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NCT ID: NCT02771327 Completed - Lung Resection Clinical Trials

Use of a Pressurized Face Mask for Preventing Respiratory Complications After Chest Surgery

Start date: February 2014
Phase: Phase 4
Study type: Interventional

Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.

NCT ID: NCT02771210 Completed - Psoriatic Arthritis Clinical Trials

Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site

ACHILLES
Start date: August 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.

NCT ID: NCT02770807 Completed - Genetic Syndrome Clinical Trials

Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients

ATTeST
Start date: March 2, 2017
Phase: Phase 3
Study type: Interventional

Objectives: The objective of study was to evaluate the safety and the efficacy of EryDex (Dexamethasone sodium phosphate encapsulated in autologous erythrocytes, using the EryDex System - EDS) at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on Neurological Symptoms in Patients With Ataxia Telangiectasia. Initial Double-Blind Treatment Period (0 to 6 Months) Primary Efficacy Objective: • Evaluate the effect of EryDex at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on central nervous system (CNS) symptoms measured by the change in the Modified International Cooperative Ataxia Rating Scale (mICARS) from baseline to Month 6 (Visit 9) in patients with ataxia telangiectasia (A-T). Secondary Efficacy Objectives: - Evaluate the effect of EryDex, compared to placebo, on the Clinical Global Impression of Change (CGI-C) in patients with A-T from baseline to Month 6 (Visit 9). - Evaluate the effect of EryDex, compared to placebo, on measures of Clinical Global Impression of Severity (CGI-S; structured) in patients with A-T from baseline to Month 6 (Visit 9) - Evaluate the effect of EryDex, compared to placebo, on measures of Adaptive behavior measures in patients with A-T by the Vineland Adaptive Behavior Scales (VABS) from baseline to Month 6 (Visit 9). Safety Objectives: • Evaluate the safety and tolerability of two non-overlapping doses of EryDex, compared to placebo, in patients with A-T over the 12-month double-blind study duration. Extension Treatment Period (6-12 Months): Primary Objective: • Evaluate the efficacy of EryDex at two dose levels (low dose and high dose DSP/infusion) compared to placebo, in treating CNS symptoms in A-T patients during longer-term treatment (up to 12 months), as measured by the mICARS. Secondary Objectives: - Evaluate the longer-term (up to 12 months) safety and tolerability of EryDex in A-T patients. - Compare the effects of EryDex on the CGI-C and CGI-S (structured), VABS, and QoL using the EQ-5D-5L scale.

NCT ID: NCT02770170 Completed - Lupus Nephritis Clinical Trials

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Start date: May 16, 2016
Phase: Phase 2
Study type: Interventional

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

NCT ID: NCT02770131 Completed - Clinical trials for Hypercholesterolaemia

Chart Review of Repatha® in Subjects With Hyperlipidaemia

HEYMANS
Start date: May 4, 2016
Phase:
Study type: Observational

Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.

NCT ID: NCT02769481 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

Start date: August 15, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

NCT ID: NCT02769364 Completed - Breast Cancer Clinical Trials

Extended Treatment in Metastatic Breast Cancer With Eribulin

EXTER
Start date: November 2013
Phase:
Study type: Observational

Decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. The purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.

NCT ID: NCT02768961 Completed - Hepatitis C Clinical Trials

Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)

JAILFREE-C
Start date: May 10, 2016
Phase: Phase 4
Study type: Interventional

The objectives of this study are: 1. To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population. 2. To perform an adequate characterization of patients and the characteristics of HCV infection in this population. 3. To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen. 4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.

NCT ID: NCT02768272 Completed - Clinical trials for Labor Epidural Analgesia

PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial

PIEB-CT
Start date: March 1, 2016
Phase: Phase 4
Study type: Interventional

The investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses versus patient controlled epidural analgesia. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.

NCT ID: NCT02767193 Completed - HIV Infection Clinical Trials

Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated in HIV-1 Infected Patients

Start date: May 2016
Phase: Phase 1
Study type: Interventional

single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective, placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with pegylated interferon.