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NCT ID: NCT04595656 Recruiting - Clinical trials for Cause of Neonatal Death

Defining Causes of Deaths in South and Southeast Asia

SEACTN-VA
Start date: December 1, 2021
Phase:
Study type: Observational

Mortality data are important in low and middle-income countries to assess the population health status and trends. Mortality statistics in the populations of Bangladesh, Myanmar and Lao PDR are considered as generally limited and a recent assessment of vital registration systems of those countries reported a poor performance of the death registration system. Majority of deaths occur at home in rural area of those countries without cause of death assigned. To address this problem, the investigators will use verbal autopsy (VA) method developed by WHO to ascertain the cause of a death based on an interview with a family member or caregiver of deceased person to obtain information about causes of death in study rural communities. Death related to a specific cause will be defined by ICD-10 codes and described as primary, secondary or underlying COD. The study is planned to conduct in approximately 390 rural village communities covered by Southeast Asia clinical trial network (SEACTN) network in proposed 3 countries. The study findings will help establish a better understanding in signs, symptoms, medical history and circumstances preceding death; prioritize future interventions for early and effective diagnostics and treatment for diseases and how to keep mortality surveillance ongoing in study rural settings.

NCT ID: NCT04580992 Recruiting - Clinical trials for Ventricular Fibrillation

Defining the Electrocardiographic Effect of Propofol on the Ajmaline Provocation Drug Challenge: A Prospective Trial

Start date: November 16, 2020
Phase:
Study type: Observational

Background: Brugada Syndrome is an inherited channelopathy associated with risk of ventricular fibrillation and sudden cardiac death in a structurally normal heart. The diagnosis is based on the characteristic electrocardiographic pattern (coved type STsegment elevation, 2mm followed by a negative T-wave in one or more of the right precordial leads V1 to V2), noted spontaneously or upon administration of a sodiumchannel blocker, such as Ajmaline. The majority of adults screened for Brugada Syndrome, undergo the Ajmaline provocation-test awake. Ajmaline is therefore injected continuously, with incremental steps through an intravenous placed catheter, according to cardiological protocols. In a subpopulation of anxious adults, or when another electrophysiological procedure is required at the same time, sedation or general anaesthesia is provided. Similarly, in the paediatric population, it is common practice to perform the challenge test under sedation. Based on the sodium channel blocking properties of propofol, it is not unthinkable that anaesthetic agents might interact with the pharmacodynamic or pharmacokinetic effects of Ajmaline on the myocardial sodium channels. Existence of such interaction would implicate altered diagnostic value of the Ajmaline-provocation-test for patients that undergo the challenge under general anaesthesia. Objective: The goal of this study is to evaluate if the Ajmaline-provocation-test results in altered electrocardiographic effects when performed under general anaesthesia with propofol. Study-design: A prospective observational study. Study population: Patients are eligible for inclusion if they have been diagnosed with Brugada Syndrome, are American Society of Anaesthesiologists (ASA) 2 - 4, older than 18 years and are scheduled for epicardial ablation. Exclusion criteria are known allergy for propofol, a body mass index (BMI) above 35 for female and 42 for male patients, obstetric patients, critical illness, conditions that exclude continuous propofol infusion due to higher risk for propofol infusion syndrome (PRIS), such as mitochondrial disease, fatty acid oxidation disorder, co-enzyme Q deficiency and any other condition that renders the patient unfit for elective surgery. Intervention: This study is prospective, observational. Main study parameters/endpoints: The primary endpoints are changes in the ST-, Jp-, QRS-, T(p-e)-segments and T(p-e)/QT -ratio changes during steady-state anaesthesia. The secondary endpoint is the occurrence of de novo arrhythmias. Nature and extent of the burden and risks associated with participation: This is an observational study; therefore, the risks associated are no other than those associated with the intervention itself. No additional blood-samples, tests or consults are necessitated during participation; therefore, no extra burden is associated.

NCT ID: NCT04569682 Completed - Clinical trials for Kidney Transplantation

Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.

NCT ID: NCT04550312 Recruiting - Non-COVID Deaths Clinical Trials

The Impact of Lifestyle Changes on Non-COVID Deaths

Start date: September 2020
Phase:
Study type: Observational

The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.

NCT ID: NCT04548804 Enrolling by invitation - Cardiac Arrest Clinical Trials

Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI

BREACH-ECGI
Start date: June 10, 2020
Phase: N/A
Study type: Interventional

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with (increased risk of) ventricular tachyarrhythmias (VTA) and sudden cardiac arrest, and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Moreover, clinical data of subjects will be gathered. By combining the data from the data gathering and the results of ECGI, the investigators hope to increase mechanistic understanding of and risk stratification for VTAs. The investigators aim to be able to identify patients at risk of an arrhythmic event, and aim for better treatment strategies in the future.

NCT ID: NCT04547244 Completed - Heart Failure Clinical Trials

CRTd Responders Optimization

Start date: January 1, 2015
Phase:
Study type: Observational

Suboptimal optimization of atrio-ventricular (AV) and inter-ventricular (VV) timings could affect the clinical response of CRTd in T2DM patients. Thus, authors hypothesize that automatic sensor guided CRTd optimization could ameliorate clinical outcomes in patients with T2DM. However, authors will evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiographic guided approach.Authors will conduct a prospective, multicenter study to recruit, from October 2016 to June 2019, patients with T2DM and heart failure (HF) candidate to receive a CRTd. After CRTd the patients will be optimized via automatic vs. echocardiographic guided approach.

NCT ID: NCT04540354 Withdrawn - Heart Failure Clinical Trials

Personalised Risk scOre For Implantation of Defibrillators in Patients With Reduced LVEF≤35% and a Low Risk for Sudden Cardiac Death

PROFID-Reduced
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The objective of the study is to demonstrate that in post-MI patients with symptomatic heart failure who receive optimal medical therapy for this condition, and with reduced LVEF ≤ 35% but low risk for SCD according to a personalised risk score, optimal medical therapy without ICD implantation (index group) is not inferior to optimal medical therapy with ICD implantation (control group) with respect to all-cause mortality.

NCT ID: NCT04540289 Withdrawn - Clinical trials for Myocardial Infarction

Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implantation of an ICD (index group) is superior to optimal medical therapy (control group) with respect to all-cause mortality.

NCT ID: NCT04466865 Active, not recruiting - Kidney Diseases Clinical Trials

A Communication Tool to Assist Older Adults Facing Dialysis Choices

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC) communication tool on receipt of palliative care and intensity of treatment at the end of life, quality of life, and quality of communication for older patients with end-stage renal disease (ESRD) receiving outpatient care at ten nephrology clinics. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and is now being testing to see if the intervention will work in a different setting. The intervention will be tested with 320 older adults who have end-stage renal disease (ESRD) and are receiving care from a nephrologist enrolled in the study. Randomly assigned nephrologists within each site will receive the intervention (training to use the BC/WC tool) or to be in the waitlist control, meaning that they will not be offered BC/WC training until the end of the study, when all participants have been enrolled. Participants will be on follow up with surveys and chart review for up to two years after study enrollment. Caregivers will also be invited to participate and complete surveys.

NCT ID: NCT04463992 Active, not recruiting - Cancer Clinical Trials

Lay Health Worker Expanded Intervention in Community Oncology Practices

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.