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1,910 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients with histologically proven adenocarcinoma of the stomach or the GE-junction.
- Patients with distant metastases or patients with locally advanced disease who are not
curatively operable proven by laparoscopy or patients with a recurrence after
gastrectomy.
- Patients who did not receive any prior palliative chemotherapy. An adjuvant
chemotherapy is allowed.
- Age between 18 and 75 years.
- Sufficient bone marrow function defined as leucocytes > 3.0 Gpt/l, thrombocytes > 100
Gpt/l
- Sufficient liver function defined as bilirubin < 1.5 mg/dl (1.5 x ULN), ALT and AST <
3 x ULN.
- Sufficient renal function defined as serum creatinine < 1.25 x ULN, or creatinine
clearance > 60 ml/min calculated according to Cockroft-Gault
- Contraception in patients with reproductive potential.
- Karnofsky-performance-index at least 60%
- Measurable tumor lesions.
- Written informed consent of the patient.
Exclusion Criteria:
- Karnofsky-performance-index less or equal 50%.
- Patients who already received a palliative first-line chemotherapy.
- Prior second malignancy, except basal cell carcinoma of the skin or curatively treated
carcinoma in situ of the cervix.
- Parallel radiation therapy
- Uncontrolled infection.
- CNS-metastasis
- Other severe medical disease
- Prior major surgery for less than 2 weeks
- Parallel treatment with other experimental therapies.
- Parallel treatment with any other therapy aiming against the tumor.
- Chronic diarrhea, subileus.
- Chronic inflammatory bowel disease or intestinal obstruction.
- Unable to take oral medication.
- Pregnancy or breast feeding.
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 | Docetaxel and Capecitabine in Advanced Gastric Cancer | NCT00142038 | Entailment |
913 | 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:
- Present anterior or retro patellar pain aggravated by two or more activities that
overload the patellofemoral joint, such as going up and down stairs, squatting,
remaining in the sitting position for long periods, getting up from the sitting
position, kneeling or during physical exercise;
- Reporting pain of at least 3 on an 11-point scale (0 for no pain and 10 for the worst
possible pain) during the activities described above and on most days during the last
month;
- Have evidence of osteophyte formation in the patellofemoral joint on radiographs in
the profile and axial skyline views through the Kellgren-Lawrence (K-L) grade ≥ 2,
with minimal impairment in the tibiofemoral joint (KL <2);
- Body mass index (BMI) <35 Kg / m². Participants with unilateral or bilateral symptoms
will be included in the study.
Exclusion Criteria:
- Current use or in the last 12 months of foot orthoses;
- Previous history of fracture or recurrent subluxation of the patella;
- Arthroscopic surgery or knee infiltrations in the last 3 months;
- Osteoarthritis known in other weight-bearing joints, including the spine;
- History of surgery on the hip, knee, ankle and foot joints;
- History of ankle sprain in the last 12 months;
- Osteotomy in the lower limbs;
- Current physical therapy in the lower limbs or in the last 6 weeks;
- Use of a cane or other walking aid;
- Any physical disability that is a contraindication for carrying out the evaluations
and;
- Punctuation that suggests dementia according to the Mini-Mental State Examination,
taking into account the education of the participants.
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 65 Years | Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis | NCT04332900 | Entailment |
2,255 | 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:
- Proven diagnosis of gout according to aspiration of Monosodium urate (MSU) crystals or
positive dual energy computer tomography (DECT) or American college of rheumatology
(ACR) criteria 2015 fulfilled (1)
- written informed consent
- age >=18 years
- ability and willingness to follow a fixed outpatient programme as judged by the
investigator
- indication for urate-lowering therapy (ULT)
- In case of established disease and intercritical gout a SUA level over 360 umol per
liter is mandatory.
Exclusion Criteria:
- informed consent not obtained
- age <18 years
- inability or unwillingness to follow a fixed outpatient programme as judged by the
investigator
- no definite diagnosis of Gout
- no indication for ULT or contraindications against ULT
- in case of established disease and intercritical gout a SUA level <360 umol per liter
is an exclusion criterion
- Pregnant or breastfeeding women can´t participate.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Nurse Led Patient Management Programme to Improve Outcomes in Gout | NCT03345186 | Entailment |
4,444 | 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:
- 18 years and above
- presenting with refractory elbow pain
Exclusion Criteria:
patients with:
- osteoarthritis,
- rheumatoid arthritis,
- olecranon bursitis,
- radial nerve entrapment
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.
| Radial Nerve Block for Treatment of Tennis Elbow | NCT03262623 | Contradiction |
4,159 | 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:
- be a participant of the MSM service evaluation and continue using Zarin at 3 months
- agree at the time of Zarin insertion to be contacted regarding an opportunity to
participate in more research related to the implant
Exclusion Criteria:
-
Female
Accepts Healthy Volunteers
| A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar | NCT01200576 | Contradiction |
6,222 | 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:
- Coronavirus Disease 2019 (COVID-19) positive diagnosis by locally obtained viral
diagnostic test (example, polymerase chain reaction [PCR]). This may be nasal swab or
saliva test or other available technology to demonstrate current infection
- Confirm that participant is known to health system, with at least 1 contact in
electronic medical records (EMR) prior to screening
- Symptoms attributable to COVID-19 (example, fever, cough, loss of taste or smell,
muscle aches, shortness of breath, fatigue)
- Initial treatment plan does not include hospitalization
- Presence of at least 1 additional risk factor: a) age more than or equal to (>=) 60
years; b) prior history of VTE; c) history of thrombophilia; d) history of coronary
artery disease (CAD); e) history of peripheral artery disease (PAD); f) history of
cerebrovascular disease or ischemic stroke; g) history of cancer (other than basal
cell carcinoma) h) history of diabetes requiring medication; i) history of heart
failure; j) body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter
square (kg/m^2); k) D-dimer greater than (>) upper limit of normal for local
laboratory (within 2 weeks of the date of the COVID-19 test and prior to
randomization)
Exclusion Criteria:
- Increased risk of bleeding such as a) significant bleeding in the last 3 months; b)
active gastroduodenal ulcer in the last 3 months; c) history of bronchiectasis or
pulmonary cavitation; d) need for dual antiplatelet therapy or anticoagulation; e)
prior intracranial hemorrhage, f) known severe thrombocytopenia g) active cancer and
undergoing treatment
- Any illness or condition that in the opinion of the investigator would significantly
increase the risk of bleeding (example recent trauma, recent surgery, severe
uncontrolled hypertension, gastrointestinal cancer, renal failure requiring dialysis,
severe liver disease, known bleeding diathesis)
- Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
- Positive COVID-19 antibody or serology test after 2-week period of acute, symptomatic
COVID-19 infection
- Known diagnosis of triple positive (positive for lupus anticoagulant, anticardiolipin,
and anti-beta 2-glycoprotein I antibodies) antiphospholipid 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.
| A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection | NCT04508023 | Contradiction |
5,103 | 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
- Woman aged ≥ 60 years
- Osteoporosis according to DXA (Dual X-Ray Absorptiometry) hip (femoral neck or total
hip) or lumbar spine.
- Back pain.
Exclusion Criteria
- Diagnosed symptomatic spinal stenosis
- Difficulty to participate in the activities included in the study due to health
problems.
- Difficulty to participate in equipment training group.
- Inability to be able to complete wearing the spinal orthosis.
- Language difficulties
- Cognitive difficulties
- Visual problems
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group | NCT03263585 | Contradiction |
2,276 | 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. | For Patients who Completed CAT-1004-201 or CAT-1004-301:
Inclusion Criteria:
- Written consent/assent by patient and/or legal guardian as per regional and/or
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements
- Completion of either CAT-1004-201 or CAT-1004-301
Exclusion Criteria:
- In the Investigator's opinion, unwilling or unable for any reason to complete all
study assessments and laboratory tests and comply with scheduled visits,
administration of drug, and all other study procedures
For Siblings of Patients who Completed CAT-1004-201 or CAT-1004-301:
Inclusion Criteria:
- Written consent/assent by patient and/or legal guardian as per regional and/or
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements
- A sibling of a patient who completed either CAT-1004-201 or CAT-1004-301
- Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase
(CK) and documentation of mutation(s) in the dystrophin gene known to be associated
with a DMD phenotype
- Followed by a doctor or medical professional who coordinates Duchenne care on a
regular basis and willingness to disclose patient's study participation with medical
professionals
Exclusion Criteria:
- Use of oral corticosteroids at screening; use of inhaled, intranasal, and topical
corticosteroids is permitted
- Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4
weeks. Exception: Patients who are currently on or plan to initiate treatment with
approved oligonucleotide exon-skipping therapies, and expected to continue treatment
throughout the study, will be eligible
- Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy,
anticoagulants, cyclosporine, dihydroergotamine, ergotamine, fentanyl, alfentanil,
pimozide, quinidine, sirolimus or tacrolimus
- Use of human growth hormone within 3 months prior to Day 1
- Other prior or ongoing significant medical conditions
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 12 Years | An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy | NCT03917719 | Contradiction |
5,303 | 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 with a T-scores of ≤ ˗1.5, all patients received the same medical treatment
for osteoporosis and the same average blood glucose level, sufficient ability to
understand the nature and potential risks of the study.
Exclusion Criteria:
- Diabetes mellitus, ischemic heart disease, arrhythmia, uncontrolled thyroid disease,
cardiac pacemaker, tuberculosis, neuropsychiatric disorders (dementia, cerebrovascular
disease, alcohol abuse, severe depression, panic disorder, bipolar disorder, or
psychosis), and malignancy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 60 Years | Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis | NCT04608162 | Entailment |
6,074 | 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 submitted to primary minimally invasive surgery for gastroesophageal reflux
diseases or hiatus hernia.
- Age > 18 years.
Exclusion Criteria:
- Patients already submitted to minimally invasive surgery for gastroesophageal reflux
diseases or hiatus hernia for recurrence of the disease.
- Patients submitted to open surgery for gastroesophageal reflux diseases or hiatus
hernia.
- Patients affected by other esophageal diseases.
- Age < 18 years.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | True Short Esophagus in Gastroesophageal Reflux Disease | NCT03848494 | Entailment |
2,442 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Subjects with a definite diagnosis of sarcoidosis according to international ATS and
WASOG guideline
Exclusion Criteria:
- Ongoing CPAP treatment
- Psychiatric disorders
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status | NCT03926832 | Entailment |
220 | 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:
Since hypogonadotropic hypogonadism is a rare condition, with an incidence of 1/10,000 to
1/86,000 for isolated GnRH deficiency (34, 35), this protocol remains open to enrollment so
that we may study all subjects that are both qualified and interested in participating.
Males or females who are greater than or equal to 14 years old with clinical findings of HH
as outlined above will be included. In certain circumstances, a patient under the age of 14
years may be considered for baseline evaluation if there is sufficient evidence suggestive
of HH, such as any two of the following: anosmia, history of cryptorchidism or
microphallus.
EXCLUSION CRITERIA:
-Because HH represents a spectrum, where associated clinical findings may provide
phenotypic clues to the assessment of inheritability and underlying physiology, exclusion
criteria are very limited:
- Patients who have additional pituitary deficiencies, effectively ruling out isolated
GnRH deficiency, whether these deficiencies are congenital or acquired (e.g. secondary
to malignancy, infection, or irradiation).
- Patients who are taking medications known to cause HH, such as corticosteroids or
continuous opiate administration.
- Pregnancy or lactation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
| Hormonal Regulation of Puberty and Fertility | NCT01511588 | Entailment |
3,454 | 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:
- patients with controlled type 2 diabetes mellitus with overt CVD
- patients with controlled type 2 diabetes mellitus over the age of 40 years without
overt CVD,but with one or more major cardiovascular risk factors
Exclusion Criteria:
- uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood
pressure >95 mm Hg); evidence of active active liver disease or hepatic dysfunction
defined as a level of liver transaminases >2 times the upper limit of normal;
uncontrolled myocardial ischaemia; congestive heart failure (New York Heart
Association classification IIIb or IV); hemodynamically important valvular disease;
secondary hypercholesterolemia; gastrointestinal disease that might limit drug
absorption or partial ileal bypass; myopathy, or rhabdomyolysis; a known
hypersensitivity to statins; using any androgenic, estrogenic, progestogenic,
antiandrogenic, or antiestrogenic agents or medications that can alter the gonadal
steroid milieu; using systemic immunosuppressants or anticoagulants; plasma creatine
kinase levels >50% above the upper limit of normal,transient ischaemic attack or
stroke in past,severe hypertriglyceridaemia (fasting triglyceride level ≥350
mg/dl,Currently on psychotropic medications, steroids, opiate analgesics, Known case
of major neuropsychiatric illness,Poor cognition at baseline [Mini-Mental State
Examination(MMSE) score ≤24],Physically or mentally unable to complete tests, history
of other risk factors for hearing loss and/or conventional assessment that presented
conductive hearing loss, confirmed by acoustic immittance measurement;presence of
non-auditory associated disorders that could lead to long-latency potentials, such as
neurological diseases or syndromes
No condition on gender to be admitted to the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition | NCT00522158 | Entailment |
6,023 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- male or female
- age of 20-75 years
- patients with GERD who have to receive PPIs for four weeks
Exclusion Criteria:
- Suffering from peptic ulcer, gallstones, cancer, and Barrett's esophagus
- previously underwent the esophagus, stomach or duodenum surgery
- Lactating women or pregnant women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients | NCT02149914 | Entailment |
5,333 | 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. When subject signs the informed contest, 18≤ age ≤ 40, Male or female;
2. Body weight: male ≥50 kg, female ≥45 kg. Body mass index (BMI) of 19.0 to 26.0 kg/m²,
inclusive;
3. Subject's with normal or or abnormity without clinical significance judged by the
investigator by physical examination, vital signs, electrocardiogram, blood routine,
blood biochemistry, coagulation tests, fecal occult blood, urine routine, serological
tests and other important indicators;
4. All subjects who adopt effective non-hormonal contraceptive measures (such as condoms,
intrauterine devices without drugs, etc.) from the signing of informed consent to
three months after the end of the study;
5. Subjects who voluntarily signed the informed consent and are able to cooperate to
complete the test according to the protocal.
Exclusion Criteria:
1. Allergic history to more than one drug or other serious allergic rhistory;
2. Serious diseases of the central nervous system, cardiovascular system, digestive
system, respiratory system, urinary system, blood system, metabolic disorders or other
diseases (such as history of psychosis, malignant tumors, etc.)In the past or now,
which were not suitable for clinical trials.
