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NCT ID: NCT01598831 Completed - Severe Sepsis Clinical Trials

Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

Start date: October 29, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

NCT ID: NCT01597908 Completed - Melanoma Clinical Trials

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

COMBI-v
Start date: June 4, 2012
Phase: Phase 3
Study type: Interventional

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

NCT ID: NCT01597414 Completed - Clinical trials for Elderly Metastatic Breast Cancer Population

Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1

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

Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients. The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.

NCT ID: NCT01597297 Completed - Multiple Sclerosis Clinical Trials

Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.

MOBILE
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The objectives of this study in Multiple Sclerosis (MS) participants treated with prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated with placebo are to assess the effect over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, and participants' global impression of change in walking . Another purpose of this study is to evaluate the safety and tolerability of prolonged-release fampridine.

NCT ID: NCT01597245 Completed - Psoriasis Clinical Trials

A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

UNCOVER-2
Start date: May 18, 2012
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

NCT ID: NCT01597024 Completed - Obesity Clinical Trials

Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse

F4H
Start date: May 2012
Phase: N/A
Study type: Interventional

The primary aim of this work is, to 'relate psychological and behavioural parameters of hunger/satiety and food preference to gut hormones, neural activation and energy metabolism by dietary manipulation, across the human lifespan'.

NCT ID: NCT01596114 Completed - Clinical trials for Chronic Myeloid Leukemia

European Stop Tyrosine Kinase Inhibitor Study

EURO-SKI
Start date: May 30, 2012
Phase: Phase 3
Study type: Interventional

The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy. Secondary goals include: - Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment) - Evaluation of quality of life (QoL) in patients stopping TKI - Evaluation of medico-economic impact of stopping TKI - Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log - Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500

NCT ID: NCT01595022 Completed - Contraception Clinical Trials

FR01 and FR20 IUS (Intrauterine System) Wearing Study

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.

NCT ID: NCT01594892 Completed - Pain Clinical Trials

Fractionated Radiosurgery for Painful Spinal Metastases

DOSIS
Start date: April 2012
Phase: N/A
Study type: Interventional

It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this II trial.

NCT ID: NCT01593852 Completed - Clinical trials for Arrhythmias, Cardiac

X-ray Dose Reduction in Electrophysiology

Start date: April 2012
Phase: N/A
Study type: Interventional

Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The primary aim of this study is to verify if a significant reduction in total procedural X-ray dose during electrophysiological interventions can be achieved by using advanced image processing (Allura Clarity).