticular hyaluronate in the target knee within the previous 6 months or
in any other joint within the previous 30 days
- Current substance abuse or history of chronic substance abuse within the past year, or
prior chronic substance abuse (including alcoholism and/or addiction to pain
medications) that is determined at the discretion of the Investigator as likely to
interfere with trial assessments or recur during the trial
- Use of any systemic (oral or parenteral) corticosteroids within the prior month
- Uncontrolled psychiatric conditions (e.g., mania, depression, anxiety, substance
dependence of any kind) that would impair the subject from safely participating in the
trial, including completing any protocol requirements
- Evidence of cognitive impairment including dementia that may interfere with subject's
ability to complete daily pain diaries requiring recall of average pain level in the
past 24 hours
- Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal,
hematological or neurological disease or prior surgery that may interfere with the
subject successfully completing the trial, including completing any protocol
requirements as determined by the Investigator
- History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or
antibodies to Hepatitis C Virus (HCV)
- Diagnosed with any form of cancer within the past 5 years, except for treated basal
cell or squamous cell carcinoma of the skin
- Any other medical conditions, diseases or prior surgeries that in the opinion of the
Investigator would impair the subject from safely participating in the trial and/or
completing any protocol requirements
- Active infection within 3 days of the Baseline visit
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain | NCT02104050 | Entailment |
5,450 | 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:
- Young adults and adults (15-29).
- Middleastern Caucasian.
- Females.
- Having the defined orthodontic appliance, slot size, prescription, and technique of
space closure.
- Class II division I of moderate space requirement that is planned to have the first
premolar extracted.
- Average or high facial type.
- Healthy patients without systematic diseases that could affect bone and tooth movement
and no contraindication (medical or psychological) to avoid oral surgery.
- No active periodontal diseases as this effect the cytokines expression (stabilized
prostaglandin (PG) health)
- Good oral hygiene.
- No other method of non-surgical acceleration technique to be used.
Exclusion Criteria:
- Patients who refused to consent for the study.
- The two extremes of age (younger than 14 and older than 29).
- Having other than the defined orthodontic appliance, slot size, prescription, and
technique of space closure.
- Extraction cases of high space requirements or other teeth than the first premolar.
- Patients with systematic diseases that could affect bone and tooth movement and no
contraindication (medical or psychological) avoid oral surgery.
- Active periodontal diseases.
- Other methods of non-surgical acceleration technique to be used.
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 29 Years | The Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design | NCT04202016 | Entailment |
3,583 | 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:
1. Subject must provide written informed consent prior to the conduct of any
study-related procedures.
2. Male or female subjects who are at least 18 years of age.
3. Subjects are suspected to have early Lyme disease based on the following criteria:
Signs, symptoms and clinical history consistent with early-stage Lyme disease.
Subjects must have a medical practitioner-diagnosed erythema migrans (EM) rash and
should have systemic symptoms indicative of disseminated infection. Symptoms may
include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute
and convalescent titers will be drawn (first draw at time of initial visit and second
draw 4 weeks later) or,
4. Subjects are suspected to have late Lyme disease based on the following criteria:
Signs, symptoms and clinical history consistent with late stage Lyme disease,
including but not limited to disseminated rash, arthritis, meningitis, facial palsy,
or carditis.
5. Subjects must be willing and have the ability to safely have the required quantity of
blood drawn for the study at the discretion of the investigator.
6. Subjects must have blood samples freshly collected (no supplemental frozen samples)
and the samples must reach ALSI's laboratory on a weekday and within 24 hours of being
drawn.
---
Exclusion Criteria:
1. Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as
being associated with Lyme disease.
2. Exposure to antibiotics of any type during the 6 weeks prior to the initial blood
sample collection.
3. Immune deficiency significant enough to render serological tests less reliable.
4. The subject is unwilling or unable to safely have the required quantity of blood drawn
for this study.
5. Subjects who are not able to understand all of the requirements of the study or unable
to give informed consent and/or comply with all aspects of the evaluation.
6. Subjects that have any other condition or situation which, in the opinion of the
investigator, would make the subject unsuitable for enrollment or could interfere with
the subject participating in and completing the study.
7. Subjects that have undergone testing for Lyme disease within the past year.
8. Subjects that have a prior diagnosis of Lyme 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 Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease | NCT02741609 | Entailment |
95 | 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. | PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Suspected or proven hypothalamic-pituitary-gonadal dysfunction, i.e.: Significant
short stature and possible hypopituitarism Delayed adolescence Precocious puberty
Isolated growth hormone deficiency (IGHD)Primary hypogonadism
- Women are also studied, including those with the following disorders: Infertility
Oligo- or amenorrhea Hirsutism
--Patient Characteristics--
- Age: 7 to 16 (18 to 35 for women and volunteers)
- Other: No pregnant or nursing women No prisoners Not in neuropsychiatric institute or
other facility for mental illness
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 35 Years | Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle | NCT00004335 | Contradiction |
4,157 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Be an admitted patient at Dayton Children's Hospital.
2. Between 7 and 21 years of age.
3. Have a documented CF diagnosis with one or more of the following clinical features:
1. Sweat chloride > 60 mEq/liter as determined by quantitative pilocarpine
iontophoresis test (QPIT).
2. Two mutations (well characterized) in the cystic fibrosis transmembrane
conductive regulator (CTFR) gene.
3. Abnormal nasal potential difference.
4. Based on Hankinson/NHanes III criteria, are able to elicit an FEV1 > 25% but with <
95% predicted value when admitted.
5. Sputum or throat swab specimen positive for P. aeruginosa and have a history of at
least one additional sputum culture positive for P. aeruginosa within the last 12
months.
6. Are able to perform an acceptable spirometry session (defined as 3 acceptable or
usable efforts per ATS/ERS criteria upon admission).
7. Have not smoked tobacco within 28 days prior to Visit 1 and agree not to smoke for the
duration of the study.
8. Are able to and have given written informed consent (if they are adults) or assent in
combination with consent of their legal representative(s) (if they are minors) in a
manner approved by the Institutional Review Board.
9. Patient is experiencing symptoms of CF exacerbation of CF: with any 4 of the following
12 signs or symptoms:
- Change in sputum;
- New or increased hemoptysis;
- Increased cough;
- Increased dyspnea;
- Malaise, fatigue or lethargy;
- Temperature above 38°C;
- Anorexia or weight loss;
- Sinus pain or tenderness;
- Change in sinus discharge;
- Change in physical examination of the chest;
- Decrease in pulmonary function by 10 percent or more from a previously recorded
value;
- Radiographic changes indicative of pulmonary infection.
Exclusion Criteria:
1. History of hypersensitivity or intolerance to meropenem.
2. History of hypersensitivity or intolerance to granisetron.
3. Are pregnant, breastfeeding, or unwilling to practice a highly effective method of
birth control or abstinence during participation 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 7 Years old.
