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NCT ID: NCT02095522 Withdrawn - NSTEMI Clinical Trials

COlchicine Improve EnDothElial Function in Non ST Elevation Myocardial Infarction Patients

CODEN
Start date: March 2014
Phase: N/A
Study type: Interventional

Colchicine has antiinflammatory properties. It has been shown to be effective in improving outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to assess the effect of colchicine on endothelial function using the EndoPATâ„¢ in NSTEMI Patients. Study Hypothesis: There will be a significant difference on the RH-PAT levels of the patients who were in treated with colchicine versus the placebo group Study design and patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial Infarction will be enrolled to a prospective randomized double-blind placebo controlled study in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their hospitalization before cardiac catheterization. All patients will sign an informed consent. Primary outcome will be the improvement in endothelial function between baseline and after 1 month in both groups

NCT ID: NCT02095457 Not yet recruiting - Anxiety Disorders Clinical Trials

Routine Outcome Monitoring in Mental Health Outpatient

ROM-Shalvata
Start date: July 2014
Phase: N/A
Study type: Interventional

Scientific Background: Inherent gaps exist between the worlds of research and clinical therapy, especially in mental-health systems. Developed as an important strategy aimed to bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a method devised for systematic ongoing quantitative measurements used in diverse clinical practices, from psychotherapies to psychiatric management. The efficacy of this approach has been repeatedly demonstrated in various measures, such as satisfaction with treatment by patients and therapists, lower drop-out rates, symptomatic benefits, and more. Objectives: The aim of the current study is to test the feasibility and the clinical benefits of implementation of a Routine Outcome Monitoring System in a public clinical center, as a pioneering project in Israel, at the "Shalvata" Mental Health Center. Working Hypotheses: Incorporation of a ROM system in routine clinical practice is hypothesized to improve patients' and therapists' overall satisfaction, allow for early detection and intervention in therapeutic raptures, decrease drop-out rates, and improve various clinical outcome measures. Methods: The suggested study is a two-stage (implementation and intervention) open trial. 900 new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention (ROM) and control groups. Assessment questionnaires will be filled periodically using 'CORE-NET', a computerized system enabling repeated measurements and feedback in a user-friendly and efficient manner. Data Analysis: The evaluation of the differential influence of monitoring processes on overall efficiency as compared to control group will be tested using Multiple Analysis of Variance (MANOVA). The predictive value of possible variables on process and outcome of therapy will be assessed using stratified regression analyses. The possible causal effects between specific lagged variables will be assessed using Hierarchical Linear Modeling and Time Series Analysis. Contribution: This pioneering study is the first in Israel to offer a routine systematic evaluation of therapeutic processes, as well as assessing its clinical effects. Consequently, a large and meaningful data-set will emerge, enabling significant enrichment of our evidence-based understanding of therapeutic processes.

NCT ID: NCT02093936 Completed - Clinical trials for Respiratory Tract Diseases

Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study

Start date: January 2005
Phase: N/A
Study type: Observational [Patient Registry]

Background: Induced sputum (IS) is a noninvasive methodology for evaluating airway inflammation in a large number of pulmonary diseases, i.e, Asthma, Chronic obstructive pulmonary disease and Interstitial Lung Diseases. Several studies have defined normal values and cut-off points for this technique based on cellular components of IS, such as percentages of eosinophils, neutrophils, macrophages and CD4/CD8 ratio of T cell lymphocytes. However, normal values and cut-off points for lymphocyte percentages indicative of pathology have not yet been established or validated. This component of IS has considerable clinical value. Similar to other constituents of IS, it can provide biological insights into the pathogenesis of respiratory disorders and contribute to establishing the diagnosis and guiding treatment management of a variety of airway diseases. The purposes of this study are to define normal values and cut-off points of lymphocytes in IS among individuals with respiratory disorders and healthy volunteers, and to verify the current reference values of the percentage of eosinophils, neutrophils and CD4/CD8 ratio in IS. Methods: A Cross Sectional study which includes a database on up to 900 patients who participated in various studies conducted in the Pulmonary Laboratory of Tel Aviv Sourasky Medical Center between 2005 to 2012 will be established. The study population will include patients diagnosed as having various pulmonary diseases and a group of healthy volunteers who will serve as controls. The cut-off for normal values of lymphocyte, eosinophil and neutrophil percentages and CD4/CD8 ratio in IS will be defined by using ROC curves and evaluating sensitivity and specificity. The comparison of the different values to those in the literature will be done by using the Spearman rank correlation. The results of this study will provide supplementary information on lymphocyte counts in IS for identifying and treating various respiratory diseases.

NCT ID: NCT02093832 Completed - Clinical trials for Total Hip Arthroplasty

Does the Femoral Head Size Can Predict the Cup Size?

Start date: July 2013
Phase: N/A
Study type: Observational

This study had four aims: 1. To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery. 2. To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter. 3. To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter 4. To suggest an additional online monitoring tool on the accuracy of the preoperative process and implant selection. We hypothesized that high accuracy rates will be found between the preoperative planned cup size and the actual implanted cup size. Furthermore, we hypothesized that strong correlations will be found between the planned and actual implanted cup size and the actual femoral head diameter size.

NCT ID: NCT02093806 Active, not recruiting - Clinical trials for Sensorineural Hearing Loss (Disorder)

Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery

Start date: January 2014
Phase: N/A
Study type: Observational

The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in order to assess preoperatively what is the extent of obstruction of the round window membrane and whether there is a surgical possibility of round window approach in the insertion of electrode array into the cochlea

NCT ID: NCT02093715 Recruiting - Acute Bronchiolitis Clinical Trials

FeNO and Cytokines in Respiratory Syncytial Virus (RSV) and Non RSV Bronchiolitis in Relation to Future Asthma

Start date: July 2007
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and blood cytokines during acute bronchiolitis, and to seek for correlation between these markers and future development of asthma.

NCT ID: NCT02093676 Completed - Type 1 Diabetes Clinical Trials

Applying the "New Authority" Model in the Treatment of Poorly Controlled Diabetic Adolescents and Their Families

Start date: July 30, 2014
Phase: N/A
Study type: Interventional

It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit from parents' counselling, guided by "the New Authority" model.

NCT ID: NCT02093663 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

PACE
Start date: December 12, 2014
Phase: Phase 3
Study type: Interventional

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

NCT ID: NCT02093182 Withdrawn - Vasospasm Clinical Trials

An Innovative Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm

Start date: n/a
Phase: N/A
Study type: Observational

The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more. HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool. We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.

NCT ID: NCT02093026 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Efficacy and Safety of Retreatment With MabThera (Rituximab) in Patients With Active Rheumatoid Arthritis (RA)

Start date: August 2002
Phase: Phase 2
Study type: Interventional

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.