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2,478 | 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:
- 10 years or older and healthy
- No eye diseases
Exclusion Criteria:
- Patients with glaucoma, macular degeneration, diabetic retinopathy, corneal disease,
eye movement disorders or any eye disease causing vision loss
- Patients with visual acuity worse than 20/40
- Patients with cataracts or opacities 2+ or greater
- Patients with refractive error +6 -6 or greater
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 90 Years | Building a Database of Results From People Without Eye Problems | NCT02627339 | Contradiction |
3,926 | 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 for OA patients:
1. Kellgren-Lawrence radiological grade of 1-3 in at least one tibio-femoral joint
diagnosed by screening x-ray.
2. 35 to < 75 years of age at the time of signing the informed consent form.
3. Bodyweight > 50 and < 150 kg and a BMI in the range 18,5-35 kg/m2.
4. Are male or female.
5. Is able to meet for all of the four study visits and comply with the dietary and
activity restrictions.
6. Can give informed consent.
Exclusion criteria for OA patients:
Medical conditions:
1. History of arthroscopy or intra-articular administration of corticosteroids or
hyaluronic acid into the target knee within 6 months before screening.
2. Kellgren-Lawrence radiological grade of 4 in at least one tibio-femoral joint
3. Previous arthroplasty of knee or hip.
4. Intention of having major surgery during the timeframe of this study.
5. OA related to eg. dysplasia, aseptic osteonecrosis, acromegaly, Paget disease,
Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or calcium
pyrophosphate deposition disease.
6. Current treatment with beta-receptor adrenergic antagonists (beta-blockers), systemic
corticosteroid treatment in doses equivalent to > 10 mg of prednisolone per day, or
Vitamin K antagonists, new oral anticoagulants, fractionated and non-fractionated
heparin
7. Active systemic infection.
8. Active systemic inflammatory or autoimmune disease.
9. Symptomatic occlusive arterial disease e.g. claudication intermittens.
10. Heart failure > NYHA class II.
11. History of transient ischaemic attack or stroke.
12. ECG findings which, in the opinion of the investigator, compromises patient safety
related to HRmax-test.
13. History of coronary artery disease, myocardial infarction, or other serious
cardiovascular disease, as evaluated by the investigator.
14. Is not currently active athlete or a highly trained individual.
Inclusion criteria for healthy subjects:
1. 18 to < 75 years of age at the time of signing the informed consent form.
2. Have a bodyweight within > 50 and < 150 kg and a BMI within the range 18,5-35 kg/m2.
3. Are male or female.
4. Is able to meet for all of the four study visits and comply with the dietary and
activity restrictions.
5. Can give informed consent.
Exclusion criteria for healthy subjects:
1. History of arthroscopy or intra-articular administration of corticosteroids or
hyaluronic acid into the target knee within 6 months before screening.
2. Previous arthroplasty of knee or hip.
3. Intention of having major surgery during the timeframe of this study.
4. Secondary OA e.g. because of dysplasia, aseptic osteonecrosis, acromegaly, Paget
disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or
calcium pyrophosphate deposition disease.
5. Current treatment with beta-receptor adrenergic antagonists (beta-blockers), systemic
corticosteroid treatment in doses equivalent to > 10 mg of prednisolone per day, or
Vitamin K antagonists, new oral anticoagulants, fractionated and non-fractionated
heparin
6. Any known active systemic infection.
7. Any known active systemic inflammatory or autoimmune disease.
8. Symptomatic occlusive arterial disease e.g. Inermittent claudication.
9. Heart failure > NYHA class II.
10. History of transient ischaemic attack or stroke.
11. History of coronary artery disease, myocardial infarction, or other serious
cardiovascular disease, as evaluated by the investigator.
12. ECG findings which, in the opinion of the investigator, compromises patient safety
related to HRmax-test.
13. Is not currently active athlete or a highly trained individual.
14. X-ray verified Kellgren-Lawrence grade 1-4.
15. Is clinically suspected of having hip OA.
Other exclusions (all subjects):
1. Legal incapacity or limited legal capacity
2. Inability to communicate or cooperate with the investigator or to comply with the
requirements of the entire study.
3. Are categorized as being very difficult to draw blood from, as evaluated by the
investigator.
4. Current alcohol abuse and/or inability to refrain from intake of alcoholic beverages
24 hours prior to study intervention.
5. Other factors e.g. self-reported drug abuse, which in the opinion of the investigator
may interfere with the study conduct.
6. Site staff, study staff members and study staff family members.
7. Other concomitant disease compromising or otherwise significantly affecting ECM
turnover in the opinion of the investigator
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis (EFEX-OA-01) | NCT04542655 | Entailment |
156 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male ages 18-68 years diagnosed as having testosterone deficiency with clinical
symptoms
- A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL,
confirmed by a second measurement of morning serum Total Testosterone concentration ≤
300 ng/dL (samples to be taken 1 - 3 weeks apart)
Exclusion Criteria:
- Abnormal prostate as evidenced by prostatic symptoms, prostatic masses or induration
on rectal examination, or elevated levels of prostate specific antigen (PSA > 4ng/ml)
or a maximum urine flow rate of less than 12 ml/sec(of a urine volume greater than
150ml) (and/or an International Prostate Symptom Score IPSS score >19)
- Hematocrit > 50%
- Major psychiatric illness
- Unable to understand the protocol or to give informed consent
- Use of paroxetine and clomipramine
- Active alcoholism
- History of drug abuse within the past five years;
- Use of drugs that might interfere with the results of the study (e.g., antiandrogen,
estrogens or P 450 enzyme inducers, barbiturates);
- BMI < 18 or > 30 according to Chinese BMI references;
- Generalized skin disease that may affect absorption of T (e.g., psoriasis) or a known
skin intolerance to alcohol;
- Prolactin > 40 mcg/L;
- Untreated severe obstructive sleep apnea;.
- Uncontrolled or poorly controlled heart failure
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 68 Years | Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism | NCT01786473 | Entailment |
2,059 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Women or men age 50 to 79 years
- history of exposure to asbestos at work and one or more of the following:
- lung cancer risk ≥2% over 3 years or
- asbestosis or pleural plaques on a chest x-ray or
- abnormal auto-antibodies level using the EarlyCDT test
- Capable of providing informed consent for screening procedures (low dose spiral CT,
lung function, blood biomarkers).
Exclusion Criteria:
- Any medical condition, such as severe heart disease (e.g. unstable angina, chronic
congestive heart failure), acute or chronic respiratory failure, or any disorder, that
in the opinion of the physician unlikely to benefit from screening due to shortened
life-expectancy from co-existing illnesses
- Have been previously diagnosed with mesothelioma
- Have had other cancer within the past 5 years with the exception of the following
cancers: non-melanomatous skin cancer,localized prostate cancer, carcinoma in situ
(CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must
have ended >6 months before registration into this study
- Pregnancy
- Unwilling to have a low dose CT scan of chest
- Unwilling to sign a consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 79 Years | Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos | NCT01719068 | Contradiction |
6,749 | 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 diagnosed with hemophilia A and B
- Patients with a medical diagnosis of hemophilic arthropathy and pain
- People over 18 years of age
- Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
Exclusion Criteria:
- Patients with neurological or cognitive disorders that impede understanding of the
questionnaires
- Pain free patients
- Amputees, epileptics or patients with severe vision problems
- Patients who are receiving Physiotherapy treatment at the time of the study
- Patients who have not signed the informed consent document
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. | NCT04549402 | Contradiction |
2,513 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- ≥13 to 65 years of age (inclusive), male or female
- Able to understand protocol and give consent
- Able to keep clinic/study appointments and comply with study related procedures
- Must be able to read, speak, and understand English
- Chronic AD, according to the American Academy of Dermatology (AAD) Consensus Criteria,
that has been present for at least 1 year before the enrollment visit
- Chronic PS, according to the AAD Consensus Criteria, that has been present for at
least 1 year before the enrollment visit.
- AD subjects: have active lesions on upper extremities, lower extremities, or trunk and
a total disease severity of high moderate-to-severe (EASI ≥12)
- PS subjects: have active lesions on upper extremities, lower extremities, or trunk and
a total disease severity of high moderate-to-severe (PASI ≥7)
Exclusion Criteria:
- Unwilling and/or unable to complete informed consent process
- <13 or > 65 years of age
- AD subjects: disease without upper extremity, lower extremity, or trunk lesions
- AD subjects: total disease severity less than moderate (EASI <12), depending on
enrollment
- PS subjects: disease without upper extremity, lower extremity, or trunk lesions
- PS subjects: total disease severity less than moderate (PASI <7), depending on
enrollment
- Control subjects: diagnosed with an inflammatory skin disease
- Severe concomitant illness(es) that, in the investigator's judgment, would adversely
affect the individual's participation in the study (Ex: HIV infection, autoimmune
disease, severe heart failure, Hx of malignancy (other than in situ cervical cancer or
basosquamous skin cancer), etc.)
- Recent bacterial, fungal, or viral infection requiring systemic therapies (PO, IV or
IM) within the last month.
- Patients with a history of keloid formation or lidocaine allergy may be enrolled but
cannot undergo optional skin biopsies.
- Patients with a history of serious life-threatening reaction to tape or adhesives may
be enrolled but cannot undergo optional TEWL measurements.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 65 Years | Study of Skin Microbiome in Atopic Dermatitis Patients | NCT04170244 | Contradiction |
4,947 | 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:
- Patients with medical refractory essential tremor or tremor-dominant Parkinson's
disease that are not candidates for deep brain stimulation (DBS), either by
medical/surgical co-morbidities or by choice.
- Patients must have an ECOG status of 0, 1, or 2.
- Patients must be at least 18 years of age.
- All patients must be given written informed consent.
Exclusion Criteria:
- Patients who have had prior radiosurgery or therapeutic brain radiation therapy.
- Patients with medical contra-indications to MRI imaging (e.g. pacemaker).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | RAD 1601: EDGE Radiosurgery for Intractable Essential Tremor and Tremor-Dominant Parkinson's Disease | NCT03305588 | Entailment |
4,375 | 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:
Volunteers may be eligible for this trial if they:
- Are able to and have given informed consent.
- Are able to understand and comply with all study procedures and to complete study
diary.
- Are aged 18 to 49 years.
- Are female, and are not pregnant.
- Are available for all study visits.
Exclusion Criteria:
Volunteers will not be eligible for this trial if they:
- Are allergic to eggs or egg products.
- Have a current chronic medical condition for which influenza vaccine is normally
recommended.
- Have received experimental vaccines or medications within 30 days of study entry.
- Have received parenteral immunoglobulin within 30 days of study entry.
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 49 Years | Half-Dose Flu Vaccine Study in Healthy Adults | NCT00006146 | Entailment |
1,009 | 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 (and family members) with early onset osteoarthritis according to the
following definition:
- symptomatic OA before 50 years old
- no obvious causes of OA (IMC > 30, dysplasia,joint traumas)
- at least three OA locations
Exclusion Criteria:
- Individuals younger than 18 years old.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phenotype/Genotype Correlation in a Family With Early Onset Osteoarthritis | NCT01999166 | Entailment |
5,695 | 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:
- Over weight / obese children
- Normal weight children
Exclusion Criteria:
- Organic disease that cause obesity
- Underweight children (BMI percentiles < 5)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 4 Years old.
Subject must be at most 13 Years | Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children | NCT02166892 | Entailment |
1,796 | 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:
- Any cachectic patient with weight loss presumed secondary to cancer or cancer related
therapy is eligible. Cachexia is defined as having one or more of the following:
- documented history of weight loss > 5%
- drop in growth rate two or more percentile ranks on standard growth charts,
- weight for height less than the tenth percentile.
- Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.
- Patients who are receiving active or palliative therapy are eligible.
- If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy)
within 8 weeks of study registration, they are also eligible.
- Patients must be ≥ 2 years and < 21 years of age at the time of admission to this
study.
- Patients must have a predicted life expectancy of at least eight weeks.
EXCLUSION CRITERIA:
- Patients who are currently taking or who have taken Periactin and/or Megace during the
past three weeks are not eligible.
- Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy.
(Intermittent steroid use is permitted IF you anticipate it will not be administered
for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid
use in 4-week intervals through the 8-week period during which study agent may be
administered (4 weeks for Periactin and potentially 4 weeks for Megace.
- Patients who have received parenteral nutrition or tube feedings within 1 week of
starting this protocol or patients who are expected to require parenteral nutrition or
tube feedings during the 4-week course of this study.
- Patients taking dronabinol (Marinol) or other appetite-stimulating medications during
the past three weeks or patients expected to be prescribed appetite-stimulating
medications during the 4-week course of this study.
- Patients with hormone sensitive tumors specifically meningiomas, breast cancer,
ovarian cancer, and endometrial carcinoma.31, 32
- Children with neurofibromatosis, type I or II, are at risk for the development of
meningiomas and are thus excluded from this study.32
- Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or
genitourinary (GU) obstruction.
- Patients with recurrent and/or persistent hypertension, defined as blood pressure
values >20% above normal.
- Patients with thromboembolic disease, congestive heart failure, or peripheral edema.
- Patients who are pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 20 Years | Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment | NCT00066248 | Contradiction |
2,823 | 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:
- All subjects must have a verifiable diagnosis of ALS of 0.5 to 2 years' duration. The
diagnosis must be supported by the Revised Criteria of the World Federation of
Neurology. The grades of diagnosis must be clinically definite ALS or clinically
probable ALS.
- All subjects must be over age 18 and below 65.
- The ALS is mildly to moderate based on ALS Health State Scale.
- Electrophysiological features show CMAP amplitude of motor nerve normal or mild
declining.
- Serum creatine kinase is normal or mild upper, less than 500U/L.
Exclusion Criteria:
- If anyone of the above eligibility requirements is not met
- Use of any other investigational agent within 30 days beginning the treatment phase of
this study
- Severe cardiac, pulmonary, hepatic or/and hematic disease
- HIV positivity or signs and symptoms consistent with HIV infection
- Pregnant or nursing women
- History of cancer with less than 5 years documentation of a disease-free state
- History of anaphylactic reaction or hypersensitivity to G-CSF or proteins derived from
E.coli
- Alcohol or drug abuse in recent 1 year
- Can't understand or obey the rules of treatment
- Blood donor in recent 30 days
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 | G-CSF Treatment for Amyotrophic Lateral Sclerosis: A RCT Study Assessing Clinical Response | NCT00397423 | Entailment |
3,603 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Are overtly healthy
- Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)
Exclusion Criteria:
- have known allergies to lasmiditan, dabigatran, rosuvastatin-related compounds or any
components of the formulation of lasmiditan, dabigatran, rosuvastatin, or a history of
significant atopy
- have an abnormal blood pressure and/or pulse rate as determined by the investigator
- have clinically significant abnormalities on electrocardiogram (ECG) as determined by
investigator
- have a history or presence of cardiovascular, respiratory, renal, gastrointestinal,
endocrine, hematological, or neurological disorders capable of significantly altering
the absorption, metabolism, or elimination of drugs; of constituting a risk when
taking the study interventions; or of interfering with the interpretation of data.
Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
- have any medical conditions, medical history, or are taking any medications that are
contraindicated in the dabigatran etexilate or rosuvastatin label
- are intending to use over-the-counter or prescription medication, including dietary
supplements, traditional medicines, and herbal supplements, within 14 days prior to
dosing and until study discharge (apart from occasional acetaminophen, hormonal
contraception, or hormone replacement therapy)
- currently use or show evidence of substance abuse (including alcohol abuse) or
dependence within the past 6 months based on history at screening
- Part 1 Only: have known bleeding disorder including prior personal or familial history
of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or
abnormal coagulation test (prothrombin time/international normalized ratio [INR] or
partial thromboplastin time/activated partial thromboplastin time greater than upper
limit of normal [ULN]) result at screening
- Part 2 only: have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined
through genotyping
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 70 Years | A Study of Lasmiditan in Healthy Volunteers | NCT04749914 | Contradiction |
6,039 | 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. Patients of either sex aged 18-80 years.
2. Diagnosis of functional dyspepsia according to Rome III criteria:
- Pain or burning localized to the epigastrium of at least moderate severity at
least once per week with a total duration of at least 6 months.
- Pain was intermittent.
- Pain was not generalized or localized to other abdominal or chest regions.
- Pain was not relieved by defecation or passage of flatus.
- Pain did not fulfil criteria for gallbladder and sphincter of Oddi disorders.
3. At assessment (visit 1 or 3) three items of GIS had to be judged at least as moderate
including reflux symptoms, but reflux symptoms not dominating the clinical picture.
4. Endoscopy of the upper gastrointestinal tract and abdominal sonography without
pathological findings that could have explained the symptoms (findings of up to 5
gastric erosions could be tolerated if patient had no concomitant intake of
acetylsalicylic acid).
5. Patients willing to comply with the study protocol.
6. Patients who were able to understand and provide written informed consent to
participate in the trial (signed informed consent).
Exclusion Criteria:
1. Concomitant treatment during the study with any medication that could influence the
gastrointestinal function (e.g. prokinetics, antacids, antibiotics, antidepressant,
laxatives, calcium antagonists, beta-blocker, antidiarrheics).
2. Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2
(COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up
to 100 mg daily).
3. History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-,
colon-, rectal-cancer.
4. History of gastric and/or duodenal ulcer.
5. History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).
6. History and/or presence of coronary heart disease.
7. Known intolerance to azo dyes E 110 and E 151.
8. Food allergies and known lactose intolerance.
9. Evidence of any gastrointestinal infectious diseases.
10. Participation in a clinical trial 30 days prior to this trial.
11. Concurrent participation in another clinical trial.
12. Female patients of childbearing potential with a positive pregnancy test, breast
feeding, or female patients of childbearing potential without adequate contraception.
13. History and/or presence of drug or alcohol abuse.
14. Patients with psychiatric illness.
15. Irritable bowel syndrome.
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 | Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus | NCT04059900 | Entailment |
6,813 | 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. Children (≥ 13 years old) and adult male and female subjects who provide written
informed consent and assent.
2. Subjects must be willing to use the mobile device and answer questions regarding their
experience.
Exclusion Criteria:
Individuals with prior or recent injury to one or both of their index fingers that would
prevent or interfere with the use of Maxim biosensor.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
| Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings | NCT04233827 | Entailment |
2,356 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Has provided written informed assent (as required by EC) and parents/guardians have
provided written informed consent.
2. Has an out-of-frame deletion(s) that could be corrected by skipping exon 51 based on
DNA sequencing data from the candidate.
3. Is male and between the ages of ≥ 5 years and ≤ 15 years.
4. Has a muscle biopsy analysis showing < 5% revertant fibres present at baseline.
5. DNA sequencing of the candidate's dystrophin exon 51 confirms that no DNA
polymorphisms are present that could compromise PMO duplex formation or there is
confirmation of in vitro dystrophin production after AVI-4658 exposure to fibroblast
or myoblast in vitro cultures.
6. Intact right and left bicep muscles or alternative arm muscle group.
7. Is able to walk independently at least 25 meters.
8. Has a forced vital capacity (FVC) ≥ 50% of predicted and does not require ventilatory
support or supplemental oxygen.
9. Receives the standard of care for DMD as recommended by the DMD care recommendations
from the North Star UK and TREAT-NMD.
10. The parent(s) or legal guardian and Subject have undergone counselling about the
expectations of this protocol and agree to participate.
11. The parent(s) or legal guardian and Subject intend to comply with all study
evaluations and return for all study activities.
Exclusion Criteria:
1. A DNA polymorphism within exon 51 that may compromise PMO duplex formation.
2. Known antibodies to dystrophin.
3. Lacks intact right and left bicep muscles or alternative arm muscle group.
4. A calculated creatinine clearance less than 70% of predicted normal for age based on
the Cockcroft and Gault Formula.
5. A left ventricular ejection fraction (EF) of < 35% and/or fractional shortening of
<25% based on echocardiography (ECHO)during screening.
6. A history of respiratory insufficiency as defined by need for intermittent or
continuous supplemental oxygen.
7. A severe cognitive dysfunction rendering the potential subject unable to understand
and comply with the study protocol.
8. Any known immune deficiency or autoimmune disease.
9. A known bleeding disorder or has received chronic anticoagulant treatment within three
months of study entry.
10. Receipt of pharmacologic treatment, apart from corticosteroids, that might affect
muscle strength or function within 8 weeks of study entry (viz., growth hormone,
anabolic steroids).
11. Surgery within 3 months of study entry or planned for anytime during the duration of
the study.
12. Another clinically significant illness at time of study entry.
13. Subject or parent has active psychiatric disorder, has adverse psychosocial
circumstances,recent significant emotional loss, and/or history of depressive or
anxiety disorder that might interfere with protocol compliance.
14. Use of any experimental treatments, has participated in any DMD interventional
clinical trial within 4 weeks of study entry or participated in the AVI-4658-33
intramuscular (i.m.) trial.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 15 Years | Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients | NCT00844597 | Entailment |
4,891 | 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:
- Written consent
- Age between 18 and 70
- Diagnosed with Cushing's syndrome
Exclusion Criteria:
- Suspected malignancy
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 | Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome | NCT00682084 | Entailment |
3,684 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- healthy volunteers
- patients with spinal lesion
- patients with cauda equina syndrome
Exclusion Criteria:
- pregnant women
- pacemaker or other metallic material implanted
- epileptic patients
- organic colorectal disease
- obese patients
- previous neurological surgery
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study of the Nervous Control of the Anal Sphincter | NCT00213356 | Entailment |
3,396 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- 18 years to 75 years of age;
- Stabilized on atorvastatin 10 mg daily and by subject reported history had taken at
least 80% of daily doses for the 4 weeks preceding Visit 1;
- LDL-C concentration greater than or equal to 2.5 mmol/L to less than or equal to 160
mg/dL (less than or equal to 4.1 mmol/L) based on blood specimens taken at Visit 1,
using the Friedewald calculation as described in the Protocol,Section 8.8. (The lipid
profiles at Visit 3 (baseline) and all subsequent visits were kept "blinded" until
data analysis);
- Triglyceride concentration of less than 350 mg/dL (less than 3.99 mmol/L) based on
blood specimens taken at Visit 1;
- Documented atherosclerotic disease, CHD, or diabetes mellitus;
- Liver transaminases (ALT, AST) less than 50% above the upper limit of normal, with no
active liver disease, and CPK less than 50% above the upper limit of normal as tested
in blood specimens taken at Visit 1;
- Clinical laboratory tests (CBC, blood chemistries, urinalysis) taken at Visit 1 must
have been within normal limits or clinically acceptable to the Investigator;
- Had been previously prescribed a cholesterol lowering diet and exercise program at
least 4 weeks prior to Visit 1 and had been advised to continue the same diet and
exercise program during the study;
- Reported a stable weight history for at least 4 weeks prior to randomization at Visit
3 (baseline visit);
- Women receiving hormonal therapy, including hormone replacement, any estrogen
antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose
and regimen for at least 8 weeks and willing to continue the same regimen for the
duration of the study;
- Women of childbearing potential (included women who were less than 1 year
postmenopausal and women who became sexually active) must have been using an
acceptable method of birth control (for example, hormonal contraceptive, medically
prescribed IUD, condom in combination with spermicide) or been surgically sterilized
(for example, hysterectomy or tubal ligation).
- Free of any clinically significant diseases other than hyperlipidemia, CHD, or
diabetes mellitus that would interfere with study evaluations;
- Understood and were able to adhere to the dosing and visit schedules, and demonstrated
their willingness to participate in the study and comply with its procedures by
signing a written informed consent.
Exclusion Criteria:
- Consumption greater than 14 alcoholic drinks per week. (A drink is: a can of beer [1/2
pint or 250 ml], glass of wine, or single measure of spirits);
- Any condition or situation which, in the opinion of the Investigator, might have posed
a risk to the subject or interfered with participation in the study;
- Body mass index (BMI) >= 35 Kg/m^2 at Visit 2 (Screening);
- Women who were pregnant or nursing;
- Failure to observe the designated washout periods for any of the prohibited
medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708) | NCT00651378 | Contradiction |
1,949 | 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 - Phase 2 Part
1. Subjects of respective country's legal age or older at the time of written informed
consent.
2. Subjects with histologically confirmed inoperable locally advanced, recurrent, or
metastatic adenocarcinoma of the stomach or GEJ cancers may include Siewert Class I,
II, or III types.
3. Mandatory provision of an unstained, archived tumor tissue sample in a quantity
sufficient to allow for local lab analysis of HER1 and HER2 expression status. If
archived tumor tissue is not available, subject must agree to undergo fresh core
biopsy to obtain adequate tumor tissue
4. Subjects with tumors with IHC evidence of expression of HER1 (at level of + or ++ or
+++) and HER-2 (at level of +, or ++) using standard criteria in the local lab.
Subjects with HER-2 over expression at level of +++ determined by IHC and subject
confirmed HER2 2+ by IHC with HER2 gene amplification confirmed by FISH but has
contradiction to trastuzumab*.
*For details of contraindication related to trastuzumab, refer to package insert or US
treatment guideline.
5. Have radiographically measurable disease as defined by RECIST v1.1
6. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Estimated life expectancy of more than 4 months
8. Able to swallow and retain oral medication
9. Subject with adequate organ and hematological function:
d) Hematological function, as follows: i. Absolute neutrophil count (ANC) ≥1.5 x 109/L
ii. Platelet count ≥ 100 x 109/L iii. HgB≥9 g/dL (packed red cell blood transfusions
are not allowed within one week prior to baseline hematology profile).
e) Renal functions, as follows: i. Serum creatinine ≤1.5x upper limit of normal (ULN)
or estimated glomerular filtration rate (eGFR)> 60 mL/min/1.73m2 f) Hepatic function,
as follows: i. Total bilirubin ≤1.5 x ULN ii. AST and ALT ≤2.5 x ULN (or ≤5 x ULN in
subjects with liver metastasis) iii. Albumin ≥25 g/L
10. Negative serum human chorionic gonadotropin (HCG)/ or urine pregnancy test within 7
days prior to randomization for premenopausal women of reproductive capacity and for
women 12 months after menopause
11. Willingness to use highly effective birth control method (failure rate <1%) while on
study.
Inclusion Criteria - Phase 3 Part
1. Subjects of respective country's legal age or older at the time of written informed
consent.
2. Subjects with histologically confirmed inoperable locally advanced, recurrent, or
metastatic adenocarcinoma of the stomach or GEJ cancers may include Siewert Class I,
II, or III types.
3. Mandatory provision of an unstained, archived tumor tissue sample in a quantity
sufficient to allow for local lab analysis of HER1 and HER2 expression status. If
archived tumor tissue is not available, subject must agree to undergo fresh core
biopsy to obtain adequate tumor tissue.
4. Subjects with tumors with IHC evidence of expression of HER1 (at level of + or ++ or
+++) and HER-2 (at level of +, or ++) using standard criteria in the local lab.
Subjects with HER-2 over expression at level of +++ determined by IHC and subject
confirmed HER2 2+ by IHC with HER2 gene amplification confirmed by FISH but has
contradiction to trastuzumab*.
5. Note: *For details of contraindication related to trastuzumab, refer to package insert
or US treatment guideline
6. Subjects with ECOG performance status of 0 to 1
7. Able to swallow and retain oral medication
8. Subject with adequate organ and hematological function:
a) Hematological function, as follows: i. Absolute neutrophil count (ANC) ≥1.5 x 109/L
ii. Platelet count ≥100 x 109/L iii. HgB≥9 g/dL (packed red cell blood transfusions
are not allowed within one week prior to baseline hematology profile).
b) Renal functions, as follows: i. Serum creatinine ≤ 1.5x ULN or eGFR> 60
mL/min/1.73m2 c) Hepatic function, as follows: i. Total bilirubin ≤1.5 x ULN ii. AST
and ALT ≤2.5 x ULN (or ≤5 x ULN in subjects with liver metastasis) iii. Albumin ≥25
g/L
9. Negative serum human chorionic gonadotropin (HCG)/ or urine pregnancy test within 7
days prior to randomization for premenopausal women of reproductive capacity and for
women 12 months after menopause
10. Willingness to use highly effective birth control method (failure rate <1%) while on
study.
Exclusion Criteria:
1. Subject with HER-2 over expression at level of +++ determined by IHC or subject
confirmed HER2 2+ by IHC with HER2 gene amplification confirmed by Fluorescence in
situ hybridization (FISH) in the central lab.
2. Prior systemic anti-cancer treatment for inoperable locally advanced, recurrent, or
metastatic adenocarcinoma of the stomach or GEJ. However, previous neo adjuvant
chemotherapy is allowed if subject has progression of disease more than 6 months after
neoadjuvant treatment.
3. Subjects have undergone major surgery within 28 days prior to randomization
4. Subject with brain lesion, known brain metastases (unless previously treated and well
controlled for a period of at least 4weeks).
5. Subject with malabsorption syndrome, diseases significantly affecting gastrointestinal
function, extensive resection of the stomach or small bowel, or difficulty in
swallowing and retaining oral medications.
6. Subjects with an uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, New York heart Association class III or IV congestive
heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia,
diabetes, hypertension, or psychiatric illness/social situations that would limit
compliance with study requirements.
7. Subjects with any history of other malignancy unless in remission for more than 1
year. (Nonmelanoma skin carcinoma and carcinoma-in-site of uterine cervix treated with
curative intent is not exclusionary).
8. Female subjects who are pregnant or breast feeding.
9. Subjects who were previously treated with varlitinib.
10. Subjects who took other investigational drugs and/or used investigational medical
devices or have undergone major surgery within 28 days before initiating varlitinib
therapy.
11. Are currently on or have received anti-cancer therapy, radiation or local treatment
within the past 28 days
12. Subject with unresolved or unstable serious toxicity (≥ CTCAE 4.03 Grade 2) from prior
administration of another investigational drug and/or prior cancer treatment(excluding
hair loss)
13. Subjects with a known history of human immunodeficiency virus (HIV), decompensated
cirrhosis, hepatitis B infection with hepatitis B virus DNA exceeding 2000 IU/mL or
hepatitis C (treatment naïve or after treatment without sustained virologic response).
