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NCT ID: NCT03937284 Completed - Parkinson Disease Clinical Trials

Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease

LiMBaLiP
Start date: May 3, 2016
Phase:
Study type: Observational

Patients with Parkinson's disease (PD) present an impaired intestinal permeability with consequent lipopolysaccharide (LPS) translocation in the systemic circulation. Plasmatic lipoproteins play a key role in the detoxification of LPS. The investigators aim to study the relationships between lipoprotein chemical composition and plasma LPS circulation in PD.

NCT ID: NCT03937219 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

COSMIC-313
Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

NCT ID: NCT03937011 Completed - Clinical trials for Gynecology - Vaginal Cuff Closure

Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS

Start date: December 13, 2019
Phase:
Study type: Observational

This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.

NCT ID: NCT03936777 Active, not recruiting - Dravet Syndrome Clinical Trials

A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

Start date: April 22, 2019
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

NCT ID: NCT03936634 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)

INNODIA
Start date: November 14, 2016
Phase:
Study type: Observational [Patient Registry]

INNODIA is a global consortium linking 26 academic institutions, 4 industrial partners, a small to medium enterprise (SME), and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu). The project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking (https://www.imi.europa.eu/projects-results/project-factsheets/innodia) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium. The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families. One of the objectives of INNODIA is to develop a new European clinical research network with standardized protocol based on repeated measures of C-peptide (including home measurements) and comprehensive collection of appropriate biological samples for 'omics', immune, viral and microbiome studies in new onset T1D patients and high-risk auto-antibody positive subjects. A protocol for the harmonization of sample collections in newly diagnosed type 1 diabetic patients and first degree relatives of patients with type 1 diabetes was developed following extensive preliminary work involving partners from across all specialities. Core laboratories with experience in their respective field were set up for analysis of auto-antibodies, fresh immune cells, handling of frozen immune cells, C-peptide measures. A series of standard operating procedures for sample collections and analysis were agreed. Sample tracking between clinical centres and central laboratories was included into a purposely designed electronic case report form (eCRF) into which all clinical and laboratory data collected are captured.

NCT ID: NCT03935763 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

PROMETCO
Start date: March 8, 2019
Phase:
Study type: Observational

A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

NCT ID: NCT03935165 Completed - Clinical trials for Pelvic Endometriosis

Prospective Evaluation of Near-infrared Fluorescence Imaging Use as a Supportive Tool in Deep Infiltrating Endometriosis Surgery

GRE-Endo-2
Start date: January 4, 2016
Phase: Phase 2
Study type: Interventional

The aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neo-vascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation. The already published Pilot Study GRE-ENDO (Cosentino F, Near-Infrared Imaging with Indocyanine Green for Detection of Endometriosis Lesions (Gre-Endo Trial): A Pilot Study.), encouraged the effort of a larger prospective trial. Based on the mini-max two-stage design by Simon [Simon R. Optimal two stage design for phase II clinical trials], the investigators tested the null hypothesis that the true rate of pathologically assessed endometriosis would improve from 87% to the clinically relevant alternative of 100.0%, as assessed by NIR-ICG laparoscopy.

NCT ID: NCT03935087 Recruiting - Heart Failure Clinical Trials

Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan

SAVE-ICD
Start date: August 1, 2018
Phase:
Study type: Observational [Patient Registry]

The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.

NCT ID: NCT03935022 Completed - Healthy Clinical Trials

Rice Anthocyanin Bioavailability in Humans

Start date: March 6, 2019
Phase: N/A
Study type: Interventional

Aims of the project 1. To determine the rice anthocyanin content via high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS 2. To study the oral bioavailability of anthocyanins in healthy volunteers after the intake of a serving (80 g) of black rice (Venere and Artemide varieties). 3. To determine the plasma biokinetics parameters of rice anthocyanins via spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS.

NCT ID: NCT03934580 Completed - Clinical trials for Change in Subjective Appetite Score (VAS)

Postprandial Effects of a Hallucinatory Meal on Appetite Regulation

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

Several and complex mechanisms are involved in the regulation of appetite and food intake in humans. By means of rapid hypnosis techniques, it is possible to induce some individuals to hallucinate a meal. The same meal (breakfast) is administered as i) a real meal and ii) is evoked as a hallucination under hypnosis in healthy postmenopausal women. The aim of this pilot randomized-controlled cross-over trial is to assess appetite sensation and the blood levels of the appetite-related hormones in the participants.