Subject must be at most 21 Years | Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis | NCT02048163 | Contradiction |
3,710 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Osteoarthritis grade 2-3 according to the Kellgren & Lawrence grading scale, as
defined on knee radiographs (less than 3 months old: face view, schuss view, profile
and patellar axial view at 30°)
- Knee Pain level of at least 3 on the 0-10-point WOMAC A subscale
- Bilateral osteoarthritis provided that the contralateral knee has a pain no more than
2 on the 0-10 point scale, and not requiring systemic analgesic treatment except
paracetamol until the maximum dose of 4g per day
Exclusion Criteria:
- Grade <2 or >3 OA according to the Kellgren and Lawrence grading scale
- Bilateral osteoarthritis provided that the contralateral knee has a pain more than 2
on the 0-10 point scale and requiring systemic analgesic treatment or paracetamol more
than 4g per day
- Viscosupplementation in the treatment site in the past 3 months
- Corticosteroid injection in the treatment site in the previous 3 months
- Systematic use of corticosteroid (except those that are inhaled) within 3 months
- History of allergy to hyaluronic acid
- Rheumatological disorders
- Clinical evidence of local inflammation such as redness or heat of the joint
- Current or medical history of autoimmune disease
- Surgery or arthroscopy surgery in the affected knee in the past 3 months
- Local infection in the affected knee
- Hematologic or clotting disorders (thrombocytopenia) or blood coagulation
(deficit-blood dyscrasia)
- Anaemia (Haemoglobin < 10g/dl)
- Platelet count below 150/mmc
- Anticoagulant treatment
- Viral disease (hepatitis, herpes, varicella, zona, etc.)
- Renal failure or hemodialysis
- Acute infection
- Immunosuppressive states
- Malignant disease
- Recent fever (within previous 2 weeks) or serious disorders (liver disease, active
gastroduodenal ulcer, digestive hemorrhage, etc.)
- Pregnancy or breastfeeding or planning pregnancy during the course of the study
- Immunosuppressants within the past 6 weeks or ongoing
- Uncontrolled diabetes
- Participation in another clinical study in the past 3 months
- Ongoing participation in another OA clinical study
- Fracture, skeletal dysplasia, congenital or acquired deformity that affects the knee
- Hemoglobin A1C > 8% within 8 weeks prior to the study treatment
- Have been given the diagnosis of fibromyalagia, neuropathic pain syndrome, or
depression
- Refusal to sign or inability to give Informed Consent
- Inability to understand or comply with the requirements of the study
- Any other reason which may interfere with the proper conduct of the study, in the
investigator's opinion
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis | NCT03201614 | Contradiction |
3,954 | 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. | 40 years and above, both genders, who have clinical and radiographic osteoarthritis
symptomatic for at least six months.
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.
| Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) | NCT00032890 | Entailment |
2,681 | 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:
- all patients referred with inguinal/femoral hernias
Exclusion Criteria:
- • workers Compensation cases
- previous extraperitoneal intervention
- unfit for a general anaesthetic
- strangulated hernias
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 86 Years | A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC) | NCT01883115 | Entailment |
4,931 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. diagnosis of essential tremor based on clinical criteria established by the Essential
Tremor Consortium
2. Moderate or severe axial-dominant (head/neck/voice) tremor (Tremor Rating Scale [TRS]
face, tongue, voice, head or trunk tremor score of 2 or above)
3. May have bilateral appendicular tremor
4. Tremor refractory to at least two medications, including primidone and propranolol
5. Age between 21 and 75
6. Male or Female
7. Significant disability due to essential tremor despite medical treatment (TRS score of
2 or above in any one of the items 16-23 [speaking, feeding other than liquids,
bringing liquids to mouth, hygiene, dressing, writing, working, and social
activities])
Exclusion Criteria:
1. Tremor due to other etiologies
2. Pregnancy
3. Presence of any other neurodegenerative disease
4. Presence of significant cognitive impairment
5. Presence of any medical condition that precludes neurological surgery
6. Patients with another implanted stimulator or metallic implant, e.g. cochlear implant,
cardiac pacemaker, spinal cord stimulator, aneurysm clips
7. Patients who have a known need for future MRIs using a full body radio-frequency (RF)
coil or a head transmit coil that extends over the chest area or that do not comply
with Medtronic's "MRI Guidelines for Medtronic Deep Brain Simulation Systems"
8. Patients with a history of seizures
9. Patients with psychiatric illness that are not well controlled
10. Patients with risk factors for intraoperative or postoperative bleeding (platelet
count less than 125,000 per cubic millimeter, PT and PTT not within normal limits)
11. Patients with brain tumors
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 75 Years | Pre-lemniscal Radiation Deep Brain Stimulation for ET | NCT00634478 | Entailment |
543 | 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 diagnosed to have unexplained infertility aged between 20-35y.
2. Regular menstruation with the length of the cycle between 21-35 days. 3. Ovulation
confirmed by appropriately timed mid-luteal progesterone. 4. Fertile semen variables
(according to world health organization criteria 2010).
5. Bilateral tubal patency (demonstrated by laparoscopy or hystrosalpingography).
Exclusion Criteria: 1- Patients aged less than 20 y. or more than 35y 2- Infertile semen
analysis. 3- Abnormal hormonal profile (FSH level more than 10). 4- Patient diagnosed as
polycystic ovary (PCO). 5- Medical disorders as hypertention,liver and renal diseases. 6-
Endocrinal disorders as hyperthyroidism,hypothyroidism and diabetes mellitus.
7- Pelvic pathology as PID or uterine fibroids. 8- No previous history or planning for IVF.
9- Unwilling to comply with the protocol. 10- Participation in another clinical trial in
the last 3 months prior to the start of this study.
-
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Endometrial Scratching by Pipelle on Pregnancy Rate in Unexplained Infertility | NCT02084914 | Contradiction |
6,327 | 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:
- To be at least 18 years of age
- To come at hospital for SARS-CoV-2 screening
- To be able to receive a nasopharyngeal swab
Exclusion Criteria:
- People under 18 years of age
- Inpatient in intensive care
- Pregnant or breastfeeding woman
- Individual with dry syndrome (Gougerot-Sjögren syndrome)
- Taking treatments that reduce salivary volume (anticholinergic activity)
- People with a COVID-19 diagnosis confirmed by a molecular biology method >7 days ago
- Contraindication to oral swabbing
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19 | NCT04550390 | Entailment |
3,510 | 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:
- Subjects with complete adrenal failure as defined as spontaneous serum cortisol of
levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak
serum cortisol of < 5 g/dl 60 minutes after a 250 g ACTH stimulation test.
- Subjects who are at their usual weight (weight stable for at least 1 year)
- Subjects on stable replacement doses of any required hormone such as thyroid, sex
hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at
least 6 months, and 4) have a normal body weight (BMI 19-27 kg/m2).
Exclusion Criteria:
- Possible confounders on body weight and insulin resistance
- Age less than 18 to exclude those who might be experiencing alterations in cortisol
production or weight as a result of adolescent growth.
- Subjects who exercise > 30 minutes/day, 3 times a week.
- Smokers.
- Heavy alcohol drinkers (> 2 drinks/ day).