3. History of abnormal bleeding or coagulation disorders (e.g. prone to bruising, gum
bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, menorrhagia,
postpartum hemorrhage, vitamin K deficiency, haemorrhagic diseases caused by acquired
coagulation factor antibodies, trauma, wound or post-operative bleeding, etc.);
4. History of severe head trauma in 2 years;
5. Severe gastrointestinal diseases occurred within three months before signing informed
consent, which affected drug absorption;
6. Have a disease which Haemorrhage could cause serious consequences, such as peptic
ulcer;
7. Had undergone surgery within six months before signing the informed consent; planned
to undergo surgery (including cosmetic surgery, dental surgery and oral surgery)
within two weeks after the end of the trial; or planned to take part in vigorous
exercise (including physical contact exercise or collision exercise) during the trial;
8. Bleed or donated more than 400 mL within three months before signing informed consent,
or planned to donate blood during the study or within one month after the end of the
trial;
9. Have taken any prescription drugs, nonpreserip drugs, biological products, traditional
Chinese medicines, herbal medicines, vitamin dietary supplements and health products
within four weeks before signing the informed consent or use oral long-acting
contraceptives or implanted long-acting contraceptives;
10. Subjects participating in other clinical trials and taking trial products, or
participated in any other clinical trials of drugs within three months before signing
the informed consent;
11. History of drugs or drug abuse or alcoholics or drug abuse screening shows positive
response;
12. current or past alcoholics (drinking more than 14 standard units per week, 1 Standard
unit containing 14g alcohol, such as 360 mL beer or 40% spirits or 150 mL wines with
45 mL alcohol), or alcohol breath test positive;
13. Smokers: The average daily smoking volume was more than 5 cigarettes within six months
before signing the informed consent;
14. Habitually consume excessive caffeine-containing beverages or foods, or foods that may
affect drug metabolism within four weeks before signing informed consent. Such as:
coffee (no more than 1100 mL per day), tea (no more than 2200 mL per day), cola (no
more than 2200 mL per day), functional drinks (no more than 1100 mL per day),
chocolate (no more than 510 g per day);
15. Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;
16. QTc interval≥450 ms, electrocardiogram abnormality with clinical significance, or
prolonged history of QTc interval;
17. Abnormal results of chest X-ray (posterior and anterior) with clinical significance;
18. Female subjects: positive pregnancy tests or pregnant or breast-feeding or planning to
conceive, who plan to conceive within three months from the signing of informed
consent to the end of the study; male subjects: whose partners plan to conceive or
plan to donate sperm within three months from the signing of informed consent to the
end of the study;
19. Not suitable for this trial according to 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 40 Years | Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers | NCT04036656 | Contradiction |
3,331 | 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:
- Able to comprehend, follow and give signed informed consent;
- 18 to 60 years of age (inclusive);
- Five year history of morbid obesity;
- Body Mass Index (BMI) >40 kg/m2 and <55 kg/m2, or BMI >35 kg/m2 and <40 kg/m2 with one
or more significant medical conditions related to obesity (co-morbid conditions of
type 2 diabetes, hyperlipidemia, obstructive sleep apnea, hypertension, metabolic
syndrome, or osteoarthritis of the hip or knee) for which the subject is being
treated, and which are generally expected to be improved, reversed, or resolved by
weight loss.
- 100 lbs. overweight or 1.5 times ideal weight;
- Documented failure of conservative, non-surgical means of weight reduction within one
year prior to the Screening Visit, including failure of supervised diet, exercise and
or behavior modification programs, and pharmacologic therapy;
- Willing to commit to significant lifestyle changes that include diet, eating, and
exercise habits for the duration of the clinical trial;
- Able to commit to long-term follow-up, including band adjustment visits:
- Living within the contiguous U.S. and is within a 100 mile radius of the study center;
- Absence of significant psychopathology that could limit the subject's ability to
understand the procedure, comply with medical, surgical, and/or behavioral
recommendations, as documented during screening assessment;
- Agrees to refrain from any type of reconstructive surgery that would affect body
weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess
skin for the follow-up period following SAGB placement; and
- Candidate for surgical weight loss intervention (i.e., meets accepted health criteria
for major surgery).
Exclusion Criteria:
- Women of childbearing potential who are not practicing an effective method of birth
control or who are pregnant or lactating;
- Previous malabsorptive or restrictive procedures performed for the treatment of
obesity;
- Documented history of drug and/or alcohol abuse within two years of the Screening
Visit;
- History of impaired mental status including, but not limited to active substance
abuse, a history of schizophrenia, borderline personality disorder, uncontrolled
depression, suicidal attempts within the past two years or current suicidal tendencies
or ideations;
- Presence of any of the following medical conditions;
- Inflammatory diseases of the gastrointestinal tract, including severe intractable
esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation
such as Crohn's disease that have been active within the past 10 years;
- Congenital or acquired anomalies of the GI tract, including atresias or stenosis,
- Severe cardiopulmonary disease or other serious organic disease that makes the
subject a high-risk surgical candidate;
- Uncontrolled hypertension;
- Portal Hypertension;
- Uncontrolled Diabetes Mellitus;
- Chronic or acute upper gastrointestinal bleeding conditions, e.g. gastric or
esophageal varices;
- Cirrhosis;
- Congenital or acquired intestinal telangiectasia;
- Esophageal or gastric disorders including severe preoperative reflux,
dysmotility, or Barrett's Esophagus;
- Presence of hiatal hernia;
- Prior surgery of the foregut including hiatal hernia repair or prior gastric
surgery;
- Chronic pancreatitis;
- Immunocompromised such as that resulting from chronic oral steroid use,
chemotherapeutic agents, or immune deficiency disorders;
- Conditions that, in the opinion of the investigator, may jeopardize the subject's
well-being and/or the soundness of this clinical study;
- History or presence of pre-existing autoimmune connective tissue disease, i.e.,
systemic lupus erythematosus or scleroderma;
- Presence of terminal illness with life expectancy <5 years;
- Use of prescription or over the counter weight reduction medications or supplements
within one month of the Screening Visit and for the duration of study participation;
- Acute or chronic infection (localized or systemic);
- Known or suspected allergy to silicone or other materials contained in the Swedish
Adjustable Gastric Band;
- History of intolerance to implanted devices;
- Not ambulatory; and
- Participation in another clinical trial within 8 weeks of the Screening Visit and for
the duration of this 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 60 Years | Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity | NCT00166205 | Contradiction |
5,342 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control
cycles)and desire contraception
Exclusion Criteria:
- Menorrhagia of endocrine or systemic origin
- other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis,
pelvic inflammatory disease.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia | NCT01266759 | Contradiction |
5,516 | 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:
- Patient suffering from giant cells arteritis.
- Inclusion while discovery of symptoms, or during relapse.
Exclusion Criteria:
- Healthy volunteer
- Treatment with corticosteroid since more than 8 days for a patient suffering from
giant cells arteritis, exept for patients under corticosteroid for a polymyalgia
rheumatica.
- Other diseases than giant cells arteritis that could introduce an inflammatory
symptom, especially a tumoral process in progress or a chronic inflammatory disease
(any other one than giant cells arteritis)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Biomarkers in Giant Cells Arteritis | NCT02844023 | Entailment |
4,842 | 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:
- Male and female patients at least 18 years old
- Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH)
production:
- Persistent hypercortisolemia established by two consecutive 24 h UFC levels at
least 1.5x the upper limit of normal
- Normal or elevated ACTH levels
- Pituitary macroadenoma (>1 cm) on MRI OR
- Inferior Petrosal Sinus Sampling (IPSS) central to peripheral ACTH gradient >2 at
baseline and >3 after CRH stimulation
- Recurrent or persistent Cushing disease is defined as pathologically confirmed
resected pituitary ACTH-secreting tumor, and 24 hour UFC above the upper limit of
normal reference range beyond post-surgical week 6
- Patients on medical treatment for Cushing's disease the following washout periods
must be completed before screening assessments are performed:
- Inhibitors of steroidogenesis (metyrapone, ketoconazole): 2 weeks
- Somatostatin analogs (pasireotide): 2 weeks
- Progesterone receptor antagonist (mifepristone): 2 weeks
- Dopamine agonists (cabergoline): 4 weeks
- CYP3A4 strong inducers or inhibitors: varies between drugs; minimum 5-6 times the
half-life of drug
Exclusion criteria:
- Patients with compromised visual fields, and not stable for at least 6 months
- Patients with abutment or compression of the optic chiasm on MRI and normal visual
fields
- Patients with Cushing's syndrome due to non-pituitary ACTH secretion
- Patients with hypercortisolism secondary to adrenal tumors or nodular (primary)
bilateral adrenal hyperplasia
- Patients who have a known inherited syndrome as the cause for hormone over secretion
(i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
- Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- Patients with cyclic Cushing's syndrome defined by any measurement of UFC over the
previous 1 months within normal range
- Patients with pseudo-Cushing's syndrome, i.e. non-autonomous hypercortisolism due to
overactivation of the HPA axis in uncontrolled depression, anxiety, obsessive
compulsive disorder, morbid obesity, alcoholism, and uncontrolled diabetes mellitus
- Patients who have undergone major surgery within 1 month prior to screening
- Patients with serum K+< 3.5 while on replacement treatment
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
- Patients who have clinically significant impairment in cardiovascular function or are
at risk thereof, as evidenced by
- Congestive heart failure (NYHA Class III or IV), unstable angina, sustained
ventricular tachycardia, clinically significant bradycardia, high grade AV block,
history of acute MI less than one year prior to study entry
- Patients with liver disease or history of liver disease such as cirrhosis, chronic
active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST
more than 1.5 x ULN, serum total bilirubin more than ULN, serum albumin less than 0.67
x LLN at screening
- Serum creatinine > 2 x ULN
- Patients not biochemically euthyroid
- Patients who have any current or prior medical condition that can interfere with the
conduct of the study or the evaluation of its results, such as
- History of immunocompromise, including a positive HIV test result (Elisa and
Western blot). An HIV test will not be required, however, previous medical
history will be reviewed
- Presence of active or suspected acute or chronic uncontrolled infection
- History of, or current alcohol misuse/abuse in the 12 month period prior to
screening
- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method of birth control. If a woman is
participating in the trial then one form of contraception is sufficient (pill or
diaphragm) and the partner should use a condom. If oral contraception is used in
addition to condoms, the patient must have been practicing this method for at least
two months prior to screening and must agree to continue the oral contraceptive
throughout the course of the study and for 3 months after the study has ended. Male
patients who are sexually active are required to use condoms during the study and for
three month afterwards as a precautionary measure (available data do not suggest any
increased reproductive risk with the study drugs)
- Patients who have participated in any clinical investigation with an investigational
drug within 1 month prior to screening or patients who have previously been treated
with seliciclib
- Patients with any ongoing or likely to require additional concomitant medical
treatment to seliciclib for the tumor
- Patients with concomitant treatment of strong CYP3A4 inducers or inhibitors.
- Patients who were receiving mitotane and/or long-acting somatostatin analogs
(octreotide LAR or lanreotide)
- Patients who were receiving pasireotide or ketoconazole before study entry must
complete a 2 week washout period prior to receiving seliciclib
- Patients who have received pituitary irradiation within the last 5 years prior to the
baseline visit
- Patients who have been treated with radionuclide at any time prior to study entry
- Patients with known hypersensitivity to seliciclib
- Patients with a history of non-compliance to medical regimens or who are considered
potentially unreliable or will be unable to complete the entire study
- Patients with presence of Hepatitis B surface antigen (HbsAg)
- Patients with presence of Hepatitis C antibody test (anti-HCV)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Treatment of Cushing's Disease With R-roscovitine | NCT02160730 | Contradiction |
6,397 | 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:
1. Signed a current EC approved informed consent form
2. Male or female participants between 18 and 75 years of age, inclusive diagnosis of
SARS-CoV-2 infection, with all of the following, with onset of any within the 48 hours
prior to testing:
1. Presence of fever at time of screening of ≥ 38.0°C (≥ 100.0°F)
2. Presence of at least one constitutional symptom associated with Covid-19 (e.g.
headache, myalgia, malaise, or fatigue, rash, diarrhea, loss or alteration of
taste/smell) of any severity,
3. Presence of at least one respiratory symptom (e.g. cough, chest tightness or sore
throat)
3. Diagnosis of COVID-19 with a positive PCR in the past 48 hours
Exclusion Criteria:
1. Critically ill with presence of one or more of the following signs:
1. difficulty breathing or shortness of breath
2. need for admission to a hospital or an intensive care unit,
3. acute respiratory failure requiring intubation/mechanical ventilation,
4. signs of shock including hypotension
5. Oxygen saturation < 92 %
2. Any clinically significant screening laboratory results that are greater than 5 times
the upper limit of normal.
3. Estimated GFR < 50 mL/min/1.73 m2 (calculated using either Modification of Diet in
Renal Disease (MDRD) or Cockcroft Gualt
4. Known genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or
autoimmune hemolytic anemia
5. Hemoglobin less than 10 gm/dL or hematocrit < 30 %
6. Retinal eye disease
7. Known chronic kidney disease, stage - 5 or receiving dialysis
8. Inability to tolerate oral medications
9. Allergy or prior adverse reaction to either ribavirin or nitazoxanide
10. QTc interval > 450 mSEC for men and women
11. History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT
interval
12. Current treatment with histamine-2 receptor antagonists (H2 blockers) and/or Protein
Pump Inhibitors and throughout the study.
13. Any physical, mental, or social condition, drug/alcohol use, history of illness or
laboratory abnormality that in the investigator's judgment might interfere with study
procedures or the ability of the subject to adhere to and complete 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 75 Years | Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19 | NCT04563208 | Entailment |
6,019 | 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:
- A history of heartburn or acid regurgitation for 3 months or longer or any history of
erosive esophagitis.
- Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep
disturbances associated with GERD for 1 month or more.
- Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in
period and sleep disturbances associated with GERD as documented in the run-in diary
card on at least 3 of the last 7 days of the run-in period..
Exclusion Criteria:
- Any condition other than GERD that is either the primary cause of, or a significant
contributor to the patients sleep disturbance.
- Shift workers who work between 12am (midnight) and 6am.
- Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that
has not been stable for at least 3 months or is not expected to remain stable during
the patients participation in the study.
- Other diseases / conditions 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 85 Years | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) | NCT00628342 | Entailment |
5,160 | 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
- Age 65 or older
- At least one visit with a primary care physician in the previous 12 months
Exclusion Criteria:
- DXA scan in the previous 5 years
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Improving Quality of Osteoporosis Care Through Patient Storytelling | NCT01112098 | Contradiction |
6,199 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum
production, nasal discharge, myalgia, headache or fatigue) on admission.
