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NCT ID: NCT01997671 Completed - Clinical trials for Cardiovascular Diseases

Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

Start date: September 2011
Phase: N/A
Study type: Interventional

OBJECTIVE: To evaluate the impact of an intervention addressed to health professionals to improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular disease and reducing expenditure in this respect. DESIGN: a cluster randomized clinical trial, not blind; Data were obtained from medical records and other primary care databases. SETTING: 279 primary health care teams in Catalonia (Spain), centers managed by Catalan Health Institute (ICS) SUBJECTS: Population from 35 to 74 years, free of cardiovascular disease, who have been started on lipid-lowering therapy during 2 consecutive years of study. INTERVENTION: Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. This information is updated monthly for 12 consecutive months.Information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information). VARIABLES: 1. Primary Outcomes are: - Variable RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period. - Variable EVITA: New lipid-lowering treatments started during the intervention period and considered as inadequate. 2. Secondary Outcomes are: - Variable COST: total cost of the inadequate new lipid-lowering treatments. - Variable RECORD: recording of the cardiovascular risk. 2.Other variables: - Principal: intervention/control group assignment of health professional. - Patient variables: demographic and clinical. - Professional variables: quality of care indicators. STATISTICAL ANALYSIS: Descriptive analysis, agreggated at health professional level, will be performed and subsequently multilevel analysis techniques will be used to estimate the effect of intervention according to hierarchic data structure and, in particular, patient variables effect.

NCT ID: NCT01997333 Completed - Clinical trials for Metastatic gpNMB Over-expressing Triple Negative Breast Cancer

Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

METRIC
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.

NCT ID: NCT01997229 Completed - Clinical trials for Refractory Generalized Myasthenia Gravis

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

Start date: December 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

NCT ID: NCT01996748 Completed - Otic Eczema Clinical Trials

Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema

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

The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.

NCT ID: NCT01996332 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Start date: April 2004
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.

NCT ID: NCT01995513 Completed - Prostate Cancer Clinical Trials

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

PLATO
Start date: October 22, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

NCT ID: NCT01995487 Completed - Clinical trials for Coronary Artery Stenosis

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

BIONICS
Start date: January 2014
Phase: N/A
Study type: Interventional

The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.

NCT ID: NCT01995201 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis

Start date: September 2013
Phase: Phase 3
Study type: Interventional

This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis and an inadequate response to non-biologic DMARDs or to one anti-TNF. In Phase 1, all patients will receive RoActemra/Actemra 162 mg subcutaneously (sc) weekly for Weeks 1 to 24, with or without methotrexate or other non-biologic DMARDs. For Part 2, patients who achieve sustained clinical DAS28-ESR remission at Weeks 20 and 24 will be randomized to receive RoActemra/Actemra 162 mg sc either weekly or every 2 weeks for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs. Patients who do not achieve sustained clinical remission but achieve low disease activity (DAS-ESR </= 3.2) will continue the initial treatment of RoActemra/Actemra 162 mg sc weekly for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs.

NCT ID: NCT01994889 Completed - Clinical trials for Transthyretin (TTR) Amyloid Cardiomyopathy

Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

ATTR-ACT
Start date: December 9, 2013
Phase: Phase 3
Study type: Interventional

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

NCT ID: NCT01994720 Completed - Clinical trials for Acute Ischaemic Stroke

[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]

SOCRATES
Start date: January 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).