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

The Artificial Pancreas in Very Young Children With T1D

KidsAP02
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

EISCAR
Start date: October 5, 2018
Phase:
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

PROOF-NEXT
Start date: January 9, 2018
Phase:
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 Recruiting - Critical Care Clinical Trials

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

NURSIE
Start date: March 29, 2018
Phase:
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

SPRING
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 ?

SPIDIMAN2
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
Phase:
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

CKBrainMeta
Start date: October 2014
Phase: N/A
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.

NCT ID: NCT03284151 Recruiting - Prostate Cancer Clinical Trials

Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

Start date: January 2015
Phase: N/A
Study type: Observational [Patient Registry]

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

NCT ID: NCT03249584 Recruiting - Metastasis to Bone Clinical Trials

OsteoCool Tumor Ablation Post-Market Study

OPuS One
Start date: October 12, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of the Medtronic OsteoCoolâ„¢ RF Ablation System.