- Time of onset of the symptoms should be acute ( Days ≤ 10).
- SpO2 ≤ 93%
- Respiratory Rate ≥ 22
Exclusion Criteria:
- Refusal to participate expressed by patient or legally authorized representative if
they are present.
- Patients with prolonged QT or PR intervals, Second or Third Degree heart block,
Arrhythmias including torsade de pointes
- Patients using drugs with potential interaction with Umifenovir Hydroxychloroquine,
Lopinavir/Ritonavir or Interferon-β 1a.
- Pregnant or lactating women.
- History of alcohol or drug addiction in the past 5 years.
- Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
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.
| Umifenovir in Hospitalized COVID-19 Patients | NCT04350684 | Contradiction |
3,399 | 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:
- Subject must be willing to provide written informed consent prior to any clinical
investigation related procedure;
- Male or female patients over 18-year-old;
- Presence of ear wax in both ear canals with a minimum of > 50% ear wax blockage in at
least one ear (level 4) and > 25% blockage in the contralateral ear (level 3) as
assessed using the TMVSS;
- Subject must be willing and able to perform all the visits, follow the PI instructions
and complete the follow-up of the study.
Exclusion Criteria:
- Subject is currently participating in another clinical investigation or has
participated in another clinical investigation in the past 30 days prior to the start
of the present study;
- Pregnant or nursing subjects and those who plan pregnancy during the clinical
investigation follow-up period;
- Presence of other anatomic or comorbid conditions (e.g. ear eczema or seborrhea), or
other medical, social, or psychological conditions that, in the investigator's
opinion, could limit the subject's ability to participate in the clinical
investigation or to comply with follow-up requirements, or impact the scientific
soundness;
- Presence or history of a tympanic membrane perforation or tympanostomy tubes at any
time during the previous 6 months;
- Presence or history of a known or suspected ear infection (i.e. otitis externa or
otitis interna) in the previous 2 months;
- Presence of a known or suspected chronic suppurative otitis media;
- Presence or history of a known or suspected keratosis obturans;
- Presence of known or suspected mastoiditis;
- Use of any ototopical drug or OTC product or ear wax-removal product (except for water
or physiologic saline) during the preceding 3 days;
- Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid
reactions;
- Temporal bone neoplasm.
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 | Earol Madrid Study | NCT04653662 | Contradiction |
1,611 | 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:
- Being an office worker between 20-35 years of age
- Using a computer for at least 4 hours a day
- Working full time for at least 1 year without any upper extremity pathology
Exclusion Criteria:
- Having a body mass index of 30 kg / m2 or more on the day of evaluation
- Using muscle relaxants 72 hours before the evaluation
- Exercising within the last 48 hours
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | A Comparison of Two Different Wrist Immobilization Methods | NCT04213352 | Contradiction |
6,903 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Diagnosis of probable AD according to the National Institute of Neurological and
Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders
Association (NINCDS-ADRDA) criteria
Exclusion Criteria:
- Has significant neurological disease, other than Alzheimer's disease, e.g., multiple
sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the
presence of subdural hygromas or subdural hematomas.
- Evidence of substance abuse (alcohol or other drug) abuse or dependence during the
previous 12 months (DSM-IV Criteria).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | Deep Brain Stimulation for the Treatment of Alzheimer's Disease | NCT01559220 | Entailment |
2,755 | 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:
- ASA physical status I or II who were scheduled to minor elective ambulatory surgery
(e.g. inguinal hernia, undescended testes, umbilical hernia) performed by experienced
surgeon under general anesthesia.
Exclusion Criteria:
- patients with full stomach
- A history of gastric reflux
- A history of convulsions, cardiovascular or neuromuscular disease
- Allergies to the study drugs
- obese children
- suspected difficult airway and hyper-reactive airway disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 8 Years | Laryngeal Mask Insertion Conditions And Hemodynamic Effects | NCT03257800 | Entailment |
3,166 | 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. | Patients:
Inclusion criteria
- 18 years and over
- Severe eye dryness (grade 3 or 4) as defined by the International Dry Eye Work Shop
(2007): Frequent symptoms, Impregnation of fluorescein at the conjunctival level,
marked fluorescein staining at the corneal level, Tear Break Up Time ≤ 5 seconds
(fluorescein test) Schirmer's test score without anesthesia ≤ 5mm at 5 minutes
Exclusion criteria
- Treatment with topical ciclosporin
- Autologous serum treatment
- Wearer of scleral lenses
- Known pregnancy or breastfeeding
Control subjects:
Inclusion criteria
- 18 years and over
- Tear Break Up Time > 5 seconds (fluorescein test)
Exclusion criteria
- Wearer of contact lenses
- Functional ocular signs
- Anomalies of the ocular surface observed during examination with the slit lamp
- Fluorescein staining of the ocular surface (cornea, conjunctiva)
- Topical ocular treatment
- Known pregnancy or breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE) | NCT03358979 | Contradiction |
2,226 | 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. | Key Inclusion Criteria:
1. Male or female patients age ≥18 to ≤85 year
2. History of established gout
3. Onset of current acute gout attack within 4 days prior to randomization with: presence
of any warm joint, swollen joint, pain score at rest ≥5 on the 0-10 pain scale,
patient self-report of acute gout attack
4. Baseline pain intensity ≥5 on a 0-10 pain scale;
5. Tender (≥1 on a 0-4-point Likert scale) and swollen (≥1 on a 0-4-point Likert scale)
index joint;
6. If on urate-lowering therapy, a stable dose and regimen for at least 2 weeks prior to
randomization, and expectance to remain on a stable dose and regimen for the duration
of the double-blind treatment period, and;
7. Body mass index (BMI) ≤45 kg/m2.
Exclusion Criteria:
1. Use of intra-articular or IM corticosteroids within 14 days prior to screening;
2. Use of an IL-1 inhibitor, TNF inhibitor or other biologic or investigational drug
within 30 days prior to screening;
3. History of a drug allergy to either study drug;
4. Diagnosis or history of:
1. rheumatoid arthritis (RA);
2. infectious/septic or other inflammatory arthritis;
3. alcoholic hepatitis or nonalcoholic steatohepatitis;
4. immunodeficiency syndromes, including Human Immunodeficiency Virus (HIV)
infection;
5. Stage IIIb, IV, or V chronic kidney disease;
6. idiopathic thrombocytopenic purpura;
7. active, severe chronic pulmonary disease (eg, requiring oxygen therapy);
8. uncontrolled hypertension (≥ 200/105 mmHg);
9. symptomatic (New York Heart Association Class II, III, or IV) congestive heart
failure;
10. uncontrolled diabetes Type I or II (recent blood glucose > 300 mg/dL);
11. myocardial infarction, unstable cardiac arrhythmias or unstable symptomatic
coronary ischemia, within the past 12 months before randomization;
12. history of malignancy of any organ system within the past 5 years;
13. multiple sclerosis or any other demyelinating disease, or;
14. major chronic inflammatory disease or connective tissue disease other than RA or
psoriatic arthritis (PsA), including but not limited to fibromyalgia or systemic
lupus erythematosus (with the exception of secondary Sjögrens syndrome, etc.);
5. Contraindication to IM injection;
6. Donation or loss of ≥400 milliliters (mL) of blood in the 8 weeks before dosing;
7. Any live vaccination in the 3 months before the start of the study;
8. Active infection (including chronic or localized infections) for which antiinfectives
were indicated within 4 weeks before screening;
9. Any serious infection, defined as requiring hospitalization or intravenous
anti-infectives, within 8 weeks before first dose of investigational product;
10. Prosthetic joint infection within 5 years of screening, or native joint infection
within 1 year of screening;
11. Known alcohol addiction or dependency, daily alcohol use, or current substance use or
abuse;
12. Positive medical history for hepatitis B or C (subjects with a history of hepatitis B
vaccination without history of hepatitis B infection are allowed to enroll);
13. History of active tuberculosis;
14. Positive test for tuberculosis during screening, defined as positive Purified Protein
Derivative (PPD) skin test (≥5 mm induration at 48-72 hours after test is placed), or
positive Quantiferon test;
15. Pregnant or nursing (lactating) women
16. Female patients who are physiologically capable of becoming pregnant must use an
acceptable method of contraception
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout | NCT03636373 | Entailment |
3,719 | 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 and radiological diagnosis of primary knee diagnosis.
- Pain intensity: Visual Analog Scale (VAS) ≥ 6;
- One of more failures with conventional treatment (drugs, Non-Steroidal
Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and
others);
- Age over 60 years;
- No use of corticosteroids in the prior 48 hours;
- No major osteoarthritis events in other joints of lower limbs (waist and ankle) and
lower back;
- No clinical evidence of related neuropathy, including radiculopathy and peripheral
neuropathy;
- Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing
spondylitis, generalized polyarthritis, cancer);
- Absence of infection or cancer at the application site;
- Absence of related endocrine and metabolic diseases;
- Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
- Absence of severe blood dyscrasias;
- Absence of severe psychiatric disturbances that requires psychiatric assessment;
- Availability to comply with the clinic visits and follow up evaluations along the
treatment
Exclusion Criteria:
- Patients who withdraw the informed consent form 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 60 Years old.
| Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis | NCT02197962 | Contradiction |
6,128 | 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:
1. 50 years or older
2. Both male and female subjects will be included
3. Positive oropharyngeal/nasal swab RT-PCR for Sars-Co- V2. Diagnosed not more than 2
days ago(diagnosis
≤2days).
4. Either asymptomatic or have mild symptoms. Onset of symptoms within no more than 4
days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever
38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal
highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of
dehydration, sepsis or shortness of breath.
5. Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic
heart disease. Under treatment and controlled by medication
6. Signed informed consent/or consent given through text message, WhatsApp ore-mail.
7. Ability to understand the requirements of the Research Protocol and follow the
research procedures.
8. Subject should be willing to be managed in isolation wards
9. Negative pregnancy test (for female participants)
10. Adequate contraception for study duration
Exclusion Criteria:
1. Less than 50years
2. With severe COVID-19 symptoms requiring immediate hospitalization
3. Investigator considers the subject unsuitable for ViraCide
4. History of symptoms of more than 4days
5. COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR forSars-Co-V2
6. History of cardiopulmonary resuscitation
7. Subjects having history of organ failure or conditions requiring ICU monitoring and
treatment, such as severe liver disease, severe renal dysfunction, upper
gastrointestinal hemorrhage, disseminated intravascular coagulation or any other
condition that in the PI"s opinion makes the subject unfit to participate
8. Respiratory failure, ARDS or need of mechanical ventilation
9. History of acute exacerbation of comorbidity like heart failure, diabetic
ketoacidosis, myocardial infection, major cardiac rhythm disorder or any other
condition that in the PI"s opinion makes the subject unfit to participate
10. History of or current hepatic failure or severely compromised liver function, or renal
failure or having chronic kidney disease or acute renal failure
11. History of or currently receiving treatment for an endocrine disorder like
hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate.
12. History of or currently under treatment for asthma [exception: patients with history
of asthma, not on medications/inhalers/nebulizers for at least 6 months before study
start), COPD, bronchiectasis, asbestosis and other such chronic lung conditions that
can compromise SpO2 and RR.
13. HIV, HBsAg, HCV positive
14. Any condition causing immunodeficiency
15. Systemic connective tissue disease or any autoimmune disease that is likely to affect
HS-CRP levels
16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on
treatment for it
17. History of or currently having malignancy and being treated for it. (exception:
histologically confirmed and cured carcinoma in situ)
18. Hypersensitivity reaction to Study drug/placebo
19. Any psychiatric issue for which the subject is currently undergoing treatment
20. Any history of drug/alcohol dependence within 30 days of screening or current
drug/alcohol dependence
21. Inability to understand the requirements of the Research Protocol and follow the
research procedures.
22. Pregnant or lactating;
23. Not willing to use adequate contraception during study duration
24. Participation in any other clinical study less than 3months before the start of 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 50 Years old.
Subject must be at most 90 Years | Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19) | NCT04596085 | Contradiction |
51 | 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:
- Early and late pubertal girls with normal androgens
- Early and late pubertal girls with hyperandrogenemia
- All subjects will be girls from pre-puberty (Stage 1 breast development and pubic hair
growth but at least 7 years old) to 7 years post menarche.
Exclusion Criteria:
- Pregnancy
- Inability to comprehend what will be done during the study or why it will be done
- Hemoglobin <11.5 g/dL for non-African American subjects; Hemoglobin < 11.0 g/dL for
African American subjects
- Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)
- Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase
(i.e., confirmed on repeat)
- Total bilirubin > 1.5 times upper limit of normal (i.e., confirmed on repeat)
- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected
congestive heart failure; asthma requiring intermittent systemic corticosteroids;
etc.)
- Untreated hypo- or hyperthyroidism (reflected by persistently abnormal TSH values)
- Total testosterone > 200 ng/dl
- Basal (follicular) 17-OHP > 200 ng/ml (in girls without a previous diagnosis of
congenital adrenal hyperplasia)
- DHEA-S > 800 mcg/dl
- Elevation of prolactin > 2 times upper limit of normal
- Weight less than 25 kg
Female
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 17 Years | Assessment of Day-night Secretion of Progesterone and LH Across Puberty | NCT02155933 | Contradiction |
5,726 | 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:
- children presented to Jordan Univeristy Hospital (JUH) outpatient endocrinology clinic
for the evaluation of short stature (SS)
Exclusion Criteria:
(i) their parents could not provide written consent for them; (ii) they were lost to follow
up; (iii) they could not perform clonidine stimulation tests (CST) or insulin tolerance
test (ITT) due to a medical contraindication (e.g. cardiac disorder, seizure disorder);
(iv) they had received GH therapy in the past; (v) they were known to have pituitary
diseases, hypothyroidism, hypogonadism or discovered to have panhypopituitarism or (vi)
they have malnutrition, diabetes mellitus, liver disease, or other chronic illnesses.
