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NCT ID: NCT01910610 Active, not recruiting - Clinical trials for Colorectal Cancer Metastatic

Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer

STRATEGIC-1
Start date: October 30, 2013
Phase: Phase 3
Study type: Interventional

STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.

NCT ID: NCT01909817 Active, not recruiting - Clinical trials for Cardiovascular Diseases

A Novel Method for Enhancement of Standard Rest Electrocardiograms (ECG) Provides New Parameters for Early Detection of Coronary Artery Disease (CAD)

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

The investigators aim to determine whether a new method of enhancing and improving ECG acquisition, analysis and display is effective. The investigators will perform superimposition and summation of multiple standard ECG cycles, in the same lead, by temporal alignment to the peak R wave and voltage alignment to an improved baseline at the T-P segment.

NCT ID: NCT01909700 Completed - Clinical trials for Post Operative Complications

Single Incision Pelvic Floor Mesh Implants

Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse. Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure. Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.

NCT ID: NCT01909479 Terminated - Clinical trials for Adult Growth Hormone Deficiency

A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

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

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).

NCT ID: NCT01909453 Active, not recruiting - Melanoma Clinical Trials

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

COLUMBUS
Start date: September 16, 2013
Phase: Phase 3
Study type: Interventional

This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: 1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or 3. vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: 1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

NCT ID: NCT01909193 Completed - Social Phobia Clinical Trials

CBT vs. ABM vs. for Social Anxiety

Start date: January 2011
Phase: N/A
Study type: Interventional

Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1). Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria. The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.

NCT ID: NCT01908829 Completed - Urologic Diseases Clinical Trials

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

BESIDE
Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

NCT ID: NCT01908699 Completed - Clinical trials for Pulmonary Arterial Hypertension

Beraprost-314d Added-on to Tyvaso® (BEAT)

BEAT
Start date: May 31, 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension. Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of experience is achieved to ensure drug tolerability before enrolling in the study. Treatment groups consist of one active and one placebo group. Subjects will be randomly allocated in a 1:1 ratio to one of the two treatment groups.

NCT ID: NCT01908452 Withdrawn - Tardive Dyskinesia Clinical Trials

Pyridoxal Kinase Activity in Tardive Dyskinesia

Start date: July 2011
Phase: Phase 3
Study type: Interventional

Objectives: The mechanisms of tardive dyskinesia (TD) remain unclear, although pathophysiologic theories have proposed mechanisms such as dopamine receptor supersensitivity, the degeneration of cholinergic striatal interneurons, γ-aminobutyric acid (GABA) depletion, and an excess of free radicals. Prior development of second generation antipsychotic agents, tardive movement disorders were widespread among neuroleptics treated patients. There were great expectations of the new novel drugs. Unfortunately, reports about tardive movement disturbances induced by these medications became more and more frequent, although it has been in use for less than two decades. A recent study demonstrated that schizophrenic and schizoaffective patients suffering from TD had the mean level of pyridoxal 5'-phosphate (PLP) below lower limit of normal range, while those patients without TD had normal values. At the same time, some open and double-blind placebo-controlled, randomized clinical studies showed that vitamin B6 was very effective in treatment of TD. Pyridoxal kinase is a key enzyme for the biosynthesis of PLP, the biologically active form of vitamin B6. Some publications reported that the finding of high vitamin B6 levels is consistent with recent reports of low levels of PLP and low activity of pyridoxal kinase. It may explain the functional need for high-dose vitamin B6 supplementation in subjects with TD. Methods: A multicenter study including 300 schizophrenia and schizoaffective subjects will be performed. The trial will be consisted of 2 parts: the first part a single comparison pyridoxal kinase plasma activity in patients with and without TD; in the second part only TD schizophrenia and schizoaffective patients will continue. It will be a 12-week, randomized, double-blind placebo-controlled trial. Vitamin B6 (1200 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 150 schizophrenia patients. Participants will be assessed at baseline and after every 2 weeks of treatment till week 12. Pyridoxal kinase activity will be compared between patients who positively respond to vitamin B6 versus non responders. In addition, PLP levels will be monitored at baseline and at the end of the study. A battery of research tools will be used for assessment of movement disorders, psychopathology, and side effects. The study will be performed along a period of 2 years.

NCT ID: NCT01907854 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

LIRA-SWITCH™
Start date: December 2, 2013
Phase: Phase 4
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.