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NCT ID: NCT01225822 Completed - Clinical trials for Venous Thromboembolism

BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

Start date: November 2002
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

NCT ID: NCT01225562 Completed - Stroke Clinical Trials

Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin

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

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

NCT ID: NCT01225380 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

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

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

NCT ID: NCT01225211 Completed - Cystic Fibrosis Clinical Trials

Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation

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

The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.

NCT ID: NCT01225003 Completed - Gliomas Clinical Trials

Advanced MR Techniques in Detection of Tumor Infiltration and Grading in Gliomas

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

In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in optimal choice and planning of treatment. Patients treated with gliomatous brain tumours are included voluntarily. They undergo one imaging session on a 3T MR scanner prior to treatment. DKI data are quantitively analyzed in order to estimate specific parameters in normal appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed quantitatively and qualitatively with peak integration, ratio calculation and classification algorithms. Histological confirmation is obtained at subsequent surgery. Information from this study can be of significant importance in avoiding brain biopsies. Furthermore, information on microscopic tumour spread can be used during neurosurgery or in radiotherapy planning. An important advantage of these advanced MR techniques is the non-invasivity and the lack of ionizing radiation, two important issues in this relatively young patient population.

NCT ID: NCT01224938 Completed - Healthy Subjects Clinical Trials

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

BioSput-Air
Start date: October 2010
Phase:
Study type: Observational

The main objectives of the study are 1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of healthy subjects and clinically different asthma patients, based on a non-invasive procedure of sputum induction. Patients will be different in function of age, in relation to the trigger (eg aspirin, without or with association with polyposis), without or with underlying atopic sensitization or different in the type of underlying inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis of molecular phenotyping in the patients. 2. to study the usefulness of asthma molecular phenotyping (by following the balance between the inflammatory markers on the one hand and the regulatory markers on the other hand) in asthma guidance (longitudinally). The final goal of this project is then to develop a sputum non-invasive biomarker array that can be used to distinguish the different inflammatory asthma phenotypes and that can predict steroid resistance and/or sensitivity to other anti-inflammatory medication, using a non-invasive technique that can be used also at young age and repetitively.

NCT ID: NCT01224600 Completed - Clinical trials for Peripheral Arterial Disease

EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

EVART
Start date: January 2008
Phase: N/A
Study type: Observational

The purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.

NCT ID: NCT01224392 Completed - Rectal Cancer Clinical Trials

Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

RectumSIB
Start date: January 2010
Phase: Phase 3
Study type: Interventional

The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome

NCT ID: NCT01224366 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

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

To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

NCT ID: NCT01224106 Completed - Alzheimer's Disease Clinical Trials

A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease

Scarlet Road
Start date: November 30, 2010
Phase: Phase 3
Study type: Interventional

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020. The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.