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 16 Years | Growth Hormone (GH) Deficiency & Insulin Like Growth Factor 1 (IGF-I)/ Insulin Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio | NCT02424240 | Entailment |
828 | 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:
- Age: 40-80
- Men or women
- Digital osteoarthritis (DIP and PIP) according to ACR criteria (with recent X-ray,
dating from less than 6 months, of the hands showing radiological signs of digital
osteoarthritis)
- Symptomatic digital osteoarthritis for more than 3 months (at least every other day)
despite taking analgesics and NSAIDs (except when there are contraindications to the
latter therapeutic group)
- Osteoarthritis affecting more than three finger joints
- Pain more than 40 mm as evaluated by pain VAS (0-100 mm)
- No contraindication to anti-TNF alpha treatments
- No digital osteoarthritis surgery scheduled within the next 2 months
- Written informed consent
Exclusion Criteria:
- Pregnant women or women of reproductive potential without effective contraception
- Known hypersensitivity
- Patients having already been treated with an anti-TNF alpha
- Finger osteoarthritis secondary to inflammatory rheumatism
- Psoriasis
- Existence of painful syndrome of upper limbs likely to interfere with the monitoring
of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint
disorders of the elbow or shoulder)
- Inflammatory rheumatism
- Contraindications to anti-TNF alpha agents: patients with suspected reactivation of
tuberculosis (phlyctenular IDR, past history of tuberculosis, chest X-ray deemed
suspect) or known leukopenia (< 3500 leukocytes), known hepatic cytolysis
(transaminases more than twice normal), a history of serious allergy, concomitant
infection, past history of serious systemic infection (septicemia), a history of known
cancer within the past 5 years, history of multiple sclerosis
- Skin disease incompatible with subcutaneous injection
- Anticoagulant (oral) or treatment with heparin at a curative dose
- Surgery scheduled within the coming 2 months
- Finger surgery scheduled within the coming 6 months
- Local injection of a corticosteroid in a symptomatic finger joint during the previous
month
- Local injection of hyaluronic acid in a symptomatic finger joint during the prior 3
months
- Treatment with a slow-acting anti-osteoarthritis agent initiated and colchicine
(amendment 26/06/2008) within the previous 3 months
- Oral corticosteroids
- Psychiatric illness
- Non-controlled diabetes "mellitus"
- Known viral hepatitis B or C, HIV infection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Efficacy Study of an Anti-Tumor Necrosis Factor (TNF) Alpha Agent in Patients With Hand Osteoarthritis | NCT00597623 | Entailment |
3,447 | 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:
- mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride
(TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol
levels higher than 130 mg/dL after 6-week diet/life style change
- Men and women who were between 20 and 70 years of age
- Having at least one history of: coronary artery disease, cerebrovascular disease or
transient ischemic attack, peripheral vascular disease, or diabetes mellitus.
- Having risk factors at least two of: age ≥45 years in male or ≥55 years in female,
elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure
≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein
(HDL)-cholesterol <40 mg/dL, family history of coronary artery disease at age <55
years in male or <65 years in female, central obesity (waist circumference ≥90 cm for
male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular
hypertrophy on electrocardiogram
- Written informed consent.
Exclusion Criteria:
- pregnant or breast-feeding
- uncontrolled hypertension
- uncontrolled diabetes mellitus
- thyroid dysfunction
- serum transaminase level >2 times the upper limit of normal
- history of gall bladder disease
- chronic alcoholic
- serum creatinine level >1.5 mg/dL
- history of myopathy
- history of acute myocardial infarction or acute stroke within 3 months before the
study began
- acute or chronic infection or inflammation
- history of cancer
- history of adverse events associated with test drugs.
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 70 Years | Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia | NCT01414803 | Entailment |
5,048 | 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. | 1. Diagnosis of essential tremor.
2. Tremor rating scale score 3 or one or both upper extremities
3. Unsatisfactory response to primidone or to propanolol
4. Not taking tremor-inducing drug
5. Able to comply with visits
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.
| Novel Therapies for Essential Tremor | NCT00018564 | Entailment |
6,556 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Age from birth to ≤12 months at time of informed consent
- Body weight ≥3 kilograms (kg) at time of informed consent. Patients with a lower body
weight can be enrolled after they have reached a body weight of 3 kg. Premature babies
(gestational age <38 weeks) may be enrolled as long as they have reached a body weight
of 3 kg. For premature babies, the corrected gestational age should be reported.
- Mandatory receipt of vitamin K prophylaxis according to local standard practice
- Diagnosis of severe congenital hemophilia A (intrinsic FVIII level <1%)
- A negative test for FVIII inhibitor (i.e., <0.6 Bethesda units [BU]/mL) locally
assessed during the 2-week screening period
- No history of documented FVIII inhibitor (i.e., <0.6 BU/mL), FVIII drug-elimination
half-life <6 hours, or FVIII recovery <66%
- Previously untreated patients or minimally treated patients (i.e., up to 5 days of
exposure with hemophilia-related treatments, such as plasma-derived FVIII, recombinant
FVIII, fresh frozen plasma, cryoprecipitate, or whole blood products)
- Documentation of the details of the hemophilia-related treatments received since birth
- Documentation of the details of the bleeding episodes since birth
- For patients from birth to <3 months of age at the time of study entry: no evidence of
active intracranial hemorrhage, as confirmed by a negative cranial ultrasound at
screening irrespective of delivery mode
- Adequate hematologic, hepatic, and renal function, as defined in the protocol
- For parents/caregivers: willingness and ability to comply with the study protocol
requirements, scheduled visits, treatment plans, laboratory tests, completion of
applicable questionnaires, and other study procedures
Exclusion Criteria:
- Inherited or acquired bleeding disorder other than severe hemophilia A
- Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use
during the study
- Receipt of any of the following: An investigational drug to treat or reduce the risk
of hemophilic bleeds within 5 drug-elimination half-lives of last drug administration;
A non-hemophilia-related investigational drug within the last 30 days or 5
drug-elimination half-lives, whichever is shorter; An investigational drug
concurrently
- Current active severe bleed, such as intracranial hemorrhage
- Planned surgery (excluding minor procedures, e.g., circumcision, CVAD placement)
during the study
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection
- Patients who are at high risk for thrombotic microangiopathy (TMA) (e.g., have a
previous medical or family history of TMA, such as thrombotic thrombocytopenic
purpura, atypical hemolytic uremic syndrome) in the investigator's judgment
- Previous or current treatment for thromboembolic disease (with the exception of
previous catheter-associated thrombosis in patients for whom anti-thrombotic treatment
is not currently ongoing) or signs of thromboembolic disease
- Any hereditary or acquired maternal condition that may predispose the patient to
thrombotic events (e.g., inherited thrombophilias antiphospholipid syndrome)
- Other diseases (e.g., certain autoimmune diseases) that may increase risk of bleeding
or thrombosis
- Known infection with HIV, hepatitis B virus, or hepatitis C virus
- Serious infection requiring antibiotics or antiviral treatments within 14 days prior
to screening
- Concurrent disease, treatment, abnormality in clinical laboratory tests, vital signs
measurements, or physical examination findings that could interfere with the conduct
of the study or that would, in the opinion of the investigator or Sponsor, preclude
the patient's safe participation in and completion of the study or interpretation of
the study results
- Unwillingness of the parent or caregiver to allow receipt of blood or blood products,
or any standard-of-care treatment for a life-threatening condition
- Any other medical, social, or other condition that may prevent adequate compliance
with the study protocol in the opinion of the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 12 Months | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors | NCT04431726 | Contradiction |
2,333 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Diagnosis of Duchenne muscular dystrophy confirmed by medical history and genetic
testing
- Body weight between 15 and 50 kg
- Receipt of glucocorticoids for 6 months and a stable daily dose for at least 3 months
prior to study entry
- Ability to rise from floor within seven (7) seconds and ability to walk
Exclusion Criteria:
- Current exposure to systemic immunosuppressant agents other than glucocorticoids.
- Prior exposure to any gene therapy agent, including exon-skipping and missense agents.
- Exposure to other investigational drugs within 30 days or 5 half-lives, whichever is
longer.
- Any injury which may impact functional testing per investigator's judgement. Previous
injuries must be fully healed prior to consenting. Prior lower limb fractures must be
fully healed and at least 3 months from injury date at screening.
- Any planned surgeries which may impact physical activity and performance.
- Presence or history of musculoskeletal or neurological disease in addition to DMD.
- Any known allergies or skin reactions to stainless steel, versaflex, and silicon that
may cause possible discomfort by wearable sensors.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, cancer, autoimmune or allergic
disease that may interfere with the study conduct as per investigator's judgment,
excluding untreated, asymptomatic, seasonal allergies at time of screening.
- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
participants who are Pfizer employees, including their family members, directly
involved in the conduct of the study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 12 Years | A Low Interventional Study to Monitor Activity Using Wearable Sensors in Duchenne Muscular Dystrophy | NCT04254172 | Entailment |
1,996 | 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 proven primary gastric adenocarcinoma
- clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed
tomography
- aged 20-80 year old,
- performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- diagnosed as diabetes or hypertension
- patients planning to undergo gastrectomy or endoscopic submucosal dissection
- written informed consent
Exclusion Criteria:
- having high risk for operation such as severe heart disease, severe respiratory
disease
- pregnant
- previous abdominal surgery or radiation therapy
- proven more advanced disease than pathological stage II requiring adjuvant
chemotherapy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients | NCT01643811 | Entailment |
6,572 | 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:
- Moderate or mild hemophilia A (FVIII:C 0.02-0.35 IU/mL) or hemophilia B (FIX:C
0.02-0.35 IU/mL)
- Age from 12 up to and including 55 years
Exclusion Criteria:
- Other clotting disorder
- Participation in another trial with an investigational product
- Comorbidity affecting the musculoskeletal status
- Clinically relevant inhibitor status at present or in the past
- Hemophilia B Leyden
- Use of anticoagulants
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 55 Years | The Dynamic Interplay Between Bleeding Phenotype and Baseline Factor Level in Moderate and Mild Hemophilia A and B | NCT03623295 | Contradiction |
4,578 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Women affected by adenomyosis with pelvic pain > 4;
- Negative Pap Smear test
Exclusion Criteria:
- Pregnancy or research of pregnancy
- Refusal or inability to sign informed consent
- Severe underlying comorbidities (hepatic, oncological)
- Pelvic inflammatory disease
- Other cervical or uterine pathologies
- Deep venous thromboembolism
- Hormonal therapy contraindications
- Smoke
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS) | NCT02556411 | Contradiction |
1,078 | 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:
- TIA or non-severe stroke within 90 days prior to randomization (including day 90)
- Modified Rankin score of < 3
- High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery,
MCA stem (M1), vertebral artery,and basilar artery) documented by conventional
angiography within 90 days prior to randomization (including day 90)
- TIA or stroke is attributed to high grade intracranial stenosis
- Age > 40 years
- Patient is able to follow an outpatient protocol(requiring monthly blood tests and
clinic visits every four months for the duration of the study) and is available by
telephone
- Patient understands the purpose and requirements of the study, can make him/herself
understood, and has provided informed consent
Exclusion Criteria:
- Extracranial carotid stenosis (> 50 percent) ipsilateral to stenosis of the
intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have
caused patient's symptoms)
- Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA
division, or a distal branch of the MCA
- Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis,
radiation induced vasculopathy, fibromuscular dysplasia
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or
paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis,
intracardiac clot or vegetation, myocardial infarction within three months, dilated
cardiomyopathy, left atrial spontaneous echo contrast
- A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer
disease, active bleeding diathesis, platelets < 100,000*, hematocrit < 30*, clotting
factor abnormality that increases the risk of bleeding, alcohol or substance abuse,
severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past
year, severe liver impairment (SGOT > 3x normal*, cirrhosis), allergy to aspirin or
warfarin, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic
pressure > 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids,
creatinine > 3.0*
- Indication for intravenous heparin beyond randomization
- A severe neurological deficit that renders the patient incapable of living
independently
- Dementia or psychiatric problem that prevents the patient from following an outpatient
program reliably
- Co-morbid conditions that may limit survival to less than five years
- Pregnancy or female in age range of childbearing potential who is not using
contraception
- Enrollment in another study that would conflict with the current study
- Excluded because difficult to measure percent stenosis of these small arteries,
lesions are uncommon, and prognosis of patients - With these lesions is unknown * on
most recent test done within 90 days prior to randomization, including day 90
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.
| Aspirin Or Warfarin To Prevent Stroke | NCT00004728 | Contradiction |
1,234 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Subject provides informed consent
- Subject is >18 years of age
- Subject is deemed competent for making medical decisions
- Subject is scheduled to undergo a staging pleuroscopy
- Subject is a surgical candidate
- A negative pregnancy test is required in women of child-bearing potential, as standard
of care.
Exclusion Criteria:
- Subject is <18 years old.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Staging Procedures to Diagnose Malignant Pleural Mesothelioma | NCT02648763 | Entailment |
6,877 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Age: over 65
- Participants (or representatives) gave their written informed consent
- Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders
(DSM IV) criteria
- For Alzheimer arm: probable Alzheimer based disease according to NINCDS-ADRDA
(National Institute of Neurological and Communicative Disorders and Stroke and the
Alzheimer's Disease and Related Disorders Association ) criteria
- For vascular dementia: diagnosis based on NINDS-AIREN (National Institute of
Neurological Disorders and Stroke and Association Internationale pour la Recherche et
l'Enseignement en Neurosciences) criteria
- For MCI: diagnosis based on Petersen index
Exclusion Criteria:
- Claustrophobia
- Diabetes
- Cardiovascular disease
- Glycemia over 1.3 g/L
- Lumbar puncture within one week before MRI examination
- Non MR-compatible implant
- Suspected brain metastases
- No informed consent signature
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging | NCT01815112 | Contradiction |
3,556 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- Signed informed consent
- Medical examination carried out before the participation in the research
- Age between 18 and 55 years
- Minimum level of studies
- Obligation to join the social security system
- normal or corrected vision normal
Exclusion Criteria:
- Subject included in another clinical and / or therapeutic experimentation in progress
- Major vision disorder
- Past or current neurological or neuropsychiatric pathologies
- History of cranial trauma with loss of consciousness.
- Medication treatments likely to modulate brain activity: benzodiazepine,
antidepressants, neuroleptics, lithium, etc.
- Diabetes, cardiac pathology, immunodeficiency.
- Medication treatments likely to modulate the activity of the cardiovascular system.
- History of abuse or recent ingestion of alcohol, hard drugs or doping products.
- Consumption of more than 15 cigarettes per day
- Subject deprived of liberty by a judicial or administrative decision (L1121-6 CSP)
- Major subject subject to a legal protection measure or unable to express their consent
(L1121-8 CSP)
- Pregnant, parturient and nursing mothers (L1121-5)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Multistability: Perception is Inspired by Noise | NCT03723044 | Contradiction |
2,209 | 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:
- a diagnosis of gouty arthritis per expert opinion and the ACR/EULAR 2015 criteria for
gout.