14. Known history of drug addiction within the past 1 year.
15. Subjects who need continuous treatment with proton pump inhibitors during the study
period.
16. Any history or presence of clinically significant cardiovascular, respiratory,
hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
neurologic or psychiatric disease or any other condition which in the opinion of the
Investigator could jeopardize the safety of the subject or the validity of the study
results.
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.
| Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line) | NCT03130790 | Entailment |
5,290 | 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:
- prior fracture
- osteoporosis diagnosis
- received home health care
Exclusion Criteria:
- hospice
- active cancer treatment
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.
| Improving Osteoporosis Care in a Home Health Setting | NCT01109472 | Entailment |
4,240 | 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. Provision of signed and dated written informed consent prior to any study specific
procedures.
2. Healthy male or female subjects aged 18 to 50 years (inclusive) at screening with
suitable veins for cannulation or repeated venepuncture.
3. Females must be of non-child-bearing potential, confirmed at screening by fulfilling
one of the following criteria:
- Post-menopausal defined as amenorrhoea for at least 12 months or more following
cessation of all exogenous hormonal treatments and follicle stimulating hormone
(FSH) and luteinising hormone (LH) levels in the post menopausal range.
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
4. Male subjects must be non fertile, i.e., surgically sterilised with documentation of
azoospermia or must practice an effective contraceptive method to prevent pregnancies.
Effective contraceptive methods are:
- Sexual abstinence from before the first administration of the IMP until 3 months
after final administration of the IMP, only if this is in line with the preferred
and usual lifestyle of the subject.
- Use of a condom plus spermicide agent in addition to having their partner use
another acceptable method (oral or injectable hormonal contraceptives,
contraceptive patch, intrauterine devices, vaginal hormonal rings, vaginal
diaphragm or cervical caps) from before the first administration of the IMP until
3 months after final administration of the IMP.
- Subject's sexual partner is of non childbearing potential, i.e., post menopausal
or surgically sterilised (e.g., tubal ligation, hysterectomy in medical history).
5. Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least
50 kg and no more than 100 kg inclusive at screening.
Exclusion Criteria:
- History of any clinically significant disease or disorder which, in the opinion of the
Investigator, may either put the subject at risk because of participation in the
study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other
condition known to interfere with absorption, distribution, metabolism, or excretion
of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks
of the first administration of IMP.
- Subject has increased risk of infection:
- History and/or presence of tuberculosis (TB); positive result for interferon
gamma release assay (IGRA) (i.e., QuantiFERON TB-Gold), subjects who have resided
in regions where tuberculosis and mycosis are endemic during 90 days before
screening, or who intend to visit such a region during the duration of the study
i.e. deserts areas, Eastern Europe, Central and South America, Africa except
Egypt, Russia, Asia, Indonesia
- Oral body temperature of > 37.7°C on Day -1, or as judged by the Investigator.
- Blood neutrophil count < 1.7 x109/L (Screening and Day -1 morning sample).
- Is in high risk-group for HIV infection within the last 6 months (i.e., men who
have had unprotected sex with men, women who have had sex without a condom with
men who have sex with men, people who have had sex without a condom with a person
who has lived or travelled in Africa, people who inject drugs, people who have
had sex without a condom with somebody who has injected drugs, people who have
caught another sexually transmitted infection, people who have received a blood
transfusion while in Africa, eastern Europe, the countries of the former Soviet
Union, Asia or central and southern America).
- Other latent or chronic infections (e.g., recurrent sinusitis, genital or ocular
herpes, urinary tract infection) or at risk of infection (surgery, trauma, or
significant infection) within 90 days of screening, or history of skin abscesses
within 90 days of screening.
- Clinically significant lower respiratory tract infection not resolved within 4
weeks prior to screening, as determined by the Investigator.
- Volunteers with active malignancy or neoplastic disease in the previous 5 years
other than superficial basal cell carcinoma.
- Disease history suggesting abnormal immune function.
- Volunteers who have received live or live-attenuated vaccine in the 4 weeks prior
to dosing.
- High-sensitivity C-reactive protein above upper limit of laboratory reference
range at screening and on Day -1.
- Some subjects lacking functional dipeptidyl peptidase 1 (DPP1) enzyme have been
described to have periodontitis and palmoplantar hyperkeratosis:
- For Part 1a and Part 1b: Subjects with signs of current gingivitis/periodontitis.
Gingival evaluation (by inspection) will be performed by a dental hygienist or
trained study physician.
- For Part 2: Subjects with a history of recurring gingivitis/periodontitis or
signs of current gingivitis/periodontitis. Gingival evaluation will be performed
by a dental hygienist or trained study physician. Evaluation of bleeding
propensity due to gingivitis will be performed by using dental hygienist
instrumentation. Exact measurement of gum pockets is not needed.
- Subjects with a history of hyperkeratosis or erythema in palms or soles.
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 | Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study | NCT02303574 | Contradiction |
2,899 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- ALS patients
- > 18 years
- Participation in the cohort study
Exclusion Criteria:
- Refusal of participating in the cohort study
- Presence of PEG
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Chewing Efficiency Measured by a Two Colour Chewing Gum Test in Amyotrophic Lateral Sclerosis (ALS) Patients? | NCT01772888 | Entailment |
2,656 | 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:
- men between 30-75 years of age
- ASA class I-II
- primary unilateral inguinal hernia
Exclusion Criteria:
- lower midline incision below linea arcuate
- large scrotal hernia
- previously or current abuse,mental disease
- obesity BMI > 35
- another simultaneous operation
- nonreducible hernia
- severe pain in the groin without nonrelated to hernia
- contraindications to general anesthesia
- need of language translator
- liver cirrhosis or ascites
- spread cancer disease
- previously irradiation in the area
- lack of operations indication
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 75 Years | Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain | NCT00803985 | Entailment |
808 | 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:
- Cases of knee joint degeneration diagnosed by orthopedics, rheumatology and immunology
physicians.
- X-ray interpretation (kellgren & Lawrence grade) grades 1 to 3 or mild to moderate
patients.
- Willing to sign written consent form.
- Pain Index (VAS) ≧ 4/10.
- Men and women over the age of 55.
- Body mass index (BMI) ≧ 27 kg/m^2.
Exclusion Criteria:
- Unable to act on your own.
- X-ray interpretation (kellgren & Lawrence level) is greater than level 3 or is a
serious level.
- Patients who have undergone knee arthroplasty on one or both feet.
- Patients with terminal liver and kidney disease.
- Those who are unable to perform physical function measurement after severe diagnosis
of heart and lung disease after diagnosis by the physician.
- High blood pressure with poor control (systolic blood pressure greater than or equal
to 180 mmHg at the time of return).
- Pregnant women or breastfeeding women.
- Those who have coronary stents, cardiac rhythms, or other metallic substances in the
body are not recommended for total body composition analysis.
- Those with severe hip, knee, and lower back pain who are unable to perform exercise,
other neuromuscular, skeletal joints, or rheumatic diseases may be exacerbated by
exercise. Or those who have musculoskeletal injuries in the past six months (such as
bruises, fractures, etc.).
- Unable to cooperate with the test or halfway through the test.
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.
| Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis | NCT03973463 | Entailment |
23 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Adult male patients (above 18 years old and below 60 years old)
- Receiving greater than 20 IV morphine equivalents/day with <20% change in dosage in
the last month.
- AM total testosterone <300 ng/dL
- Report "worst pain during the past week" grater than 4 on an 11-point numeric scale.
Exclusion Criteria:
- Females
- Poorly controlled, symptomatic, active medical or psychiatric problems (e.g., HIV,
hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major
depression)
- Neurological or psychiatric disorder that would compromise the patient's ability to
give informed consent or adhere to the requirements of the protocol.
- History of prostate cancer, abnormal findings on digital rectal exam, or PSA greater
than 4.0 ng/m
- History of polycythemia
- Renal or hepatic dysfunction
- Hematocrit >55%
- Known history of hypersensitivity to transdermal testosterone gel.
- Abnormalities during digital rectal exam.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain Patients: A Pilot Study. | NCT00398034 | Contradiction |
5,282 | 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:
- DXA (dual energy X-ray absorptiometry) T-score known clinically to be = or < -2.5 OR
presence of low-energy osteoporotic fractures (i.e. excluding those of the skull,
fingers and toes) [for osteoporosis and calcium malabsorption patients]
Exclusion Criteria:
- inability to provide written informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders | NCT02252679 | Entailment |
1,890 | 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:
- Histologically confirmed adenocarcinoma of the stomach, the esophagus or the
gastroesophageal junction
- Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or
metastatic disease.
- CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor
tissue sample.
- Measurable and/or non-measurable disease as defined according to RECIST v1.1
- Age ≥ 18 years
- Written informed consent
- ECOG performance status (PS) 0-1
- Life expectancy > 3 months
Exclusion Criteria:
- Prior hypersensitivity reaction or intolerance to one of the compounds of the study
treatment
- Known HIV infection or known symptomatic hepatitis (A, B, C)
- Clinical symptoms of cerebral metastases
- Pregnancy or breastfeeding
- Patients treated with any bisphosphonate-based therapeutic for any indication during
the previous year
- Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum
calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL (3.0 mmol/L)
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 Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer | NCT01671774 | Entailment |
4,923 | 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:
- clinical diagnosis of parkinsonism and/or dystonia and/or tremor due to:
1. idiopatic parkinson's disease
2. atypical parkinsonism
3. sporadic or inherited/genetic dystonia
4. young-onset Parkinson's disease
5. Ataxia syndrome
6. Choereic syndrome
7. Essential tremor
8. Dystonic tremor
- 18 to 80 years of age
- Willing and able to provide informed consent
- able to walk unassisted
Exclusion Criteria:
- Change in pharmacological therapy in the last 3 months.
- Participated in a clinical drug trial up to 3 months before inclusion into the present
study
- Orthopaedical comorbidities affecting gait or posture.
- Cognitive deficit
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 | Technology-based Analysis of Movement Disorders | NCT04591132 | Entailment |
3,031 | 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:
- Molecular genetics diagnosis of the syndrome (number of CGG repeats in the FMR1 gene
over 200).
- Presenting characteristic symptoms of fragile X syndrome.
- Patients older than 6 years and younger that 19 years.
- Signed informed consent by parents and/or legal tutor prior to enrolment in the trial.
- Both parents and patients must commit to participate for the duration of the 30 week
trial.
Exclusion Criteria:
- The study excludes individuals with other neurological disorders not linked to the
syndrome.
- Patients that have had serious medical problems in the previous 12 months.
- Are taking more than 100mg of vitamin E or vitamin C daily for the past 4 months.
- Have physical problems, mental or sensory impairments that preclude the assessment of
effectiveness.
- Hypersensitivity to any component of the preparation.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 18 Years | Safety and Efficacy Study of Antioxidants for the Treatment of the Fragile X Syndrome | NCT01329770 | Entailment |
5,777 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- 1. Histopathologically proven patients of OLP of all age groups complaining of symptoms
such as pain, burning sensitivity to hot and spicy food.
2. Who have signed informed consent.
Exclusion Criteria:
- 1. Patients who have taken any medication for OLP within 4 weeks before the start of
study.
2. Pregnant and lactating women. 3. History of lichenoid reactions to beta blockers,
dapsone, oral hypoglycemics, NSAIDS, pencillamine, phenothiazines, sulfonylureas, gold
salts or amalgam fillings.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Treatment Modalities of Oral Lichen Planus | NCT03237533 | Contradiction |
6,416 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Male or non-pregnant, non-lactating female, 18 years of age or older.
2. Signed informed consent form, which meets all criteria of current FDA regulations.
3. Females of child bearing potential must not be pregnant or lactating at Screening and
Randomization (as confirmed by a negative urine pregnancy test with a sensitivity of
less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of
childbearing potential must agree to the use of a reliable method of contraception
(e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm
with spermicide], oral, transdermal, injected or implanted non- or hormonal
contraceptive), throughout the study. A sterile sexual partner is not considered an
adequate form of birth control.
All females will be considered to be of childbearing potential unless they:
- Are post-menopausal, defined as women who have been amenorrheic for at least 12
consecutive months, without other known or suspected primary cause.
- Have been sterilized surgically or who are otherwise proven sterile (i.e., total
hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior to
Screening. Tubal ligation will not be considered a surgically sterile method.
Female patients of childbearing potential are defined as:
- Women without prior hysterectomy, or who have had any evidence of menses in the
past 12 months.
- Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possibly
due to other causes, including prior chemotherapy, anti-estrogens, or ovarian
suppression.
4. Have a clinical diagnosis of facial rosacea and fewer than 3 inflammatory lesions on
the face at Screening and at Randomization (before drug application on Day 1).
5. Have moderate to severe facial erythema according to both CEA and PSA (i.e., an
erythema score of 3 or more for each of the CEA and PSA) at Screening and at
Randomization (before drug application on Day 1).
6. Free from any systemic or dermatologic disorder (other than rosacea) that, in the
opinion of the Investigator, will interfere with the study evaluations or increase the
risk of AEs.
7. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., hot
environments, prolonged sun exposure, strong winds and emotional stress) within 24
hours of the Screening and Randomization visit.
8. Any skin type or race, providing the skin pigmentation will allow discernment of
erythema.
9. Willingness and capability to cooperate to the extent and degree required by the
protocol.
Exclusion Criteria:
1. Patients with particular forms of rosacea (rosacea conglobata, rosacea fulminans,
isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial
dermatoses similar to rosacea, such as peri-oral dermatitis, demodicidosis, facial
keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
telangiectasia, that are present on the face (i.e., 5 areas: chin, nose, both cheeks,
and forehead), that in the opinion of the Investigator would interfere with study
evaluations.
2. Have 3 or more facial inflammatory lesions of rosacea.
3. Have an erythema score of 2 (mild), 1 (almost clear), or 0 (clear) on the CEA and/or
the PSA at Screening and at Randomization (before drug application on Day 1).
4. Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that would
interfere with the diagnosis or assessment of rosacea.
5. Patients with moderate to severe telangiectasial masses in the 5 areas of the entire
face: forehead, chin, nose and each cheek, that would interfere with study
evaluations.
6. History of hypersensitivity or allergy to Mirvaso® including the active ingredient
brimonidine tartarate or other component within the formulation.
7. Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to
randomization.
8. Exposed to excessive ultraviolet (UV) radiation within 1 week before screening or
randomization visit and/or patient was unwilling to refrain from excessive exposure to
UV radiation during the course of the study.
9. History of blood dyscrasia.
10. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
or hepatic impairment, scleroderma, Sjögren's syndrome, or depression, or any other
condition causing uncontrolled blood flow or blood pressure.
11. Females who are pregnant, lactating or likely to become pregnant during the study.
12. Significant history or current evidence of chronic infectious disease, system
disorder, organ disorder or other medical condition that in the Investigator's opinion
would place the study patient at undue risk by participation.
