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NCT ID: NCT02731976 Completed - Human Microbiome Clinical Trials

Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

Start date: November 2011
Phase: N/A
Study type: Interventional

Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.

NCT ID: NCT02729844 Completed - Clinical trials for Pulmonary Hypertension

Neolifes Heart - Pulmonary Hypertension in Preterm Children

Start date: June 1, 2016
Phase:
Study type: Observational [Patient Registry]

NeoLifeS is a cohort follow up study that prospectively collects data of regular care of children born preterm in the University Medical Center Groningen (UMCG) and aims to improve the quality of care for these children. NeoLifeS-Heart is a sub-study that focuses on the problem that a high proportion of preterm infants develop cardiovascular disorders. Related to the immaturity of their lungs, preterm infants are at risk to develop the condition Bronchopulmonary dysplasia (BPD). Also, the vasculature of the lungs is often not fully developed, making them more vulnerable for the development of Pulmonary Hypertension (PH), a high blood pressure in the lungs. 15-20% of the infants with extremely low birth weight are believed to develop PH, this proportion has been suggested to raise to 50% in infants with severe BPD. The presence of PH significantly worsens the prognosis and survival of these children. The condition PH is insufficiently characterized. Knowledge of incidence, prevalence, risk factors for the development of PH and survival, will be the first step in improving detection strategies, possible treatment options and thereby prognosis and survival of these children. Objective: To determine the incidence and prevalence of PH in preterm infants. In addition we aim to identify risk factors for the development of PH and determine the survival and prognosis of these preterm infants. Study design: A prospective cohort study. Study population: All preterm infants, admitted at the neonatology UMCG, born <30 weeks and/or birth weight < 1000 gram, who participate in NeoLifeS Primary parameters: The occurrence of PH (Incidence and Prevalence). Secondary parameters: - Maternal and neonatal patient characteristics that are potential risk factors for the development of PH, - Morbidity-score (quality of life and hospital admissions) and mortality.

NCT ID: NCT02729727 Completed - Esophageal Cancer Clinical Trials

Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy

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

To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

NCT ID: NCT02729025 Completed - Clinical trials for Subjects With Hyperlipidemia, Dyslipidemia

Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))

ANITSCHKOW
Start date: April 14, 2016
Phase: Phase 3
Study type: Interventional

A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).

NCT ID: NCT02728752 Completed - Dermatomyositis Clinical Trials

Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)

IIM
Start date: February 27, 2017
Phase: Phase 3
Study type: Interventional

Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")

NCT ID: NCT02725268 Completed - Clinical trials for Endometrial Neoplasms

A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer

Start date: April 1, 2016
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.

NCT ID: NCT02725203 Completed - Clinical trials for Cardiovascular Diseases

Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients

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

A two-armed, cluster randomized controlled trial will be conducted comparing the Activate intervention with care as usual in 31 general practices in the Netherlands, in which approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention focuses on increasing physical activity and is developed using the Behavior Change Wheel (BCW). The activate intervention consists of four nurse-led consultations divided over a 3-months period. Primary outcome is the level of physical activity measured with an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline amount of minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months of follow up. Nurses will be trained in delivering the intervention by a one-day training and coaching sessions supervised. A process evaluation will be conducted.

NCT ID: NCT02723955 Completed - Neoplasms Clinical Trials

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Start date: June 23, 2016
Phase: Phase 1
Study type: Interventional

GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

NCT ID: NCT02722889 Completed - Thoracic Aorta Clinical Trials

Aortic Elongation and Dissection

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

Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.

NCT ID: NCT02722538 Completed - Clinical trials for Urinary Bladder Cancer

Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

Start date: May 31, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).