- have had at least one self-reported flare in the last 12 months
- BMI >30kg/m2
- >18 years of age
Exclusion Criteria:
- pregnant
- hisotry or suspicion of drug abuse within the past 5 years
- Active muscle disease, cancer, previous kidney disease, and/or fatty liver
- An estimated creatinine clearance <30 mL/min calculated by the Cockcroft-Gault formula
using ideal body weight.
- An investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior
to the screening visit.
- Any other medical or psychological condition which, in the opinion of the investigator
and/or medical monitor, might create undue risk to the patient or interfere with the
patient's ability to comply with the protocol requirements, or to complete 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.
| Weight Loss for Obese Individuals With Gout | NCT03664167 | Contradiction |
2,978 | 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:
- Patients with Fragile X Syndrome, who are at least moderately ill based on a Clinical
Global Impression Severity score of at least 4 and have qualifying scores on the ABC-C
and IQ test at Visit 1
Exclusion Criteria:
- Advanced, severe or unstable disease that may interfere with the study outcome
evaluations
- Cancer within the past 5 years, other than localized skin cancer
- Current treatment with more than two psychoactive medications, excluding
anti-epileptics
- History of severe self-injurious behavior
Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome | NCT01253629 | Contradiction |
721 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Patient is diagnosed by the investigator to be medically acceptable for a surgical
procedure?
- Patient is aged 40 to 75 inclusive?
- Patient has symptomatic osteoarthritis of the carpometacarpal (CMC-1) joint as
demonstrated by a minimum DASH score of 40 at baseline?
- Patient has pain in the target CMC joint as demonstrated by an average VAS pain score
greater than or equal to 40 at baseline on a 100mm VAS?
- Patient has radiographic evidence of Stage II OA with no free-floating bodies in the
CMC-1 joint?
- Radiographic Stage II OA is defined according to the Eaton-Glickel classification
system (based upon lateral view) as follows:
"Slight narrowing of the TM [trapezio-metacarpal/CMC] joint will be present with minimal
sclerotic changes of the subchondral bone. There may be joint debris not exceeding 2 mm in
diameter in the form of osteophytes or loose bodies The ST [scapho-trapzeial joint] should
appear normal."
- Patient has subluxation of less than one-third of the target CMC joint?
- Patient agrees to return to the clinic for follow-up visits at the required times per
protocol and follow the requirements of this protocol?
- Patient is able and willing to provide voluntary consent to participate?
Exclusion Criteria:
- Patient has non-symptomatic osteoarthritis of the first CMC joint?
- Patient has small bone or calcific fragments (spurs, osteophytes) in the target CMC
joint greater than two millimeters (>2mm) in diameter?
- Patient has free floating bodies of any size within the target CMC joint?
- Patient has radiographic/imaging evidence of significant osteoarthritic changes within
the first metacarpal, or scaphotrapezotrapezoidal (STT) joint of the target wrist
consistent with Stage III/IV OA, according to Eaton-Glickel, as defined below?
"Stage III OA: The joint space will be markedly narrowed or obliterated with cystic
changes, sclerotic bone, varying degrees of dorsal subluxation, and joint debris exceeding
2 mm in diameter. The ST joint will appear normal."
"Stage IV OA: There is complete deterioration of the TM [CMC] joint as in stage III and, in
addition, the ST joint will be narrowed with sclerotic and cystic changes apparent."
- Patient has concomitant musculoskeletal pathology of the target hand, such as carpal
tunnel syndrome, palmar tenosynovitis, scaphoulnate ligament instability/degeneration,
ulnocarpal impaction syndrome, or trigger finger;
- Patient has concomitant rheumatic disease (e.g., inflammatory rheumatoid arthritis,
cutaneous psoriasis, polyarticular chondrocalcinosis, gout, fibromyalgia) or exhibits
signs of metabolic disorders affecting the bone or joint (e.g., osteoporosis,
osteomalacia, hyper- or hypo-parathyroidism, Paget's disease)?
- Patient has an active infection, sepsis or osteomyelitis?
- Patient has skin disease or eruption at the CMC target site?
- Patient had previous surgery on the target CMC joint or on the wrist of the target
hand?
- Patient had significant injury to the target CMC joint within the 6 months prior to
study enrollment or a significant permanent injury at any time prior to study
enrollment?
- Patient has a significant comorbid medical condition that could exacerbate pain
symptoms or adversely affect physical functioning or healing of the thumb CMC joint
(e.g. de Quervains disease, Ehlers-Danlos Syndrome, Complex Regional Pain Syndrome)?
- Patient has had corticosteroid injections in the target CMC joint within 6 months
prior to study enrollment?
- Patient takes concomitant immunosuppressive therapy (e.g., oral/injectable
glucocorticoids, alkylating agents, antimetabolites, antibodies, drugs acting on
immunophilins [Ciclosporin, Sirolimus], interferons, opioids) that could adversely
affect healing?
- Patient has uncontrolled diabetes mellitus?
- Patient takes anticoagulation and or antiplatelet therapy that cannot be stopped prior
to surgery?
- Patient is planning a pregnancy, or patient is pregnant and/or lactating? (If a
subject becomes pregnant after enrollment in the study, then the subject will continue
to be followed, even though she may miss some follow-up appointments. During the
pregnancy, X-rays will not be performed.)
- Patient is participating in any other clinical investigation that could impact the
outcome of this study?
- Patient has a known history of drug or alcohol abuse in the previous 12 months?
- Patient has a history of, or is currently engaged in, litigation for musculoskeletal
injuries or disorders or medical malpractice?
- Patient has other life circumstances that the Investigator feels would interfere with
study participation such as planned relocation, difficulty complying with schedule of
study follow-up visits, is generally uncooperative?
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC)for Osteoarthritis of the First CarpoMetacarpal Joint | NCT01961570 | Contradiction |
6,985 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
- must be able to swallow pills
Exclusion Criteria:
- known or suspected bipolar disorder
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.
| A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease | NCT01320527 | Entailment |
2,827 | 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:
- El Escorial Classification of laboratory supported probable, probable,or definite ALS
- Age 18 - 80 years,
- ALS symptoms for no more than 3 years,
- FVC greater than or equal to 60% predicted,
- Riluzole naïve or have been on a stable dose of Riluzole for at least 2 months,
- Patients must have the ability to attend monthly study visits in Edmonton or Calgary,
Alberta
Exclusion Criteria:
- Presence of significant sensory abnormalities, dementia, other neurologic diseases,
uncompensated medical illness and psychiatric illness
- Female patients who are breastfeeding
- Use of concurrent investigational drugs,
- Patient unlikely to comply with study requirements
- Poor adherence to study protocol during run-in phase
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 Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS) | NCT00409721 | Entailment |
1,010 | 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:
- A patient is considered having definite RA if he/she scores at least 6 points in the
established classification system
- A patient is considered having Hand OA if he /she Hand pain, aching, or stiffness plus
3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue
enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity
of at least 1 of 10 selected joints which are are the second and third distal
interphalangeal (DIP), the second and third proximal interphalangeal, and the first
carpometacarpal joints of both hands
Exclusion Criteria:
- Any subject with liver diseases, coronary artery diseases, kidney diseases or other
inflammatory conditions was excluded from the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Serum IL-17 Correlated With Inflammatory Changes in Osteoarthritis and Rheumatoid Arthritis | NCT04474912 | Entailment |
1,983 | 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:
- The patients who were diagnosed of primary gastric adenocarcinoma and drew up
agreement for understanding and enrollment of this study.
Exclusion Criteria:
- Being treated (surgery, endoscopic resection and chemoradiation) after the diagnosis
of gastric cancer; metastatic gastric cancer; refusal to participation of this study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Gastric Cancer Registry for Epidemiology and Molecular Risk Factor | NCT03046745 | Entailment |
4,732 | 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:
- Female
- Sedentary or Active
- 18.5-34.9 kg/m2 BMI
- Normal menstrual cycle defined as 28 to 30 days and a duration of 3 to 7 days
- Age range is 18-45 years old
- The inclusion of other participants may alter the results as an increase in body fat
has been linked to known changes in different hormonal levels and those changes might
influence substrate utilization
- Changes in the hormonal status of pre-menopausal women may appear without symptoms
- Younger females also display variations in their hormones since they are going through
the process of development
Exclusion Criteria:
- Previous physiological and mental health history
- Pregnant females
- Males
- Irregular menstrual cycle, menstrual dysfunction or unusual sex hormone levels
- Musculoskeletal injuries
- Contraceptives, a medication that alters hormonal or cardio-respiratory responses
- Pre-menopausal symptoms
- On moderate to high-intensity exercise regime more than 2 days/week
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effects of Resistance Training in Body Composition and Body Image Perception of Women Throughout the Menstrual Cycle | NCT04038463 | Entailment |
2,222 | 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:
- History of at least 1 gout flare prior to the Screening Visit
- Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the
classification of acute arthritis of primary gout.
- Presence of acute gout flare for no longer than 5 days.
- Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS.
- Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.
Exclusion Criteria:
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis.
- Presence of severe renal function impairment
- Contraindication to intramuscular injection
- Known presence or suspicion of active or recurrent bacterial, fungal or viral
infection at the time of enrollment
- Evidence of active pulmonary disease
- Live vaccinations within 3 months prior to the start of the study
- Use of forbidden therapy
Other protocol-defined inclusion/exclusion criteria applied
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 | Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients | NCT00798369 | Contradiction |
5,419 | 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:
- Historically lowest VWF:Ag and/or VWF:RCo and/or VWF:CB ≤ 0.30 IU/mL and/or FVIII:C ≤
0.40 IU/mL
- Treatment at a Hemophilia treatment center in the Netherlands
- All types of VWD
- All ages
Exclusion Criteria:
- Other known bleeding disorders present.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Von Willebrand Disease in the Netherlands | NCT03521583 | Entailment |
4,585 | 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 females between the ages of 18-40 (inclusive)
- BMI between 26.5-35.4 kg/m² (inclusive)
- Regular menstrual cycle (28 ± 3 days)
- Weight stable (within ± 3-kg) 2 months prior to study inclusion
- Must use barrier contraception (e.g. male/female condom) for the study's duration
- Must be willing to follow the prescribed diet/exercise plan for the study's duration
Exclusion Criteria:
- On hormonal contraceptives or any other daily use of medications which can make the
subject unsuitable for inclusion in the study.
- Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular
disease, untreated hypothyroidism, etc.)
- Restrictions against participating in cardiovascular exercise and strength training
- Any condition, which in the opinion of the investigator makes the subject unsuitable
for inclusion in the study.
- Women who are pregnant, lactating, or planning to become pregnant during the study
period
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Association Between the Menstrual Cycle and Weight Loss | NCT01119976 | Contradiction |
465 | 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:
- Unexplained infertility
- Both ovaries are present
- Day 2 FSH <10 mIU/L
- Day 2 Estradiol <80 pg/L
Exclusion Criteria:
- Known other cause of subfertility
- Expected poor responders according to Bologna criteria (9)
- Abnormalities affecting the uterine cavity
- Uncontrolled diabetes
- Allergy to gonadotrophins
- Cancelled cycles during the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Role of Follicular Output Rate in the Prediction of in Vitro Fertilization and Intracytoplasmic Sperm Injection in Women With Unexplained Infertility | NCT02154958 | Contradiction |
797 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- • Female subjects aged 60 years and over, non-obese (BMI between 18.5 and 24.9 kg /
m2), with diagnosis of knee OA according to the criteria of the American College of
Rheumatology (Altman et al. , 1986), which are: knee pain most of the day during the
last weeks and age greater than 60 years (mandatory criteria), and at least two of the
following criteria: stiffness after rest less than 30 minutes, crackle in the affected
knee , joint increase of firm consistency, absence of temperature increase and painful
hypersensitivity to palpation;
- Individuals with radiographic signs of degeneration of the knee joint;
- Individuals with any degree of degeneration according to the Kellgren-Lawrence
scale;
- Individuals with a pain scale above 3 according to NPRS;
- Stiffness in the knee for at least 6 months prior to screening;
- Stiffness during the beginning of activities;
- Intermittent swelling;
- Never have used KT;
- Individuals with no history of associated joint disease or systemic rheumatic
disease and / or history of surgery in the affected lower limb;
- Individuals who are not under physiotherapeutic treatment during the
intervention;
- Individuals without neurological, vestibular, visual or auditory deficits that
make evaluations impossible.
Exclusion Criteria:
- • Individuals who report pain during the procedure;
- Individuals who do not complete the treatment time or who do not perform the
evaluation procedures correctly, making it impossible to collect any of the data
investigated;
- Individuals with allergy to bandage or cutaneous injury in the region where KT
will be applied;
- Individuals who present hypertensive peak during the evaluations.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 75 Years | Effect of Kinesio Taping in Women With Knee Osteoarthritis | NCT03624075 | Entailment |
815 | 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:
- Verified knee osteoarthritis in accordance with the ACR (knee pain combined with one
of the following signs: age above 50 years, knee crepitus or morning joint stiffness
lasting for less than 30 minutes combined with radiologic signs of knee
osteoarthritis);
- Kellgren Lawrence radiological grade II-III knee osteoarthritis with the predominant
involvement of the medial tibiofemoral region of the knee joint;
- Joint space width (JSW) of the target knee joint at least 2.5 mm.
Exclusion Criteria:
1. History of any injury or surgical intervention on the target knee joint (except for
diagnostic arthroscopy made not longer than 60 days at the study entry);
2. Severe degenerative changes in the target knee joint determined as the joint space
narrowing less than 2 mm;
3. Varus or valgus deformation of the target knee joint;
4. Instability of the target knee joint;
5. Active inflammation of the target knee joint (edema, hyperemia, present effusion) at
the study entry;
6. Microcrystalline arthropathies;
7. Systemic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus,
etc.);
8. Seronegative spondyloarthritis and reactive arthritis;
9. Inflammatory diseases of the skin and soft tissues in the proposed injection site for
the test MD or placebo in the target joint;
10. History of venous thrombosis and thromboembolia;
11. Coagulogram abnormalities (APTT, prothrombin time, prothrombin index, fibrinogen);
12. Inflammatory changes in the complete blood count (leukocytosis, increase of
erythrocyte sedimentation rate [ESR]);
13. Platelet count abnormality (in accordance with the reference ranges of the local
laboratory;
14. Increase of rheumatoid factor level;
15. Increase of uric acid level > 360 μmol/l;
16. Diabetes mellitus;
17. Hemophilia and other hemorrhagic diatheses, as well administration of anticoagulants
and disaggregants;
18. Positive results of HIV, HBs-Ag, anti-HCV, RW tests;
19. Intra-articular injection to the target knee joint:
- Noltrex - within 24 months prior patient's inclusion to the study;
- hyaluronates - within 6 months prior patient's inclusion to the study;
- glucocorticosteroids - within 1 month prior the study inclusion;
- non-steroidal anti-inflammatory drugs (NSAID) - within 3 weeks prior patient's
inclusion to the study.