- Subjects with medical diagnosis including diabetes, heart disease, and cancer.
- Subjects with psychiatric illness (i.e., depression, psychosis, bipolar,
schizophrenia; or are taking medications for these disorders).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation | NCT00688987 | Contradiction |
4,144 | 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:
- Family with at least one child 2-12 years old.
Exclusion Criteria:
- Not able to fill out questionnaires in Danish
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| The Effectivenes of Family Club Denmark #Strongertogether | NCT03657888 | Contradiction |
5,766 | 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:
- The participants in this study will be male and female (aged over 18 years) diagnosed
with symptomatic oral lichen planus, based on the clinical and histopathological
criteria of the World Health Organization (WHO).
Exclusion Criteria:
- Patients with ongoing cancer; pregnant or breastfeeding women; patients with history
of corticosteroids and nonsteroidal anti-inflammatory treatment in the last one
months, patients with uncontrolled systemic disease; consumption of illicit drugs; use
of medication associated with oral lichenoid reactions; amalgam restoration near to
OLP lesions; epithelial dysplasia in the histopathological examination.
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.
| Photobiomodulation in Oral Lichen Planus | NCT03320460 | Contradiction |
740 | 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 suffering from Arthritis
Exclusion Criteria:
- Patients with Hypertension, Cardiovascular disorders and Kidney disorders were
excluded
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 60 Years | Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine for the Management of Arthritis | NCT03506919 | Contradiction |
3,869 | 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:
- Subjects having at least one or more sign and symptoms of Osteoarthritis like Pain in
joints (at Knee, Hip, Ankle, Elbow and Shoulder), stiffness, difficulty in flexion and
extension, crepitus, swelling etc for more than 3 months prior to the study.
- Pain score of at least 4 cm on a 10-cm linear visual analogue scale.
- Are free of any systemic or dermatologic disorder, which, in the opinion of the
investigator, will interfere with the study results or increase the risk of adverse
events.
- Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation
(natural or artificial) for the duration of the study.
- Are willing to refrain from using any lotions, gel, balm, moisturizer, cleansers,
cosmetics or creams, other than those issued as part of the study, on the treatment
areas during the treatment period.
- If female of childbearing potential, must be willing to practice an acceptable form of
birth control for the duration of the study.
- Are able to give written informed consent in a manner approved by the Institutional
Ethics Committee and comply with the requirements of the study.
- Are willing to avoid participation in any other interventional clinical trial for the
duration of this study.
Exclusion Criteria:
- Are pregnant, breast-feeding, or planning to become pregnant during the study.
- Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis,
Gouty Arthritis.
- Complications of OA, like Pseudogout, Spontaneous osteonecrosis of the knee, Ruptured
Baker cyst, Bursitis, Anserine bursitis (knee)interfere with the disease and
treatment.
- Severe Stomach infection.
- Severely traumatised and/or very severe or mucosal inflammation
- Peritonsillar abscess
- Long term use (≥ 3 times per week within the last month or regular intake within the
last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow
release analgesic intake including Non Steroidal Anti-Inflammatory Drugs
(NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
- Any anti-inflammatory drugs intake by systemic route within 12 hours before
randomization
- Any paracetamol intake within 6 hours before randomisation
- Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6
hours before randomisation
- Heavy smokers (>10 cigarettes/day)
- Have open sores or open lesions in the treatment area(s).
- Have any condition that, in the opinion of the investigator, would confound the safety
and/or efficacy assessments of plaque Arthritis.
- Have participated in any interventional clinical trial in the previous 30 days.
- Have a known sensitivity to any of the constituents of the test product
- Have used, are using, or are planning to use immunosuppressive or immunomodulatory
medication (i.e., biologics), including oral or parenteral corticosteroids.
- Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or
illegal drug/substance abuse in the past 2 years.
- Plan to seek alternative treatment of any kind for their Arthritis, in the eligible
treatment areas or otherwise, during the trial period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years | NGA-01 Gel for the Treatment of Osteoarthritis With Joint Pain | NCT04612283 | Entailment |
5,691 | 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
All subjects will be outpatients.
Patients must be females with Turner's syndrome diagnosed by leukocyte karyotype
Chronologic age greater than or equal to 5 years.
Prepubertal Tanner I status. If breast development is Tanner II or III, demonstration of
castrate status through measurement of serum FSH (greater than 12 MIU/ML).
All patients must be below the 10th percentile for chronologic age.
Patients must have at least 6 months accurate, growth measurements available for
calculation of pre-study growth velocity. Pretreatment measurements must be obtained during
a time when the patient is not receiving a potential growth-promoting agent.
Patients judged to be thyroxine deficient must have replacement which has resulted in
normal thyroid function tests over the three-month period prior to enrollment (T4, T3,
Thyroid Stimulating Hormone).
Patients and/or parents or legal guardians of patients must sign an informed consent
statement. Assent should be obtained from all patients competent to understand the
protocol. Local IRB requirements apply.
EXCLUSION CRITERIA
Patients who have received any form of human growth hormone within the past 3 months, or
who have received a cumulative course of therapy totaling greater than one year.
Patients who have received treatment with estrogen or androgen in the past three months or
who have received a cumulative course of therapy totaling greater than one year.
Patients who have any Y component in their chromosome analysis.
Patients with a chronologic age greater than 12 years.
Patients with a bone age greater than 12 years.
Patients who have clinically significant cardiac, pulmonary, gastrointestinal, hepatic or
renal disease or who have had any malignancy.
Patients who have significant hematuria or proteinuria in pretherapy evaluation.
Patients who have diabetes mellitus.
Patients who have any active chronic infection (tuberculosis).
Patients who are taking amphetamines or any other drugs known to interfere with growth
hormone secretion or actions.
Patients who are poor medical, psychological, or psychiatric risks for whom, in the opinion
of the principal investigator, the investigational drug would be unwise.
Patients whose parents are substance abusers, nor those who come from homes in which
appropriate emotional development may be limited.
Patients who cannot be seen on the schedule required by the protocol.
Female
No healthy subjects accepted to join the trial.
| Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome | NCT00001221 | Entailment |
5,319 | 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:
- Normal, healthy males and females 16 to 40 years of age
- Outpatients who have moderate to severe post-operative pain (confirmed by a Visual
Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS
PSR) following surgical extraction of two or more third molars, at least one of which
must be a partial or complete bony mandibular impaction
- Use of only the following pre-operative medication(s)/anesthetic(s): topical
benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine)
with or without vasoconstrictor and/or nitrous oxide
Exclusion Criteria:
- Pregnancy or breast-feeding
- Alcohol or substance abuse
- Any serious medical or psychiatric disorder
- History of stomach ulcers, stomach bleed, or other bleeding disorders
- Use of a prescription or over-the-counter (OTC) drug with which administration of
ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen
(APAP); or codeine or any other opioid is contraindicated (including: opioids,
antipsychotics, antianxiety agents, or other central nervous system depressants
[including alcohol])
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 40 Years | Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain | NCT01216163 | Contradiction |
3,702 | 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
The following are inclusion criteria for participants:
- Older than 18 years;
- Fluent or native Portuguese language speaker;
- Continuous or intermittent low back pain for at least three months;
- Low back pain with or without irradiation to the gluteal region indicating facet
syndrome (pain is aggravated by spine extension or bending toward the affected side;
pain is exacerbated by prolonged sitting or walking up steps, as well as retaining one
position for a prolonged time);
- Failure of traditional treatment includes, but is not limited to, physical or drug
therapy;
- Understand the purpose of the study;
- Voluntarily provide a free and informed consent form, by themselves or through their
partners, and complete the questionnaires, before undergoing infiltration, over the
telephone or online during the follow-up.
