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NCT ID: NCT01218607 Completed - Clinical trials for Heart Septal Defects, Atrial

Bosentan for Mild Pulmonary Vascular Disease in Asd Patients.

BOMPA
Start date: October 2010
Phase: Phase 3
Study type: Interventional

Volume overload due to left-to-right shunting in patients with atrial septal defect type secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring cardiac output and pulmonary artery pressures at different stages of exercise, a pressure-output plot can be obtained. The slope of the pressure-output plot reflects pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years, pulmonary vascular resistance was higher when compared to age-matched controls, indicating the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease pulmonary vascular resistance. The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD repair after the age of 40 years, administration of bosentan decreases pulmonary vascular resistance as assessed by bicycle stress echocardiography.

NCT ID: NCT01218386 Completed - Infertility Clinical Trials

Pretreatment With Estradiol Valerate

Start date: May 2010
Phase: Phase 4
Study type: Interventional

The present study is set up to evaluate the efficacy of a programmation by administration of estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days during the luteo-follicular transition period of the menstrual cycle.

NCT ID: NCT01218373 Completed - Frailty Clinical Trials

The Clinical Evaluation of Continuous Assistance Offered to Older People Living Independently.

HOMESWEETHOME
Start date: December 1, 2010
Phase: N/A
Study type: Interventional

The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. The trial will test the hypothesis that while providing a level of safety equivalent to or better than that enjoyed in older people‟s homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.

NCT ID: NCT01217684 Completed - Validity Clinical Trials

Test-retest Reliability of a Standard Protocol on the Biodex Dynamometer

Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of the present study is to evaluate test-retest reliability of a standard protocol on the Biodex dynamometer in older adults. In addition, the test-retest reliability and validity of an experimental measure of knee extension strength will be assessed in older adults.

NCT ID: NCT01217476 Completed - Clinical trials for Diabetic Foot Ulcer of Neuropathic Origin

The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study

TRANS-North
Start date: December 2010
Phase: Phase 3
Study type: Interventional

Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product. We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 40 investigational sites in Europe.

NCT ID: NCT01216917 Completed - Muscle Quality Clinical Trials

The Influence of Ageing on Muscle Quality

Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of the present study is to evaluate the influence of the ageing process on muscle quality. Therefore, muscle mass, muscle density and force-velocity characteristics are measured after a 5-yr interval in older adults (65+).

NCT ID: NCT01216774 Completed - Strength Training Clinical Trials

The Role of Mechanical Stress and Muscle Fatigue in Strength Gains

Start date: September 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the impact of different levels of mechanical stress and muscle fatigue in strength training conditions on muscle strength, muscle mass and inflammatory processes.

NCT ID: NCT01215747 Completed - Amyloidosis Clinical Trials

Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.

NCT ID: NCT01215643 Completed - Chronic Pain Clinical Trials

Efficacy and Safety of DEB025 Alone or Combined With Either Ribavirin or Peg-IFN α2a in Chronic Hepatitis C Genotype 2 and 3 naïve Patients

Start date: October 2010
Phase: Phase 2
Study type: Interventional

The study is to investigate whether DEB025 alone or in combination with either ribavirin or peg-IFNα2a is more efficient compared to SOC in treatment-naïve patients with HCV genotype 2 and 3. In addition, triple therapy with DEB025 plus SOC will be applied to patients not achieving RVR in the different arms.

NCT ID: NCT01214720 Completed - Pancreatic Cancer Clinical Trials

A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer

Start date: July 2005
Phase: Phase 3
Study type: Interventional

This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.