20. Oral administration of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks
prior the study inclusion;
21. Necessity of systemic glucocorticosteroids in any dosage form;
22. Paracetamol administration within 48 hours prior the study inclusion;
23. Pregnancy and lactation;
24. Hypersensitivity to components of the test MD or placebo;
25. Severe liver disorder determined as the increase of one of the values: ALT, AST, ALP,
total bilirubin, GGTP more than 3 times the upper limit of normal;
26. Renal diseases with the glomerular filtration rate estimated per Cockraft-Gault
formula less than 60 ml/min/1.73 m2 (III-V stage chronic renal disease [CRD]);
27. Clinically manifest hip osteoarthritis;
28. History of knee and coxofemoral endoprosthesis;
29. Acute infectious diseases or infectious aggravations of chronic diseases (respiratory
infections) within one month prior the study inclusion;
30. Severe decompensated chronic or acute diseases and other conditions which, by the
opinion of the study physician, may preclude the patient's participation in the study
or affect 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 50 Years old.
| Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis | NCT03897686 | Entailment |
6,919 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Diagnosis of probable or possible Alzheimer's disease (AD);
- 15≤ Mini-Mental State Examination (MMSE) score ≤26;
- Clinical Dementia Rating score 0.5-2;
- Community-dwelling, e.g., homes and assisted living;
- Age 66 years and older;
- English-speaking;
- Verified exercise safety by the primary care providers and the cardiologists if
subjects have significant cardiac history;
- Stable on AD drugs >1 month if AD drugs are prescribed.
Exclusion Criteria:
- Resting heart rate (HR) ≤50 or ≥100 beats/min;
- Neurological disorders in the past 5 years;
- Psychiatric disorders in the past 5 years;
- Alcohol or chemical dependency in the past 5 years;
- Contraindications to exercise;
- New symptoms or diseases that have not been evaluated by a health care provider, e.g.,
hip fracture, ongoing and unplanned weight loss, severe shortness of breath, deep vein
thrombosis, hernia, unhealed sores, joint swelling, pain or trouble walking;
- Cardiac ischemia or serious arrhythmia on the electrocardiograph during the screening
exercise test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 66 Years old.
| Effects of Aerobic Exercise for Treating Alzheimer's Disease | NCT01954550 | Entailment |
5,545 | 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:
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of
Rheumatology (ACR) criteria for the diagnosis of GCA:
1. At least 50 years of age at disease onset
2. New onset or new type of localized pain in the head
3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
decreased pulsation unrelated to arteriosclerosis of cervical arteries)
4. ESR of greater than 40 mm in the first hour by the Westergren method
5. Temporal artery biopsy showing vasculitis characterized by a predominance of
mononuclear cell infiltration or granulomatous inflammation, usually with
multinucleated giant cells
- Corticoid treatment since less than 14 days
- Signed informed consent
- Affiliation to the social security system
Exclusion Criteria:
- Dementia
- Predictable non observance
- Neoplasia since less than 5 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis | NCT01400464 | Entailment |
3,523 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Primary or secondary chronic adrenal insufficiency, previously or newly diagnosed.
- ACTH-dependent or ACTH-independent Cushing's Syndrome diagnosis during active disease
(new diagnosis or recidivating).
- Signed informed consent to participate in the study.
Exclusion Criteria:
- acute adrenal insufficiency;
- clinical or laboratory signs of significant respiratory, hepatobiliary, or pancreatic
disease;
- pregnancy;
- severe infections, surgery, trauma requiring hospitalization within 3 months before
study entry;
- any active blood or rheumatic disorders, and active liver disease in the previous 5
years;
- clinically significant chronic kidney disease;
- severe psychiatric diseases;
- history of neoplasms in the last 5 years (except for adrenal or pituitary adenoma in
Cushing Syndrome, pituitary adenoma or related neolpasms in secondary adrenal
insufficiency);
- heart disease with a class III or class IV functional capacity;
- BMI greater than 40 kg/m²;
- use of medication that interferes with cortisol metabolism within 1 month before study
entry;
- treatment with systemic Glucocorticoid (GC) therapy other than hydrocortisone (HC), or
cortisone acetate (CA);
- alcoholism and/or drug addictions;
- night-shift workers;
- use of melatonin, antipsychotic medications, estroprogestinic preparations
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 | Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders | NCT04374721 | Contradiction |
2,673 | 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:
1. Demonstrable hernia evident using ultrasound, computed tomography, or on physical
exam.
2. Pt scheduled for unilateral inguinal hernia repair.
3. Symptoms present for < 6 months.
Exclusion Criteria:
1. Non-elective surgery.
2. Previous hernia repair at the same site, or surgery near the site of the hernia.
3. Demyelinating neurological disease.
4. Current or recent (< 6 years) history of substance abuse.
5. Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing
age.
6. Pre-existing untreated psychiatric condition that could preclude an optimal treatment
response (e.g. untreated posttraumatic stress disorder).
7. Unstable medical condition (e.g. unstable angina or congestive heart failure or
severe).
8. Rheumatoid arthritis, or other systemic conditions that might respond to TNF
inhibitors.
9. Pt is immunosuppressed or is taking other drugs (e.g. corticosteroids) that might
suppress the immune system.
10. Systemic infection.
11. Any opioid analgesics within 48 hours of skin incision.
12. Any use of tricyclic antidepressants, serotoninin-norepinephrine reuptake inhibitors,
or anticonvulsants within 72 hours of skin incision.
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 | Preoperative Etanercept Before Inguinal Hernia Surgery | NCT00825344 | Entailment |
3,798 | 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:
- Diagnosed unilateral knee osteoarthritis by a qualified physician
- Recent (within 3 months of entrance into the study) radiographic confirmation of OA
grade (I-IV) as evidenced by joint space narrowing and the presence of osteophytes
- A score of 50-90 mm on a 100 mm visual analogue pain scale for walking
- Ability to walk independently without the use of assistive devices
Exclusion Criteria:
- History of lower extremity joint surgery or other lower extremity injury that would
hinder ambulation
- Severe foot deformity that would prevent the accommodation of the wedged orthotic
device
- Other disease process such as neurologic, cardiac, or oncologic, that would hinder
one's ability to ambulate
- Any condition, such as diabetes, that results in loss of sensation in the lower
extremities
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 75 Years | Wedged Orthoses and Knee Osteoarthritis | NCT00420147 | Entailment |
6,957 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Alzheimer's disease
- Cognitive Impairment
Exclusion Criteria:
- any previously noted epileptic seizures, including febrile seizures.
- any significant disease of the eye, such as macular degeneration. Since the 40Hz light
therapy is delivered via eye stimulation, healthy eyes are required.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy | NCT03657745 | Entailment |
2,998 | 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:
- FMR1 premutation carriers (55-200 CGG repeats)
- symptomatic (with possible or probable FXTAS) or neurologically asymptomatic.
Exclusion Criteria:
- Severe disability unable to perform tests
- treatment with neuroleptics
- other brain disease or pathology
- deafness or blindness
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Brain Network Activation and Gait and Posture in FXTAS | NCT02936531 | Contradiction |
4,059 | 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:
- Symptomatic Knee Osteoarthritis according to criteria of American College of
Rheumatology
- Antero-medial knee pain of at least 6 months duration
- Matching symptoms with Knee X-ray findings of KOA
- Kellgran-Lawrence staging of 2-4
- Pain score of at least NRS(Numerical Rating Scale) 4/10 during weight bearing
Exclusion Criteria:
- Presence of other knee diseases such as fracture or rheumatic diseases
- Referred pain from the back suggestive of lumbar radiculopathy
- Previous knee surgery
- Lateral knee pain
- History of knee joint injections (Intra-articular injections or ACB) within 3 months
of study
- Neuropathic knee pain
- Unable to give 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.
| Adductor Canal Block Versus Intra-articular Steroid and Lignocaine in Knee Osteoarthritis Pain Management | NCT04264481 | Entailment |
439 | 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:
- Body mass index (BMI) between 18 and 30 kg/m2
- Not taking the contraceptive pill in a previous cycle
- Non-pregnant: beta human chorionic gonadotropin (HCG) test with negative result at the
beginning of the study)
- No previous history of inflammatory diseases, circulatory diseases, abdomen or pelvic
diseases
- Physical gynecological exploration without pathological findings
- Gynecological ultrasound study of the uterus with a normal result
Exclusion Criteria:
- Ultrasound studies with technical defects in image acquisition
- Simultaneous participation in other studies
- Previous participation in other study which can affect the results of the present
study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Ultrasound Study by Texturization as a Predictor of Pregnancy in Oocyte Donation Programs | NCT03507322 | Contradiction |
5,301 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
Postmenopausal women with osteoporosis at high risk for fracture defined as
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
- a history of fragility fracture or at least 2 other risk factors
Exclusion Criteria:
- BMD T score < -3.50 at the total hip or femoral neck.
- History of hip fracture.
- History of metabolic or bone disease (except osteoporosis).
- Use of agents affecting bone metabolism.
- Vitamin D insufficiency.
- History of solid organ or bone marrow transplants.
- Hyper- or hypocalcemia.
- Hyper- or hypothyroidism.
- Hyper- or hypoparathyroidism.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 Years | A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis | NCT02016716 | Entailment |
1,813 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I ~II.
4.BMI 18 ~ 24 kg/m2
Exclusion Criteria:
- 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100
mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral
vascular obstructive disease 7.receiving long-term treatment with vasopressors.
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 80 Years | SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia | NCT04388995 | Entailment |
2,603 | 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:
- both males and females either professional or non-professional athletes or physically
active adults
- age 18-50 years
- unilateral or bilateral complains (in bilateral pain both sides are to be operated and
the randomization is on patient level and not hernia level)
- chronic dull, diffuse groin pain lasting > 6weeks
- history, physical examination and MRI indicating sportsman's hernia/athletic pubalgia
- pain above inguinal ligament in the deep inguinal ring, may radiate inner thigh,
scrotum or pubic bone
- minor radiating pain can be at adductor origin or symphysis pubis
- grade I-II edema at pubic symphysis on MRI scan is allowed (can be secondary after
groin disruption)
Exclusion Criteria:
- patients not willing to participate
- inguinal or femoral hernia
- MRI reveals other major pathology (bursitis, hip injury, stress fracture etc)
- isolated adductor tendonitis with groin pain below inguinal ligament
- femoro-acetabular impingement (FAI)
- isolated severe osteitis pubis (marked x-ray changes; grade III edema in MRI)
- former surgery to the actual groin
- allergy to polypropylene or other contra-indication 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.
Subject must be at most 50 Years | TEP Versus Open Minimal Suture Repair for the Sportsman's Groin | NCT02297711 | Contradiction |
480 | 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 of good physical and mental health
- under 37 years old, with regular menstrual cycles of 25-35 days
- normal basal FSH and LH levels
- BMI less than 30 kg/m2
- presence of both ovaries and intact uterus
- absence of polycystic ovaries
- endometriosis, or gynaecological / medical disorders and a negative result in a
screening for sexually transmitted diseases
- all patients signed a written informed consent form
- no patient had received any hormone therapy for at least 60 days preceding the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 35 Years | Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days | NCT01468441 | Contradiction |
4,488 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Age 18 through 35 years (inclusive) at screening
2. Non-pregnant women in general good health as determined by the site clinician
3. Premenopausal with history of regular menstrual cycles (regular cycles defined as
occurring every 21-35 days when not using hormones and with a variation of typical
cycle length of no more than 5 days)
4. Regular and consistent condom use, prior surgical sterilization by participant or
sexual partner, or heterosexually abstinent since last menses prior to enrollment
5. Able and willing to provide written informed consent to be screened for and to take
part in the study, including willingness to undergo all study-related assessments and
follow all study-related procedures
6. Able and willing to provide adequate locator information
7. HIV-uninfected based on testing performed by study staff at enrollment
Exclusion Criteria:
1. Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment
2. Use of depot medroxyprogesterone acetate (DMPA) within 10 months of enrollment
3. Pregnancy or breastfeeding within 60 days of enrollment
4. Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes
dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and
endometrium)
5. Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms,
menstrual collection devices, and pessaries; excludes tampons and condoms) or product
(includes spermicide, microbicide, douche, antifungal, steroid, or hormone) in the 30
days prior to enrolment (includes investigational products and devices)
6. New sexual partner within 90 days of enrollment
7. Urogenital infection or suspected infection within 30 days of enrollment including:
symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis;
or cervical infection, including N. gonorrhoea (GC), C. trachomatis (CT), or
mucopurulent cervicitis; syphilis; herpes simplex virus (HSV) lesions, or other sores
(Note: seropositive HSV without active lesions will not be excluded); acute pelvic
inflammatory disease; urinary tract infection; recent exposure to a partner with GC,
CT, Trichomonas, syphilis, or non-gonococcal urethritis (NGU)
8. Any history of immunosuppression (includes diabetes, HIV infection, and chronic
steroid use or other immunosuppressive medications)
9. Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
10. Menses or other vaginal bleeding at the time of enrollment* (*Women who have vaginal
bleeding at the scheduled enrollment visit may return at a different date to be
re-examined and possibly enrolled provided they are still within the 90-day screening
window and meet all criteria).
11. Vaginal or anal intercourse within 36 hours prior to enrollment
12. Heterosexual intercourse since last menses that places the participant at risk of
pregnancy (without condom use or sterilization of at least one partner)
13. History of hysterectomy
14. History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)
15. Any condition that, in the opinion of the Investigator, would preclude provision of
consent, make participation in the study unsafe, complicate interpretation of study
outcome data, or otherwise interfere with achieving the study objectives
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Expression of IFN-epsilon in the Female Reproductive Tract | NCT02416154 | Contradiction |
4,588 | 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:
- Pathological confirmed diagnosis with atypical hyperplasia and malignant
transformation of adenomyosis glandular epithelium (including endometrioid, serous and
clear cell carcinoma), with or without concurrent endometrial carcinoma
- Signed an approved informed consents
Exclusion Criteria:
- Not meeting all the inclusion criteria.
- The formalin fixed paraffin-embedded (FFPE) tissue was not acquired at the required
time period.