13. Patients with severe, unstable or uncontrolled cardiovascular disease.
14. Patients who meet study restrictions at Screening and Randomization and/or
unwillingness to comply with all restricted treatments
15. Receipt of any drug as part of a research study within 30 days before dosing.
16. Employees of the research center or Investigator.
17. Previous participation in this study.
18. Patients who are unable and/or unwilling to follow the study requirements, and
procedures.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea | NCT02289352 | Contradiction |
3,616 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- All patients above 18 years
- who are having blood taken for biochemical analysis when attending the ED
Exclusion Criteria:
- Acute medical patients that do not have blood drawn for routine biochemical testing.
- Pregnant
- Under 18 years old
- Terminally ill patients.
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 104 Years | Use of suPAR Algorithm for the ED Decision Making | NCT04402281 | Entailment |
5,815 | 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:
- Episodes of heartburn (described as a burning feeling, rising from the stomach or
lower part of the chest up towards the neck) for 2 days or more during the last 7 days
prior to baseline.
- Confirmed Erosive Esophagitis within 1 week prior to starting the study.
Exclusion Criteria:
- Any signs of gastrointestinal bleeding at the time of the starting the study.
- Any previous gastric or esophageal surgery.
- Various gastrointestinal diseases as listed in the protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis | NCT00641602 | Contradiction |
1,225 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. Subject is at least 18 years of age.
2. Subject is cooperative and capable of following instructions.
3. Healthy subjects:
1. Never smokers.
2. No known history of respiratory, cardiovascular, hepatic, renal or metabolic
disease.
3. BMI < 35.
4. No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea,
chronic cough, wheezing or phlegm).
5. No history suggesting upper respiratory infection during the three weeks prior to
testing.
4. Patients with known disease affecting the respiratory system, with previous
documentation of obstructive, restrictive, or mixed obstructive plus restrictive
ventilatory abnormality.
Exclusion Criteria:
1. Subjects who are unable to satisfactorily perform routine, full lung function
testing(due to non-compliance or claustrophobia).
2. Subjects unable or unwilling to give informed consent.
3. Subjects who have performed any significant physical activity during 1 hour prior to
the Study.
4. Patients with a tracheostomy.
5. Pregnant women.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT) | NCT01952431 | Entailment |
2,615 | 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:
- hernia repair between 2006 and 2011
- laparoscopic hernia repair using intraperitoneal onlay-mesh (IPOM)
- patient agrees to be surveyed by phone
Exclusion Criteria:
- Patient rejects participation in survey
- patient already rejected use of his/her data for research purposes at admittance to
surgery
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM) | NCT01839942 | Contradiction |
466 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women with poor response to ovarian stimulation. The definition of poor response was
based on the presence of at least one of the following criteria: Age > 40 years old,
day 2 FSH >9.5 mIU/ml, AMH < 2ng/ml ,at least one previous COH with less than 3
oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less
than 500 pg/ml on the day of HCG.
Exclusion Criteria:
- All other women that do not fulfill the above mentioned criteria
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF | NCT02099916 | Contradiction |
2,242 | 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. Be at least 18 years of age;
2. Be able to provide informed consent
3. Be able to read and speak English
4. Have reliable Internet access and e-mail
5. Have a self-reported doctor diagnosis of arthritis, limited to the following
conditions - osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis
(AS), or other arthritis conditions (e.g., psoriatic arthritis)
6. Have a self-reported pain level of 4 or more in the past week on the 0 to 10 Numeric
Rating Scale (McCaffery & Beebe, 1993) because 4 indicates moderate or higher level of
pain.
Exclusion Criteria:
1. Participation in another Inflexxion pain management study.
2. Participation in an online research study related to arthritis in the past year
3. Currently in pain from a recent injury
4. Has been hospitalized for non-medical reasons related to emotional or mental health in
the past year
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Web-based Support to Manage Arthritis Pain | NCT01463189 | Entailment |
3,881 | 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 40 Years old.
Subject must be at most 85 Years | AP-007 Study to Evaluate Safety and Exploratory Efficacy of Three Intra-articular Injections of Ampion in the Knee of Adults With Pain Due to Osteoarthritis | NCT02184156 | Entailment |
1,318 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | DISEASE CHARACTERISTICS:
- Histologically confirmed advanced, metastatic, recurrent, or unresectable soft tissue
sarcoma or gastrointestinal stromal tumor
- Measurable disease defined as lesions that can be measured in at least one dimension
as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
- Must have received prior chemotherapy with no response or progression after initial
response
- Evidence of disease progression in past 3 months
- No CNS metastases or primary brain tumors
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: ECOG 0-1
- Life expectancy: At least 12 weeks
- WBC greater than 2,000/mm3
- Platelet count greater than 100,000/mm3
- Fibrin split products no greater than 0.001 mg
- Fibrinogen greater than 200 mg/dL
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT less than 1.5 times ULN
- PT/PTT less than 1.25 times ULN
- Creatinine no greater than 1.5 mg/dL
- At least 1 year since bypass surgery for atherosclerotic coronary artery disease
- No uncompensated coronary artery disease
- No history of myocardial infarction or unstable/severe angina in past 6 months
- No severe peripheral vascular disease
- No history of deep venous or arterial thrombosis in past 3 months
- No history of pulmonary embolism in past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No diabetes mellitus
- No history of bleeding diathesis
- No known active retroviral disease
- No AIDS-associated Kaposi's sarcoma
- No history of allergic reaction to Cremophor or paclitaxel
- No uncontrolled illness or psychiatric disorder that would preclude study
PRIOR CONCURRENT THERAPY:
- No concurrent immunotherapy
- At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)
- No concurrent chemotherapy
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
- Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major
surgery)
- No concurrent antiinflammatory 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.
| SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas | NCT00005862 | Contradiction |
6,087 | 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:
1. Diagnosis of DS. This is the diagnosis that is being investigated
2. Speak English. This is the language spoken by the PI.
3. Medically stable, without physician- ordered restrictions. Some children with DS have
cardiac surgery or other complications that would contraindicate handling or movement.
These children would not be considered medically stable.
4. Between the age of 6 to 24 months. This captures the full range of the outcome measure
being investigated.
Exclusion Criteria:
1. Meet inclusion and exclusion criteria for part 1 of the study. Children for part 2 of
the study will be a sub-sample of those in part 1 of the study.
2. Between the age of 9 to 18 months. This captures the age when most children with DS
are able to bear weight through their lower extremities, but before they can walk
independently. This is necessary to be able to use the home programs and demonstrate
gross motor changes.
3. Unable to ambulate independently. Children who can walk independently cannot use the
home program devices.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 24 Months | Investigating Trunk Control in Young Children With Down Syndrome | NCT03544840 | Contradiction |
1,840 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Age from 18 to 80 years
2. Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring
cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy.
3. Clinical stage: cTNM: stage I or above at preoperative evaluation according to the
American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
4. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to
symptomatic but in bed less than half the day)
5. Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic,
and pulmonary function.
6. Written informed consent
Exclusion Criteria:
1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous gastrectomy, endoscopic mucosal resection, or endoscopic
submucosal dissection
4. History of other malignant diseases within the past five years
5. History of unstable angina or myocardial infarction within the past six months
6. History of a cerebrovascular accident within the past six months
7. History of continuous systematic administration of corticosteroids within one month
8. Requirement of simultaneous surgery for other diseases
9. Emergency surgery due to complication (bleeding, obstruction, or perforation) caused
by gastric cancer
10. Forced expiratory volume in 1 second (FEV1)<50% of predicted values
11. Inclusion in another clinical trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Prognosis of Gastric Cancer | NCT04819958 | Entailment |
515 | 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:
- Histologically proven low-risk gestational trophoblastic neoplasia (persistent
hydatidiform mole or choriocarcinoma), defined as 1 of the following:
- Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over
3 weekly titers
- Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
- Persistently elevated beta HCG titer more than 4 months after initial curettage
(greater than 5 mIU/mL minimum)
- Histologically proven nonmetastatic choriocarcinoma
- Metastases to vagina, parametria, or lung (if no single pulmonary lesion is
greater than 2 cm)
- WHO score 0-6 (not including blood group or CT lung)
- No histologically confirmed placental site pseudotumor
- Must have undergone at least 1 uterine curettage
- Previously untreated disease
- Performance status - GOG 0-2
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGPT and SGOT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
- No significant prior abnormal hepatic function
- Creatinine no greater than 2.0 mg/dL
- No significant prior abnormal renal function
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for one year after study
entry
- No other prior or concurrent malignancies within the past 5 years except
nonmelanomatous skin cancer
- No prior chemotherapy for gestational trophoblastic neoplasia
- No concurrent curettage except as needed to control vaginal bleeding or to rule out
placental site pseudotumor
Female
No healthy subjects accepted to join the trial.
| Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia | NCT00003702 | Contradiction |
1,822 | 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:
- Any kind of malignancy
- Gastrointestinal bleeding in the last 48 hours
- Referred to emergency endoscopy
Exclusion Criteria:
- under 18 years old
- bleeding from non malignant lesions
- previous endoscopic treatment with another method done in the last 48h
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.
| Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions | NCT02820077 | Entailment |
5,505 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Enrolled in the VCRC Contact Registry
- Patient reported diagnosis of Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis,
Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis),
Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's
Arteritis.
- 18 years of age or older
- English speaking
Exclusion Criteria:
- Inability to provide informed consent and complete survey
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Educational Needs of Patients With Systemic Vasculitis | NCT02190929 | Entailment |
3,658 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Adults more than 18 years of age and less than 65 years of age..
- Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
- Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural
compression.
- Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
- Symptoms not responding to conservative treatment for at least 3 months.
Exclusion Criteria:
- Previous spinal fusion or instrumentation.
- Spinal tumours, infection and fractures.
- Patients with severe osteoporosis
- BMI more than 35.
- Non-ambulant patients and patients with severe preoperative neurological affection
(Cauda Equina Syndrome)
- Patients not willing to participate in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion | NCT03692845 | Contradiction |
5,172 | 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:
- Female: 50 years of age or older
- >5 years since last menses natural or surgical
- have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD)
below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult
female mean value and also have at least one prevalent vertebral body fracture
Exclusion Criteria:
- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- BMI (body mass index) >32 kg/m^2
- use of medications within 3 months of starting study drug that impact bone metabolism
such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and
parathyroid hormone
- hypocalcemia or hypercalcemia of any cause
- markedly abnormal clinical laboratory measurements that are assessed as clinically
significant by the investigator
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| A Study of Monthly Risedronate for Osteoporosis | NCT00247273 | Entailment |
2,388 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Dystophinopathy (Duchenne or severe Becker)
- >8yo
- with social insurance
- informed consent
Exclusion Criteria:
- arythmia
- impossibility to undergo an MRI (pacemaker, ....)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
| IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère | NCT02078076 | Entailment |
6,447 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Male or females at least 18 years of age;
- Women of childbearing potential must agree to use adequate contraception when sexually
active. Acceptable methods of contraception include, but are not limited to, (i)
condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or
cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based
contraception (stable dose for 3 months); (v) partner vasectomy.
- Subjects with general good health as determined by a medical history form;
- Subjects with erythematotelangiectatic and/or papulopustular rosacea, at the baseline
evaluation, as determined by the Investigator;
- Subjects with Fitzpatrick Skin Types I through III, as determined by the
dermatologist;
- Subjects willing and capable of understanding and providing written informed consent,
willing to sign a confidentiality agreement, Health Insurance Portability and
Accountability Act (HIPAA) Authorization Form, and to cooperate and participate by
following study requirements.
Exclusion Criteria:
- Subjects with only phymatous or ocular rosacea;
- Female subjects of child-bearing potential who test positive in a urine pregnancy test
at Baseline (Visit 1), are trying to become pregnant or are nursing;
- Subjects with known allergies to any type of skin care product and/or sunscreen
product and/or any ingredients in the test product;
- Subjects with any facial skin disorders which may influence results, in the opinion of
the Investigator;
- Subjects with a reported history of acute or chronic dermatological (except for
rosacea), uncontrolled hypertension, other medical and/or physical conditions which,
in the opinion of the Investigator, interferes with evaluation of the test product or
places the subject at risk;
- Subjects currently using medications or oral supplements which, in the opinion of the
Investigator, may influence the outcome of the study or interfere with study
observations, including rosacea treatment products;
- Individuals using or who have used any systemic medication considered to affect
rosacea, specifically, but not exclusively, antibiotics or steroids, who do not agree
to continue taking the specified medication at the same dose and regimen throughout
the study;
- Subjects who started hormone replacement therapies (HRT) or hormones for birth control
less than 3 months prior to study entry or who plan on starting, stopping, or changing
doses of HRT or hormones for birth control during the study;
- Subjects with excessive facial hair that would, in the opinion of the Investigator,
interfere with diagnosis or assessment of rosacea;
- Subjects who spend excessive time out in the sun;
- Subjects that have received or used an Investigational New Drug within 30 days prior
to the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| 4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness | NCT03841032 | Entailment |
711 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Subject is able to understand and sign the informed consent.
2. Subject is willing and able to comply with the protocol.
3. Male or female subjects of any race, aged 40 to 64 years
4. Subject has a BMI of 24 to 40 kg/m2
5. Subject has had pain in one or both knees for a minimum of 15 days within the 30 days
prior to the start of the study.
6. Subject has had symptoms of knee pain for at least 6 months.
7. Subject has been diagnosed within the previous 30 days with moderate to severe knee
osteoarthritis - based on attending physician's diagnosis from physical exam in
conjunction with Kellgren-Lawrence X-ray grade of ≥ 2 (radiographs taken within
previous 30 days must be available to the investigator, or be obtained at the
screening visit).
8. Subject can walk.
9. Before study enrollment, subject routinely uses acetaminophen (at any dose) with a
history of therapeutic benefit.
10. Subject has a visual analogue scale (VAS) score of ≥ 4 at the initial visit. Subject
may continue taking acetaminophen at the screening but will not have taken additional
analgesics for at least 48 hours prior to the initial visit.
11. Female subject abstains from sexual intercourse, is surgically sterile,
post-menopausal, or agrees to use a FDA-approved method of birth control.
Exclusion Criteria:
1. Subject has any of the following medical conditions:
1. active heart disease - defined as currently under the care of a cardiologist
2. high blood pressure (≥ 140/90 mmHg)
3. renal or hepatic impairment/disease
4. Type I or II diabetes
5. Bipolar or major depressive disorder or a history of other psychiatric illness
requiring hospitalization in the past 6 months.
6. Parkinson's disease
7. unstable thyroid disease
8. immune disorder (such as HIV/AIDS)
9. multiple sclerosis or any other autoimmune disorder
10. any arthritic condition, other than OA, affecting a joint other than the knee
11. acute septic arthritis
12. fibromyalgia or other chronic pain syndromes (OA in locations other than knee
allowed)
13. gout and hyperuricemia
14. peptic ulcer disease and/or history of upper gastrointestinal bleeding
15. any medical condition deemed exclusionary by the Principal Investigator (PI)
2. Subject has a history of cancer (except localized skin cancer without metastases or in
situ cervical cancer) within five years prior to screening.
3. Subject has had a significant injury to the target joint within the past 12 months.
4. Subject plans to have knee surgery in the next 2 months.
5. Subject has had an asthma attack, hives, or other allergic reaction with aspirin or
any other NSAID medication.
6. Subject has an allergy to avocados, soybeans, shellfish or any other ingredient in the
test product.
