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

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

Start date: November 14, 2016
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". ( The project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking ( 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: NCT03932201 Not yet recruiting - Hemophilia A Clinical Trials

Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A

Start date: June 30, 2019
Study type: Observational

The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment.

NCT ID: NCT03784027 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

The Artificial Pancreas in Very Young Children With T1D

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

The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme with additional funding by JDRF. The project evaluates the use of the Artificial Pancreas (or closed loop system) in very young children with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial is an outcome study to determine whether 24/7 automated closed loop glucose control will improve glucose control as measured by time in range compared to sensor augmented pump therapy. The study adopts an open-label, multi-centre, multi-national, randomised, two period, cross-over design study, contrasting a 4 month period during which glucose levels will be controlled either by a closed loop system (intervention group) or by sensor augmented pump therapy (control group). The two intervention periods will last 4 months each with a 1 to 4 weeks washout period in between. The order of the two interventions will be random. A total of up to 80 young children aged 1 to 7 years with T1D on insulin pump therapy (aiming for 72 randomised subjects) will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Prior to the use of study devices, participants and parents/guardians will receive appropriate training by the research team on the safe use of the study pump and continuous glucose monitoring device, and the hybrid closed loop insulin delivery system. Carers at nursery or school may also receive training by the study team if required. During the closed loop study arm, subjects and parents/guardians will use the closed loop system for 4 months under free-living conditions in their home and nursery/school environment without remote monitoring or supervision by research staff. During the control study arm, subjects and parents/guardians will use sensor augmented pump therapy for 4 months under free-living conditions in their home and nursery/school environment. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA).

NCT ID: NCT03780231 Recruiting - Clinical trials for Athletes With Isolated Non-ischemic LGE With no Underlying Labelled Cardiomyopathy

Effect of Intense Sport Practice in Athletes With Non-ischemic Scar

Start date: October 5, 2018
Study type: Observational

The prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines to not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice. The principal objective of the study is to evaluate during a five-years follow up, the clinical outcome of athletes with this kind of findings. The secondary objective is the determination of prognostic factors. The management and follow-up of the athletes will be let at the appraisal of each center.

NCT ID: NCT03732859 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

PROOF-Registry New and Extended Belgium -Luxembourg

Start date: January 9, 2018
Study type: Observational [Patient Registry]

A Prospective Observational Registry to describe the disease course and outcomes of Idiopathic Pulmonary Fibrosis patients in a real-world clinical setting.

NCT ID: NCT03475238 Completed - Critical Care Clinical Trials

Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units

Start date: March 29, 2018
Study type: Observational

Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations. Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..) Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

NCT ID: NCT03386929 Recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

Survival Prolongation by Rationale Innovative Genomics

Start date: November 29, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.

NCT ID: NCT03300934 Completed - Clinical trials for Type1 Diabetes Mellitus

Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?

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

This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep

NCT ID: NCT03289273 Recruiting - Liver Neoplasms Clinical Trials

Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)

Start date: September 13, 2017
Study type: Observational

Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)

NCT ID: NCT03286023 Recruiting - Metastasis Brain Clinical Trials

Stereotactic Radiotherapy for Brain Metastases

Start date: October 2014
Study type: Observational

Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.