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NCT ID: NCT02240784 Completed - Clinical trials for Acute Hepatic Porphyria

EXPLORE: A Natural History Study of Acute Hepatic Porphyria (AHP)

Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to characterize the natural history and clinical management of Acute Hepatic Porphyria (AHP) patients with recurring attacks.

NCT ID: NCT02240693 Completed - Alzheimer Disease Clinical Trials

Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo

Start date: January 15, 2015
Phase: Phase 2
Study type: Interventional

The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease

NCT ID: NCT02240680 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin as Add on to Basal Insulin in the Elderly

Start date: September 23, 2014
Phase: Phase 4
Study type: Interventional

To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed. In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.

NCT ID: NCT02240147 Completed - Clinical trials for Congenital Heart Defect

Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

S2S-ACHD
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even though outcomes are good, they need lifelong follow-up because of a higher risk for cardiovascular diseases. Studies have shown that patients with CHD are not active enough and that a substantial amount of patients is overweight. Hence preventive strategies and education should not only focus on the heart problem, but also on a healthy lifestyle including physical activity. Recently a new guideline introduced exercise prescription based on the absence/presence of certain key elements. However, a number of important questions remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport' program for adults with CHD, based on this new guideline, will be investigated. This study is a randomized controlled trial that investigates the effects of the program on daily physical activity, exercise capacity, quality of life and exercise self-efficacy both in short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by using a new exercise-testing protocol that looks simultaneously to all body parts that are involved during exercise. Ultimately, our findings will result in the implementation of the guideline in clinical practice.

NCT ID: NCT02239120 Completed - Stroke Clinical Trials

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Start date: November 27, 2014
Phase: Phase 3
Study type: Interventional

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

NCT ID: NCT02238847 Completed - Pancreatic Cancer Clinical Trials

Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Start date: March 24, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.

NCT ID: NCT02236975 Completed - Clinical trials for Coronary Artery Disease

First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis

Start date: April 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal. Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.

NCT ID: NCT02236637 Completed - Prostate Cancer Clinical Trials

A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care

Start date: June 14, 2013
Phase:
Study type: Observational

The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.

NCT ID: NCT02235181 Completed - Clinical trials for Twin Pregnancy With Antenatal Problem

An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy

STOPPIT-2
Start date: November 1, 2014
Phase: N/A
Study type: Interventional

This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

NCT ID: NCT02235168 Completed - Healthy Elderly Clinical Trials

Effect of Rollator on Walking Distance in Elderly Patients

Start date: September 2014
Phase: N/A
Study type: Interventional

To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.