7. Subject requires additional analgesic or a change from acetaminophen. (Subjects
requiring acetaminophen dose adjustments may remain in the study and all such dose
and/or schedule changes shall be recorded in the raw data and daily patient diary).
8. Subject is currently taking any medication or suffers from a medical condition, deemed
to potentially interfere with the objectives of the study as determined by the PI.
9. Subject has a history of drug or alcohol abuse in the past 12 months.
10. Subject is currently consuming more than 2 standard alcoholic beverages a day. A
standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5
ounces of liquor.
11. Subject does not agree to use a FDA-approved method of birth control or is pregnant,
lactating, or planning to become pregnant during the study period.
12. Subject has any condition or abnormality that, in the opinion of the investigator,
would compromise the safety of the subject or the quality of the study data.
13. Subject is participating or has participated in another research study within 30 days
prior to screening.
14. Subject has used, or intends to use, any oral or injectable NSAID (e.g., ketorolac,
aspirin, ibuprofen, naproxen, diclofenac, etc.) within 7 days prior to screening
through study completion.
15. Subject has been treated with oral corticosteroids within 4 weeks prior to screening.
16. Subject had intra-articular corticosteroids in the target joint within 3 months prior
to screening.
17. Subjects may not take any dietary, vitamin, mineral, or herbal supplements within 7
days prior to Day 0 through study completion. For subjects taking such products at
time of the initial visit, a seven-day washout period prior to study Day 1 is allowed
EXCEPT for joint health/anti-inflammatory products (see # 18).
18. Subjects who are currently taking or have taken for ≥ 30 consecutive days OR ≥ 60 days
total, within the 180 days prior to screening, dietary products intended to decrease
inflammation, body pain and/or improve joint health; including, but not necessarily
limited to, glucosamine, chondroitin, avocado-soybean unsaponifiable (ASU), and
methylsulfonylmethane (MSM) shall be excluded from the study.
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 64 Years | Nutramax Joint Health Formulation Biochemical Response Study | NCT02614274 | Contradiction |
5,167 | 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. older than 50 years of age
2. high risk as defined from one of the following criteria: score≥1 on one minute
osteoporosis risk questionnaire; 10 year predicted fracture risk≥20% for major
osteoporotic fracture or ≥3% for hip fracture from FRAX; fall≥2 times in pass 1 year
3. having a bone mineral density test within one year period
4. having the capability to understand the study and complete the study interventions
5. willing to participate for the intervention and study follow ups
Exclusion Criteria:
1. People younger than 50 years of age
2. Could not communicate because of hearing, visual, or cognitive problems
3. Unable to stand and walk unaided (walking aids are acceptable)
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 100 Years | Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area | NCT02803190 | Contradiction |
91 | 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:
bioavailable testosterone less than 103 nanogram/dl and DHEA-S level less than 157
microgram/dl for men; DHEA-S less than 95 microgram/dl for women;
Exclusion criteria:
significant ischemic heart disease, renal disease, uncontrolled hypertension, diabetes
mellitus, malignancy, malabsorption, bone disorders, chronic obstructive pulmonary disease,
or sleep apnea.
Others exclusion criteria include abnormal serum calcium, phosphorus, alkaline phosphatase,
asparate aminotransferase, creatinine, urinary calcium, thyroid stimulating hormone, and
erythrocyte sedimentation rate.
People taking medication that may affect outcome measures such as adrenal steroids,
anticonvulsant therapy thiazide diuretics, and estrogen replacement were also excluded.
People engaged in a regular exercise program lasting more than 20 minutes more than two
times per week and those men whose PSA level (age adjusted upper limit) were also excluded.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
| DHEA and Testosterone Replacement in Elderly | NCT00254371 | Contradiction |
1,430 | 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:
1. Adult Tibetan, who have been living in the Tibetan Plateau since he/she was born.
2. Consistent with diagnosed hypertension, blood pressure, for 1-3 grade.
3. Aged 18-80 years old.
4. To sign informed consent.
Exclusion Criteria:
1. diagnosis of secondary hypertension
2. Hypertensive emergencies and urgencies
3. Malignant hypertension
4. Bilateral renal artery stenosis, Chronic Kidney Disease（CKD）, serum creatinine>
133μmol / L.
5. Suffering from congenital heart disease, rheumatic heart disease, hypertrophic
cardiomyopathy, aortic stenosis.
6. Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA),
unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty
(PTCA).
7. clinical significance of arrhythmia
8. Active liver disease, history of chronic persistent hepatitis, alanine
aminotransferase（ALT）> upper limit of normal.
9. Pregnancy, pregnancy or breast-feeding women to prepare.
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 | Treatment of Hypertension in Tibetan Adult Population | NCT02217852 | Contradiction |
1,374 | 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:
- Confirmed histopathological diagnosis of Hirschsprung disease from January 1, 1990 to
August 31, 2019
- Long-segment Hirschsprung disease (type A and B)
- Total colonic aganglionosis (TCA)
- Surgery at CHUSJ
- Tissue blocks of proximal resection margin available for pathological analysis
- Minimum 1 month of postoperative follow-up
Exclusion Criteria:
- Short-segment Hirschsprung disease (conventional form, rectosigmoid junction)
- Total colonic with small bowel aganglionosis (TCSA)
- Surgery done at another institution
- Early deaths
- Lost to follow-up
- No documented post-operative outcome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Months | The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease | NCT04149093 | Contradiction |
2,667 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- 18 years older
Exclusion Criteria:
- recurrent inguinal hernia
- previous low abdominal operation
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.
| Preperitoneal Versus Pre-trasversalis Hernia Repair | NCT01350830 | Entailment |
6,305 | 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:
- Man above 18 years of age, of reproductive age, needing oncofertility preservation
through spermatozoa cryopreservation prior to a putative gonadotoxic treatment during
the COVID-19 pandemic.
- Symptomatic and asymptomatic COVID-19 patients. A patient is considered as symptomatic
if he presents one or several of the following clinical signs: fever, cough,
cephalalgia, myalgia, diarrhea, anosmia, pharyngodynia.
- A sufficient number of remaining spermatozoa straws to perform at least six ART
attempts
Exclusion Criteria:
- Azoospermia
- Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
- Semen collection failure
- Non-emergency fertility preservation or treatment with low gonadotoxic risk
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients ? | NCT04487639 | Entailment |
2,372 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Diagnosis of DMD resulting from a nonsense mutation by whole genome sequencing of the
dystrophin gene
2. To have intact right or left biceps muscles, or an alternative muscle group that is
able to be underwent for appropriate evaluation of efficacy
3. To meet the following criteria at screening (baseline visit), within 30 days prior to
the first dose of study drug
- Ambulant and able to walk at least 75 meters during the 6MWT
- Able to comply with and complete all protocol requirements, and judged by the
investigator to be appropriate to participate in the study from the screening
results
4. Aged at least 4 years at the time of giving informed consent
5. Male
6. Able to be hospitalized for the study requirement
7. Signed Informed consent by parents/legal guardian and/or signed assent by the subject
(age of assent to be determined by IRB)
Exclusion Criteria:
1. Prior exposure to investigational medicines that have a potential of restoring
dystrophin or other functional protein (readthrough, exon skipping, utrophin
upregulation therapy etc.)
2. Known mutation at nucleotide 1555 in 12S rRNA gene of mitochondrial DNA, and/or
personally or families have been treated or have a history of eight cranial nerve
disorder （hearing loss、vertigo、tinnitus etc.）as a result of aminoglycoside use
3. Inability to hear within the range of 0 to 25 dB by pure tone audiometry,
abnormalities on auditory brainstem response audiometry, and/or loss of frequency by
distortion product oto acoustic emissions at screening
4. Poor oral intake or enable to oral intake, and/or bad general status
5. Known allergies to NPC-14, other aminoglycosides, and/or bacitracin
6. Presence of anti-dystrophin antibody at the baseline assessments
7. Cys-C ≥1.2 mg/L and/or creatinine concentration >1.5 times the upper limit of age
corrected normal range
8. Left ventricular ejection fraction (EF) <40% or left ventricular fractional shortening
(FS) <25%, and/or ≥480 msec QTc (corrected QT interval by Fridericia's method)
9. Need of mechanical ventilation
10. Forced vital capacity (FVC) <50% predicted
11. Clinically significant concomitant diseases (hematology, psychoneurotic, hepatic,
pulmonary, endocrine, immune, renal, and gastroenterological diseases), and/or cancer
12. Impairment of intellectual functions, and/or expressive language ability which might
interfere with study assessments
13. Treatment with other systemic aminoglycoside within 6 months prior to the first
administration of study drug
14. Initiation of systemic glucocorticosteroids treatment, and/or start exercise cure,
physical therapy, or occupational therapy which might interfere with study
assessments. Changing of dose and schedule of systemic glucocorticosteroids within 6
months prior to the first administration of study drug
15. History of any surgical procedure within months prior to the first administration of
study drug or have a plan during study
16. History of sever allergy from food and medicine like an anaphylaxis shock or
generalized rash
17. Participation in any other clinical trial and intake of any investigational drug
within 6month of study entry
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
| Phase II Study of NPC-14 (Arbekacin Sulfate) to Explore Safety, Tolerability, and Efficacy in Duchenne Muscular Dystrophy | NCT01918384 | Entailment |
1,238 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- age over 18 years
- presence of pleural effusion
- have undergone chest drain for fewer than 24 hours
Exclusion Criteria:
- contraindication to the use of non-invasive equipment that generates positive airway
pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion,
hemodynamic instability requiring vasopressor therapy, systolic blood pressure < 90
mmHg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting,
upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours,
pneumothorax or bullous emphysema)
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.
| Positive Airway Pressure on Pleural Effusion After Drainage | NCT02246946 | Entailment |
286 | 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 three or more unsuccessful IVF-ET cycles with at least two
good quality embryos transferred and candidates for fresh embryo transfer
Exclusion Criteria:
Age less than 18 years or more than 35years and body mass index more than 30 kg/m2.
Patients with PCOS, endometriosis, uterine anomalies , Ashermann syndrome, chronic
endometritis, chromosomal abnormalities, increased peripheral NK cells, hereditary
thrombophylia and anti phospholipid syndrome
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | A RCT on the Effect of Platelets Rich Plasma in ICSI Patients With Recurrent Implantation Failure | NCT04434547 | Contradiction |
2,489 | 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:
- Snellen VA or equivalent ≤ 6/60 in both eyes
- Patient has capacity to give consent and to undertake vision tests
Exclusion Criteria:
- Diagnosis of functional vision loss
- Unwilling and/or unable to sign informed consent and complete the vision tests
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.
| Visual and Functional Assessment in Low Vision Patients | NCT01876147 | Entailment |
1,843 | 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. Consecutive patients with preoperative pathologically con-firmed gastric cancer by
endoscopy and preoperative imaging data (esophagography\CT\EUS\MRI) were included.
2. No contraindications for MRI examination. No contraindications contrast.
3. The patients participate in this study with informed consent.
Exclusion Criteria:
1. The patients couldn't performed MSCT or MR scanning or artefacts affect the
evaluation.
2. The patients are extremely anxious and uncooperative about surgery or neoadjuvant
therapy .
3. PatientsThe patients refuse to participate in the project.
4. Other situations considered by investigators not meet the inclusion criteria.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Study of CT and MR in the Gastric Cancer | NCT04028375 | Entailment |
1,316 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Stage III, IVA, or IVB
- Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past
4-12 weeks
- Prior radiotherapy must have been given with a radical intent with receipt of at
least 90% of planned dose
- No evidence of disease or presence of inoperable minimal residual disease, defined by
1 of the following:
- Complete response at primary tumor site and nodes (with or without nodal surgery
after chemoradiotherapy)
- Negative lymph node status (by physical or radiological exam) AND persistent
tumefaction less than 25% of original tumor size or residual mass due to scarring
- Tumor tissue samples available for EGFRvIII mutation analysis
- No known brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- ALT/AST < 2 times upper limit of normal (ULN)
- Bilirubin < ULN (unless due to Gilbert's syndrome)
Renal
- Creatinine < 1.5 times ULN
Cardiovascular
- No myocardial infarction within the past year
- No cardiac ventricular arrhythmias requiring medication
- No history of cardiac disease
- No uncontrolled high blood pressure
- No unstable angina
- No congestive heart failure
Ophthalmic
- No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis
sicca
- No severe exposure keratopathy
- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- No disorder that might increase the risk for epithelium-related complication (e.g.,
bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No ocular inflammation or infection
Gastrointestinal
- Able to take oral medication
- No gastrointestinal (GI) tract disease requiring IV alimentation
- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- No active peptic ulcer disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious active infection
- No other serious underlying medical condition that would preclude study participation
- No prior allergic reaction to compounds of similar chemical or biological composition
to erlotinib
- No other malignancy with the past 5 years except adequately treated non-melanoma skin
cancer (unless in the same area treated with radical radiotherapy) or carcinoma in
situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- See Disease Characteristics
- No prior surgical procedure affecting absorption
- No concurrent ophthalmic surgery
Other
- More than 4 weeks since other prior investigational drugs
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased
vigilance with respect to INR
- Concurrent nasogastric or gastrostomy tube feeding for dysphagia allowed provided
there is no evidence of significant residual mucositis (i.e., > grade 1)
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 120 Years | Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck | NCT00079053 | Contradiction |
3,230 | 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:
- diagnosis of pSS according to ACR/EULAR classification criteria
Exclusion Criteria:
- patient does not possess a smartphone with web connection
- patient unable to sign an 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.
| Eye Dryness Evaluation in Primary Sjögren's Syndrome | NCT03614299 | Entailment |
838 | 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:
- Adults over 18 years, there is no upper age limit.
- Osteoarthritis of the knee (defined as joint space narrowing and osteophytes in 1 or
more compartment) and moderate to severe knee pain (defined as 40-80mm on a 100mm
visual analogue scale).
Or
- Persistent moderate to severe knee pain (40 - 80mm on a 100mm visual analogue scale),
one year following total knee replacement
Exclusion Criteria:
- People who have previously participated in a 8 week Mindfulness course
- Terminal illness and other conditions leading to incapacity to participate in the
study
- Acute knee injury, knee joint surgery or steroid injection to the knee within previous
3 months or currently on a waiting list for knee joint surgery
- Inflammatory arthritis (eg Rheumatoid arthritis or psoriatic arthritis)
- Patients who are unable to provide informed consent
- Patients who are unable to communicate in English, as the intervention is delivered in
English
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.
| Mindfulness for Osteoarthritis-related Knee Pain | NCT02595099 | Entailment |
4,418 | 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:
- Adult > 18 years of age
- Closed fracture
- Isolated injury
- No prior injury to ipsilateral forearm
- Less than or equal to two attempts at reduction
Exclusion Criteria:
- Ipsilateral upper extremity injury
- Open injury or neurovascular compromise
- Greater than two attempts at reduction
- Presentation greater than 24 hours after injury
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures | NCT02679066 | Contradiction |
569 | 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:
- Symptomatic patients that were suspected as having intrauterine pathology such as
submucosal myoma, endometrial polyps or other endometrial pathological findings based
on the transvaginal ultrasound were enrolled.
