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NCT ID: NCT02312258 Completed - Multiple Myeloma Clinical Trials

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

Start date: April 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

NCT ID: NCT02312193 Completed - Hypertension Clinical Trials

Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects

Start date: January 2015
Phase:
Study type: Observational

Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive patients and to better understand the mechanisms controlling the myogenic tone. Evaluations will be performed through ex vivo studies of peripheral arterioles in human adipose tissue from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the myogenic function in response to progressive blood pressure increases, in order to correlate myogenic function to arterial hypertension and to the molecular mechanisms already identified in the preclinical models.

NCT ID: NCT02311244 Completed - Clinical trials for Type 2 Diabetes Mellitus

The Sapienza University Mortality and Morbidity Events Rate (SUMMER) Study in Diabetes

SUMMER
Start date: January 2014
Phase:
Study type: Observational

This observational study is aimed at identifying new molecular promoters of mortality (and morbidity) in patients with type 2 diabetes mellitus (T2DM).

NCT ID: NCT02310906 Completed - Clinical trials for Duchenne Muscular Dystrophy

Phase I/II Study of SRP-4053 in DMD Patients

Start date: January 13, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.

NCT ID: NCT02310672 Completed - Clinical trials for Pulmonary Arterial Hypertension

REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

REPAIR
Start date: June 1, 2015
Phase: Phase 4
Study type: Interventional

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

NCT ID: NCT02310269 Completed - Cushings Disease Clinical Trials

Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

Start date: March 28, 2013
Phase:
Study type: Observational

This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.

NCT ID: NCT02310217 Completed - Hypertension Clinical Trials

Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients

Start date: February 2015
Phase:
Study type: Observational

The relationship among hypertension, aging and cognitive decline is complex and not completely understood. Purpose of this project will be evaluating early markers of cognitive deterioration in patients with arterial hypertension. In particular, this cross-sectional observational study will be articulated in three phases: 1. Neuropsychological evaluation of general cognitive abilities 2. Identification and measurement of specific biomarker levels 3. Correlation among hypertension, cognitive abilities and biomarkers.

NCT ID: NCT02310061 Completed - Clinical trials for Kidney Failure, Chronic

Lung Water by Ultrasound Guided Treatment in Hemodialysis Patients (The Lust Study).

LUST
Start date: March 2013
Phase: N/A
Study type: Interventional

Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function. Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested. The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).

NCT ID: NCT02309957 Completed - Clinical trials for Tear of Articular Cartilage of Knee, Current

EAGLE European Post Market Study

EAGLE
Start date: May 2011
Phase:
Study type: Observational

Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.

NCT ID: NCT02309411 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis

EINSTEINJr
Start date: January 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.