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NCT ID: NCT01635790 Recruiting - Clinical trials for Diabetic Macular Edema

Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (BRDME)

BRDME
Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in the treatment of patients with DME (OCT central area thickness > 275 μm) as determined by the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.

NCT ID: NCT01634906 Completed - Atherosclerosis Clinical Trials

Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy

EBABAST
Start date: July 2012
Phase: N/A
Study type: Interventional

Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB) may be protective against atherosclerosis. However, statins may have an effect on ery-apoB. Objective: to investigate the effect of statins on ery-apoB levels. Study design: a non-randomized intervention study. Ery-apoB will be measured twice in volunteers who are on statin therapy for medical reasons. After a baseline measurement of ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a second measurement of ery-apoB. Consecutively subjects will start with their original statin therapy again. Study population: patients on statin therapy aged 18 years or older. Intervention: temporary discontinuation of statin therapy for a period of six weeks. Main study endpoints: changes in ery-apoB levels. Risks, burden and benefits on participation: volunteers will visit the outpatient clinic twice, the second visit will be exactly six weeks after the first visit. The volunteers' general practitioner and medical specialist (internist or cardiologist) will be informed about their participation. Subjects have to fast for 10 hours before every visit and venous blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will discontinue their usual statin therapy for a period of six weeks. No major risks are involved with temporary discontinuation of statin therapy in stable chronic cardiovascular disease. Volunteers will receive 25 euro's in total for participation. Participation serves to further investigate the relation of statins and potentially beneficial binding of apoB on erythrocytes.

NCT ID: NCT01634711 Completed - Clinical trials for Complete Tear, Knee, Anterior Cruciate Ligament

Clinical Evaluation of a Resorbable PLLA Implant for Regeneration of the Anterior Cruciate Ligament (ACL)

Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior cruciate ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will participate in this study. The hypothesis of this study is that the L-C Ligament will successfully regenerate the ACL with clinical outcomes similar to or better than surgical intervention with auto graft tissue.

NCT ID: NCT01634113 Completed - Asthma Clinical Trials

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

NCT ID: NCT01633489 Recruiting - Clinical trials for Lysosomal Acid Lipase Deficiency

Lysosomal Acid Lipase (LAL) Deficiency Registry

ALX-LALD-501
Start date: December 31, 2012
Phase:
Study type: Observational [Patient Registry]

This is an observational, multi-center, international disease registry designed to collect longitudinal data and create a knowledge base that will be utilized to improve the care and treatment of patients with LAL Deficiency. Participation in the Registry by both physicians and patients is voluntary.

NCT ID: NCT01633411 Completed - Barrett's Esophagus Clinical Trials

Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Start date: December 2011
Phase:
Study type: Observational

This is a feasibility study without a primary study hypothesis or statistical comparison.

NCT ID: NCT01633060 Terminated - Clinical trials for Metastatic Breast Cancer

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

BELLE-3
Start date: October 3, 2012
Phase: Phase 3
Study type: Interventional

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

NCT ID: NCT01632254 Recruiting - Atherosclerosis Clinical Trials

Study to Investigate the Sensitivity and Specificity of 3.0 Tesla MRI for Carotid Artery Plaque

Start date: July 2009
Phase: N/A
Study type: Observational

The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify the plaque composition and lipid content of plaques and will have the potential for repeated in vivo measurements. To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for dimension and composition assessment of carotid artery plaques, in particularly those plaques with lipid rich necrotic cores. This non-invasive cross-sectional study, compares carotid parameters of in-vivo 3.0 Tesla MRI, MRS and B-mode ultrasound with histology specimens collected at endarterectomy.

NCT ID: NCT01631864 Completed - Hypertension Clinical Trials

Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

Start date: October 2012
Phase: Phase 2
Study type: Interventional

This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.

NCT ID: NCT01631422 Completed - Healthy Volunteer Clinical Trials

A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.