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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: NCT01595438 Completed - Clinical trials for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

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

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

NCT ID: NCT01590589 Completed - Huntington Disease Clinical Trials

REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)

REGISTRY
Start date: June 2004
Phase: N/A
Study type: Observational

This is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers to: - obtain natural history data on many HD mutation carriers and individuals who are part of an HD family - relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers) - expedite identification and recruitment of participants for clinical trials - develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care - plan for future research studies

NCT ID: NCT01580943 Completed - Dental Plaque Clinical Trials

Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base

Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to compare the antiplaque efficacy of a 0,12% chlorhexidine and 0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) with a 0,2% chlorhexidine non-alcohol base mouth rinse (Corsodyl Care®).

NCT ID: NCT01578239 Completed - Clinical trials for Carcinoid Tumor of the Small Bowel

A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

NETTER-1
Start date: September 6, 2012
Phase: Phase 3
Study type: Interventional

This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.

NCT ID: NCT01572038 Completed - Breast Neoplasms Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer

PERUSE
Start date: June 1, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

NCT ID: NCT01569295 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

Tugela
Start date: June 15, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

NCT ID: NCT01568164 Completed - Heart Failure Clinical Trials

Safety and Efficacy Study of the BioVentrix PliCath HF System

CONFIGURE-HF
Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.

NCT ID: NCT01568073 Completed - Parkinson's Disease Clinical Trials

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

NCT ID: NCT01568034 Completed - Parkinson's Disease Clinical Trials

A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

Start date: April 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.