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A 24-week, multicenter, international, randomized (1:1), parallel-group, open-label, comparative study of insulin glargine versus liraglutide in insulin-naïve patients with Type 2 diabetes treated with oral agents and not adequately controlled, followed by a 24-week extension period with insulin glargine for patients not adequately controlled with liraglutide

The primary objective of this study is to demonstrate the superiority of insulin glargine over liraglutide in termsof percentage of patients reaching a HbA1c < 7% at the end of the comparative period in Type 2 diabetic patientsfailing…

Clinical evaluation of Remote monitoring with dirEct Alerts* to reduCe Time from event to clinical decision

St. Jude Medical developed the Merlin.net* Patient Care Network (Merlin.net* PCN) to augment or replace routine scheduled in-clinic visits. This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic…

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine
the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral
Hip Fracture, Status Post Surgical Fixation

To investigate the effect of AMG 785 compared to placebo on functionalhealing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjectswith fresh unilateral low energetic hip (intertrochanteric or femoral neck) fracture

Study of the effectiveness of a coping self-help intervention for women in the waiting period after an embryo transfer during an IVF/ICSI treatment

To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.

INTERVENTIONAL MANAGEMENT OF STROKE TRIAL CLINICAL PROTOCOL - IMS III
A phase III, randomized, multi-center, open label, 900 subject clinical trial that will examine whether a combined intravenous (IV) and intra-arterial (IA) approach to recanalization is superior to standard IV rt-PA (Activase®/Actilyse®) alone when initiated within three hours of acute ischemic stroke onset.

The primary objective of the trial is to determine if ischemic stroke subjects with a baseline NIH Stroke Scale Score (NIHSSS] >= 10 (8-9 with positive CTA) treated with recombinant tissue plasminogen activator (rt-PA; [Alteplase recombinant…

Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component

Primary objectiveThe primary objective is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol PR (300 mg per day after run in, up titration to 500 mg per day) versus a combination of tapentadol PR (300 mg per…

(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

Intermittent neurogenic claudication due to lumbar stenosis is frequently diagnosed among older persons. Due to an aging population it is to be expected the incidence of lumbar stenosis will increase over time. Patients are operated on because of…

A pivotal trial of safety and efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction â¤* The ADVANCE Trial

The objective of this study is to determine the Safety and Efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).Investigation of stem and regenerative cell therapy…

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL
EVALUATING THE SAFETY AND EFFICACY OF EARLY TREATMENT WITH
EPLERENONE IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION

To assess the impact of eplerenone on cardiovascularmortality and morbidity in patients with acutemyocardial infarction (STEMI) when initiated withinthe first 24 hours of onset of symptoms (preferablyduring the first 12 hours)To investigate the…

Effect of aminobisphosphonates and statins on circulating Vgamma9Vdelta2-T cells

To study (in patients who have an indication for treatment with an intravenous aminobisphosponate because of bone metastases of a malignant tumor) the effects of aminobisphophonate treatment on the phenotype and function on circulating Vy9Vd2-T…

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event

The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…

A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial.

CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…

Paediatric distal radius torus fracture treatment comparison in a prospective randomized control trial: mitella versus plaster cast

If the study shows that the treatment with a sling gives an earlier return to normal function en does not give a clinically significant difference in pain experience compared to cast therapy than the traditional treatment can be adjusted. We aim at…

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)

A prospective randomized phase III clinical trial to study the effectiveness of pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and compare these with untrested platelet concentrates in plasma, stored for up to 7 days. The…

Pain education for patients with painful bone metastases undergoing palliative radiotherapy: reducing pain by increasing patient's knowledge and self-management.

The hypothesis of this study is that patient barriers regarding pain management can be diminished by individual nurse-led education (the Pain Education Program), resulting in lower pain intensity and better quality of life of patients.

Randomized controlled trial of escitalopram versus placebo for patients with irritable bowel syndrome and panic disorder.

PRIMARY OBJECTIVE· 1. To study the effect of escitalopram versus placebo in the treatment of abdominal pain, in IBS patients with panic disorder.SECONDARY OBJECTIVES· 2.1. To assess the effect of escitalopram on gastrointestinal and psychiatric…

Phase III intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with concomitant and adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma.

To determine the best treatment for anaplastich oligodendroglial tumors with combined 1p/19q loss, and to determine the optimal treatment with respect to the maintenance of a maximal neurological and cognitive functioning.

Randomized trial assessing the significance of Bevacizumab in recurrent grade II and Grade III gliomas. The TAVAREC trial.

To explore if the addition of bevacizumab to temozolomide improves outcome as compared to treatment with temozolomide alone in patients with recurrent low grade and anaplastic glioma without combined 1p/19q co-deletion after prior radiotherapy and…

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence

The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…

*An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer*

Primary:The primary objective of this study is to demonstrate that the overall progression-free survival (PFS) of 8 cycles of intermittent (2 times 4 cycles) chemotherapy (paclitaxel) is not inferior in efficacy, compared to 8 continuous cycles of…