- women who are more than 20 years of age with having sexual contact history
- women whose last menstrual period are within the last two months.
Exclusion Criteria:
- Post menopausal women
- any evidence of a contraindication or allergy to PGs
- any sign of genital infection, history of cervical surgery, endometrial lesions with
suspected endo- or exocervical lesions that could affect the cervical resistance or
patients that were not candidates for surgery.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 55 Years | Cervical Priming With Misoprostol Prior to Operative Hysteroscopy | NCT01024270 | Entailment |
4,557 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Patients diagnosed pathologically of Endometriosis or Adenomyosis among those who had
undergone laparoscopic surgery due to pelvic pain
- Patients who have been on GnRH agonist treatment for 6 months after being diagnosed
Endometriosis or Adenomyosis
- Patients who agreed a written consent by their own will
- Patients' compliance and geographical adjacency appropriate for proper follow up
survey
- continuous pelvic pain over VAS 5 during past 1 week on screening visit(after 6 weeks
of surgery) (0='no pain', '10=most severe')
Exclusion Criteria:
- Those who had taken hormones or drugs that can affect diagnosis of endometriosis or
adenomyosis for past 1 year
- Patients found to have malignant tumor of uterus and adenexa, PID or pregnancy during
surgery
- Allergies to metal or contraindications for acupuncture treatment (ex: coagulopathy,
epilepsy)
- Unable to participate in clinical trial by doctor's judgment
- irritable bowel syndrome
Female
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 55 Years | Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis | NCT01259180 | Contradiction |
1,104 | 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:
- Patients admitted to the emergency department for syncope as defined by European
Society of Cardiology (ESC) recommendations.
Exclusion Criteria:
- Patient under guardianship or safeguard of justice
- Refusal to participate
- Inability to contact the patient again at M1, M3, M6
- Malaise without loss of consciousness (lipothymia)
- Loss of post-traumatic knowledge (after head trauma)
- Loss of consciousness of toxic origin
- Loss of consciousness of confirmed epileptic origin (known epileptic or strongly
evocative history with post-critical state)
- Diagnosis performed during the initial emergency assessment of a major adverse
cardiovascular event.
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.
| Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term | NCT03528161 | Entailment |
3,163 | 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. Men or women aged 18 - 60 yrs old in generally good health.
2. Healthy oral cavity with no pre-existing oral diseases including cancer,
periodontitis, or mucositis.
3. No chewing or swallowing disorders.
4. No known clotting disorders.
5. Willingness to follow the investigator instructions and requirements of the protocol.
6. Ability to give consent.
7. Proficiency with the English language (both written and verbal)
Exclusion Criteria:
1. Pre-existing oral diseases including oral cancer, periodontitis, or mucositis.
2. Chewing or swallowing disorder.
3. Iron deficiency or anemia. The level of deficiency needed for exclusion will be at the
discretion of the CRC physician associated with the study.
4. Pregnant, lactating, or planning to become pregnant during the study.
5. Phenylketonuric
6. Medical, social, or economic circumstance which is likely to prevent adherence to the
protocol.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Vitamin Gum Pharmacokinetics | NCT03230396 | Contradiction |
6,139 | 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:
- Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or
positive RT-PCR test for COVID-19
- Oxygen saturation drop below 93%
- Systolic blood pressure drop below 100 or blood pressure drop of 30 mm Hg from the
patient's previous normal systolic blood pressure
- Fever
- Dry cough
- Positive PCR for COVID-19
- Laboratory indices include CRP and ESR indicating COVID-19
Exclusion Criteria:
- Patient dissatisfaction
- Existence of drug interactions
- Lack of proper conditions for receiving medication
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 100 Years | Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients | NCT04409522 | Contradiction |
3,479 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion criteria:
Male and female patients, 18-70 years of age.
Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index [BMI] >30
kg/m^2) and the following other abnormalities:
- Abdominal obesity (waist circumference >102 cm in men and >88 cm in women). According
to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).
- Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might
reasonably suggest more stringent A1c goals [such as 6.5%] for selected individual
patients, if this can be achieved without significant hypoglycemia or other adverse
effects of treatment. Appropriate patients might include those with short duration of
diabetes, long life expectancy, and no significant cardiovascular disease).
- Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL,
cholesterol <300 mg/dL. In order to exclude patients who might be suffering from a
primitive dyslipidemia).
- Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <40 mg/dL in men
and <50 mg/dL in women).
Written informed consent.
Exclusion criteria:
Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid
suppressant (Thyroid Stimulating Hormone [TSH] >5 mU/L with clinical symptoms of
hypothyroidism).
Hepatic disease (Aspartate Aminotransferase [ASAT] or Alanine Aminotransferase [ALAT] >2
times the upper limit of normal).
Renal disease (serum creatinine >1.7 times the upper limit of normal). A history of
coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6
months before enrollment.
History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg
and/or diastolic blood pressure ≥110 mmHg. Triglycerides >600 mg/dL. History of chronic
pancreatitis or of idiopathic acute pancreatitis.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients | NCT02274740 | Entailment |
5,114 | 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:
- Older adults living independently;
- medical approval.
Exclusion Criteria:
- Non-smokers;
- Non-morbidly obese;
- No history of severe hypertension;
- No history of falls;
- No orthopaedic, neurological, pulmonary, or cardiac problems.
Male
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
Subject must be at most 79 Years | Study of the Long-term Effects of Exercise on Heath Indicators in Older People | NCT01874132 | Contradiction |
2,060 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- IPF as diagnosed by chest CT or lung biopsy, and documented by a pulmonologist in the
patient's medical record
- Capacity to provide informed consent
Exclusion Criteria:
- Documented malignancy that would impact mortality within the study enrollment period
- Inability to pay for palliative care visit, insurance or personally.
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.
| Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis | NCT03981406 | Contradiction |
4,471 | 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. Clinical diagnosis of elbow pain not related by trauma.
2. Cases with self-reported history of overuse, infection, autoimmune disease, bleeding
tendency and neoplasm of bone, joint, soft tissue at elbow.
Exclusion Criteria:
1. Recent acute traumatic cases.
2. Cases not fulfilling MRI criteria(contraindicated for MRI): metal implant (pacemaker,
artificial valve prosthesis ,implantable cardiovascular defibrillator, nerve
simulator, intro-ocular implant, cochlear implants, arterial clips, bullets or metal
fragments, swan-guns catheter).
3. Pregnancy and breast milk feeding.
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 65 Years | Role of MRI in Evaluation of Non-traumatic Causes of Painful Elbow | NCT03182127 | Entailment |
4,408 | 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:
- clinical diagnosis defined as pain over the lateral epicondyle provoked by palpation;
- A visual analogue scale (VAS) score for pain greater than 40mm;
- symptoms duration for more than 1 month.
Exclusion Criteria:
- other diseases that can alter clinical evaluation detected through history, clinical
examination, ultrasound or other exams for comorbidities such as carpal tunnel
syndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies,
previous elbow surgery or clinically significant or recent trauma, fibromyalgia and
major psychiatric conditions;
- VAS score for pain less than 40mm;
- any of the following treatments during the previous 4 weeks before baseline visit:
physical therapy, bandage, mesotherapy and local corticosteroid injection or a
combination of these: NSAIDS taken during the week previous to inclusion;
- pregnancy;
- allergy to any of the study drugs;
- severely immunosuppressed patients;
- known coagulopathies. During the study period, enrolled patients are not allowed to
take oral corticosteroids, NSAIDs or receive any other medical intervention during the
treatment period (physical therapy, bandage, mesotherapy and local corticosteroid
injection or a combination of these).
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.
| Mesotherapy In Lateral Epicondylitis | NCT04201249 | Contradiction |
2,234 | 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. Male or female 18 - 70 years of age
2. Previously met the preliminary criteria of ARA for the classification of the acute
arthritis of primary gout
3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain
of at least moderate severity
4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments
of the gouty index joint
5. Current presentation of acute gout flare in 3 joints or less
Exclusion Criteria:
1. Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48
hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month
prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and
indomethacin SR within 5 days prior to baseline visit.
2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment
with topical analgesics within 12 hours before baseline assessments
3. History of NSAID intolerance
4. Participants with history of chronic, gouty arthritis
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 | Study Utilizing Rilonacept in Gout Exacerbations | NCT00855920 | Entailment |
5,405 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Healthy female volunteers
- Age: 18 - 35 years (inclusive), smokers must not be older than 30 years at inclusion
- History of regular cyclic menstrual periods (with a cycle length between 25 and 35
days)
- Willingness to use barrier methods of contraception (condoms with spermicide,
diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during
the trial
Exclusion Criteria:
- Pregnancy, lactation (less than three menstrual cycles before Visit 1 following
delivery, abortion, or lactation) - Obesity (BMI > 30.0 kg/m2)
- Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at
Visit 1 or a normal result has to be documented within the last 6 months before Visit
1)
- Laboratory values outside inclusion range at Screening - Any disease that may worsen
under hormonal treatment or might interfere with the conduct of the study or the
interpretation of the results, as e.g.: - Cardiovascular -- presence or a history of
venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis,
pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including
prodromi (e.g., transient ischemic attack, angina pectoris) and conditions which could
increase the risk to suffer from any of the above mentioned disorders, e.g., a family
history indicating a hereditary predisposition. -- uncontrolled arterial hypertension
(repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood
pressure > 90 mmHg)
- Liver -- presence or history of liver tumor (benign or malignant) -- presence or
history of severe hepatic disease as long as liver function values have not returned
to normal -- jaundice and/or pruritus related to cholestasis -- history of cholestatic
jaundice associated with pregnancy or previous COC use
- Metabolic diseases -- uncontrolled diabetes mellitus with vascular involvement severe
dyslipoproteinemia
- Other diseases: any known or suspected malignant or premalignant disease, uncontrolled
thyroid disorder, chronic inflammatory bowel disease, severe renal insufficiency or
acute renal failure, hemolytic uremic syndrome, sickle cell anemia, porphyria, history
of hypertriglyceridemia-associated Pancreatitis, systemic lupus erythematodes,
pemphigoid gestationis during a previous pregnancy, Sydenham chorea, herpes
gestationis, otosclerosis-related hearing loss, history of migraine with focal
neurologic symptoms, epilepsy, current or history of clinically significant
depression, hereditary angioedema
- Additional sex steroids, other hormonal contraceptive methods (oral, transdermal)
during treatment (blister in use at randomization should be finished); intra-uterine
devices (IUD) with or without hormone release within 1 month prior to Visit 1,
implants within 1 month prior Visit 1, depot progestins within 6 months prior to Visit
1 - Surgical interventions scheduled in the study period
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Cycle Control and Safety of E2-DRSP | NCT00653614 | Entailment |
5,449 | 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 - Part A:
- Moderately severe (≤2% FVIII) hemophilia A
- <3 Years of age at the time of informed consent
- Caregiver (parent or legal guardian) has provided written informed consent
- ≤2 EDs to pdFVIII, rFVIII, or a single dose of FFP, Cryoprecipitate or PRBCs.
- Adequate hematologic function (HgB >8 g/dL and platelet count >100,000 µL)
- Adequate hepatic function (total bilirubin ≤1.5x ULN and both AST/ALT ≤3x ULN at
screening (excluding known Gilbert's)
- Adequate renal function (≤2.5 x ULN and CrCl ≥30 mL/min)
- Negative test for inhibitor (<0.6 BU/mL) with a 72-hour washout within 4 weeks of
enrollment
- No documented FVIII inhibitor since birth *Participants will be encouraged to
co-enroll in the ATHN 8 Study
Inclusion Criteria - Part B
- Moderately severe (≤2% FVIII) hemophilia A
- <21 Years of age at the time of informed consent
- Documented on 2 occasions a persistent low (>0.6 BU/mL) or high titer inhibitor (>5
BU/mL) with a 72-hour washout within 8 weeks of enrollment after either the first time
ITI or after single attempt of <6 months of continuous 3x/week factor ITI
- Caregiver and/or participant provided written informed consent
- Adequate hematologic function (HgB >8 g/dL and platelet count >100,000 µL)
- Adequate hepatic function (total bilirubin ≤1.5x ULN and both AST/ALT ≤3x ULN at
screening (excluding known Gilbert's)
- Adequate renal function (≤2.5 x ULN and CrCl ≥30 mL/min)
Exclusion Criteria - Part A and B
- Inherited or acquired bleeding disorder other than severe hemophilia A (participants
with previous documentation of low von Willebrand factor (vWF) defined as vWF antigen
and vWF ristocetin cofactor both between 40-50 will be permitted)
- Previous or current treatment for thromboembolic disease or signs of thromboembolic
disease
- Conditions that may increase risk of bleeding or thrombosis. Will not require or
request a thrombophilia evaluation
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the HEMLIBRA® injection (with the exception of rituximab)
- Known HIV infection with CD4 count <200 cells/µL within 24 weeks prior to screening.
Testing not required if can demonstrate negative testing in mother prior to pregnancy
- Use of systemic immunomodulators at enrollment or planned use during the study
- Participants who are at high risk for thrombotic microangiopathy (TMA) (for example,
have a previous medical or family history of TMA), in the investigator's judgment
- Concurrent disease, treatment, or abnormality in clinical laboratory tests that could
interfere with the conduct of the study, may pose additional risk, or would, in the
opinion of the investigator, preclude the participant's safe participation in and
completion of the study
- Planned surgery (excluding minor procedures or central line placement) during the
study
- Receipt of HEMLIBRA® as part of a prior investigational study; an investigational drug
to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug
administration; a non-hemophilia-related investigational drug concurrently, within
last 30 days or 5 half-lives, whichever is shorter
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 21 Years | Emicizumab PUPs and Nuwiq ITI Study | NCT04030052 | Entailment |
5,302 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria: patients who are postmenopausal women or men who aged older than 50
years and meet the indications for osteoporosis treatment according to the Thai
Osteoporosis Foundation's 2010 treatment guidelines.
- History of spinal or hip fractures with low energy trauma.
- BMD by Dual energy X-ray absorptiometry (DXA) scan with T-score ≤ -2.5 at the femoral
neck, total hip, or L1-L4 spine.
- BMD by DXA scan with T-score between -1 and -2.5 at the femoral neck, total hip, or
L1-L4 spine and a 10-year hip fracture probability ≥ 3% or a 10-year major
osteoporosis-related fracture probability ≥ 20% based on Fracture risk assessment tool
(FRAX)
Exclusion Criteria:
- Patients who have contraindications to use bisphosphonates e.g. gastroesophageal
reflux disease or drug allergy to bisphosphonates
- Patients with an abnormality of serum calcium levels (more than 10.2 mg/dl or less
than 8.7 mg/dl)
- Patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2
- Patients with metabolic bone diseases such as Paget's disease, hyperparathyroidism,
etc.
- Patients who were received anti-osteoporotic drugs during the past 1 year.