Exclusion criteria
The following are exclusion criteria for participants:
- Younger than 18 years old,
- Symptomatic lumbar spinal stenosis with claudication or radiculopathy;
- Evidence of radiculopathy;
- Active rheumatologic diseases;
- Congenital or acquired deformities of the lumbar spine;
- Fracture or sequel of lumbar spine fracture of traumatic, pathological or osteoporotic
origin;
- Surgical manipulation of the lumbar spine;
- MRI scans of limited quality and incomplete sequences;
- Treated with systemic steroids less than one month before the IFI;
- Treated with IFI with steroids within the last six months;
- Diagnosed with uncontrolled diabetes mellitus;
- History of allergy to anesthetics or adverse reaction to steroids;
- Pregnant women or women who breastfed;
- Who could not be contacted over the phone during follow-up.
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.
| Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study | NCT03304730 | Contradiction |
4,561 | 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:
- BMI ≥ 27 kg/m2
- Willing and able to come to the GCRC 5 days per week to consume a supervised meal and
pick-up food for all other meals
- Available for scheduled hospital admissions
- Willing to abstain from alcohol consumption for the duration of the study
- If female, regular menstrual cycles (defined as 26 to 30 days between cycles; no more
than one day variation in the duration of menstrual flow)
Exclusion Criteria:
- Weight > 350 lbs
- Change in body weight (± 10%) over preceding year
- Taking any medications or dietary supplements that might affect body weight, appetite,
or energy expenditure
- Smoking (1 cigarette in the last week)
- High levels of physical activity
- Currently following a special diet
- Abnormal laboratory screening tests
- Type 2 diabetes mellitus
- Allergies or aversions to foods on the study menu
- Previous diagnosis of an eating disorder or any other mental health disorder
- If female, pregnant in the past 12 months or planning to become pregnant during the
study period
- If female, lactating in the preceding 12 months
- If taking birth control medication, change in medication in previous 3 months or plans
to change medication during the study period
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Popular Diets Study | NCT00315354 | Contradiction |
3,279 | 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:
Physician eligibility criteria:
- Primary physician specialty identified as Rheumatologist
- Physicians who currently treat 7 or more pSS subjects in a typical month
- Physicians who are actively involved in the management and treatment decisions of pSS
subjects
Subject eligibility criteria:
- Subjects with a diagnosis of Sjogren's syndrome in the opinion of the rheumatologist
in the absence of Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) or
Systemic Sclerosis.
- For main sample (6 subjects per rheumatologist)
- Subjects with age >=18 years and with confirmed diagnosis of pSS and are currently, or
have previously, exhibited disease activity in one or more of the categories: fever of
non-infectious origin, lymphadenopathy/lymphoma, glandular swelling/enlarged parotid
gland, arthralgia/synovitis, erythema/vasculitis/purpura, pulmonary involvement, renal
involvement, myositis, peripheral nervous system involvement, central nervous system
involvement, cytopenia of autoimmune origin (with neutropenia) and/or anemia and/or
thrombocytopenia and/or lymphopenia, hypocomplementemia and/or hypergammaglobulinemia
and/or cryoglobulinemia or hypogammaglobulinemia and/or Ever received
immunosuppressant or biologic treatment.
- For oversample (1 subject per rheumatologist)
- Subjects with age >=18 years and with confirmed diagnosis of pSS that fit the
following criteria: Has never exhibited disease activity in any of the categories
above, Moderate or severe fatigue (in the opinion of the rheumatologist)
Exclusion Criteria:
- Not applicable
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP) | NCT03501420 | Entailment |
4,836 | 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:
- Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol
Exclusion Criteria:
- Use of steroids ( tablets, inhalations, lotions)
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.
| Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors | NCT02543697 | Contradiction |
2,193 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Adult patients with gout diagnosed by a Rheumatologist.
2. patients with a history of at least two gout attacks in the target joint
3. Patients with a target joint amenable to biopsy. Target joint defined as:
Joint that has been affected by acute gout attack at least twice in the 12 months prior to
enrollment.
Ultrasound finds grade 2 gray-scale synovitis in joint. Joint is amenable to biopsy. At the
time of enrollment, the joint is without signs of acute inflammation: redness, swelling,
and severe pain (>7/10).
Exclusion Criteria:
1. Patients on anti-coagulation therapy.
2. Patients with an active infection.
3. Tophus present at the biopsy site.
4. Target joint with signs of acute gout attack (pain >7/10, redness, warmth)
5. Known chondrocalcinosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout | NCT04125459 | Contradiction |
4,493 | 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:
1. Subjects must be aged between 18 to 35 years
2. Have a diagnosis of atopic asthma (based on at least one positive skin prick test and
methacholine PC20 ≤16 mg/ml)
3. FEV1 ≥ 70% of predicted
4. Demonstrate a cough response to capsaicin with a minimum of 3 coughs during the
screening capsaicin challenge
Exclusion Criteria:
1. Subjects who are in a pollen season that affects their asthma
2. Subjects who report allergies to capsaicin or bronchoconstrict at the end of the full
dose capsaicin cough challenge and require short acting bronchodilator therapy (assess
after visit 1)
3. Subjects who do not display evidence of airway hyper-responsiveness (methacholine
PC20>16mg/ml) (assess after visit 1)
4. Symptoms of upper respiratory tract infection in the last 1 month which have not
resolved.
5. Lower respiratory tract infection or pneumonia in the last 6 weeks.
6. Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6
months
7. Asthma exacerbation in the previous month requiring a start of inhaled or oral
corticosteroids.
8. Any asthma medication with the exception of infrequent (less than twice weekly)
short-acting β2-agonist.
9. Subjects who have changed asthma medication within the past 4 weeks prior to screening
10. A previous asthma exacerbation requiring Intensive Care Unit admission.
11. Significant other primary pulmonary disorders in particularly; pulmonary embolism,
pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis,
emphysema or bronchiectasis.
12. Pregnancy or breast-feeding
13. Use of ACE inhibitors
14. Any centrally acting medication (opioids, gapapentin, pregabalin, amitriptyline) which
in the view of the investigator could alter the sensitivity of the cough reflex
15. History of psychiatric illness, drug or alcohol abuse which may interfere in the
participation of the trial.
