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NCT ID: NCT02909543 Recruiting - Clinical trials for Women With Congenital Heart Diseases

The Life Experience of Young Women (Age 18-38) Who Live With Congenital Heart Disease

Start date: September 2016
Phase: N/A
Study type: Observational

This research will focus on young women between the ages of 18-38 who underwent a heart operation and their life experiences. This research will focus on these life events and the paradigm of these women being raised as "heart sick," and consequently lacking self-esteem (Frigiola, Bull, & Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on the quality of life compare men and women, completely ignoring women's body image and the experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al., 2013). This study aims to focus on women's stories about their life experiences and the influence of surgery(ies) on their daily life using an the qualitative phenomenological approach.

NCT ID: NCT02908971 Completed - Clinical trials for Puberty and Body Composition

Association Between Soy Based Formula in Infancy and Puberty

Start date: May 1, 2013
Phase:
Study type: Observational

Background: Children in industrialized and developing countries have a higher tendency to present earlier signs of puberty. One hypothesis includes the hormonal effects of phytoestrogens found in soy products. Objective: to examine the association between consumption of soy-based food in early infancy and childhood and the incidence of early or precocious puberty and overweight in school-aged children. Methods: the study population for this case control study is randomized from a prospectively followed cohort of all babies born at Assaf Haroffeh medical center and followed for milk allergy signs and food intake until the age of 3 years (A nested cohort). It is divided to those who were allergic to milk, and thus consumed only soy based formula and food during infancy and childhood (soy group) and a randomized control group who consumed non-soy based intake. For both groups data are available of food habits during infancy and collected from 3 days food diaries during the current study. Physical examination, including weight , height, blood pressure and Tanner Pubertal Staging will performed annually.

NCT ID: NCT02908711 Completed - Clinical trials for Anesthesia, Regional

Adductor Canal Block (ACB) Before and After Primary Total Knee Arthroplasty (TKA)

Start date: October 2016
Phase: Phase 4
Study type: Interventional

Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1. Perineural analgesia offers the advantage of extended pain relief up to 24 hours after surgery2. This is a prospective, randomized control trial designed to compare the analgesic efficacy of the adductor canal block (ACB) performed immediately before or immediately after primary total knee arthroplasty (TKA). The primary objective of this study is to measure pain score associated with knee motion following TKA among patients receiving ACB as part of their analgesic regimen for TKA. Secondary end points include assessment of postoperative ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction between the two analgesic approaches. The investigators hypothesize that ACB before the surgery will reduce a patient's postoperative pain and improve patient satisfaction. All consecutive patients undergoing primary TKA will be recruited for enrollment in the study. Patients will be for randomized preoperatively to receive either preemptive ABC (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will receive the block prior to incision. Patients randomized to the PostACB group will receive the block at the end of the surgery. Both techniques are in accordance to the standard of care at our institute. All patients will have the ACB done by a regional anesthesiologist in the regional anesthesia unit, or in the operating room. Patient medical history will be obtained and blocks will be placed per usual protocol. Operative and anesthetic details, including medications given, will be recorded. Pain scores and pain medications given in the PACU will be recorded. Supplementary analgesics will be provided per institutional PACU protocol. Study data will be recorded for up to 72 hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the orthopedic follow-up appointment to evaluate the patient's late pain scores and overall satisfaction. Data will be analyzed both at the conclusion of the study and at several intervals prior to completion of the study.

NCT ID: NCT02908672 Active, not recruiting - Melanoma Clinical Trials

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

Start date: January 13, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

NCT ID: NCT02908607 Not yet recruiting - Cervical Neoplasia Clinical Trials

Thermal Imaging for Evaluation of the Cervix

Start date: November 2016
Phase: Phase 1/Phase 2
Study type: Interventional

When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low. Thus, a technology that improves the accuracy of the colposcopic exam is needed. This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.

NCT ID: NCT02907437 Recruiting - Schizophrenia Clinical Trials

Minocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia

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

Current medications have only a limited effect on two core symptoms of schizophrenia, negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline which has a beneficial effect in various neurological disorders. In the past years, various findings from clinical studies showed its potential role for the treatment of these symptoms of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on treatment for alleviating positive, negative and cognitive symptoms in schizophrenia patients.The current study is a single center, double-blind, randomized study that assess the adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic medications, in adult patients suffering from schizophrenia. Patients will be recruited and randomly allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of treatment. In addition, all patients will receive probiotics (450mg/day) in order to prevent any gastrointestinal influences of antibiotics administration. Positive and negative symptoms , as well as cognitive functions will be assessed before and after treatment.

NCT ID: NCT02907385 Active, not recruiting - Rectal Cancer Clinical Trials

Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing

Start date: November 2016
Phase: Phase 3
Study type: Interventional

LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored. RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis. In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge. STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery. SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.

NCT ID: NCT02907242 Completed - Stillbirth Clinical Trials

Revealed Versus Concealed Cerebroplacental Ratio

Start date: May 4, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the role of an integrated strategy at selecting fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.

NCT ID: NCT02906501 Not yet recruiting - ADHD Clinical Trials

Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances

Start date: September 2016
Phase: N/A
Study type: Observational

Introduction: The use of low dose risperidone and other antipsychotic drugs off-label as augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) and Disruptive Behavioral Disorder (DBD) has become widely common worldwide, usually to help control behavioral difficulties. While some argue that agents that block dopaminergic receptors may have a deleterious cognitive effect, others stress their moderating effects, which possibly improve function in all domains, including cognitive functions. Only a few studies have examined this topic, with inconclusive results. Aim of study: To measure the effect of risperidone treatment on various cognitive functions in a population of ADHD diagnosed children and adolescents with normal IQ. Design: The study is an observational prospective open label clinical controlled trial. The investigators will compare the performance in a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP) and the IGT, in children and adolescents diagnosed with ADHD, with and without risperidone. Study population: Children and adolescents diagnosed with ADHD, 8-17 years old, may be eligible for this study. We will recruit subjects who their psychiatrist is considering rispieridone treatment, those who are already treated with risperidone and subjects with only stimulants treatment. All pharmacological treatment is supervised and prescribed to subjects by their personal psychiatrist unrelated to the study. Significance: Better knowledge of the specific cognitive effects of this form of therapy will help us guide both clinical decisions, and recommended monitoring in daily clinical work.

NCT ID: NCT02906020 Terminated - Parkinson's Disease Clinical Trials

A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation

MOVES-PD
Start date: December 15, 2016
Phase: Phase 2
Study type: Interventional

Primary Objectives: - Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants. - Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: - To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation. - To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation. Part 2: - To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo. - To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.