- Patients who currently taking steroids, hormone replacement therapy, or selective
estrogen receptor modulators (SERMs) within 1 year.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment | NCT02371252 | Entailment |
1,560 | 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:
- Have a body mass index between 19.0 and 30.0 kilogram square meter (kg/m²), inclusive,
weight less than 125.0 kilogram (kg), and physical dimensions which appear small
enough to fit into the magnetic resonance imaging (MRI) and positron emission
tomography scanners (PET)
- Must be in good health, as determined by a medical history, vital signs, physical
examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
- Have venous and arterial access sufficient to allow blood sampling
- Are nonsmokers for at least 3 months prior to Screening, according to self report
(meaning zero cigarettes smoked)
- Have a calculated creatinine clearance of greater than (>)70 milliliters per minute
(mL/min) at Screening
- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures
- Will have given their written informed consent to participate in the study and to
abide by the study restrictions
Exclusion Criteria:
- Male subjects who are not, or whose partners are not willing to use appropriate
contraception (condom with spermicidal foam/gel/film/cream/suppository) from the time
of the first dose until 3 months after dosing
- Have received any prescribed systemic or topical medication within 14 days of the
first dose administration, unless in the opinion of the Investigator the medication
will not interfere with the study procedures or compromise safety
- Have used any nonprescribed systemic or topical medication (including herbal remedies)
within 7 days of the first dose administration (with the exception of vitamin/mineral
supplements) unless in the opinion of the Investigator the medication will not
interfere with the study procedures or compromise safety
- Have received any medications, including St. John's Wort, known to chronically alter
drug absorption or elimination processes within 30 days of the first dose
administration unless in the opinion of the Investigator the medication will not
interfere with the study procedures or compromise safety
- Currently enrolled in, have completed, or discontinued within the last 30 days from a
clinical trial involving an investigational product or are concurrently enrolled in
any other type of medical research judged not to be scientifically or medically
compatible with this study
- Have donated or lost 50 to 499 mL of whole blood within 30 days, or more than 499 mL
whole blood within 56 days preceding first dose administration
- Have a significant history of drug allergy as determined by the Investigator
- Have any clinically significant allergic disease (excluding nonactive hay fever), or
any known allergy to LY2940094 as determined by the Investigator
- Have a semi-reclined blood pressure and pulse rate higher than 130/90 millimeters of
mercury (mmHg) and 100 beats per minute, respectively, or lower than 90/50 mmHg and 40
beats per minute, respectively
- Consume more than 14 units of alcohol per week or who have a significant history of
alcoholism or drug/chemical abuse/dependence as determined by the Investigator (one
unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine,
or 1/6 gill [25 mL] of spirits)
- Have a positive urine drug screen or alcohol breath test result that indicates
substance abuse at screening or at admission to any treatment period
- With, or with a history of, any clinically significant neurological, gastrointestinal,
renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or
other major disorders as determined by the Investigator
- With, or with a history of, any psychiatric illness as assessed with the Symptom
Checklist (SCL-90R)
- Have had a clinically significant illness within 4 weeks of the start of dose
administration as determined by the Investigator
- Have serum hepatitis (B or C), or who are carriers of the hepatitis B surface antigen
or hepatitis C antibody, or who have a positive result to the test for human
immunodeficiency virus (HIV) antibodies
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
investigator, increases the risk of participating in the study. In addition, subjects
with the following findings will be excluded:
- Confirmed Bazett's corrected QT interval (QTcB) greater than (>) 450 milliseconds
(msec)
- Bundle branch blocks and other conduction abnormalities (including 2nd or 3rd
degree atrioventricular block, complete left bundle branch block, complete right
bundle branch block or Wolffe-Parkinson-White syndrome, defined as PR interval
less than (<) 110 msec, confirmed by a repeat ECG other than mild first-degree AV
block
- Irregular rhythms other than sinus arrhythmia or occasional rare supraventricular
ectopic beats
- History of unexplained syncope
- Family history of unexplained syncope or sudden death due to long QT (cardiac
output) syndrome
- T wave configurations are not of adequate quality for assessing corrected QTc
intervals
- Have previously completed or been withdrawn from this study or any other study
investigating LY2940094
- Subjects who, in the opinion of the Investigator, should not participate in the study
- Taking any excluded medications that cannot be discontinued at admission to the
clinical research unit (CRU)
- Have a personal or family history of recurrent seizures or complicated febrile
seizures
- Have a history of a significant brain condition/trauma
- Indicates presence of suicidal ideation by answering "yes" to either of the first two
questions on the baseline version of the Columbia Suicide Severity Rating Scale
(C-SSRS) at Screening
- Have any contraindication to magnetic resonance imaging (MRI) , such as implanted or
embedded metal objects or fragments in the head or body that would present a risk
during the magnetic resonance imaging (MRI) scanning procedure, or have worked with
ferrous metal either as a vocation or hobby (for example, as a sheet metal worker,
welder or machinist) in such a way that might have led to unknown, indwelling metal
fragments that could cause injury if they moved in response to placement in the
magnetic field
- Have had exposure to ionizing radiation in a research study that, in combination with
the study tracer, would result in a cumulative exposure that exceeds recommended
exposure limits of greater than (>) 20 millisieverts (mSv) in 1 year
- Suffer from claustrophobia and would be unable to tolerate the confined spaces of
magnetic resonance imaging (MRI) or positron emission tomography (PET) camera as
evidenced by claustrophobia screening
- Without a minimum of 37 inches (112 centimeters [cm] ) from the top of the head to the
end of the wrist so as to allow reasonable access to the wrist to take a blood sample
during the positron emission tomography (PET) scan
- Have a significant history of hypersensitivity reactions to gelatin capsules.
- Any other condition which, in the opinion of the investigator, would preclude
participation in the study
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | A Study of Nociceptin/Orphanin FQ Peptide Receptor Occupancy in Healthy Subjects | NCT01404091 | Contradiction |
4,018 | 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:
- 18 to 45 years.
- Unilateral symptomatic KOA.
- Patient in waitlist at the Schulthess Clinic for knee arthroplasty.
- Patient has mild to average pain levels
- Living place: Canton of Zurich or neighbouring Cantons.
- Signed written informed consent.
Exclusion Criteria:
- Symptomatic OA in lower extremity joints other than the knee.
- Bilateral symptomatic KOA.
- Usage of walking aids.
- Surgery to the lower limbs in the prior 12 months.
- BMI >35 kg/m2.
- Disorders that affect visuomotor function.
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 | Somatosensory Stimulation in Knee Osteoarthritis | NCT02854176 | Entailment |
5,457 | 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:
- Systemically free as reported by the patients
- Minimum of 20 teeth present in the dentition (excluding wisdom teeth);
- Clinically healthy gingiva (on intact periodontium)
- Dental biofilm-induced gingivitis (plaque induced gingivitis) according to the
criteria set by the American Academy of Periodontology for classification of
periodontal diseases and conditions in 2017
- Moderate to high caries risk patients
Exclusion Criteria:
- Patients with periodontitis or requiring other immediate dental treatments (within the
current 6 months)
- Subjects on antibiotics within last 6 months
- Periodontal therapy for the past 6 months
- Pregnant women and lactating mothers
- Medically compromised patients
- Subjects with tobacco consumption in any form
- Subjects wearing partial dentures or having clinically unacceptable restorations or
bridges
- Subjects wearing orthodontic appliances
- History of allergy to chemical or any herbal products
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash | NCT04575948 | Entailment |
4,925 | 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:
- Age 18-45 years, inclusive, of both genders
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
- No history of episodic wheezing, chest tightness, or shortness of breath consistent
with asthma, or physician-diagnosed asthma.
- forced expiratory volume at one second (FEV1) of at least 80% of predicted and
FEV1/forced vital capacity (FVC) ratio of >0.70.
- Oxygen saturation of >93%
- Ability to provide an induced sputum sample.
- Subject must demonstrate a >10% increase in sputum %PMNs 6 hours following inhaled WSP
exposure, when compared to baseline sputum (to be completed in a separate protocol
IRB# 15-1775).
Exclusion Criteria:
- Clinical contraindications:
- Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic renal
disease, chronic thyroid disease, history of chronic infections/immunodeficiency.
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
- Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85
mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading
less than 93%.
- Physician diagnosis of asthma
- If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic
rhinitis at the time of study enrollment.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
- Medications which may impact the results of the WSP exposure, interfere with any other
medications potentially used in the study (to include steroids, beta antagonists,
non-steroidal anti-inflammatory agents)
- Cigarette smoking > 1 pack per month
- Unwillingness to use reliable contraception if sexually active (IUD, birth control
pills/patch, condoms).
- Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS.
Oral contraceptives are acceptable, as are antidepressants and other medications may
be permitted if, in the opinion of the investigator, the medication will not interfere
with the study procedures or compromise safety and if the dosage has been stable for 1
month.
- Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.
- Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
- Allergy/sensitivity to study drugs or their formulations
- Pregnant/lactating women and children (< 18 years as this is age of majority in North
Carolina) will also be excluded since the risks associated with WSP exposure to the
fetus or child, respectively, are unknown and cannot be justified for this
non-therapeutic protocol. Individuals over 45 years of age will not be included due to
the increased possibility of co-morbidities and need for prohibited medications.
- Inability or unwillingness of a participant to give written informed consent
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 | Woodsmoke Particulate + Hypertonic Saline | NCT03851406 | Entailment |
3,810 | 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:
- Ages between 40 and 70 years, both gender
- Kellgren and Lawrence grades of I to III;
- The subjects volunteered participate in the study and complied with the regulations
and signed the written consent voluntarily.
- Meet the following clinical and radiological criteria for diagnosis:
- Clinical criteria:
1. most of the time have knee pain nearly a month
2. bone fricative
3. morning stiffness is less than or equal to 30 min
4. age is more than or equal to 38 years
5. bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee
osteoarthritis.
- Radiological criteria:
1. most of the time have knee pain nearly a month
2. the X-ray showed osteophyte formation
3. joint fluid examination confirmed with osteoarthritis
4. age is more than or equal to 40 years
5. morning stiffness is less than or equal to 30 min
6. bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6).
Exclusion Criteria:
- Patient with a history of allergy to similar constituents or chemical components of
the drug;
- Patients with limited liver and kidney function;
- Patients with hematopoietic system disease;
- Patients with diabetes, Cushing's syndrome and other endocrine disorders;
- Patients with severe heart and brain disease;
- Patients with low immunity;
- Patients directly involved with the staff in the study;
- Women during pregnancy or lactation;
- Participating in other clinical studies or Participated in 3 months;
- The investigators judged who be unfit for the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis | NCT02484508 | Entailment |
2,089 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- All subjects/patients:
- Willing and able to complete the requirements of this study including the
signature of the written informed consent,
- Able to complete the study in 5 working days or less,
- Able to perform pulmonary function tests
- Healthy volunteers:
- Never smoker or subject who stopped smoking at least 6 months before selection
(strictly less than 10 pack-years),
- Having pulmonary function tests within the normal range(according to predicted
values for age, sex and height as referenced in ATS/ERS 1993 standards)
- Patients with moderate/severe persistent asthma:
- Documented clinical diagnosis of moderate or severe persistent asthma (according
to GINA 2006 guidelines),
- Stable asthma in the 4 weeks prior to selection as evidenced by no change in
asthma medication, no treatment for asthma in an emergency,acute care setting and
no admission to hospital for acute asthma
Patients with moderate / severe COPD:
- Aged ≥ 45 and £ 80 years old,
- Documented clinical diagnosis of moderate or severe COPD(according to GOLD 2006
guidelines),
- With a smoking history of 10 pack-years or more,
- Stable COPD in the 4 weeks prior to selection as evidenced by no change in COPD
medication, no treatment for COPD in an emergency, acute care setting and no admission
to hospital for COPD exacerbation
Exclusion Criteria:
- Obese subject/patient having a Body Mass Index (BMI) > 35,
- Past or present respiratory disease including being free from the common cold and
rhinitis for at least 4 weeks before selection except asthma for asthmatic patients
and COPD for COPD patients,
- Daily need for 12 hours or more of long term oxygen therapy,
- Pregnant or lactating woman,
- Lack of efficient contraception according to CPMP/ICH 286/95 note 31,
- Any contra-indication to perform pulmonary function tests or light cycling exercise,
- Clinically significant or uncontrolled pathologic conditions which may interfere with
the study procedures,
- Drug abuse or psychic disorders resulting in an inability to fully understand the
requirements of the study,
- Legal status which prohibits informed consent,
- Participation in any interventional clinical trial within 30 days prior to selection
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 | Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease | NCT00801307 | Entailment |
6,428 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of
moderate facial rosacea;
- Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3
as per the IGE
Exclusion Criteria:
- Female subjects who were pregnant, nursing, or planning to become pregnant during
study participation;
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel | NCT03094403 | Entailment |
4,267 | 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. | Key Inclusion Criteria:
- Written informed consent or assent
- Subject has completed study TR02-108, and has been compliant with the study protocol
- Women of childbearing potential must agree to use reliable methods of contraception
for the duration of the study
Key Exclusion Criteria:
- Subject met any of the listed criteria for study drug discontinuation in protocol
TR02-108.
- Abnormal laboratory assessments including LFT (≥ 3× upper limit of normal [ULN]),
serum creatinine (> 2× ULN) and absolute neutrophil count [ANC] (< 1000).
- Psychotic, addictive or other disorder limiting the ability to provide informed
consent or to comply with study requirements.
- History of alcohol, medication or illicit drug abuse within the 6 months prior to
consent.
- Smoking tobacco or any substance within 6 months prior to consent or anticipated
inability to refrain from smoking throughout the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection | NCT01316276 | Entailment |
937 | 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:
- Presence of osteoarthritis of the knee. Traditional American College of Rheumatology
criteria, which are based on the presence of pain (gonalgia) plus at least three of
the following characteristics, will be used for the diagnosis of osteoarthritis of the
knee:
- Age > 50 years
- Stiffness in the morning < 30 minutes
- Presence of articular rusting
- Painfulness of the bones
- Tumefaction of the bones
- Absence of palpable heat
Exclusion Criteria:
- - pregnancy and breastfeeding (if the potential participant does not declare to be in
a menopausal state)
- other specific contraindications/intolerances to the compounds contained in the
supplement (e.g. celiac disease, allergy)
- simultaneous intake of other supplements
- to be at the time of enrolment for treatment with anti-inflammatory or pain-relieving
treatment for other clinical conditions
- Participation in other clinical studies
- State of inability to understand or desire
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 100 Years | Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in Osteoarthritis | NCT04207021 | Entailment |
5,351 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
1. Menstruating females with menorrhagia or menometrorrhagia referred to hematology or
gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular
periods with heavy menstrual bleeding with a PBAC score greater than 100;
menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals.
2. PBAC Score greater than 100 for 2 consecutive cycles
3. Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12
months prior to study participation.
4. Normal external genitalia examination within 6 months prior to study participation.
5. Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study
participation.
6. Negative urine or serum pregnancy test within 4 weeks prior to study participation.
Exclusion Criteria:
1. Presence of intra uterine device.
2. Presence of a diagnosed bleeding disorder based on the standard work-up including
complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen,
von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation.
