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NCT ID: NCT01719055 Recruiting - Pain Clinical Trials

RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

RELIEF
Start date: November 19, 2012
Phase:
Study type: Observational

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use - and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

NCT ID: NCT01718769 Completed - Malnutrition Clinical Trials

Validation of the STAMP Screening Tool For Pediatric Nutritional Risk

STAMP2
Start date: October 2012
Phase: N/A
Study type: Interventional

Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file. Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements. A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.

NCT ID: NCT01718548 Not yet recruiting - Physical Fitness Clinical Trials

The Effects of Cordyceps Sinensis and Lingzhi on Cardiovascular Fitness and Cognitive Function

Start date: December 2012
Phase: N/A
Study type: Interventional

Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many years for treatment of a variety of conditions. The aim of this study is to evaluate the effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on cardiopulmonary fitness and cognitive functioning in young, healthy physical education students.

NCT ID: NCT01718457 Active, not recruiting - Obesity Clinical Trials

Endobarrier Treatment in Obese Subjects With T2DM

Start date: December 2012
Phase: Phase 4
Study type: Interventional

Diabesity (Diabetes accompanied by obesity) is a prevalent condition many times complicated by micro- and macrovascular disease. Many treatments for Diabesity paradoxically cause further weight gain and hypoglycemia. The Endobarrier enables diabetes control along with weight loss as an alternative to bariatric surgery for patients who are not interested or not qualified for surgery. The aim of this study is to assess the efficacy and safety of the Endobarrier Diabesity patients in Israel. This study will include 45 men and women between the ages of 18-65 with HbA1c level of 8% and above and a BMI of 30 kg/m2 or above. Exclusion criteria: use of anti-coagulant, use of steroids or inability to discontinue these medications. The cohort will be followed for two years during which the patients will be monitored for diabetes control (by using a continuous glucose monitor), weight, blood pressure, lipid profile, fatty liver (by Ultrasound and blood markers for inflammation and fibrosis) and change in plasma gut peptide levels. The Endobarrier will be explanted after one year, however the monitoring of the patients will continue for another year.

NCT ID: NCT01718405 Not yet recruiting - Executive Function Clinical Trials

Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function

Start date: November 2012
Phase: N/A
Study type: Interventional

Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. The main purpose of our study is to examine whether genetic variation is a moderator of this effect and whether resistant exercise is comparable to aerobic exercise in improving cognition following a single bout of exercise.

NCT ID: NCT01718184 Recruiting - Refractive Error Clinical Trials

Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

Start date: October 2012
Phase: N/A
Study type: Interventional

A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric intraocular lens in pseudophakic patients for correcting refractive errors following corneal transplantation

NCT ID: NCT01718158 Completed - Hepatitis C Clinical Trials

Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy

STRUCTURE
Start date: January 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

NCT ID: NCT01717807 Not yet recruiting - Lung Cancer Clinical Trials

C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).

EGFR; PET/CT
Start date: April 2013
Phase: N/A
Study type: Observational

The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments. New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.) Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors. Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors. The purposes of the study are: 1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response. 2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.

NCT ID: NCT01717664 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS)

CEASE-MS
Start date: June 2013
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that Mycobacterium avium paratuberculosis positive Relapsing Remitting MS subjects will have a greater response to Interferon beta-1a therapy plus RHB-104 than from Interferon beta-1a alone.

NCT ID: NCT01716754 Completed - Asthma Clinical Trials

Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.