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NCT ID: NCT02477618 Completed - Clinical trials for Super-Refractory Status Epilepticus

A Study With SAGE-547 for Super-Refractory Status Epilepticus

Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).

NCT ID: NCT02476487 Completed - Clinical trials for Staphylococcus Aureus Bacteremia

The Benefit of FDG PET CT in the Treatment Algorithm of Staphylococcus Aureus Bacteremia

PETCT4SAB
Start date: August 1, 2015
Phase: N/A
Study type: Interventional

Background: Staphylococcus aureus bacteremia (SAB) is frequently encountered in hospitals, with high rates of morbidity and mortality. Duration of antimicrobial treatment for SAB, other than in cases of Infective endocarditis (IE), recommended by different guidelines relies on risk stratification for relapse of infection rather than definite diagnosis of septic foci that eventually determine the relapse rate. In recently published studies fluorodeoxyglucose (FDG) PET CT was found to be a sensitive imaging test for identifying metastatic infectious foci in Gram-positive bacteremia, including SAB. Objectives: To examine the impact of using FDG PET CT in the diagnostic algorithm of non-IE SAB compared to standard treatment recommendations on treatment duration and clinical outcomes. Methods: A prospective interventional non-comparative cohort study conducted at Rambam Health Care Campus. Patients with SAB, defined as microbiologically and clinically, will undergo FDG PET CT 10-14 days following the first positive blood culture for diagnosis of septic extra-cardiac foci of infection. Patients with IE will be excluded. Short (2 weeks) versus long treatment (4-6 weeks) will be recommended for negative and positive PET CT tests, respectively. Patients will be followed-up for 1 year for relapse of infection and mortality. We will document the sensitivity and specificity of PET CT for detection of complications among patients with SAB. We will examine the percentage of patients in whom the use of PET CT changed treatment duration compared to standard recommendations. We will compare also, the relapse rate and 1 year mortality rate with data from previous studies and local data. Assuming a 15% rate of management changes compared to consensus recommendations, a sample of 150 patients will achieve the required 95% CI. Significance: Our trial will serve for improving decision making in patients with non-IE SAB, shortening treatment duration in unnecessary cases and decreasing relapse rate by giving prolonged appropriate treatment for metastatic infection not identified by standard management algorithms. PET CT is assuming an increasingly important role in infection diagnosis and management. The current study will be the first to examine the role of PET CT in directing management of patients with SAB.

NCT ID: NCT02476344 Not yet recruiting - Motor Activity Clinical Trials

Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects

Start date: July 2015
Phase: N/A
Study type: Interventional

2 young candidates have tragically died during army pre-recruitment sorting series in 2006. As part of the classification and characterization of the physical aspects of the training, this experiment was requested. We aim at determining the characteristics of physical strains in sorting series, by objective and subjective parameters and evaluating the difficulty levels and intensity of those strains.

NCT ID: NCT02476214 Completed - Prenatal Care Clinical Trials

Comparison of Group Guidance to Routine Care for Pregnant Women at Low Risk

Start date: July 2015
Phase: N/A
Study type: Interventional

Prenatal care is defined as pregnancy-related health care services provided to a women between conception and delivery. Early, comprehensive prenatal care can promote healthier pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing preexisting medical conditions, by providing health behavior advice, and by offering a gateway into the health care system for socially disadvantaged women . The customary approach for prenatal care includes routine individual care, which is provided by nurses and physicians in healthcare clinics and hospitals. Since 1995, citizens of Israel, have been entitled to health care services according to the National Health Insurance Law . Israeli citizens are covered by National Health Insurance, and get maternal and child preventive services including prenatal care by local Mother and Child Health Clinics . The prenatal care is individual. A nurse meets with every registered pregnant women, assess the medical and emotional condition and provide guidance related to the pregnancy week of the woman. Since the 70, a number of group prenatal care intervention programs are described in the literature. Group prenatal care is designed to answer the recommended content for prenatal care for improving the quality of care and resulting in improved pregnancy outcome . The group prenatal care includes three important components: risk assessment. Guidance and support and combines them into the prenatal care22. Creation of the group provides a meeting place for pregnant women. A safe place for sharing and learning from each other and to build a community for mutual support . The investigators hypothesize that, relative to women who receive standard individual prenatal care, the women who receive group prenatal care will be more likely to: 1. Report higher levels of satisfaction. The investigators also anticipate higher levels of staff satisfaction within the intervention group medical staff. 2. Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy). 3. Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT, first and second trimester screening, US) 4. have better perinatal outcomes: better health behaviors during pregnancy (e.g., nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low birthweight,), and better postpartum indicators (e.g., increased breastfeeding);

NCT ID: NCT02475681 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

ElevateTN
Start date: June 26, 2015
Phase: Phase 3
Study type: Interventional

This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria. 2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)

NCT ID: NCT02475057 Completed - Clinical trials for Cardiovascular Diseases

Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists

Start date: August 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.

NCT ID: NCT02475044 Recruiting - Clinical trials for Post-Concussion Syndrome

Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the role of psychosocial factors in creating Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a) Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution for the child injury by their parents and (2) embracing of a more permissive and authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral symptoms?

NCT ID: NCT02474433 Recruiting - Clinical trials for Cervical Preparation Prior to Hysteroscopy

Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

Start date: July 2015
Phase: Phase 4
Study type: Interventional

This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.

NCT ID: NCT02474264 Recruiting - BRCA2 Gene Mutation Clinical Trials

The Link Between BRCA Mutation and Endothelial Function

Start date: February 2015
Phase: N/A
Study type: Interventional

This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.

NCT ID: NCT02474056 Withdrawn - Clinical trials for the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical Patients

The Impact of the Fluid Resuscitation on the Venous Volume and Flow Characteristics in Hypovolemic Shock

Start date: January 2010
Phase: N/A
Study type: Observational

We hypothesis that in various situation when the effective blood volume decreased the venous volume flow characteristics change according to the fluid resuscitation