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NCT ID: NCT02595814 Terminated - Acute Heart Failure Clinical Trials

Global Non-interventional Heart Failure Disease Registry

REPORT-HF
Start date: July 23, 2014
Phase:
Study type: Observational [Patient Registry]

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.

NCT ID: NCT02594124 Completed - Clinical trials for Spinal Muscular Atrophy

A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies

SHINE
Start date: November 4, 2015
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.

NCT ID: NCT02593851 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Start date: December 4, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are hospitalized with RSV infection.

NCT ID: NCT02592824 Completed - Heart Failure Clinical Trials

Glutamate for Metabolic Intervention in Coronary Surgery II

GLUTAMICSII
Start date: November 15, 2015
Phase: Phase 3
Study type: Interventional

The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery reduces the risk of postoperative heart failure as measured by plasma NT-proBNP in patients undergoing moderate to high-risk coronary artery bypass graft surgery. Patients accepted for coronary artery bypass surgery of at least two vessel disease or left main stenosis with or without concomitant procedure and considered to be at moderate to high surgical risk preoperatively with regard to postoperative heart failure will be studied. The primary endpoint is postoperative increase of NT-proBNP from the day before surgery to the third postoperative day.

NCT ID: NCT02592564 Active, not recruiting - Anxiety Disorders Clinical Trials

Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder

UMEII
Start date: October 2015
Phase: N/A
Study type: Interventional

This study evaluates underlying psychological and biological mediators in Internet-delivered cognitive behavior therapy for adults with social anxiety disorder.

NCT ID: NCT02592499 Recruiting - Clinical trials for End-stage Heart Failure

Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure

SweVAD
Start date: June 2016
Phase: N/A
Study type: Interventional

The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device system or to pharmacological treatment (optimal medical management, OMM) according to current guidelines. Eighty (80) patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III and OMM, based on a modified power calculation.

NCT ID: NCT02592369 Completed - Clinical trials for Aortic Valve Stenosis

CoreValve™ Evolut R™ FORWARD Study

FORWARD
Start date: January 2016
Phase:
Study type: Observational

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

NCT ID: NCT02592200 Completed - Clinical trials for Functional Constipation

Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women

Start date: October 5, 2015
Phase: N/A
Study type: Interventional

The primary objective is to determine the change in frequency of complete spontaneous bowel movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123 in healthy adult women with functional constipation.

NCT ID: NCT02592083 Active, not recruiting - Clinical trials for Hormone Receptor Positive Tumor

Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

PREDIX LumA
Start date: October 2015
Phase: Phase 2
Study type: Interventional

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are then randomized between either continuous endocrine therapy (arm A) or the same treatment with addition of palbociclib (arm B). Patients with no change of proliferation are allocated to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations.

NCT ID: NCT02589483 Recruiting - Rectal Cancer Clinical Trials

Reinforcement of Rectal Anastomosis-RORA

Start date: February 2016
Phase: N/A
Study type: Interventional

The anastomotic leaks are multivariable in its origin. The incidence varies among different centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be devastating for the patient and very costly for the health care system. Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences. The future of colorectal surgery will increasingly include older patients with increased preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks spectrum into a subclinical and therefore self-healing one.