16. History of current or previous anabolic steroid use in men.
17. For the natural cycle group, the female patients must have regular (24 to 35 day)
natural cycles and no oral contraceptive use for ≥6 months
18. For female's taking the oral contraceptive pill they must be taking this ≥6 months
19. Use of B-blockers
20. Patients with clinically significant cardiovascular disease
21. Patients with known allergy to any of the study medications or excipients
22. Patients with a known potentially life threatening allergy (e.g. food allergy,
stinging insect allergy), history of anaphylaxis, mastocytosis, angioedema
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 35 Years | Effect of Sex Hormone During the Menstrual Cycle on Capsaicin Evoked Cough Responses | NCT04233762 | Contradiction |
2,745 | 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 hernia repair (no re-operation for recurrent hernia)
- good compliance can be expected
- informed consent
Exclusion Criteria:
- chronic pain
- acute pain requiring analgesic others than paracetamol or more than a single dose
non-steroidal anti-inflammatory drugs treatment within 48 h before surgery
- current treatment with psychopharmaceutical drugs
- mental incapacity
- known incompatibility (allergies) with the Tisseel compounds
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Use of Human Fibrin Glue Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal Hernioplasty | NCT01641718 | Entailment |
2,958 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Patients between 18 and 80 years of age
- Clinical diagnosis of amyotrophic lateral sclerosis with predominant affection of the
lower motor neuron or the clinical ALS variant of progressive muscular atrophy (PMA)
- Clinical signs of lower motor neuron degeneration in at least one anatomic region
beyond the brain stem
- Sporadic and familial ALS
- Onset of paresis six months to four years before study inclusion
- Treatment with riluzol 100mg/d at least 1 month before study inclusion
Exclusion Criteria:
- Diagnosis of amyotrophic lateral sclerosis with predominant affection or the upper
motor neuron without clinical signs of a concurrent affection of the lower motor
neuron in at least one anatomic region beyond the brain stem (spastic ALS) - Diagnosis
of primary lateral sclerosis (PLS)
- Patients with known intolerance to anakinra, riluzol or one of the additives
- Clinically severe hypoventilation syndrome with vital capacity < 50%
- Pregnancy or breastfeeding
- Continuous non-invasive ventilation with ventilator-free time < 2 hours - Tracheotomy
and mechanical ventilation
- Laboratory parameters outside the normal range that correspond to a clinically severe
cardiovascular, pulmological, hematological, hepatological, metabolic or renal disease
- Malignancies
- Severe renal insufficiency (creatinine clearance < 30 ml/min)
- History of recurrent infections or a disease that may predispose to infections
- Severe neutropenia (absolute neutrophil count < 1.5 x 109/l)
- Monoclonal gammopathy of unknown significance
- Infections including infections with HIV and hepatitis B and C
- Dementia and unable to give informed consent
- History of epilepsy and epileptic seizures
- Contraindication to E coli-derived proteins, anakinra or any components of the product
- Concurrent therapy of anakinra and etanercept or other TNF blocking agents
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis | NCT01277315 | Entailment |
175 | 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:
- Ages 18-75
- History of hypogonadism
- In good health based on medical history, physical examination, and clinical laboratory
tests
- Serum testosterone deficiency
- One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or
reduced sexual functioning)
- Body mass index (BMI) between 18 and 35 kg/m^2
- All screening lab tests within 20% of the normal range (exceptions are liver function
tests)
- HIV, Hepatitis B and C negative
Exclusion Criteria:
- Previous use of FE 999303
- Prostate cancer
- Breast carcinoma, patient or partner
- Palpable prostatic mass(es)
- Serum PSA levels ≥3 ng/dL
- Chronic use of any drug of abuse
- Lower urinary tract obstruction
- Clinically significant anemia or renal dysfunction
- Cardiovascular disease
- Hyperparathyroidism or uncontrolled diabetes
- Generalized skin irritation or significant skin disease
- Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone
(DHEA)) or could interfere with androgen metabolism (e.g. spironolactone,
5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
- Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous
12 months of screening)
- Use of testosterone products (within 8 weeks of screening for parenteral products, or
6 weeks of screening for other preparations)
- Sleep apnea
- Untreated depression
- Subject with a partner who is pregnant or will not use contraception
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator | NCT01464879 | Entailment |
303 | 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:
- ≤40 years of age at the time of IVF/ICSI treatment
- BMI ≥18 to ≤30 kg/m2 with a documented history of infertility
- Have undergone COS as part of an ART treatment and have had an unsuccessful fresh
embryo transfer in that cycle, OR, have undergone freeze all strategy
- Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement
therapy (HRT) regimen
- Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval
- Elective single embryo (blastocyst) transfer (SET)
- Normal ultrasound examination at enrollment (or if <12 months old)
- Signed patient authorization for use/disclosure of data.
Exclusion Criteria:
- Women with a history of recurrent miscarriage, defined as >2 consecutive miscarriages
(biochemical pregnancy losses are not included)
- Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF,
ICSI or FET where the cumulative number of transferred embryos was >4 cleavage-stage
embryos and >2 blastocysts
- Presence of hydrosalpinx that is not surgically treated
- Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial
polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid
accumulation, or endometrial adhesions
- Participating in another clinical study at the same time
- Known allergic reactions to dydrogesterone or other progestogens products
- Any contraindication or other condition that precludes use of dydrogesterone in a
particular patient, in accordance with the precautions listed in the locally approved
label
- Mental disability or any other lack of fitness, in the Investigator's opinion, to
preclude subjects in or to complete the study
- History of prior chemotherapy
- Contraindication for pregnancy
- Transfer of >1 embryo
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles | NCT04758871 | Contradiction |
1,112 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Subject who cannot tolerate ventricular septum resection or transcatheter ethanol
ablation and volunteer for the operation
- Subject meets HOCM diagnosis standards verified by the echocardiogram; the obstruction
is located in the basal part of ventricular septum
- Subject has significant clinical symptoms, including progressively increasing fatigue,
angina, exertional dyspnea, and syncope; subject receives poor effect after drug
therapy or cannot tolerate side effects of medication
- Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with
Systolic Anterior Motion）in the resting-state or after exercise stress test
- Subject over 18 years old
Exclusion Criteria:
- Subject has non-obstructive hypertrophic cardiomyopathy
- Subject has combined cerebral vascular diseases
- Subject has diseases that must receive surgeries, including severe mitral valve
lesions and coronary heart disease which requires coronary artery bypass grafting.
