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NCT ID: NCT01986114 Completed - Bipolar I Disorder Clinical Trials

A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

Start date: January 29, 2014
Phase: Phase 3
Study type: Interventional

The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

NCT ID: NCT01986101 Completed - Bipolar Depression Clinical Trials

A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

Start date: February 19, 2014
Phase: Phase 3
Study type: Interventional

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

NCT ID: NCT01982955 Completed - Clinical trials for Non-small Cell Lung Cancer

Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)

Start date: December 23, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm).

NCT ID: NCT01980511 Completed - Clinical trials for Covert Postoperative Stroke

Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN

NeuroVISION
Start date: March 24, 2014
Phase:
Study type: Observational

The NeuroVISION Study will characterize the incidence, impact, and risk factors of covert stroke in adults undergoing noncardiac surgery. We will determine the incidence of acute covert stroke using an MRI study of the brain in the days following noncardiac surgery. We will characterize the epidemiology and the impact of covert stroke in patients undergoing noncardiac surgery, and its association with cerebral deoxygenation.

NCT ID: NCT01973400 Completed - Clinical trials for Cognitive Impairment

Neuroprotection by Tocotrienols in Type 1 and Type 2 Diabetes Mellitus

VENUS
Start date: June 2011
Phase: Phase 3
Study type: Interventional

Given that the tocotrienols have been shown to possess neuroprotective effects and that both type 1 and type 2 diabetes can lead to peripheral neuropathy and cognitive impairment, the present study aims to determine the beneficial effects of tocotrienols in ameliorating such neurological related events in both type 1 and type 2 diabetic patients.

NCT ID: NCT01973387 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma

Start date: October 28, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus rituximab in adult Asia Pacific region patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

NCT ID: NCT01972841 Completed - Overactive Bladder Clinical Trials

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

SYNERGY
Start date: November 5, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

NCT ID: NCT01972295 Completed - Atrial Fibrillation Clinical Trials

Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry

WASP
Start date: January 13, 2014
Phase:
Study type: Observational [Patient Registry]

This is an observational, prospective, non-randomized, multicenter study with the following objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect health care usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

NCT ID: NCT01971216 Completed - Breastfeeding Women Clinical Trials

Mother-infant Signalling During Breastfeeding

MOMS
Start date: December 2013
Phase: N/A
Study type: Interventional

Primary hypotheses 1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition) Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.

NCT ID: NCT01968733 Completed - Clinical trials for Community-acquired Bacterial Pneumonia

Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

SOLITAIRE-IV
Start date: November 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.