3. Intake of medications with increased risk of bleeding
4. Taking herbal products.
5. Sexually active status.
6. Body weight less than 40 kg.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 21 Years | Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study | NCT01428713 | Contradiction |
2,796 | 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 or recurrent inguinal hernia
Exclusion Criteria:
- previous major lower abdominal surgery, patient refusal of randomization, or unable to
accept general anesthesia
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 85 Years | Prospective Randomized Trial Comparing Three-port and Single-port TEP Repair in Adults | NCT01591395 | Entailment |
2,784 | 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:
- Diagnosed primary or recurrence unilateral or bilateral inguinal hernia
- Age between 18 and 90;
Exclusion Criteria:
- Patients who prefer other surgical approach than TEP
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Corona Mortis in Patients Undergoing TEP for Inguinal Hernia | NCT04303442 | Entailment |
3,060 | 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:
- Age limit: 5 -50
- Primary diagnosis of mental retardation (IQ < 70)
- willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
transplantation.
- To give an informed consent as well as sign the required Informed Consent Form
(ICF)/video Consent for the study.
- willingness to regularly visit the hospital / clinic for follow up during the follow
up period / on prior agreed time points as per the protocol.
Exclusion Criteria:
- Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and
Syphilis
- Advanced age that may produce deteriorating cognitive or motor functioning
- Multiple sensory or motor disabilities that will interfere with seeing the stimuli and
responding to the computer
- Poor general health
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 50 Years | Safety and Efficacy of BMMNCin Patients With Mental Retardation | NCT01908400 | Entailment |
6,009 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
Patients aged > 18 years with severe GERD symptoms and esophagitis associated with short
esophagus
Exclusion Criteria:
Patients aged < 18 years Patients aged > 18 years with sliding hiatal hernia
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.
| Minimally Invasive Collis-Nissen for the Treatment of Short Esophagus | NCT02288988 | Entailment |
4,769 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Patients with unilateral Ménière's disease (definite or probable, according to
Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and
presenting with recurrent vertigo, not responding to medical treatment for at least 6
months will be included. There should be normal, age appropriate hearing in the
contralateral ear.
Exclusion Criteria:
- Patients with Ménière's disease in later stages (not having vertigo attacks).
- Age: patients older than 70 years at the start of the trial.
- Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious
concurrent illness that might interfere with treatment or follow up.
- Active additional neuro-otological disorders that may mimic Ménière's disease (e.g.
vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the
objective follow up difficult.
- Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active
middle ear disease).
- Family history of unexplained deafness (possibility of genetic susceptibility to
gentamicin toxicity).
- History of known adverse/allergic reaction to steroids or gentamicin.
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 | Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease | NCT00802529 | Entailment |
398 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women with clomiphene citrate failure (defined as at least previous 3 ovulatory cycles
with clomiphene citrate, with no pregnancy),
- persistently thin endometrium (less than 7 millimeters in at least 3 cycles).
- normal baseline Follicle Stimulating Hormone, Luteinizing Hormone, and free
testosterone levels, patent tubes by hysterosalpingography, and satisfactory male
semen analysis
Exclusion Criteria:
- previous ovarian surgery;
- endocrine disorders ;
- pelvic pathologies;
- chronic hepatic, cardiovascular, or renal disease;
- other factors of infertility and
- use of gonadotropins or hormonal contraception through the latest 6 months.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium | NCT03770026 | Contradiction |
5,497 | 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
- Affiliation to a social security system
- Diagnosis of GCA, as defined by the revised GCA diagnosis criteria:44
- Age ≥50 years at disease onset
- AND History of erythrocyte sedimentation rate (ESR) ≥50 mm/h OR CRP≥20 mg/L (not
mandatory if TAB is positive: see below)
- AND At least one of the following:
- unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw
claudication, temporal artery abnormality, ischemia-related vision loss)
- unequivocal symptoms of polymyalgia rheumatica (PMR)
o AND At least one of the following:
- Temporal artery biopsy (TAB) compatible with the diagnosis of GCA (non-necrotizing
vasculitis with a predominance of mononuclear cell infiltration or granulomatous
inflammation, usually with multinucleated giant cells)
- Evidence of large vessel vasculitis (aorta and/or epiaortic arteries):
- angio-CT or angio-MRI: thickened arterial wall (≥2mm for the aorta and ≥1mm for
epiaortic arteries) and/or contrast-enhanced arteries in T1-weighted sequences
- PET scan: grade 3 tracer uptake of the arterial wall (grade 3 = arterial SUVmax
superior to the SUVmax of the liver)
- Active GCA within 6 weeks before randomization. Active GCA is defined by ESR ≥30 mm/h
or CRP ≥10 mg/L and at least one of the following:
- ≥1 unequivocal cranial symptom(s) of GCA (new onset localized headache, scalp or
temporal artery tenderness, ischemia-related vision loss, or otherwise
unexplained mouth or jaw pain upon mastication)
- ≥1 unequivocal symptom(s) of PMR, defined as shoulder and/or hip girdle pain
associated with inflammatory stiffness
- any other feature(s) judged by the clinical investigator to be consistent with
GCA or PMR flares
Exclusion Criteria:
- Uncontrolled psychotic state
- Patient unable to give his/her consent
- Premenopausal women (menopause is defined as amenorrhea for more than 12 consecutive
months)
- Non-compliant patients
- Weight<40 Kg or >100Kg
- Patients under maintenance of justice, wardship or legal guardianship
- History of intoxication (alcohol or medication) requiring hospitalization within 12
months before inclusion
- Current chronic alcohol abuse (consumption > 20g/day)
- Recent or incoming surgery within 12 months after inclusion
- History of stem cell or organ transplantation (except corneas performed more than 3
months prior inclusion)
- Primary or secondary immunodeficiency
- Hypersensitivity to methotrexate or tocilizumab, one of its excipients or another
human or murine monoclonal antibody
- History of diverticulitis, inflammatory bowel disease, or other symptomatic
gastrointestinal tract condition that might predispose to bowel perforation
- Patient refusing to sign methotrexate safety contract
- Prior treatment with any of the following:
- Tocilizumab or methotrexate within 12 weeks before inclusion
- Cell-depleting agents (i.e., anti-CD20)
- Alkylating agents including cyclophosphamide
- Hydroxychloroquine, cyclosporine A, dapsone, azathioprine, mycophenolate mofetil
or janus kinase inhibitors within 4 weeks before inclusion
- Tumor necrosis factor inhibitors within 8 weeks (infliximab) or 2 weeks
(adalimumab or etanercept) before inclusion
- Anakinra within 1 week before inclusion
- Long-term systemic glucocorticoid therapy ((except dermocorticoids and inhaled
corticoids) for other conditions than GCA or PMR
- Patient with ≥3 prior glucocorticoid systematic therapies for another disease than GCA
or PMR within the 6 months before inclusion
- Long-term treatment with sulfamethoxazole/trimethoprim (Bactrim®)
- Live vaccine administered within 30 days before inclusion
- Laboratory abnormalities:
- AST or ALT >1.5 x upper limit of normal (ULN)
- total bilirubin >ULN
- platelets<100 G/L
- leukocytes <3 G/L
- neutropenia <1.5 G/L
- lymphopenia <0.5 G/L
- haemoglobin <8 g/dL (not related to GCA activity)
- clearance of creatinine <30 ml/min/1,73 m2 [CKD EPI 2009]
- positive HBs antigen or positive HCV antibodies
- Infections:
- History of viral hepatitis B or C (chronic or acute)
- HIV infection
- Persistent infection or severe infection requiring hospitalization or intravenous
antibiotics within 30 days before inclusion (antibiotic treatment tests are
allowed, regardless of duration and route of administration)
- Proven infection requiring oral antibiotics within 14 days before inclusion
(antibiotic treatment tests are allowed, regardless of duration and route of
administration)
- Prior history of histoplasmosis or listeriosis
- Active tuberculosis
- Latent tuberculosis (diagnosis based on history of non-treated contact, opacity
with a diameter greater than 1 cm on chest radiography, or positive in vitro
test: Quantiferon Gold® or T-Spot-TB®).
NB: a history of tuberculosis for which treatment is over and was correctly precribed
regarding usual recommendations is not an exclusion criteria, whatever the results of
Quantiferon Gold® or T-Spot-TB® tests.
- Unstable or poorly controlled, acute or chronic disease, not due to GCA, and which
contraindicates tocilizumab or methotrexate:
- Recurrent infections, unstable ischemic heart disease, renal failure (creatinine
clearance <30 ml/min/1,73 m2 [CKD EPI 2009]), liver failure, current liver disease,
heart failure ≥ NYHA stage III/IV, respiratory failure
- Neoplasia < 5 years, (except for in situ cervical cancer and skin carcinoma, except
melanoma, with R0 resection)
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.
| MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | NCT03892785 | Entailment |
669 | 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:
- Willing and able to give informed consent for participation in the study
- Men and women aged 18 years or older and generally in good health
- For iron-deficient volunteers: ferritin ≤ 15 microg/L and transferrin saturation < 16%
- For iron-replete volunteers: ferritin ≥ 20 microg/L and transferrin saturation ≥ 20%
Exclusion Criteria:
- Haemoglobin < 8.0 g/dL
- Haemoglobinopathy
- Iron overload, defined as ferritin > 300 microg/L
- Hypoxaemia (SpO2 < 94%) or significant co-morbidity that may affect haematinics,
metabolic or ventilatory responses
- Iron supplementation or blood transfusion within the previous 6 weeks
- Pregnancy or breast feeding
- Inability to exercise isolated calf muscle using a pedal or on a bicycle ergometer
- Contraindication to magnetic resonance spectroscopy exposure such as metallic implant
- Contraindication to receiving intravenous ferric carboxymaltose
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Iron Status and Human Metabolism | NCT02308449 | Contradiction |
5,508 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
1. 18 years of age or over
2. A clinical suspicion of a new diagnosis of GCA e.g. patients with a new onset of
headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue
claudication with or without visual loss
3. Participants must be willing to give informed written consent or willing to give
permission for a nominated friend or relative to provide written informed assent if
they are unable to do so because of physical disabilities e.g. sudden onset of
blindness/vision loss which can be caused by GCA (this will be made clear in the
ethics approval application)
Exclusion Criteria:
1. Previous diagnosis of GCA
2. Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions
other than PMR, within three months prior to study entry
3. Inability to give informed consent (either written consent or verbal assent from a
relative or carer)
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.
| Aetiology of TemporaL Arteritis Study | NCT02584517 | Entailment |
1,313 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
1. Individuals with a documented diagnosis of achondroplasia based on:
1. Genetic confirmation of achondroplasia and/or
2. Clinical diagnosis of achondroplasia (clinical examination or radiological
assessment)
2. ≥ five years of age at the time of enrolment
3. Has the cognitive and linguistic capacities necessary to complete questionnaires in
the language of his/her country (and/or parents/legally acceptable representatives, as
applicable)
4. Agrees to participate in the study and has read, understood, completed and signed:
1. Informed Consent Form (ICF) - for adult subjects
2. Informed Assent Form (IAF) - for minor subjects, accompanied by a parental ICF
completed by their parents/legally acceptable representatives. The age at which
the minor subjects sign the IAF will be subject to local requirements.
5. Has medical records available for at least the five years prior to the date of
enrolment.
Exclusion Criteria:
1. Currently participating, or participated within the last six months, in
1. a clinical trial of a medicinal product or medical device or,
2. other non-clinical, low interventional studies
2. Currently participating or participated in any BioMarin study at any time.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 70 Years | Lifetime Impact of Achondroplasia Study in Europe-LIAISE | NCT03449368 | Contradiction |
4,566 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Healthy women, inclusive of ages 18-35* years at the enrollment visit
- Intact uterus and both ovaries
- Prior history of regular menstrual cycles that usually occur every 28 ± 7 days when
not using hormonal contraception; if postpartum or post-abortal, history of regular
menstrual cycles of 21-35 days in length and resumption of at least one cycle with a
cycle length consistent with her past cycles
- In the opinion of the investigator, able to comply with the protocol, e.g. live within
the study site catchment area or within a reasonable distance from the study site
- May be sterilized or at risk of becoming pregnant
- Willing to use a non-hormonal method of contraception for one month prior to the
initial insertion of the NES/EE CVR and the one month washout period
- Willing to abstain from sexual intercourse during the miconazole nitrate treatment
period(s)
- Signed informed consent prior to entry into the trial
Exclusion Criteria:
- Known hypersensitivity to estrogens or progestins
- Pregnant, trying to become pregnant, or breastfeeding
- Known hypersensitivity to silicone rubber
- Undiagnosed abnormal vaginal bleeding
- Undiagnosed vaginal discharge, vaginal lesions or abnormalities. Subjects diagnosed at
screening with a Chlamydia or gonococcus infection may be included in the trial
following treatment; partner treatment is also recommended. Investigators should make
a determination if subjects are at high risk for reinfection, e.g., multiple sex
partners, untreated partner, and whether such subjects can be included
- History of pelvic inflammatory disease since the subject's last pregnancy
- History of toxic shock syndrome
- In accordance with the Bethesda system of classification: Women with a current (within
the last 20 months) abnormal Pap smear suggestive of high-grade pre-cancerous lesion
(s), including HGSIL
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a
vaginal ring
- Women planning to undergo major surgery during the trial
- Women who smoke 15 cigarettes or more per day must be evaluated by the PI for
inclusion based on risk factors that would increase their risk for cardiovascular
disease and thromboembolism, e.g., lipid levels, glucose level, BP, BMI, family
history of cardiovascular disease at a young age
- Current or past thrombophlebitis or thromboembolic disorders
- History of venous thrombosis or embolism in a first-degree relative, <55 years of age
suggesting a familial defect in the blood coagulation system, which in the opinion of
the PI, suggests that use of a hormonal contraceptive could pose a significant risk
- Cerebrovascular or cardiovascular disease
- History of retinal vascular lesions, unexplained partial or complete loss of vision
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Past history of any other carcinoma unless in remission for more than five years
- Current or history of medically diagnosed severe depression, which, in the opinion of
the investigator, could be exacerbated by the use of a hormonal contraceptive
- Headaches with focal neurological symptoms
- Severe constipation in the opinion of the investigator
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid use
- Benign or malignant liver tumors; active liver disease
- Diastolic blood pressure (BP) >85 mm Hg and/or systolic BP >135 mm Hg after 5-10
minutes rest (at screening)
- Known or suspected alcoholism or drug abuse within their lifetime
- Elevated serum fasting clinical chemistry values or complete blood count (CBC) values
designated clinically significant by the investigator and/or medically qualified
sub-investigator
- Screening hemoglobin levels less than 12.5 g/dL or hematocrit less than 38%.
- Participation in another clinical trial involving an investigational drug within the
last 30 days (prior to screening)
- BMI >29
- Use of liver enzyme inducers on a regular basis
- Use of monthly injectable contraceptives, unless suspended 2 months before initiation
of the treatment. Use of Depo-Provera [depo-medroxyprogesterone (DMPA)] unless
suspended 6 months before treatment
- Current use of implanted hormonal contraceptives, including Mirena [progestin
containing intrauterine system (IUS)], Jadelle, Norplant, Implanon or Nexplanon (if
now available in the USA).**
- Known HIV, Hepatitis B or Hepatitis C infection
- History of frequent vaginal infections in the opinion of the investigator
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women | NCT02215395 | Contradiction |
Subsets and Splits