- Subject has end-stage heart failure
- Subject has intraventricular septal thickness (IVST) ≥ 30mm
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.
| Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy | NCT02888132 | Entailment |
4,501 | 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:
- Age 18 - 50 years, inclusive
- General good health, by volunteer history and per investigator judgment
- History of regular menstrual cycles of 21 - 35 days (inclusive), by volunteer report
- History of a normal PAP smear or ASCUS with negative HPV testing within the previous
12 months
- Willing to abstain from intercourse and use of vaginal medications, lubricants, and
other products as required in the protocol
- Willing to use non-spermicidal, lubricated condoms for any vaginal intercourse from
the first day of each menstrual cycle until 72 hours before expected midcycle
- In a mutually monogamous relationship with a male partner who:
- Is at least 18 years old
- Has no known risk for sexually transmitted infections (STIs)
- Is willing and able to comply with protocol requirements including sexual
activity/ abstinence and condom use requirements
- Can engage in vaginal intercourse with the participant, with and without condoms,
as specified in protocol
- Protected from pregnancy by female surgical sterilization
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Surgical sterility or known history of infertility in male partner
- Sterility or known history of sperm dysfunction in male partner
- Currently pregnant by urine pregnancy test at the enrollment visit, or within two
calendar months from the last pregnancy outcome. Note: If recently pregnant must have
had at least two spontaneous menses since pregnancy outcome
- Current use of any hormonal contraceptive or a copper or hormonal IUD, or use of
Depo-Provera in the last 120 days
- Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study
- Significant gynecological abnormalities (including abnormal vaginal bleeding,
excessive vaginal discharge, or vulvar/vaginal pain or irritation)
- Current UTI, vaginal candidiasis, or symptomatic bacterial vaginosis
- History of sensitivity/allergy to ZB-06 film components, for either the volunteer or
her male partner
- In the last three months, either the volunteer or her male partner diagnosed with or
treated for any STI or pelvic inflammatory disease, or either partner with known risk
factors for sexually transmitted infections. Note: Women with a history of genital
herpes or condylomata who have been asymptomatic for at least six months may be
considered for eligibility
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
or HIV at the screening visit
- Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
vesicles suspicious for an STI
- Known current drug or alcohol abuse which could impact study compliance
- Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or her male partner which, in the opinion of the
investigator, would make participation in the study unsafe or would complicate
interpretation of data
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film | NCT04731818 | Contradiction |
11 | 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:
- Female subjects aged ≥ 42 years and ≤ 65 years, in post-menopausal period for at least
1 year and with active sexual life;
- Serum testosterone levels < 33 ng/mL;
- Follicle-stimulating hormone (FSH) levels > 22 mU/mL;
- Absence of other significant diseases which, at the physician's discretion, could
impact subject's participation in the trial, according to protocol requirements, and
study evaluations: medical history, blood pressure and heart rate measurements,
physical examination and complimentary laboratory tests;
- Ability to understand the nature and objective of the trial, including risks and
adverse events, which shall be confirmed by Informed Consent Form signature.
Exclusion Criteria:
- Screening laboratory tests results presenting clinically relevant deviations that, at
the investigator discretion, prevent the subject to participate in the trial due to
possible risks;
- Drugs addiction, including alcohol;
- Treatment with any drugs known to have a well-established toxic potential to major
organs, within 3 months before the trial, ;
- Participation in any other experimental research or administration of any experimental
drug within six months before the initiation of this trial;
- Pregnancy, labor or miscarriage in the last 12 weeks before the antecipated date of
the study treatment start;
- Any conditions, according to investigator's best judgement, that prevents the subject
to participate in the trial.
Female
Accepts Healthy Volunteers
Subject must be at least 42 Years old.
Subject must be at most 65 Years | Phase I Clinical Trial for Evaluation of Pharmacokinetics, Pharmacodynamics and Safety of Testosterone Gel 1% for Topical Use, After Administration of Three Different Doses (2.2 mg, 4.4 mg, 8.8 mg and Placebo) for 28 Consecutive Days in Post-menopausal Women. | NCT02667561 | Contradiction |
5,894 | 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:
1. atypical GERD symptoms (cough, globus, or NCCP)
2. with or without typical GERD symptoms (heartburn or acid regurgitation)
3. A total Reflux Symptom Index (RSI) score ≥13
Exclusion Criteria:
1. Patients who currently took pro-kinetic agents, baclofen, antacid, sucralfate,
histamin-2 receptor antagonists, PPI, antitussive, non-steroid anti-inflammatory
drugs, anxiolytics, or anti-depressants during screening and during study period
2. Patients who have severe cardiac, pulmonary, hepatic, or renal diseases
3. Patients who have uncured underlying malignancy
4. Patients with laryngeal or pharyngeal disorders
5. Patients with a history of gastrointestinal (GI) surgery, symptoms of GI tract
obstruction
6. Patients with a contraindication for PPI use
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 80 Years | Comparison of the Efficiency of Two Different PPI Formula in Atypical GERD | NCT03418337 | Contradiction |
2,493 | 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:
- Man or woman
- Aged 18 years or older
- Subject having signed a free and informed consent
- Subject affiliated to a social protection scheme Arm 1 :Subjects with primary
sleep-wake disorder Arm 2 : subjects presenting a neurological pathology with disorder
of the controls of the wake and the sleep Arm 3 : subject presenting a psychiatric
pathology pathology with disorder of the controls of the wake and the sleep Arm 4 :
subject presenting an ophthalmological pathology with possible alteration of the
photoreception and / or phototransduction Arm 5 : subjects with photosensitivity with
regulation disorder of sleep and wake Arm 6 : healthy subject
Exclusion Criteria:
Age-Related Macular Degeneration (AMD) and all maculopathies (retinopathies pigmentosa,
macular involvement of diabetes)
- Cataract with significant vision loss <5/10
- Chorioretinal neovascularization
- Subject in exclusion period determined by previous or current study
- Impossibility to give the subject information enlightened (subject in emergency
situation, difficulties of understanding the subject, ...)
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy / Breastfeeding
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies | NCT03811964 | Entailment |
1,630 | 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 inclusion criteria:
- men and women, aged 18-55 years
- who are able to read and write
- who are able to give voluntary written informed consent
- have no current uncontrolled medical condition such as neurological, cardiovascular,
endocrine, renal, liver, or thyroid pathology
- have no history of a neurological or psychiatric disorder, e.g., no DSM-IV Axis 1
diagnosis in 2 preceding years)
- drink less than 21 drinks/week for women and less than 35 drinks per week for men
- have not used marijuana in the past 30 days and have not met criteria for dependence
in the past 2 years
- do not suffer from claustrophobia or any MRI contradictions
- to participate in imaging studies including 2 PET scans and 1 MRI scan
- nonsmokers (smoked < 100 cigarettes in lifetime with urinary cotinine levels 0-30
ng/mL both at intake evaluation and on scan day)
- smokers (smoked at least 10 cigarettes/day for at least one year with an Fagerstrom
score (FTND)>3, urine cotinine >150 ng/mL and carbon monoxide (CO) >12 ppm at intake)
General exclusion criteria:
- psychosis
- presence of acute or unstable medical or neurological illness. Subjects will be
excluded from the study if they present with any history of serious medical or
neurological illness or if they show signs of a major medical or neurological illness
on examination or lab testing including history of seizures, head injury, brain tumor,
heart, liver or kidney disease, eating disorder, diabetes.
- regular use of any psychotropic drugs including anxiolytics and antidepressants and
other over-the-counter medications and herbal products within the last six months
- pregnancy/Breast feeding (as documented by pregnancy testing at screening or at days
of the imaging studies),
- suicidal ideation or behavior
- pacemaker or other ferromagnetic material in body.
