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NCT ID: NCT04027777 Recruiting - Blood Pressure Clinical Trials

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

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

Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

NCT ID: NCT04027374 Completed - Meningomyelocele Clinical Trials

Stress-associated Epigenetic Alterations in Newborns After Fetal Surgery

Start date: July 1, 2019
Phase:
Study type: Observational

Open spina bifida or myelomeningocele (MMC) is a devastating congenital defect of the central nervous system for which there is no cure. The etiology of MMC remains poorly understood. Primary failure of neural tube closure at the caudal neuropore in the embryonic period results in exposure of the developing spinal cord to the uterine environment. Without protective tissue coverage, secondary destruction of the exposed neural tissue by trauma or amniotic fluid may occur throughout gestation. In order to protect the spinal cord from this secondary destruction, a fetal surgical repair can be performed between gestational weeks 20 and 26. From a psychological point of view fetal repair of MMC constitutes a highly stressful event both for the mother and the fetus. To date, however, stress of mothers and children in case of prenatal surgery for MMC repair has never been studied. It is therefore unclear, if and to what extend the procedure and its consequences are associated with stress, and if there are short- or longer-term consequences. The aims of this study are threefold: 1. Do newborns after fetal surgery for MMC show epigenetic alterations in genes that are involved in stress regulation? 2. With which medical and psychosocial variables are epigenetic alterations associated? 3. At age 3 months, do infants after fetal surgery have a more difficult temperament compared to controls?

NCT ID: NCT04027309 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

HOVON 156 AML
Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has shown promising clinical activity in AML.

NCT ID: NCT04027283 Completed - Clinical trials for Physiological Satiation Mechanisms

Acute Effects of the Two Alternative Sweeteners D-allulose and Erythritol on Metabolism

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The aim of this project is to investigate the effect of intragastric (ig) D-allulose on metabolic parameters in general and to investigate the effect of sweet taste receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and appetite-related sensations to ig administration of erythritol and D-allulose.

NCT ID: NCT04027231 Recruiting - Clinical trials for Osteoarthritis, Knee

Electrochemical Behavior of Biomedical Alloys Exposed to Human Synovial Fluid

Start date: October 15, 2019
Phase:
Study type: Observational

Biomedical implant metals are reactive when in contact with body fluids. Some reactions may adverse the biocompatibility character of the material and should be studied. This can be achieved by direct measurement through electrochemical, gravimetric, spectrophotometric and surface analysis of reaction occurring at the interface between functionalized metal samples and body fluids (synovia) directly extracted from patients. The general aim of this project is to contribute to develop a comprehensive vision of interfacial reactions occurring on biomedical alloy surfaces exposed to human synovial fluid and to link them to clinical data

NCT ID: NCT04026685 Completed - Clinical trials for Maternal Haemodynamic Stability

Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery

NICOM-USB
Start date: January 9, 2020
Phase: N/A
Study type: Interventional

Spinal anaesthesia is the anaesthetic technique of choice for elective caesarean delivery. Hypotension, a result of the decrease in systemic vascular resistance caused by spinal anaesthesia, is a frequent complication occurring in up to 80%. This study is to investigate fluid loading plus vasopressors to vasopressors alone to maintain stable maternal haemodynamics in elective caesarean delivery. The effect of the two methods (continuous prophylactic phenylephrine infusion with and without crystalloid co-loading) on maternal haemodynamics will be compared using the Starling SV Monitor. The Starling SV device is a non invasive cardiac output monitor (NICOM) which is certified and validated for the use in pregnancy.

NCT ID: NCT04026412 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

CheckMate73L
Start date: October 8, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

NCT ID: NCT04026360 Recruiting - Clinical trials for Confirmed Diagnosis of Cystic Fibrosis

Impact of Early Lung Physiology, Viral Infections and the Microbiota on the Development and Progression of Lung Disease in Children With Cystic Fibrosis

SCILD
Start date: July 1, 2011
Phase:
Study type: Observational

This study collects data on microbiological factors and lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess their interaction on the lung growth and lung development of infants and children with Cystic Fibrosis (CF).

NCT ID: NCT04025788 Terminated - Clinical trials for Coronary Artery Disease

BIOSOLVE-IV Magmaris Swiss Satellite Registry

Start date: March 26, 2019
Phase:
Study type: Observational [Patient Registry]

BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzerland. After percutaneous coronary intervention (PCI) with the Magmaris scaffold and signature of the informed consent form, all subjects will be followed through hospital discharge and will undergo follow up evaluations at 6, 12 and 24 months post procedure. The follow up evaluations, part of the standard care can be either performed on site (12 months) or by phone (6 and 24 months) and according to routine clinical practice.

NCT ID: NCT04025775 Completed - Type 2 Diabetes Clinical Trials

Closed-loop in Adults With T2D Requiring Dialysis

AP-Renal
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over a 20 day period in adults with type 2 diabetes (T2D) requiring maintenance dialysis. This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting. This is an open-label, two-centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. Each treatment arm is 20 days long with a 2-4 week washout period between treatments. A total of up to 40 adults with T2D requiring maintenance dialysis will be recruited through outpatient clinics or the dialysis unit, to allow for 32 completed participants available for assessment. Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system). Participants in the control arm will continue with standard therapy and will wear a blinded CGM system. The primary outcome is time spent with glucose levels in the target range between 5.6 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 in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.