cyrilzakka/clinical-trials huggingface dataset:
Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome

The clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. EBV seems to be an interesting candidate regarding its involvement MS pathophysiology. It can be easily assess in blood sample in contrast to others prognostic biomarkers validated in RIS : oligoclonal bands and NfL levels in cerebrospinal fluid and serum. In RIS, treatment targeting EBV could significantly modify the course of the disease. The investigators aim to make the fisrt description of the EBV epidemiology (immunoglobulin (Ig)M and IgG anti-viral capsid antigen (VCA), IgG anti Epstein-Barr nuclear antigen (EBNA)) among RIS patients and to investigate a correlation between the different antibodies' titers (IgM VCA, IgG VCA, IgG EBNA) and the course of the disease (clinical conversion or evidence of disease activity (EDA)).


Eligibility Criteria:
Inclusion Criteria:

Patients with RIS confirmed by the RIS expert center of the Nice CHU; EBNA status at RIS diagnosis available

Exclusion Criteria:

none
Evaluating the Expression Levels of MicroRNA-10b in Patients With Gliomas

MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b expression patterns will serve as a prognostic and diagnostic marker. This study will also characterize the phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the critical function of anti-mir-10b in blocking established glioblastoma growth, the investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from patients diagnosed with gliomas over a period of two years. These samples will be examined for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic variations will be correlated to mir-10b expression levels.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

* 18 years of age
* Brain tumor(s) to be resected for clinical reasons.
* Histological pathology confirmation that tumor is of glial origin, WHO Grade II, III or IV.
* Adequate tissue available for processing as determined by Pathology.
* Adequate decision making ability to review, discuss and sign a consent form to allow their tumor samples to be used for future human brain tumor biology laboratory research. Determination of capacity to consent is made by one of the co-investigators based on clinical assessment.
* Patients opting for the standard treatment regimen for their disease as well as ongoing clinical trials will be are eligible to participate in this study. Standard care for newly-diagnosed glioblastomas typically consists of surgical resection followed by radiotherapy with concomitant temozolomide, followed by adjuvant temozolomide chemotherapy.
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants

The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Body weight of at least 55 kg.
* Body mass index (BMI) of 19.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/(height \[m\])².
* Healthy female subjects of non-childbearing potential, or male subjects, as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

* Any significant acute or chronic medical illness or any other condition listed as a contraindication in the itraconazole, phenytoin, or gemfibrozil package inserts.
* History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant 12-lead ECG abnormalities, or any congenital heart disease.
* History of stroke or transient ischemic attacks.
* History of asthma or chronic obstructive pulmonary disease diagnosed or treated within the past 5 years.

Other protocol-defined inclusion/exclusion criteria apply
The ACS Ethnicity Platelet Function Study

This study is being done to assess the effects of the CTP inhibitor on the function of your platelets (cells within your blood that are involved in the formation of blood clots) and to assess whether you have responded to the ticagrelor well enough to prevent the formation of blood clots within the stent or site in which angioplasty was performed.

Recent studies have looked at how racial differences can affect platelet reactivity, the way blood clots. But these studies have not looked at the way different racial backgrounds can affect the way the blood forms clots. Minorities, such as African-Americans are underrepresented. Therefore, we are conducting this platelet reactivity study to better understand if there are differences in how this drug affects African-Americans from how they affect Caucasian patients undergoing percutaneous coronary intervention and receiving ticagrelor. These data will be compared to a historical control of Caucasian patients who underwent similar platelet function testing.


Eligibility Criteria:
Inclusion Criteria:

* Female (post menopausal or surgically sterile) and/or male aged 18 years or older
* Presenting with ACS fulfilling the following:

  1. Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG)
  2. Elevation of biomarkers (CK-MB ≥2 ULN or troponin ≥ ULN)
* Self-identified as African-American
* Treatment with 75-100mg ASA daily

Exclusion Criteria:

* Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, PE, DVT) for antithrombotic treatment during study period.
* Fibrinolytic therapy within 48 hours before randomization
* Concomitant therapy with a drug having possible interaction with ticagrelor. (concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer)
* Increased bleeding risk including: recent (\<30 days) GI bleeding, any history of intracranial, intraocular, retroperitoneal, or spinal bleeding, recent (\<30 days of dosing) major trauma, sustained uncontrolled hypertension (systolic blood pressure \[SBP\]\>180mmHg or diastolic blood pressure \[DBP\]\>100mmHg), history of hemorrhagic disorders that can increase the risk of bleeding, platelet count less than 100,000 mm3 or hemoglobin \<10 g/dL.
* Any history of hemorrhagic stroke.
* Contraindication or other reason that ASA or ticagrelor should not be administered (e.g., hypersensitivity, active bleeding, major surgery within 30 days of dosing).
* Severe renal failure (creatinine clearance \<30mL/min or patient requires dialysis)
* History of moderate or severe hepatic impairment with aspartate amino transferace, alanine amino transferase or total bilirubin \> 1.5 x upper limit of the reference range.
* Pregnant or lactating women.
* Patients receiving any glycoprotein IIb/IIIa inhibitors \<8 hours before platelet reactivity testing.
Anti-Inflammatory Effects of Pioglitazone

There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.