- use of medications which affect dopamine transmission within 2 weeks of the PET study
- Participation in other research studies involving ionizing radiation within one year
of the PET scans that would cause the subject to exceed the yearly dose limits for
normal volunteers.
- Blood donation within 8 weeks of the start of the study.
- history of a bleeding disorder or are taking medication to thin their blood
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers | NCT02348385 | Entailment |
4,198 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Male or female older than 40 years
2. Clinical diagnosis of COPD (confirmed with a post-bronchodilator forced expiratory
volume in 1 s [FEV1]/forced vital capacity [FVC] ratio ≤70%) at least 4 weeks prior to
the study and post-bronchodilator FEV1 is 50% or less than the predicted value
3. Former smokers or current smokers with at least a 10 pack-year history
4. A history of exacerbation (scheduled/unscheduled visits to primary care physicians,
specialists or allied healthcare professionals, or emergency room, or hospitalization
due to purulent sputum or increased sputum, or increased dyspnea) in the previous year
(at least one)
5. Chronic bronchitis (cough and sputum production for at least three months within two
years)
6. Able to have the signed written informed consent prior to any study-related
procedures.
Exclusion Criteria:
1. COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit
2. Known a1-antitrypsin deficiency
3. Need for long-term oxygen therapy
4. Moderate to severe liver impairment (Child-Pugh B or C)
5. Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus
erythematosus, etc)
6. Severe acute infectious diseases
7. Cancers
8. Subjects being treated with immunosuppressive medicinal products (i.e.: methotrexate,
azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term)
except short-term systemic corticosteroids)
9. Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and
herpes zoster
10. Subjects with congestive heart failure (NYHA grades 3 and 4)
11. Subjects with a history of depression associated with suicidal ideation or behavior
12. Clinically meaningful bronchiectasis
13. Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to
use effective contraception
14. Patients with known hypersensitivity to Roflumilast or rescue medication and their
ingredients
15. Patients with previous Roflumilast therapy within past 3 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Strategy to Improve Adherence of Roflumilast | NCT02018432 | Contradiction |
5,169 | 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
- osteoporotic burst fracture at a single level of the thoracolumbar region
- dual-energy X-ray absorptiometry and T-score value less than -2.5
Exclusion Criteria
- translational displacement at the fracture site (fracture-dislocation)
- loss of structural integrity within the posterior osteoligamentous complex (such as
flexion-distraction ligament disruption)
- spondylolisthesis of the adjacent vertebrae
- malignancy
- chronic steroid administration
- previous spinal surgery
- prior vertebroplasty and infection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Short Segment Fixation in Thoracolumbar Osteoporotic Fracture | NCT02719340 | Contradiction |
2,463 | 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:
- Diagnosed with sarcoidosis
- Signed informed consent
Exclusion Criteria:
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Validation of King's Sarcoidosis Questionnaire in a Danish Population | NCT04388085 | Entailment |
3,255 | 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. Ability to sign informed consent form
2. Fulfilling one the definitions below:
1. Sj(SqrRoot)(Delta)gren s defined by European-American (EA) classification
criteria for primary or secondary Sj(SqrRoot)(Delta)gren s syndrome (SS
group)
2. Excluded from the EA criteria because of a comorbid condition but otherwise
fulfilling the European-American classification criteria (EA excluded SS
group)
3. Incomplete SS
i. at least 2 of the EA criteria with a common manifestation of SS not included
in these criteria (e.g., fatigue, vasculitis, arthritis, etc)
ii. 2 or more common manifestations of SS which are not included in the EA
criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and
are not explained by other conditions
EXCLUSION CRITERIA:
1. Age <16 years
2. inability or unwillingness to comply with follow up requirements
3. Any medical or psychological/psychiatric condition or treatment that, in the
opinion of the Principal Investigator, would exclude the subjects from the
research studies (e.g., alternative explanation for subjects signs and symptoms)
4. NIH employees who report directly to the principal investigator or who are a
co-worker or relative of the principal investigator..
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| The Pathogenesis and Natural History of Sjogren s Syndrome | NCT01425892 | Entailment |
1,037 | 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:
Individuals will be included in the study if they are:
- at least 55 years old,
- cognitively able to understand directions,
- able to ambulate at least 50 feet without stopping,
- are currently experiencing knee pain and
- meet at least 3 out of 6 criteria of the European League Against Rheumatism (EULAR)
criteria for knee osteoarthritis diagnosis.
Exclusion Criteria:
Individuals will be excluded from the study if they have:
- a diagnosed medical condition that would limit physical ability, including acute or
active fractures, myocardial infarctions, stroke,
- a traumatic brain injury within the last 6 months, or
- joint replacement within the last 12 months. Individuals with chronic neurological
disorders limiting motion or present with any known contraindication for balance
training will also be excluded from 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 55 Years old.
| Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis | NCT02350387 | Entailment |
1,887 | 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 suspected or with an established diagnosis of diffuse gastric cancer who
are capable of stating a formal consent to participate in the study.
Exclusion Criteria:
- Mental illness
- Extreme co-morbidity (ASA>3)
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 | Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer | NCT02594943 | Entailment |
4,468 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- 1.skeletally mature patients (over 17 years old) including both sexes. 2.Acute
fractures within 3 weeks of injury. 3.Isolated & closed fractures . 4.polytrauma
trauma patients with no other injuries in the same limb.
Exclusion Criteria:
- 1. pathological fracture of proximal radius and ulna. 2. deteriorateed general health.
3. previous history of dysfunction with the affected elbow.
No condition on gender to be admitted to the trial.
Subject must be at least 17 Years old.
| Evaluation of Surgical Treatment of Terrible Triade Injury of the Elbow Joint | NCT04578977 | Entailment |
3,945 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Male or female ≥ [greater than or equal to] 40 years of age
- If a participant in the previous DIC3-08-05 study, completed the study and did not
discontinue for lack of efficacy or safety
- Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
- Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or
acetaminophen for his/her OA pain and is anticipated to benefit from continuous
treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a
subject who has used these treatments for ≥ [greater than or equal to] 20 days of the
last 30 days before screening
Exclusion Criteria:
- Has a known history of allergic reaction or clinically significant intolerance to
acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including
diclofenac
- Requires chronic use of opioid or opioid combination products to control OA pain of
the knee or hip
- Has any clinically significant unstable cardiac, respiratory, neurological,
immunological, hematological, or renal disease
- Has significant difficulties swallowing capsules or is unable to tolerate oral
medication
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.
| Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain | NCT01510912 | Entailment |
925 | 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:
- This must be a primary knee replacement on this knee.
