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NCT ID: NCT02774616 Completed - Heart Failure Clinical Trials

BIO|MASTER.Ilivia Family / Plexa

Start date: June 2016
Phase: N/A
Study type: Interventional

Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region

NCT ID: NCT02774135 Completed - Clinical trials for Limited Participation in Daily Life Activities

Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention

Start date: May 1, 2017
Phase:
Study type: Observational

This study evaluates the improvement of participation in everyday occupation among preschool children with mild developmental disabilities as a result of Occupational Therapy intervention.

NCT ID: NCT02774083 Completed - Clinical trials for Mild Cognitive Impairment

Cognitive Training Using Feuerstein Instrumental Enrichment

Feuerstein
Start date: September 3, 2015
Phase: N/A
Study type: Interventional

Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above. The program is an applied practicable program based on the theories of Structural Cognitive Modifiability as well as on a Mediated Learning Experience. The program takes into consideration the unique characteristics and requirements of the older population. The program is composed of a variety of cognitive tasks that offer systematic activities intended to stimulate mental and cognitive development. Objective: To examine the influence of the Feuerstein Program on the cognitive function and well-being of participants suffering from Mild Cognitive Impairment (MCI). Hypothesis: The Feuerstein Program will improve cognitive abilities and functional well-being of the participants. Methods: Residents of retirement homes will be offered to participate in the research. Participants will undergo cognitive and functional assessments that will be carried out on four specific dates. The participants of the Intervention Group will participate in the Feuerstein program using a method of mediated learning while the Control Group will participate in a program of the Adler Institute involving activities aimed at social and emotional development without specific cognitive skill training.

NCT ID: NCT02773030 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma

Start date: October 14, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 monotherapy and CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma (RRMM), CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX and DARA for Newly Diagnosed Multiple Myeloma (NDMM).

NCT ID: NCT02772393 Recruiting - Schizophrenia Clinical Trials

A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

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

The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

NCT ID: NCT02772211 Not yet recruiting - Clinical trials for Treatment Resistant Depression

D-cycloserine for Relapse Prevention Following Intravenous Ketamine in Treatment-resistant Depression

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

This is a two-stage experiment; the first stage is an open label trial in which participants receive six intravenous (IV) treatments of ketamine. The second stage includes participants that responded to ketamine (i.e. reduction of 25% in their symptoms of depression, as measured by the Montgomery Asberg Depression Scale MADRS). The second stage is a double-blind, controlled clinical trial of D-cycloserine (DCS) vs. placebo, as maintenance treatment in patients who responded to ketamine treatment. The aim of the study is to determine whether 8 weeks of DCS maintenance therapy will prevent relapse of depressive symptoms following ketamine infusions

NCT ID: NCT02772198 Recruiting - Clinical trials for Non-Hodgkin Lymphoma, B-cell

T-cells Expressing Anti-CD19 CAR in Pediatric and Young Adults With B-cell Malignancies

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

This phase 1 / 2 study will evaluate the response of B-cell malignancies expressing CD19 to autologous T cells transduced with a second generation anti-CD19 chimeric antigen receptor in children and young adults.

NCT ID: NCT02770807 Completed - Genetic Syndrome Clinical Trials

Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients

ATTeST
Start date: March 2, 2017
Phase: Phase 3
Study type: Interventional

Objectives: The objective of study was to evaluate the safety and the efficacy of EryDex (Dexamethasone sodium phosphate encapsulated in autologous erythrocytes, using the EryDex System - EDS) at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on Neurological Symptoms in Patients With Ataxia Telangiectasia. Initial Double-Blind Treatment Period (0 to 6 Months) Primary Efficacy Objective: • Evaluate the effect of EryDex at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on central nervous system (CNS) symptoms measured by the change in the Modified International Cooperative Ataxia Rating Scale (mICARS) from baseline to Month 6 (Visit 9) in patients with ataxia telangiectasia (A-T). Secondary Efficacy Objectives: - Evaluate the effect of EryDex, compared to placebo, on the Clinical Global Impression of Change (CGI-C) in patients with A-T from baseline to Month 6 (Visit 9). - Evaluate the effect of EryDex, compared to placebo, on measures of Clinical Global Impression of Severity (CGI-S; structured) in patients with A-T from baseline to Month 6 (Visit 9) - Evaluate the effect of EryDex, compared to placebo, on measures of Adaptive behavior measures in patients with A-T by the Vineland Adaptive Behavior Scales (VABS) from baseline to Month 6 (Visit 9). Safety Objectives: • Evaluate the safety and tolerability of two non-overlapping doses of EryDex, compared to placebo, in patients with A-T over the 12-month double-blind study duration. Extension Treatment Period (6-12 Months): Primary Objective: • Evaluate the efficacy of EryDex at two dose levels (low dose and high dose DSP/infusion) compared to placebo, in treating CNS symptoms in A-T patients during longer-term treatment (up to 12 months), as measured by the mICARS. Secondary Objectives: - Evaluate the longer-term (up to 12 months) safety and tolerability of EryDex in A-T patients. - Compare the effects of EryDex on the CGI-C and CGI-S (structured), VABS, and QoL using the EQ-5D-5L scale.

NCT ID: NCT02768974 Recruiting - Ulcerative Colitis Clinical Trials

Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis

Start date: September 2016
Phase: Phase 2
Study type: Interventional

This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.

NCT ID: NCT02768142 Completed - Clinical trials for Postpartum Hemorrhage

The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.

Start date: August 2016
Phase: N/A
Study type: Interventional

Throughout the history, the neonate was dependent on maternal touch and care for survival. In modern obstetrics, with hospital care the neonates are seldom separated from their mothers after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk production, lactation and improve maternal and neonatal outcome. Oxytocin is the primary hormone responsible for uterine contraction and prevention of postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion. The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was found to decrease postpartum milk production, postpones early lactation and decreases exclusive breastfeeding. During the typical CD, the neonate is usually presented for a short while to the mother and breastfeeding is usually delayed at least a number of hours until after the surgery and the recovery period. Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin secretion increases with ESTS and during breastfeeding. The aim of this study is to examine blood loss that occurs after Natural CD compared to standard CD without an ESTS contact.