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NCT ID: NCT01143675 Completed - Clinical trials for Proximal Humeral Fractures

Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures

Start date: March 2007
Phase:
Study type: Observational

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).

NCT ID: NCT01143324 Completed - Clinical trials for Lumbar Spine Degeneration

A Prospective, Multicenter Observational Study on MASTâ„¢ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

MASTERS-D
Start date: June 2010
Phase:
Study type: Observational

The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MASTâ„¢ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.

NCT ID: NCT01143233 Completed - Clinical trials for Disturbance of Growth

Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up

HippHA
Start date: April 2010
Phase: N/A
Study type: Interventional

The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants. Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life. 4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.

NCT ID: NCT01143064 Completed - Brain Injuries Clinical Trials

Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

SyNAPSe
Start date: June 2010
Phase: Phase 3
Study type: Interventional

The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

NCT ID: NCT01141023 Completed - Parkinson Disease Clinical Trials

Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression

PPMI
Start date: June 2010
Phase: Phase 2
Study type: Interventional

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

NCT ID: NCT01140581 Completed - Atrial Fibrillation Clinical Trials

Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation

ARTEMIS Load
Start date: September 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: - Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: - Evaluate the rate of AF recurrences two months after randomization. - Assess the safety of the change from amiodarone to dronedarone - Assess dronedarone safety - Explore dronedarone and its active metabolite plasma level (in a subset of countries) - Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

NCT ID: NCT01140347 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib

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

This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study. Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm. Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.

NCT ID: NCT01138527 Completed - Prostate Cancer Clinical Trials

Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach

PCa-MAP
Start date: June 2010
Phase:
Study type: Observational

The primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.

NCT ID: NCT01137812 Completed - Clinical trials for Diabetes Mellitus, Type 2

The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

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

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

NCT ID: NCT01137578 Completed - Thrombosis Clinical Trials

Pediatric Catheter-related Thrombosis Imaging Study

AESOP
Start date: February 2011
Phase: N/A
Study type: Interventional

This protocol will serve as a pilot study to determine the validity and feasibility of contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children