Atherosclerotic patients with impaired glucose tolerance and type 2 diabetes will undergo the FDG-PET/CT imaging at baseline and again following 4 months after treatment. Patients who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone or 4 mg/day glimepiride. Physical examinations will be done at baseline, 4 months, and 12 months. During study, subjects will have body weight, and vital signs (HR, BP, etc) assessed as well as waist circumference. Laboratory assessments will be done at each baseline, 4 month.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 35 and 85 years
* Subjects with impaired glucose tolerance and type 2 diabetes, who had atherosclerosis detected by carotid ultrasound and/or CT
* Subjects who had vascular FDG uptake by FDG-PET

Exclusion Criteria:

* Subjects with insulin treatment
* Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease
* Subjects taking more than three antidiabetic medications
* Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones (TZDs) within 8 weeks prior to randomization
* Subjects with cardiac failure (New York Heart Association Class \> III) or left ventricular dysfunction (LVEF \< 40%)
* Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease
Sensing-glove System in Manual Therapy

The objective of this clinical trial is to assess manual therapists' attitudes towards using a sensing-glove system for measuring spinal manipulation force and to compare the effectiveness of two interventions in enhancing their attitudes. The primary questions it aims to address are:

* Are manual therapists receptive to employing a sensing-glove system to measure the force applied during spinal manipulations on patients?
* Can we enhance manual therapists' attitudes towards this system through either a brief informational video demonstration or a supervised practice session with the system?

Researchers will compare the impact of a 7-minute informational video to that of a 20-minute supervised practice session to determine if manual therapists' attitudes towards the use of a sensing-glove while treating their patients can be positively influenced.

Participants will:

* Engage in a single experimental session.
* Complete a questionnaire at the beginning of the experimental session.
* Undergo one of the two interventions and promptly complete two questionnaires following this intervention.
* Undergo the other intervention and promptly complete the same two questionnaires following this intervention.

This study aimed to evaluate manual therapists' acceptability of a sensing-glove system for measuring spinal manipulation's force-time characteristics and compare the effectiveness of two interventions in enhancing their acceptability and usability perception. Participants will undergo two acceptability-enhancing interventions in randomized order: a 7-minute informational video and a 20-minute supervised practice session. At the start of the session and after each intervention, the acceptability and perception of usability towards the system will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Being a licensed chiropractor or a last-year intern in a University outpatient chiropractic clinic

Exclusion Criteria:

* Reported any upper limb injury preventing them from executing manual therapies during the time of the study
* Previous experience with the sensing-glove system
Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)

The purpose of this study is to determine whether inexpensive, flexible and non-heeled footwear is effective in improving of clinical, functional and gait biomechanics in elderly women with knee osteoarthritis.

* The clinical and functional aspects will be evaluated using a visual analogue scale (VAS) for pain, Western Ontario and McMaster Universities (WOMAC) and Lequesne questionnaires of quality of life in patients with knee osteoarthritis and testing of six-minute walk (6MWT).
* Biomechanical analysis of gait will be performed by infrared cameras and a force platform. From the data of kinematics and kinetics, will be calculated moments of the knee joint strength by inverse dynamics.

The process (steps) will be divided as follows:

* step 1, in this step there will be sorting and initial assessment of potential participants; pain will be evaluated through VAS, function and quality of life by means of questionnaires WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of gait.
* step 2,(3 month follow-up), both groups will be evaluated again by the VAS and WOMAC and Lequesne questionnaires.
* step 3, after 6 months of starting the monitoring process, both groups will be reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of gait. This step is the final evaluation, characterizing the end of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Kellgren and Lawrence grade 2 or 3
* Being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living
* Knee pain between 3 and 8 on the visual analogue scale

Exclusion Criteria:

* Previous history of surgery on knees, ankles and hips in the last 2 years
* Neurological disease
* BMI \> 35 kg/m2
* Difference in lower limb length \> 1 cm
* Prostheses and / or lower limb orthoses
* Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively
* Present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer)
* OA of the hip and / or ankle incapacitating or diagnosed OA in lower limbs and spine
* Inflammatory arthritis (eg. rheumatoid arthritis)
* Asymptomatic OA of one or both knees
* Dementia or inability to provide consistent information
* Introduction of Nonsteroidal Anti-inflammatory Drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion
* Being under physiotherapy or acupuncture treatment
* Patients with an indication of prosthesis or orthosis
* Patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months
Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.

This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent.
* Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)
* At least one measurable site of disease on CT/MRI as defined by RECIST criteria.

Exclusion Criteria:

* Prior treatment with nilotinib.
* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1.
* Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
* Impaired cardiac function at visit 1
* Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.

Other protocol-defined inclusion/exclusion criteria may apply
Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy

Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.

Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 32 weeks or more gestational age
* Pre-eclampsia
* Singleton pregnancy

Exclusion Criteria:

* Intrauterine fetal death
* Fetus with apparent congenital anomalies
* Pregnant females with other medical disorders
* History of essential hypertension.
* History of antepartum hemorrhage.
* History of rupture of membranes.
Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites

Multicentric, observational and prospective study with two groups of treatment: Refractory ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic blockers as primary or secondary profilaxis for variceal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80
* Patients previously prescribed with beta-blockers
* Any type of hepatic cirrosis that has been diagnosed by clinical, analytic and image criteria
* Mild to serious ascites. Classification on refractory or non-refractory ascites depends on the patient´s response to diuretic treatment. Refractory ascites is defined by the Ascites´Board International Criteria as the lack of response, ascites recurrency or complications occurrence by diuretic drugs uptake
* Esophageal varicose vein in which beta blockers treatment is indicated as primary or secondary prophylaxis. Primary prophylaxis is indicated for big esophageal varicose veins, small varicose veins with red signs or varicose veins in patients with B-C Child-Pugh stage. Secondary prophylaxis is indicated for all those patients that have previously presented varicose bleeding.
* Patients giving a written consent to participate in the study after having received enough information about the design, objectives and risks.

Exclusion Criteria:

* Hepatocellular carcinoma \>5 cm
* Total portal vein thrombosis or Cavernous transformation of the portal vein
* Insuficiencia renal (creatinina sérica \>3 mg/dl).
* Kidney insufficiency (seric creatinine \>3 mg/dl)
* Contraindications to beta-blockers: Cardiac or breathing insufficiency, auricular-ventricular blocking grade \>1.
* Anticoagulant treatment
* Patients with a intrahepatic portosystemic shunt
* Beta-blockers Hypersensitivity
* Pregnancy and breastfeeding
* Women of childbearing age must commit to undergo an effective contraception during the treatment and at least one month after finishing it.
* Patients with severe controlled or not controlled psychiatric condition
* Patients´ lack of commitment to follow all visits.
the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients

this study examines the incidence of newly developed delirium in patients who admit to university hospital stroke unit for cerebral infarction, and analyze the association between delirium motor subtypes and short-term outcome in post-stroke delirium patients.


Eligibility Criteria:
Inclusion Criteria:

* All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.

Exclusion Criteria:

* Any patients who refuse to enroll the study.
* Any patients who admit to Intensive Care Unit(ICU), because ICU is well-known for precipitating delirium.
Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography (SONO-URETHRA)

Conventional urethrography is the standard diagnostic evaluation for patients with a suspicion of urethral stricture. The radiation dose of this examination is 5-9 mSV. Sono-urethrography was introduced in 1988 (McAninch et al. , J Urol 1988); the diagnostic accuracy of sono-urethrography is equal compared to conventional urethrography, with even a better measurement of stricture length and degree of spongiofibrosis with sono-urethrography. However, sono-urethrography remained underused among urologists and radiologists.

Patients will be randomly assigned into two groups:

Group A: conventional urethrography Group B: sono-urethrography In case sono-urethrography is inconclusive or of poor quality, a conventional urethrography will be performed.

The radiation dose in the two groups will be measured. The stricture length and location will be recorded and compared with the perioperative findings in order to evaluate the diagnostic accuracy. The complications of the procedure(s) will be recorded with a questionnaire directly after and two weeks after the conventional or sono-urethrography.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a suspicion of urethral stricture disease for which an indication of imaging of the urethra exists.

Exclusion Criteria:

* Transsexual patients.
* Patients with perineostomy.
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

Intraventricular hemorrhage (IVH) or bleeding in the brain remains a major problem of preterm infants. This randomized, placebo-controlled multicenter trial enrolled 505 infants of 600 to 1250g birth weight to determine if indomethacin lowers the incidence of IVH, and 125 term infant controls. During this longitudinal trial, follow-up assessments have been performed at the ages of 3, 4 1/2, 6, 8, 12 and 16 years. The initial results at age 3 years revealed no advantages to the indomethacin group over and above the decreases in IVH, however, the results did show a significant increase in ventriculomegaly in the "placebo" group. Results at 4 1/2, 6 and 8 years of age showed beneficial effects of indomethacin on cognitive and behavioral outcomes over and above the effects on preventing IVH but not at later ages. At 12 and 16 years, no significant influence of indomethacin on cognitive outcome was noted.

Age, gender and zip-code matched control subjects were added when the preterm subjects were 8 years. Throughout all subsequent testing, term controls have higher IQ and Peabody Picture Vocabulary Scores.

Additional longitudinal volumetric, functional and diffusion tensor MR imaging studies showed differences between preterm and term control subjects at 8, 12 and 16 years of age. These were consistent with utilization of the right hemisphere and left cerebellum for language in the preterm group compared to term controls. No effects of indomethacin were seen.

The study closed on 31 March 2012.

Eligibility Criteria:
* Preterm infants \< 1250 g birth weight
* Admitted to participating institution \< 6 hrs of age
* No evidence for congenital malformations
* Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular hemorrhage