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NCT ID: NCT01930279 Not yet recruiting - Sleep Deprivation Clinical Trials

Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood

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

Sleep deprivation was found to affect many organs including the immune system and predisposing for various health consequences including diabetes hypertension infections and increase in neoplastic diseases. Subjects will be evaluated for immune parameters in peripheral blood test following a regular nigh sleep and compared with a test performed following a night shift in which they slept less than 3 hours. Each participant will serve as its own control.

NCT ID: NCT01930266 Recruiting - Clinical trials for Bone Mineral Density in Cow's Milk Allergic Patients

Young Adults With Life Threatening Cow's Milk Allergy: Risks of Decrease Bone Mineralization and Methods of Calcium Supplementation

Start date: August 2013
Phase: N/A
Study type: Interventional

Diet is the only source for calcium and the most important dietary source are dairy products. This presents a difficulty for children with IgE-mediated cow's milk allergy, who are unable to consume milk. We noted that IgE-CMA allergic young adults have a significant decrease in bone mineral density (BMD) compared to international reference values and also to geographically and age matched normal controls. Working hypothesis: Young adults with IgE-CMA have significantly lower BMD than age and gender matched controls. This can be reversed by introducing dairy products following recovery from allergy, or by enriching the diet via other calcium sources.

NCT ID: NCT01929733 Completed - Clinical trials for Patent Ductus Arteriosus

Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Start date: January 1998
Phase: N/A
Study type: Observational

Percutaneous closure is one of the methods used to treat, among other congenital heart disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus, using various devices. In this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device. Aim of study: To create an algorithm that can be used to choose the proper device for percutaneous closure of the PDA, based on the characteristics of the patient and the PDA type.

NCT ID: NCT01929447 Completed - Sleep Disorders Clinical Trials

Evaluation of WP200 With the Unified Probe (WP200U)

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

The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems. The primary objective of the study is to evaluate the newly developed WP200 with the unified probe (WP200U) compared to the currently used configuration of WP200 that uses an incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.

NCT ID: NCT01926912 Completed - Schizophrenia Clinical Trials

A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting

HOSPIPalm
Start date: May 2013
Phase: Phase 4
Study type: Observational

The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.

NCT ID: NCT01926886 Completed - Breast Cancer Clinical Trials

A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)

Start date: November 19, 2013
Phase: Phase 3
Study type: Interventional

This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC. Participants who have completed the first 6 cycles of intravenous (IV) trastuzumab as part of the (neo)adjuvant treatment will be eligible to receive a further 12 cycles of trastuzumab in this study. Participants will receive IV trastuzumab at initial loading dose of 8 milligrams per kilogram (mg/kg) body weight (BW) for three-weekly (q3w) regimen and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by subcutaneous (SC) administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18).

NCT ID: NCT01926782 Completed - Clinical trials for Hypercholesterolemia

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if the study drug (alirocumab)administered every 4 weeks, given by injection under the skin is effective and safe compared with placebo in lowering cholesterol, if used alone or added to the participants' current cholesterol-lowering medication.

NCT ID: NCT01926691 Completed - Stroke Clinical Trials

Predictors for Poststroke Outcomes: Tel Aviv Brain Acute Stroke Cohort Acute Stroke Cohort (TABASCO)

TABASCO
Start date: April 1, 2008
Phase:
Study type: Observational [Patient Registry]

Background: Recent studies have demonstrated that even mild stroke survivors experience residual damage, which persists and in fact increases in subsequent years. About 45% of stroke victims remain with different levels of disability. While studies on cognitive impairment and dementia after stroke are receiving increasing clinical attention, the underlying pathophysiology is poorly understood. Identifying the mechanisms involved and recognizing early biomarkers for individual vulnerability, require a multi-modal approach, as the mechanisms involved in cerebrovascular disease and individual trajectories of post-stroke recovery may impact upon each other on various levels. Aims and Hypothesis: To date there is no single measure that can be used to identify patients who are prone to develop cognitive impairment and other disabilities from those with better recovery prospects. We hypothesize that data based on biochemical, neuroimaging, genetic and psychological measures can, in aggregate, serve as better predictors for subsequent disability, cognitive and neurological deterioration, and suggest possible interventions. Design: The TABASCO (Tel-Aviv Brain Acute Stroke Cohort) study, a prospective cohort study aim to recruit about approximately 1125 consecutive first-ever mild-moderate stroke patients. It is designed to evaluate the association between predefined demographic, psychological, inflammatory, biochemical, neuro-imaging and genetic markers, measured during the acute phase, and long-term outcome: subsequent cognitive deterioration, vascular events (including recurrent strokes), falls, affective changes, functional everyday difficulties and mortality. Discussion: This study is an attempt to comprehensively investigate the long term outcome of mild-moderate strokes. Its prospective design will provide quantitative data on stroke recurrence, the incidence of other vascular events and the evaluation of cognitive, affective and functional decline. Identifying the factors associated with post stroke cognitive and functional decline could potentially yield more effective therapeutic approaches. The investigators believe that an extensive approach of analyzing the interaction between different risk factors would more accurately predict neurological and cognitive deterioration.

NCT ID: NCT01925898 Recruiting - Lacerations Clinical Trials

A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Start date: August 2013
Phase: Phase 4
Study type: Interventional

Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery Hypothesis: Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.

NCT ID: NCT01923233 Withdrawn - Clinical trials for Hepatocellular Carcinoma

In-Situ Therapeutic Cancer Vaccine for Refractory Liver Cancer

Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an individualized anti-cancer vaccine protocol where the vaccination occurs inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a process called "Radiofrequency Ablation" or RFA. RFA causes the tumor to release its internal contents to the surrounding environment, such contents include tumor-specific antigens. Immune cells respond to the tissue damage and take-up these tumor antigens. The injection of the experimental cell drug, AlloStim(TM) into the lesion is designed to cause the responding cells to signal the immune system of the danger of the tumor, creating tumor-specific immunity.