- Have knee joint disease related to one or more of the following
- degenerative joint disease, including osteoarthritis or traumatic arthritis
- Avascular necrosis of the femoral condyles
- Post-traumatic loss of joint configuration, particularly when there is
patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus, or flexion deformities
- Rheumatoid arthritis
- Patient is likely to be available for evaluation for the duration of the study
- Able and willing to sign the informed consent and follow study procedures
- Patient is not pregnant
- Patient must be over 18 years of age
Exclusion Criteria:
- If there has been a total knee replacement on this knee in the past (no revisions
allowed in study)
- Infection, or history of infection, acute or chronic, local or systemic
- Alcoholism or other addictions
- Muscular, neurological or vascular deficiencies which compromise the affected
extremity
- Obesity
- Insufficient bone quality
- Loss of ligamentous structures
- High levels of physical activity
- Materials sensitivity
- Prisoner
- Mental conditions that may interfere with the patient's ability to give an informed
consent or willingness to fulfill the study requirements
- Patient is pregnant
- Is younger than 18 years of age
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The 3DKnee™ System: A Post-Market Study | NCT00764673 | Entailment |
1,865 | 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:
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
- clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to
the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby
in the preoperative examinations
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of predicted values
- Diffuse; widespread; plastica
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 | Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection | NCT03050879 | Entailment |
1,882 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1.18 ≤ age ≤ 70, Male or Female; 2.Minimum life expectancy of 6 months; 3.Patients with
localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4.Patients
must have a performance status of < 2 Eastern Cooperative Oncology Group (ECOG); 5.No prior
major surgery of the stomach or radiation therapy to the stomach or immunotherapy or
chemotherapy; 6.CT or MRI, endorectal ultrasonography (EUS), laparoscopic exploration are
required to stage; 7.Without other benign diseases such as lung, kidney, liver infections;
8.Without participating other clinical trials; 9.Patient must sign an informed consent
prior to study entry; 10.Patients must have adequate bone marrow function (defined as
peripheral absolute granulocyte count of >1,500/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). 11)Patients without cardiac disease , severe uncontrolled diabetes,
hypertension, cerebrovascular disease, or infection.
Exclusion Criteria:
1. Pregnant women are excluded from study entry due to the potential teratogenic effects
of the study treatment;
2. Female patients who planed to have a baby;
3. Prior radiation therapy to the stomach, liver or kidney;
4. Dysfunction of important organs such as liver, kidney or heart; 5.Abnormalities of
mental status;
6.Active coronary artery disease; 7.Cardiac arrhythmia, and need to receive medication
therapy; 8.Severe uncontrolled hypertension; 9.Active clinical serious infection; 10.The
known human immunodeficiency virus (HIV) infection history; 11.The known central nervous
system diseases, including brain metastatic tumors; 12.Patients have had clinical clear
gastrointestinal bleeding in 6 months; 13.Drug abuse; 14.Swallowing difficulties for drugs;
15.Poor compliance; 16.Presence of concurrent or previous malignancies (except for cervical
carcinoma in situ or basal cell carcinoma of the skin); 17.Presence of peritoneal
metastasis, distant organs or lymph nodes metastasis; 18.Presence history of major surgery
in the past three months; 19.Poor tolerability; 20.Prior history of medication; 21.allergy
for chemotherapeutic 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 70 Years | Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma | NCT02024217 | Entailment |
3,760 | 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. Previous enrollment in study TPX-100-1
- Cruciate and collateral ligament stability as defined by clinical examination
2. Able to read, understand, sign and date the subject informed consent
3. Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study
medication during the injection period and through study day 30. The maximum dose of
acetaminophen must not exceed 2 grams/day (2000 mg per day).
4. Willingness to use only hydrocodone or hydrocodone/acetaminophen (e.g. Norco) for
breakthrough pain through study day 30.
5. Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin,
ibuprofen, naproxen through study day 30.
6. Female subjects of child bearing potential who are sexually active (non-abstinent)
must agree to and comply with using 2 highly effective methods of birth control (oral
contraceptive, implant, injectable or indwelling intrauterine device, condom with
spermicide, or sexual abstinence) while participating in the study.
Exclusion Criteria:
1. "Possibly, probably or definitely" drug-related SAEs in TPX-100-1; severe or ongoing
"possibly, probably or definitely" related AEs in TPX-100-1.
2. Contraindication to MRI, including: metallic fragments, clips or devices in the brain,
eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300
lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
3. Prior surgery in the knees, excluding procedures for debridement only (no previous
microfracture procedure)
4. Joint replacement or any other knee surgery planned in the next 12 months
5. History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or
infectious cause for arthritis
6. Knee effusion > 2+ on the following clinical scale:
- Zero = No wave produced on downstroke
- Trace = Small wave on medial side with downstroke
- 1+ = Larger bulge on medial side with downstroke
- 2+ = Effusion spontaneously returns to medial side after upstroke (no downstroke
necessary)
- 3+ = So much fluid that it is not possible to move the effusion out of the medial
aspect of the knee screening
7. Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected
into either knee < 3 months before screening
8. Last intra-articular knee injection of corticosteroids < 2 months before screening
9. Use of any steroids (except inhaled corticosteroids for respiratory problems) during
the previous month before screening
10. Known hypersensitivity to TPX-100
11. Known hypersensitivity to acetaminophen or hydrocodone
12. History of arthroscopy in either knee in the last 3 months before screening
13. History of septic arthritis, gout or pseudo-gout, of either knee in previous year
before screening
14. Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms
consistent with meniscal tear)
15. Patellar chondrocalcinosis on X-Ray
16. Skin problem, rash or hypersensitivity, affecting either knee at the injection site
17. Bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's
opinion, intra-articular injection
18. Active systemic infection
19. Current treatment or treatment within the previous 2 years prior to the Screening
Visit for any malignancy except basal cell or squamous cell carcinoma of the skin,
unless with specific written permission is provided by the Sponsor's medical monitor
20. Women of childbearing potential who are pregnant, nursing, or planning to become
pregnant, and those who do not agree to remain on an acceptable method of birth
control throughout the entire study period
21. Participation in other clinical osteoarthritis drug studies, with the exception of
TPX-100-1, within one year prior to screening
22. Currently taking Paclitaxel (mitotic inhibitor), natalizumab (anti-integrin monoclonal
antibody), or any other anti-integrin treatment.
23. History of significant liver disease or consumption of more than 3 alcoholic drinks a
day. (Definition of one alcoholic drink: 12-ounces of beer, 8-ounces of malt liquor,
5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor such
as gin, rum, vodka, or whiskey).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 75 Years | A Study Evaluating the Safety and Efficacy of a Second Course of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees | NCT02837900 | Contradiction |
6,570 | 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:
- One or more lipomas, based on clinical and histological diagnosis, which are
accessible for treatment and assessment, are quantifiable along at least 2
perpendicular diameters, and have the following characteristics:
- History of slow growth followed by dormancy, and stable for at least 6 months
- Greatest length multiplied by greatest perpendicular width between 1 and 16 cm²,
inclusive
- Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- Without changes in overlying skin (ie, inflammation, pain or tenderness,
hyperpigmentation)
- Located on the trunk, arms, legs, or neck
- Signed informed consent.
Exclusion Criteria:
- Absence of significant medical conditions that could affect safety
- History of surgical or deoxycholate treatment for lipomas
- Treatment with an investigational agent within 30 days before ATX-101 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.
Subject must be at most 65 Years | Phase 2 Study for the Treatment of Superficial Lipomas | NCT00608842 | Contradiction |
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.