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NCT ID: NCT02817633 Recruiting - Neoplasms Clinical Trials

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

Start date: July 8, 2016
Phase: Phase 1
Study type: Interventional

This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy.

NCT ID: NCT02817360 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Purpose and rationale The purpose of this study is to evaluate the effect of high dose Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM) with no evidence of a preexisting cardiac disease. An additional aim is to demonstrate an interaction between concentrations of amino-terminal pro-B type natriuretic peptide (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic impact of the intervention overall and in the biomarker stratified subgroups. Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml. There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset and progression of diabetic retinopathy.

NCT ID: NCT02815891 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Start date: July 2016
Phase:
Study type: Observational [Patient Registry]

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.

NCT ID: NCT02813746 Recruiting - Clinical trials for Fetal Origin of Adult Diseases

Maternal Transcriptomic Regulation of the Preimplantation Embryo

Start date: April 2016
Phase: N/A
Study type: Observational

The aim of this study is to understand the epigenetic and transcriptomic mechanisms that regulate the fetal origin of adult diseases (FOAD), either for the presence of metabolic disorders in the future mothers, such as obesity or for the exposure to certain contaminants such as tobacco. To do that, the miRNAs profiles secreted to the endometrial fluid in obese women vs normoweight women during the window of implantation will be identified. Likewise, it will be studied how that miRNA signature is normalized once a substantial loss of weight is produced by the patients involved in the studied. In parallel, a comparison of the miRNA expression profiles secreted in the endometrial fluid in smoker women vs nonsmoker women will be performed. As in the previous case, it will be studied if after the exposure to these contaminant, the normalization of the miRNA expression signature occurs. Finally, an in silico analysis will be carried out in order to define the target genes and the metabolic pathways affected by the miRNAs profile secreted in both pathological conditions

NCT ID: NCT02813135 Recruiting - Pediatric Cancer Clinical Trials

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

ESMART
Start date: August 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019). The aims of the trial are: 1. To determine the recommended phase II dose (RP2D) of a specific anticancer agent and/or a relevant combination in a pediatric population, to document its tolerability and 2. To explore first signals of activity in a molecularly enriched study population.

NCT ID: NCT02810314 Recruiting - Multiple Sclerosis Clinical Trials

Default Mode Network in Multiple Sclerosis

CONNECT-15
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

The study will evaluate connectivity regardless whether patients present a clinical type that requires medical treatment. In this point, investigators will include patients with progressive evolution as well as initial forms of the disease (CIS) and properly established forms of multiple sclerosis (MS) in remittent-recidivant (RR) forms. The researches will not focus on medical treatment as some of these clinical forms have no indication for disease modifying drugs.

NCT ID: NCT02804204 Recruiting - Clinical trials for Rheumatoid Arthritis

Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF

AROMA
Start date: June 2016
Phase:
Study type: Observational

Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.

NCT ID: NCT02803866 Recruiting - Parenting Clinical Trials

Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates

CAP-PREM
Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

In a hospital environment, initial parenting of a family with a preterm neonate will be very different than expected. This unusual and stressful situation may determine the self-confidence perceived by mothers and fathers in caring their baby and therefore could shape future interaction with him/her as well as neurodevelopmental and behavioral development of preterm infants. 24/7 neonatal units allow parents stay with their baby whenever they want but this free access nor guarantee neither encourage parenting self-efficacy if it isn`t hand in hand with a specific training program for parents.

NCT ID: NCT02802280 Recruiting - Clinical trials for Cardiovascular Diseases

Endothelial Dysfunction and Subclinical Atheromatosis in Chronic HCV Infection. Response to DAA Agents.

C-Endys
Start date: October 2015
Phase: Phase 4
Study type: Interventional

Hypothesis: In addition to the liver deleterious effects, Chronic Hepatitis C (CHC) can cause changes in other organs highlighting the increased cardiovascular risk (CVR) through accelerated atherosclerosis, whose consequences may persist even after healing infection with new antiviral treatments. This can have major impact on the health system. Obtaining a Sustained Virological Response (SVR) with a free Interferon (IFN) antiviral treatment is probably able to reverse, at least partially, increased vascular risk induced by Hepatitis C virus (HCV) and perhaps ultimately reverse the subclinical atherosclerosis. Aims: To study the presence of early-subclinical atherosclerotic disease (endothelial dysfunction and subclinical atherosclerosis) in patients with CHC and evaluate the influence of treatment in the short and medium term on the CVR derived. Studying these same issues but in patients with established atherosclerotic disease.

NCT ID: NCT02798276 Recruiting - Clinical trials for Myocardial Infarction

Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial

AGTP II
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac function in patients with a chronic myocardial infarction. Preclinical studies in the porcine model of myocardial infarction have shown that the AGTP reduces infarct area and improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in patients.