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NCT ID: NCT01671566 Completed - Clinical trials for Congenital Heart Defects

Interval Training in Adults With Congenital Heart Disease a Randomized Trial

Start date: September 2012
Phase: N/A
Study type: Interventional

Adults with congenital heart disease have various degrees of impaired exercise capacity compared to healthy controls. Impaired exercise capacity makes everyday activities more difficult and demanding. There are few studies on effect of exercise training in adults with congenital heart disease. The hypothesis of this study is that structured home based exercise training will improve exercise capacity and health status in the studied population.

NCT ID: NCT01671007 Completed - Stroke Clinical Trials

GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

Start date: August 22, 2012
Phase:
Study type: Observational

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

NCT ID: NCT01670851 Completed - Rectal Cancer Clinical Trials

Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

PRESSUR
Start date: March 2013
Phase: N/A
Study type: Observational

This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.

NCT ID: NCT01670591 Completed - Clinical trials for Problem Behaviors Among Students

Effects of Prevention in School (PS): a Swedish School-wide Positive Behavior Support Program at the Primary Prevention Level

Start date: January 2009
Phase: N/A
Study type: Interventional

Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the universal prevention level, developed by Swedish researchers for the school years 4 -9. By defining and teaching school rules to all teachers and students, and by consistently acknowledging students when meeting behavioural expectations, the program aims to reduce problem behaviours in school areas and to improve the classroom learning climate. Against this background, the purpose of this study is to examine whether PS is more effective than schools' ordinary practices in meeting these goals.

NCT ID: NCT01669902 Completed - Clinical trials for Rheumatoid Arthritis

An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis

Start date: April 2012
Phase: N/A
Study type: Observational

This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.

NCT ID: NCT01669330 Completed - Clinical trials for Gastroesophageal Reflux

Laparoscopic Nissen Versus Anterior Partial Fundoplication

Start date: January 2001
Phase: N/A
Study type: Interventional

The most widely used operative technique for gastroesophageal reflux is total fundoplication where the gastric fundus is sutured around the distal esophagus like a wrap. This operation effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related to over-competence of the gastroesophageal junction. 40% of the operated patients experience increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of the front wall of the esophagus is covered with fundus. An anterior fundoplication is un attempt to create a more physiologic reflux control and less functional problems postoperatively. The aim with this study is to compare the results postoperatively, both short time and long time results.

NCT ID: NCT01668784 Completed - Clinical trials for Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Start date: October 9, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

NCT ID: NCT01667822 Completed - Anxiety Disorders Clinical Trials

Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

Start date: August 2012
Phase: Phase 3
Study type: Interventional

Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy (CBT) has been shown to be an effective treatment of these disorders. Despite the strong evidence for CBT there is a lack of evidence-based psychological treatment in primary care. For various reasons, the progress of research has not affected clinical practice. For successful implementation of CBT in primary care cost-effective therapies, access to therapists with proper training and supervision, evidence-based manuals and management that support the implementation is needed. Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All patients are first treated with self-help CBT (N = 400). Patients that do not improve after treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based on published studies 2/3 is expected to be improved after self-help and therefore do not undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to individual CBT (N = 67) or continued self-help treatment (N = 67).

NCT ID: NCT01667809 Completed - Anxiety Disorders Clinical Trials

CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care

Start date: August 2012
Phase: Phase 3
Study type: Interventional

Background: Common mental illness, such as anxiety disorders and depression, is the main cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be effective in alleviating target symptoms of these disorders, but its effect on sick leave rates has not been sufficiently addressed. The investigators have developed an intervention called return to work (RTW), which is based in cognitive behavioral theory, that has a primary aim of helping sick-listed patients with common mental illness return to work. This new treatment has not been evaluated in a randomized controlled trial. Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical common mental illness in a randomized controlled trial conducted in primary care. Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes are days of sick leave and clinician severity rating of psychiatric symptoms. This study could contribute to new knowledge regarding how to best treat patients on sick leave with mild common mental illness.

NCT ID: NCT01667419 Completed - Melanoma Clinical Trials

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

BRIM8
Start date: September 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.