- The patients enrolled had accompanied some other kinds of carcinoma (such as ovarian
cancer, cervical cancer, primary peritoneal cancer).
- Patients had cancer history of certain organ (such as colorectal cancer, gastric
cancer, etc.)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis | NCT04010487 | Contradiction |
6,413 | 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. Must be a new patient/parent dyad arrived at the main pediatric dermatology clinic
2. Patient must be under the age of 18.
3. Consenting parent or guardian must be present and able to speak English to
participate.
4. Patients are either already enrolled in MyCHOP (MyChart) or are willing to enroll
during the encounter.
5. Parent or legal guardian has a mobile phone with the capability to download the free
MyChart app.
6. Parents have a data plan that allows them to download the MyChart app (if not already
downloaded) and upload pictures, and are willing to accept any potential data charges
incurred with these activities.
7. Patient has active skin lesion or rash that can be photographed during the clinic
visit.
Exclusion Criteria:
1. Patient is over the age of 18.
2. Parent or guardian is not present or not able to speak English.
3. Parent or guardian is not able to enroll in MyCHOP (MyChart).
4. Parent or guardian does not have a mobile phone capable of downloading the MyChart
app.
5. Photographs are not able to be taken (phone battery dies, phone/app does not work,
patient is not cooperative, participant does not have time).
6. If there are no active skin lesions to photograph the patient/parent will not be
enrolled (e.g. hives that are inactive, hyperhidrosis [excessive sweating], itching
without a rash, resolved skin lesions [e.g. warts, molluscum]).
7. Patients presenting for a general full body skin exam will be excluded, as this would
require full body photography, which is too time consuming. (Note: this does not
include evaluation of one individual mole [nevus], which can be included in the
study).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 17 Years | Photograph Quality Rating Scale Study ("PQRS Study") | NCT03246945 | Contradiction |
6,120 | 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 or woman ≥ 18 years old
- Affiliated to a health insurance program
- Providing free, informed, written and signed consent to participate (at the latest on
the day of inclusion and before any research procedure is initiated)
- Effective contraception if women in the age to procreate
- In the patient group : history of COVID-19 infection with either a positive Reverse
Transcriptase Polymerase Chain Reaction (RT-PCR) test on nasopharyngeal swab or a
positive COVID-19 serology in the acute stage. Presence of all following symptoms in
the acute stage: fever>38°C, asthenia, arthromyalgia, associated with at least 2 of
the following: coughing and/or spitting, dyspnea and/or chest discomfort, anosmia
and/or ageusia.
Exclusion Criteria:
- age < 18 years old
- History of cardiac disease or acute coronary syndrome associated with troponin rise
- History of allergic reaction to gadolinium-based contrast agents
- History of severe renal failure
- Presence of a pacemaker, implantable defibrillator, intra-orbital metallic material,
intra-cranial surgical clip, valve prosthesis Star-Edwards pre 6000, neurostimulator
or implantable insulin pump
- Claustrophobia or inability to lay on the back for 50 min
- Pregnant or breast feeding women
- Inability to express informed consent
- Person deprived of liberty by judicial or administrative decision
- Person under legal protection
- In the healthy volunteer group:
- Symptoms suggestive of COVID-19 infection over the epidemic period (after
February 1st 2020)
- Person not willing to be informed of potential incidental CMR findings
- In the patient group:
- Hospitalization for infectious syndrome suggestive of COVID-19.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Prevalence of Myocardial Scars on CMR After COVID-19 Infection | NCT04636320 | Contradiction |
4,384 | 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. | Patients and their families with known or suspected genetic disorders within the following
categories will be recruited:
Hereditary connective tissue disorders;
Phacomatoses;
Chromosomal disorders;
Dysmorphic syndromes;
Neuromuscular or neurological disorders;
Inherited immunological and hematologic disorders.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study of Clinical and Molecular Manifestations of Genetic Disorders | NCT00001466 | Entailment |
3,648 | 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:
- The entire population of Manitoba is considered for inclusion.
Exclusion Criteria:
- Individuals less than or equal to 6 months of age;
- Having less than one year of insurance coverage before the enrolment period;
- Not registered with MH during the enrolment period;
- Physician or hospitalization records indicating a diagnosis of any demyelinating
condition between 1971 (earliest year for which information is available) and the
index date.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
| A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada | NCT02367222 | Entailment |
4,156 | 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. Normal lung function, defined as (Knudson 1976/1984 predicted set): FVC > 75 %
predicted for gender, ethnicity, age and height; FEV1 >75 % predicted ; FEV1/FVC ratio
>0.70 and < 0.90.
2. Oxygen saturation of > 94%
3. Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
4. Symptom Score no greater than 6 (out of a possible 39) for total symptom score
5. On the day of a challenge, body temperature must be no greater than 37.8 degrees,
measured orally
Exclusion Criteria:
1. A history of significant chronic illnesses (to include diabetes, autoimmune diseases,
immunodeficiency state, known ischemic heart disease, chronic respiratory diseases
such as chronic obstructive pulmonary disease or asthma, hypertension)
2. Positive pregnancy test within 48 hours of the time of challenge
3. Use of any inhaled substance (for medical or recreational purposes). Nonsmokers must
have been abstinent from smoking for the prior 12 months, having not smoked more than
1 pack over the course of the previous year and does not smoke at all 1 week prior to
entrance in the study.
4. Receipt of LAIV in the current season
5. History of allergy to eggs
6. Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or
bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally
resolved symptomatically for 3 weeks
7. Unspecified illnesses, which in the judgment of the investigator increase the risk
associated with the experimental LAIV infection, will be a basis for exclusion.
8. Expected exposure of subject to immunocompromised individuals (who can be infected by
LAIV) for the 3 weeks following LAIV inoculation
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers | NCT02183753 | Contradiction |
805 | 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:
- OA patients
Exclusion criteria:
- active or passive opposition of the patient and / or its legal representatives 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 100 Years | COVID-19 in Osteoarthritis Patients | NCT04791462 | Entailment |
5,475 | 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:
- members of the family
Exclusion criteria:
- patient who refused to participate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Vascular Abnormalities and Bleeding Diathesis | NCT04553172 | Entailment |
2,975 | 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:
- Adult patients, 18 to 50 years of age
- Fragile X Syndrome
- IQ less than 75
- Reliable caregiver
Exclusion Criteria:
- Current psychosis or presumption of psychosis
- History of suicidal behavior or considered a high suicidal risk
- Severe self-injurious behavior
- Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension,
diabetes)
- Current seizure disorder
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | A Study With RO4917523 in Patients With Fragile X Syndrome | NCT01015430 | Contradiction |
1,917 | 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 or cytologically proven adenocarcinoma of the stomach. Patients who
have adenocarcinoma of the gastroesophageal junction will be eligible if the majority
of the tumor bulk is below the junction.
- Metastatic or Loco-regionally advanced disease
- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral CT /MRI scan. See
section 11.2 for the evaluation of measurable disease.
- Age >= 18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status <= 2 (Karnofsky >= 60%).
Exclusion Criteria:
- Patients who have received more than one line of palliative chemotherapy are allowed,
provided that (i) the prior chemotherapy does not contain taxane, cisplatin or
carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study
treatment, and that (iii) they have recovered from adverse events due to previous
treatment [except alopecia].
- Patients who have had radiotherapy or major surgery within 4 weeks prior to entering
the study or those who have not recovered from adverse events due to treatment
administered more than 4 weeks earlier.
- Patients who are on CYP3A4 modifiers are excluded from the study
- Patients with known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to RAD001.
Significant cardiovascular disease including unstable angina pectoris, uncontrolled
hypertension, congestive heart failure related to primary cardiac disease, a condition
requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a
myocardial infarction within 6 months prior to the trial entry.
- Patients with severe concurrent medical illness such as severe impairment of lung
function should be excluded from studies of RAD001.
- Uncontrolled intercurrent such as, but not limited to, ongoing or active infection, or
psychiatric illness/social situations that would limit compliance with study
requirements.
- Poorly controlled diabetes mellitus
- High LDL cholesterol or triglyceride level
- Pre-existing neuropathy of >= grade 2
- Patients with a history of second malignancies are eligible they have been disease
free for at least 5 years and are deemed by the investigator to be at low risk of
recurrence. Par8entswith the following cancers are eligible if diagnosed and treated
within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell
or squamous cell carcinoma of the skin
- Pregnancy or lactation.
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.
| Gastric Cancer RAD001 Study | NCT01514110 | Entailment |
2,512 | 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:
Healthy subjects and AD patients
1. Male or female
2. Aged between 11-60 years
3. Volunteer understands the purpose, modalities and potential risk of the trial
4. Volunteers able to read and understand English
5. Volunteers willing to sign the informed consent
AD patients:
1. Volunteers with AD defined according to the UK working party diagnostic criteria
2. Must have an AD lesion present at either the right or left forearm (Proximal end).
3. For 10 participants in each AD group: visible AD lesion present on either the right or
left cheek.
4. For 10 participants in each AD group: Global severity score (EASI) that matches their
cohort allocation (Mild/Moderate/Severe).
According to the UK working party diagnostic criteria, eczema is defined as exhibiting an
itchy skin condition plus 3 or more of:
- History of involvement of the skin creases
- Personal history of asthma or hay fever
- History of generally dry skin in past year
- Visible flexural dermatitis
- Onset below age 2
Instructions to participants 1. Do not ingest caffeine (e.g Coffee) or take
anti-inflammatory drugs (e.g Ibuprofen) on the imaging day (until after imaging).
Exclusion Criteria:
1. Treatment with the following medications within 4 weeks: systemic
immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine,
azathioprine, mycophenolate-mofetil, Janus kinase inhibitors, etc.), systemic
corticosteroids.
2. Three or more bleach baths during any week within 4 weeks.
3. Treatment with biologics within 5 half-lives (if known) or 12 weeks.
4. Treatment with the following medications within 2 weeks if mild/moderate global
severity or 1 week if severe global severity: topical corticosteroids, topical
calcineurin inhibitors.
5. Treatment with any topical leave-on product on the test areas 7 days prior to
participation if healthy/mild and 24 hours prior to participation if moderate/severe
global severity.
6. Volunteers with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense
body hair that obstruct the test areas.
7. Volunteers with a condition that in the opinion of the investigator contradicts
participation in the study.
8. Volunteer is incapable of giving fully informed consent.
9. Volunteers judged by the PI to be inappropriate for the trial.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 11 Years old.
Subject must be at most 60 Years | Skin Pathology Assessment With Optical Technologies | NCT04295824 | Contradiction |
2,137 | 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. Patient with gouty arthritis
2. Patient with asymptomatic hyperurecemia
3. Patient of osteoarthritis but without hyperuricemia and gout
Exclusion Criteria:
1.Patient younger than 20 y/o.
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.
| The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome | NCT01818505 | Contradiction |
5,769 | 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. Patients with classic papular eruption of PLC (scaly erythematous papules with
mica-like scales) with diagnosis documented histopathologically with or without
associated hypopigmented lesions
2. Age: > 6 years
3. Both sexes.
Exclusion Criteria:
1. Patients presenting with only hypopigmented macules whom their skin biopsy revealed
PLC.
2. Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.
3. Patients with PLC associated with classic MF.
4. Patients with known absolute contraindications to NB-UVB.
5. Patients with impaired liver and/or kidney functions.
6. Patients with history of any heart disease.
7. Patients with known hypersensitivity to Azithromycin
-
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.
| Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin | NCT03831269 | Contradiction |
6,963 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- 18 years of age or older
- family history of Alzheimer's disease and no cognitive complaints OR subjective
cognitive decline OR preclinical AD OR mild cognitive impairment due to AD or other
conditions
Exclusion Criteria:
- none
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Comparative Effectiveness Dementia & Alzheimer's Registry | NCT03687710 | Entailment |
2,459 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- age ≥ 18years;
- presence of at least one hilar/mediastinal adenopathy >1 cm on short axis assessed by
contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L;
- ability to give an informed consent.
Exclusion Criteria:
- presence of mediastinal adenopathy in stations 2R and 2L;
- coagulopathy or bleeding diathesis that cannot be corrected;
- severe refractory hypoxemia;
- unstable hemodynamic status;
- inability to give 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.
| Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies | NCT01658280 | Entailment |
4,921 | 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:
- Male or female patients with alcohol-responsive ET according to published clinical
criteria
- Tremor in both upper limbs should be predominant feature of ET
- Subjects must be willing and safely able to comply with the study protocol and
therefore abstain from any medication for the treatment of tremor for a period of at
least 5 plasma half-lives of the individual drug prior to study participation. (For
Propranolol/Inderal(Registered Trademark), Gabapentin/Neurontin(Registered Trademark),
Topiramate/Topamax(Registered Trademark) this will be 4 days; for
Primidone/Mysoline(Registered Trademark): 28 days).
- Subjects must be willing to refrain from alcohol and caffeine intake starting 48 hr
prior to hospitalization until study termination
- Subject must be willing and able to fast for periods of up to 12 hours during the
study
EXCLUSION CRITERIA:
- Patients with any other significant pathological finding in the neurological
examination other than typical symptoms of ET
- Acute or chronic severe medical conditions which would preclude the subject from
participating (e.g., severe heart disease NYHA grade 3 or 4, renal failure, hepatic
failure, lung disease, uncontrolled hyperthyroidism)
- Subjects with diabetes mellitus, hypoglycemia or severe hyperlipidemia (must be
documented by referring physician with copy of last fasting routine blood test within
one year before the screening visit including glucose and lipid levels; according to
NIH guidelines, fasting LDL levels of greater than or equal to 160 mg/dl are
considered severe hyperlipidemia; if under treatment, LDL-levels less than 160 have to
be documented to be eligible for the study)
- Subjects with active or past alcohol abuse or dependence
- Subjects with concomitant therapy with warfarin or NSAIDs, when taken on a regular
basis and cannot be discontinued at least 14 days prior to study participation,
because of potential interactions with octanoic acid (displacement of albumin binding
in human serum)
- Subjects with clinically significant abnormalities on their baseline laboratory tests
- Subjects aged less than 21 years
- Female subjects who are pregnant or lactating
- Subjects with cognitive impairment interfering with the ability to give informed
consent or to cooperate during the study
- Subjects of Far East Asian or Native American descent, who may possess variant alleles
of the genes for alcohol metabolism, i.e., alcohol dehydrogenase and aldehyde
dehydrogenase, resulting in altered (slower) metabolism and potentially increased
sensitivity to alcohols and their metabolites
- Subjects where no written informed consent is received or subjects who are unwilling
to cooperate during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor | NCT00848172 | Entailment |
5,039 | 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:
Diagnosis of essential tremor with bilateral hand tremor as the predominant feature
Unequivocal spirographic tremor of both hands on screening examination
Subjects must be willing and safely able to comply with the study protocol and therefore
abstain from any medication for the treatment of tremor for a period of at least 5 plasma
half-lives of the individual drug prior to study participation. (For Propranolol/Inderal ,
Gabapentin/Neurontin this will be 1 day; for Primidone/Mysoline : 26 days).
