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NCT ID: NCT03299270 Recruiting - Elderly Clinical Trials

Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery

GOSAFE
Start date: February 27, 2017
Phase: N/A
Study type: Observational

Multicenter, international, prospective, observational study, designed to evaluate the postoperative results in terms of quality of life and functional recovery of elderly patients after major cancer surgery. The global expected duration of the study is 3 years, during which cancer patients over 70 years old undergoing major surgery will be evaluated before and after the surgical intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the observational nature of the study, the original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion. Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.

NCT ID: NCT03297346 Recruiting - Clinical trials for Breast Cancer Female

Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer

EARLY-HEART
Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications. In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.

NCT ID: NCT03290781 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of the Effect of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Ulcerative Colitis Who Achieved Clinical Response in Induction Studies

FIGARO UC 303
Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies. This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study.

NCT ID: NCT03289897 Recruiting - NAFLD Clinical Trials

Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan

RADIcAL1
Start date: September 4, 2017
Phase: N/A
Study type: Interventional

A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several European countries.

NCT ID: NCT03283085 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis (AIDA)

Start date: January 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC).

NCT ID: NCT03280550 Recruiting - Clinical trials for Nasal Polyps, Chronic Rhinosinusitis

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

POLYP 1
Start date: October 27, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.

NCT ID: NCT03280433 Recruiting - Clinical trials for Coronary Artery Disease

Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study

EPICHEART
Start date: September 1, 2014
Phase: N/A
Study type: Observational

This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The investigators expect to identify new biochemical factors and biomarkers in the crosstalk between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.

NCT ID: NCT03271957 Not yet recruiting - Clinical trials for Manual Rotation of A Liveborn

Manual Rotation in Persistent Occiput Posterior Position

Start date: October 1, 2017
Phase: N/A
Study type: Observational

Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a persistent OP at delivery. Nevertheless, little is known about the success of this intervention or about the relation of some ultrasound measures with the outcome.

NCT ID: NCT03262753 Recruiting - Arterial Stiffness Clinical Trials

Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment

LOVE-COARCT
Start date: June 1, 2013
Phase: N/A
Study type: Observational

Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty or stent implantation. Although short-term results are excellent with all three treatment modalities, long term cardiovascular (CV) morbidity and mortality remain high, likely due to persistently abnormal vascular function. The effects of treatment modality on long term vascular function remain uncharacterized. The goal of this study is to assess vascular function in this patient population for comparison among the treatment modalities. Methods: Vascular function in large and small arteries will be prospectively assessed fusing multiple non-invasive modalities, and the results will be compared among the three groups of CoA patients previously treated using surgery, balloon angioplasty or stent implantation after frequency matching for confounding variables. A comprehensive vascular function assessment protocol was created to be used in 7 centers. The primary outcome is arterial stiffness measured by arterial tonometry. Inclusion and exclusion criteria were carefully established after consideration of several potential confounders. Sample size was calculated for the primary outcome variable. Conclusions: Treatment modalities for CoA may have distinct impact on large and small arterial vascular function. The results of this study will help identify the treatment modality that is associated with the most optimal level of vascular function, which, in the long term may reduce CV risk.

NCT ID: NCT03259308 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).