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NCT ID: NCT00752921 Not yet recruiting - Headache Clinical Trials

Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache

Start date: September 2008
Phase: Phase 4
Study type: Interventional

Headache during fasting is a known entity in the scientific literature. The prevalence of such a headache is high and in a study conducted in Israel was found in 60% of people with a previous predilection for headache. A prior study showed a significant decrease in the incidence of fasting headache using rofecoxib, but the drug has been taken off the market. The goal of this project is to evaluate the efficacy of etoricoxib as treatment taken before the fast- a COX-2 inhibitor with a relatively long half life to prevent fasting induced headache. The study will be a prospective double blind placebo controlled trial using adult volunteers with a history of a fasting headache who will be abstaining from food and drink on Yom Kippur. The study hypothesis is that treatment with etoricoxib prior to a 25 hour fast will decrease the incidence of fasting headache.

NCT ID: NCT00751114 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

EASIE
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: - HbA1c level - Fasting Plasma Glucose (FPG) - 7-point plasma glucose (PG) profiles - Percentage of patients with HbA1c <7% and <6.5% Safety objectives consisted of: - Hypoglycemia occurrence - Body weight - Overall safety

NCT ID: NCT00750789 Not yet recruiting - Atherosclerosis Clinical Trials

The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults

Start date: September 2008
Phase: Phase 4
Study type: Interventional

It has been proven in in-vitro studies that dates decrease the oxidative stress in serum. There have been no in-vivo studies to this date. The current study aims to test whether dates consumption by healthy adults decreases serum oxidative stress and improves serum PON1 activity and serum lipid profile.

NCT ID: NCT00750659 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Nilotinib Pre and Post Allogeneic Stem Cell Transplantation

Start date: July 2009
Phase: Phase 2
Study type: Interventional

Current therapeutic results in advanced chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL) are rather disappointing. Most of these patients will eventually undergo allogeneic stem cell transplantation. Nilotinib is a novel TKI tyrosine kinase inhibitor with 30 fold more potency than Imatinib. Based on previous preliminary experience the author we rationalize that Nilotinib therapy pre- allogeneic transplantation for patients with advanced CML and Ph+ALL will reduce tumor mass pre- transplant achieving a state of minimal residual disease (MRD) and therefore may improve transplantation outcome without increasing toxicity. In addition it will allow time for improving patient medical condition and for finding an unrelated donor which will enable allogeneic transplantation , and to induce anti tumor effect post PBSC w\o DLI ( donor lymphocyte infusion)

NCT ID: NCT00750464 Completed - Breast Cancer Clinical Trials

Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

Start date: November 2008
Phase: N/A
Study type: Observational

Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.

NCT ID: NCT00749931 Completed - Breast Cancer Clinical Trials

MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

Pivotal
Start date: October 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

NCT ID: NCT00749905 Terminated - Colon Preparation Clinical Trials

Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Start date: January 2009
Phase: Phase 2
Study type: Interventional

A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination

NCT ID: NCT00749814 Not yet recruiting - Sleep Disorders Clinical Trials

Sleep Disturbances in Hospitalized Children

Start date: October 2008
Phase: Phase 4
Study type: Interventional

Background Sleep disturbances are prevalent in hospitalized adult patients manifested as reduced sleep time and sleep efficiency as well as increased awakenings. Insomnia is the most frequent sleep disturbance. The effect of the change in sleep patterns in children prior to and after an elective surgery has not been evaluated objectively. Sleep in hospital may influence biological processes related to circadian rhythm. Melatonin is a hormone secreted by the pineal gland in a diurnal rhythm regulated by light- light suppresses melatonin secretion, while darkness enhances it. Melatonin has both chrono-biotic and sleep promoting properties. Exogenous administration of melatonin shortens sleep latency, increases sleep efficiency and total sleep time. Melatonin also improves disrupted circadian rhythm. Melatonin promotes sleep in a similar way to the natural sleep process, and maintains normal sleep architecture. Melatonin has a positive effect on children with sleep disturbances and is routinely administrated in pediatric sleep centers around the world for insomnia and a variety of sleep disorders. Side effects of melatonin are rare and scarce. Circadin is a slow released formulation of melatonin, which mimics night time secretion of natural melatonin. Children with sleep disorders who were treated with controlled release melatonin, demonstrated improvement in sleep latency and total sleep time. It is reasonable to assume that hospitalized children have disturbed sleep patterns prior to and following elective surgery. We hypothesize that melatonin will improve sleep patterns prior to and following surgery, by reducing sleep latency and extending total sleep time. We also hypothesize that this improvement will have positive impact on anesthetic stress measures and on recovery. The purposes of the study are: 1. To characterize sleep patterns in children undergoing surgery on the admission night prior to surgery; 2. To evaluate the effect of melatonin on sleep parameters on the night prior to surgery in children; 3. To evaluate the effect of melatonin on physiologic stress parameters during anesthesia and surgery in children; 4. To evaluate the effect of melatonin on sleep parameters of children postoperatively; 5. To evaluate the effect of melatonin on postoperative outcome measures in children. Patients, Methods. Ninety children (aged 4-18 years) will be evaluated. Sleep disorders will be screened by a pediatric sleep questionnaire. Sleep will be assessed by sleep logs and actigraphy for sleep onset time, sleep latency, total sleep time, total wake time, number and length of awakenings, sleep efficiency, sleep fragmentation index and sleep mean activity score. Recovery measures will include: length of hospitalization, infection rate, body temperature, cortisol levels, cooperation with medical staff. Study plan. The research will comprise of 5 consecutive steps. Step 1 will include the week prior to surgery and include sleep evaluation to all participants by sleep log and actigraphy. Step 2 is the night prior to surgery and will include sleep log and actigraphy. 30 children will receive melatonin (Circadin) 2mg, 30 children will receive placebo and 30 children will constitute the control group. Step 3 will be conducted during anesthesia and surgery where stress variables and need for anesthesia will be recorded. Step 4 will take place during post-operative hospitalization and will include actigraphy and sleep logs. Step 5 will take place at home two weeks after discharge and will include actigraphy and sleep logs.

NCT ID: NCT00749619 Completed - Clinical trials for End Stage Renal Disease

Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?

Start date: May 2007
Phase: Phase 3
Study type: Interventional

Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.

NCT ID: NCT00749541 Completed - Clinical trials for Vitamin D Deficiency

Vitamin d Levels and Coronary Catheterization

Start date: November 2008
Phase: N/A
Study type: Observational

decreased vitamin d levels are associated with increased inflammatory markers,and renin angiotensin levels. decreased levels were also found to be connected to increased cardiovascular mortality. we therefore hypothesise that in patients with pathological results of coronary catheterization we will find decreased levels of 25 hydroxy vitamin d. we will examine patients undergoing elective coronary catheterization and compare two groups: those with normal results and those with pathological results.