Subjects must be willing to refrain from alcohol and drinks or food containing caffeine
starting 48 hours prior to the study visit(s)
EXCLUSION CRITERIA:
Patients with any other significant pathological finding in the neurological examination
other than typical symptoms of ET
Acute or chronic severe medical conditions which would preclude the subject from
participating (e.g., severe heart disease NYHA grade 3 or 4, renal failure, hepatic
failure, lung disease, uncontrolled hyperthyroidism)
Subjects with active or past alcohol abuse or dependence
Elevated liver function parameters (AST, ALT, GGT), higher than the 1.5 fold upper limit of
the normal range (as defined by the NIH Clinical Center Laboratory Medicine Department).
The limit for AST therefore will be 51 U/l, for ALT 62 U/L, and GGT 128 U/l.
Female subjects who are pregnant or lactating
Subjects aged < 21 years
Subjects with unable or unwilling to give informed consent
Subjects unable or unwilling to cooperate with study requirements Use of prescription or
OTC medications that interact with ethanol or influence brain excitability (e.g. hypnotic,
antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants,
etc.).
Known flushing symptoms after alcohol intake or allergy to alcohol.
ADDITIONAL EXCLUSION CRITERIA FOR SUBJECTS ALSO PARTICIPATING IN PHASE 2:
History of seizure disorder or hearing loss
Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye.
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.
| Ethanol Response in Essential Tremor: Clinical and Neurophysiological Correlates | NCT01200966 | Entailment |
5,751 | 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. Female or Male, 18 years and older
2. Fitzpatrick Skin Type I-VI
3. Subject has visible signs of moderate sun-damages and/or aging facial skin with
visible areas of fine rhytides, pigmentation, and erythema or telangiectasia.
4. Desires non-ablative photo-revitalization of the skin.
5. Subject must agree to not make any changes in their skin regimen for the duration of
the study, including the follow-up period.
6. Subject must be able to read, understand and sign the Informed Consent Form.
7. Must be willing and able to adhere to the treatment and follow-up schedule and post-
treatment care instructions.
8. Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or
higher on the treatment area every day for the duration of the study, including the
follow-up period.
9. Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.
10. Agree to not undergo any other procedure(s) in the treatment area during the study,
such as laser- or light-based treatment, non-light based device treatment such as
radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid
filler or other dermal filler, chemical peel, or surgical procedure
Exclusion Criteria:
1. Participation in a clinical trial of another device or drug within 6 months prior to
enrollment or during the study.
2. Any type of prior cosmetic treatment to the target area within 3 months of study
participation, such as laser or light-based procedures or surgery.
3. Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal
filler in the target area within 1 week of study participation.
4. History of malignant tumors in the target area.
5. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large
moles.
6. Pregnant and/or breastfeeding.
7. Having an infection, dermatitis or a rash in the treatment area.
8. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease,
e.g., uncontrolled hypertension.
9. Suffering from coagulation disorders or taking prescription anticoagulation
medications.
10. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
11. History of immunosuppression/immune deficiency disorders or currently using
immunosuppressive medications.
12. History of vitiligo, eczema, or psoriasis.
13. History of connective tissue disease, such as systemic lupus erythematosus or
scleroderma.
14. History of seizure disorders due to light.
15. Any use of medication that is known to increase sensitivity to light according to
Investigator's discretion.
16. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes
zoster (shingles) in the treatment area, unless treatment is conducted following a
prophylactic regimen.
17. History of radiation to the treatment area or undergoing systemic chemotherapy for the
treatment of cancer.
18. History of pigmentary disorders, particularly tendency for hyper- or hypo-
pigmentation.
19. Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable,
within 6 months of study participation.
20. Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the
target area within 1 month of participation.
21. Anytime in life, having have used gold therapy (gold salts) for disorders such as
rheumatologic disease or lupus.
22. Excessively tanned in areas to be treated, or unable/unlikely to refrain from tanning
during the study (for example, subject's occupation requires regular sun exposure).
23. Current smoker or history of smoking within 6 months of study participation.
24. Has infectious disease
25. Has been on long-standing systemic steroids (e.g. Prednisone, Dexamethasone)
26. Has medical condition that may affect wound healing
27. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions | NCT03944278 | Contradiction |
2,675 | 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
- Consecutively all patients with a groin hernia (inguinal and/or femoral hernia)
operated starting 01.01.2018.
- Male and female
- 18 years or older
- Operated of supervised by a participating surgeon (participating in this study is not
necessarily by a whole surgical department of a hospital, but by specific surgeons)
- Elective and emergency surgery
- Primary and recurrent hernia
- Metachronous and synchronous hernia
- Signed informed consent form
Exclusion criteria
- Younger than 18 years
- Not operated or supervised by participating surgeon
- Pregnant at inclusion in the registry
- No signed informed consent form
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.
| Flemish Inguinal and Femoral Hernia Prospective Registry | NCT04623580 | Entailment |
1,278 | 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:
- Histopathologic confirmation of malignant pleural mesothelioma
- Patients who are able to tolerate surgical cytoreduction but unable to undergo
extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion
- 18 years of age or older
- Malignancy is confined to the affected hemithorax.
- Grossly normal cardiac function with an EKG showing no cardiomyopathy or acute changes
- Evidence of adequate renal and hepatic function
- Karnofsky performance status of 70% or greater
Exclusion Criteria:
- Extended disease outside the ipsilateral hemithorax as determined radiologically and
intraoperatively
- Distant metastases
- Non-malignant systemic disease
- Active concomitant malignancy
- Psychiatric or addictive disorders which would preclude obtaining informed consent
- Prior treatment within the last 2 months, other than surgical resection for their
current 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.
| Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma | NCT00165555 | Entailment |
4,552 | 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:
- Abnormal bleeding in the presence of Adenomyosis as demonstrated by MRI
Exclusion Criteria:
- Other causes of abnormal bleeding such as fibroids, endometrial polyps, malignancy
- Presence of endometriosis
Female
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Adenomyosis: Genomic Mechanisms and Biological Response | NCT03428854 | Contradiction |
3,169 | 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:
Each woman enrolled in the trial must meet the following inclusion criteria:
- Competent to provide informed consent to participate in the trial and has done so.
- At least the minimum age is 18 to 45 years old.
- Had sex 1 to 4 days in past month and expects to continue at that frequency for the
next 6.5 months.
- At low risk for sexually transmitted infection (STI), operationally meaning that
neither she nor her partner to her knowledge has had any of the following:
- More than one sexual partner currently or any expectation of having more than one
sexual partner in the next 6.5 months
- Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or
hepatitis C
- Treatment for a STI within the past 6 months, excluding recurrent genital herpes
or condyloma
- Sharing of illicit injection drug equipment ever in the past.
- Willing to use the study regimen as her only contraceptive method for the next 6.5
months (except that she may also use condoms if needed for protection from STIs).
- Wants to avoid pregnancy for at least the next 6.5 months.
- Willing to accept an uncertain risk of pregnancy during the study.
- Gives correct answers to the informed consent quiz.
- Willing and able to follow all study requirements.
Exclusion Criteria:
To be eligible for enrollment, a woman must not meet any of the following exclusion
criteria:
- Pregnant as verified by a pregnancy test at enrollment.
- Has an indication of current subfecundity, specifically:
- Her last pregnancy ended within the last 8 weeks, or she has had fewer than two
menstrual periods since resolution of last pregnancy
- She has not had normal monthly menses for the past 2 months
- She is currently breastfeeding
- She has used any hormonal contraceptive other than emergency contraceptive pills
since the onset of her last menstrual period
- Has received an injection of a long term injectable contraceptive in the last 9
months
- Currently has an intrauterine device
- Has had a sterilization procedure or ectopic pregnancy
- Has been diagnosed by a clinician as having a fertility problem
- Her partner has had a sterilization procedure or infertility diagnosis, to her
knowledge.
- She currently has known contraindications to progestin-only pills, specifically
including the following conditions:
- Unexplained abnormal vaginal bleeding
- Deep venous thrombosis or pulmonary embolus
- Active viral hepatitis
- Decompensated cirrhosis
- Liver tumor
- History of breast cancer within the past 5 years.
- Has a breast mass on examination.
- Has a personal or family history suggestive of predisposition to thrombosis.
- Has a serious contraindication to pregnancy (medical condition or use of chronic
medication such as isotretinoin or thalidomide).
- Taking drugs that are known to interact with progestins (such as rifampicin or
anticonvulsant medications).
- Has previously participated in this study.
- Currently participating in another medical research study.
- The site investigator or designee perceives another reason to exclude her from the
trial.
Female
Accepts Healthy Volunteers
Subject must be at most 45 Years | Pericoital Oral Contraception With Levonorgestrel | NCT00922233 | Entailment |
4,512 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Is sexually active and has been in a steady relationship and plans to remain in that
relationship for the duration of the study.
2. Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and
Baseline Visits.
3. If female, has a regular menstrual cycle.
4. Has normal sexual functioning, as defined by a Changes in Sexual Functioning
Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and
Baseline Visits.
5. If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months
prior to the Baseline Visit and continues on the stable dose for the duration of the
study.
Exclusion Criteria:
1. Has received vortioxetine and/or paroxetine in a previous clinical study or as a
therapeutic agent.
2. Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)
antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any
known sexually transmitted diseases.
3. Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
4. Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
5. Has a known history of or currently has increased intraocular pressure or is at risk
of acute narrow-angle glaucoma.
6. Has a history of depression or any other psychiatric illness.
7. Has a significant risk of suicide according to the investigator's clinical judgment,
or has made a suicide attempt in the previous 6 months.
8. Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual
dysfunction.
9. Has had a surgical or medical procedure on reproductive/genitourinary organs
(excluding uncomplicated vasectomy and tubal ligation).
10. If female, has polycystic ovarian syndrome.
11. Has hypogonadism or has a free testosterone value outside the normal range at the
Screening Visit that is indicative of hypogonadism.
12. Has a thyroid-stimulating hormone (TSH) value outside the normal range at the
Screening Visit that is deemed clinically significant by 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 40 Years | Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers | NCT02932904 | Contradiction |
1,812 | 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... | Key Inclusion Criteria:
- Patients with histologically verified, unresectable or metastatic, HER2-negative,
adenocarcinoma of the esophagus or stomach
- Men or women less than 80 years of age
- Performance status 0 or 1
- Life expectancy >12 weeks
- Adequate organ-function
- Written informed consent
Key Exclusion Criteria:
- Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the
chemotherapy-free interval is less than 6 months
- Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma
of the esophagus or stomach
- Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less
than 6 months before study entry
- Prior cumulative dose of >300 mg/m2 of epirubicin
- Grade ≥ 2 side-effects from previous chemotherapy
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 79 Years | Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma | NCT02177552 | Entailment |
4,733 | 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:
Ovarian Cancer and Endometrial Cancer cases:
1. Women age 19 or older.
2. Histologically confirmed high grade serous cancer (had a pre-operative core biopsy) of
ovarian/fallopian tube/peritoneal origin or histo-cytologically confirmed endometrial
cancer, not yet treated by surgery or chemotherapy.
3. Give consent to access primary tumour tissue following surgery or biopsy.
Healthy participants:
1) Healthy women between the ages of 19 and 60.
Exclusion Criteria:
Ovarian Cancer and Endometrial Cancer cases:
1. Women with self-reported, known pregnancy.
Healthy participants:
2. Women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial,
cervical, or vulvar cancer) will be excluded.
3. Women who report irregular bleeding (spotting between menstrual cycles, or
post-menopausal bleeding), or who have self-reported gynecologic concerns (e.g. pelvic
pain, pelvic masses, dyspareunia) or have had a recent evaluation for gynecologic
concerns (consultation with a gynecologist, pelvic ultrasound, endometrial biopsy) are
ineligible.
4. Women with known Lynch Syndrome and/or BRCA1 or BRCA2 germline mutations will not be
eligible to participate as healthy volunteers for this study.
5. Women with self-reported, known pregnancy.
Female
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
| Advanced Methods for Cancer Detection by Vaginal Screening | NCT02622776 | Entailment |
3,532 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Aged 18 - 85 years
- Male or female
- Participants who are otherwise healthy enough to participate, as determined by
pre-study medical history and physical examination
Patient groups only:
- Diagnosed with AI for over 6 months according to standard diagnostic criteria or with
a medical condition requiring acute high dose steroid therapy for anti-inflammatory
purposes
- If diagnosed with AI, established on stable HC replacement or prednisolone
replacement, dose not altered for at least 3 months
- Established on a stable dose of Fludrocortisone, if taking, dose not altered for at
least 3 months
- Participants taking other hormone replacements (e.g. levothyroxine, testosterone or
growth hormone in secondary adrenal insufficiency) are accepted providing that their
replacement doses have not altered for at least 3 months
- Participants who are able and willing to give written informed consent to participate
in the study.
Exclusion Criteria:
- Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
- Unable to give informed consent.
- Excessive caffeine intake above 500 mg per day.
- Taking supplements or herbal medications that the participant is unwilling or unable
to stop prior to and during the study period e.g. St John's Wort (may decrease
prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).
- Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the
participant is unwilling or unable to stop prior to and during the study period e.g.
phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone,
aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.
- Pregnancy, taking the oral contraceptive pill, or oral oestrogen replacement therapy
due to the effects on cortisol binding globulin levels and determination of
prednisolone levels. Transdermal oestrogen replacement is permitted. Females of
child-bearing age will be asked to provide a urine sample for a pregnancy test at each
visit.
- Diagnosis of growth hormone deficiency, untreated
- History of any medical, psychological or other condition, or use of any medications,
including over-the-counter products, which, in the opinion of the investigators, would
either interfere with the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Objective Markers and New Indicators in AI Disease (OMNI-AID Study) | NCT03615859 | Entailment |
2,208 | 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:
- mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal
- patients with a known history of gout or at high risk
Exclusion Criteria:
- Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjoegren's
syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis,
seronegative spondyloarthropathy
- History of intra-articular injection in the last 3 months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study | NCT04734093 | Contradiction |
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