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NCT ID: NCT05431946 Enrolling by invitation - Quality of Life Clinical Trials

Palliative Care for Patients With Liver Cirrhosis

LiverCare
Start date: August 1, 2023
Phase:
Study type: Observational

Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment. Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services. Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services. Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status. Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention. Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.

NCT ID: NCT05423990 Enrolling by invitation - Clinical trials for Sudden Unexpected Death in Epilepsy

Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study

Start date: April 1, 2022
Phase:
Study type: Observational

Sudden unexpected death in epilepsy (SUDEP) is regarded as a leading cause of premature death in epilepsy patients. We aim to capture the whole process of SUDEP and near-SUDEP occurrence in patients with epilepsy, and expolre video-electroencephalograph (V-EEG) changes and marker. A Chinese multicenter study was carried out to determine electroencephalo-graph marker related to SUDEP to provide a scientific basis for the prevention of SUDEP in patients with epilepsy.

NCT ID: NCT05418283 Completed - Depressive Disorder Clinical Trials

Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals

EXDES
Start date: June 10, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.

NCT ID: NCT05397678 Recruiting - Morbidity;Newborn Clinical Trials

Trial to Compare BCG-Bulgaria and BCG-Denmark

BCGSTRAIN IV
Start date: October 21, 2022
Phase: Phase 4
Study type: Interventional

The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of Hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines, Copenhagen 1331 strain) versus BCG-Bulgaria (BB-NCIPD, BCG-SL 222 Sofia strain) 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission. The trial will also examine the association between BCG strains and BCG skin reaction kinetics and characteristics. As a secondary aim, this large study will be used to further evaluate the role of maternal BCG immune priming for overall health, since there are indications that the maternal BCG scar status influences offspring health outcomes.

NCT ID: NCT05396313 Recruiting - Clinical trials for Sudden Cardiac Death

Prediction of Mortality After CIED Implantation (PM-CIED)

PM-CIED
Start date: August 2004
Phase:
Study type: Observational

The study aims to develop and validate predictive models for the mortality of patients receiving CIED (including CRT and ICD) implantation.

NCT ID: NCT05390047 Recruiting - Clinical trials for Sudden Cardiac Death

The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)

iSuSI
Start date: June 1, 2022
Phase:
Study type: Observational

The entirely subcutaneous implantable defibrillator (S-ICD) (Emblem, Boston Scientific, Marlborough, MA, USA) was introduced as a new therapeutic alternative to the conventional transvenous ICD in 2009 and implantations are rapidly expanding since then.1 Implantation of the S-ICD seems to reduce implant-related perioperative complications such as pneumothorax, hematoma and cardiac tamponade. The aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting.

NCT ID: NCT05374291 Enrolling by invitation - Heart Failure Clinical Trials

The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD

Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR<30 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of the SGLT2 inhibitor dapagliflozin in reducing cardiovascular, heart failure and renal outcomes persisted in the population with impaired kidney function. Furthermore, in the DAPA-CKD trial patients continued to use dapagliflozin or placebo when dialysis was initiated. In the subgroup of patients who initiated dialysis, dapagliflozin was associated with a relative risk reduction for mortality of 21%. Finally, in kidney transplant recipients, SGLT2 inhibitors have been shown to be effective in lowering HbA1c, body weight, blood pressure and stabilize kidney function, and these agents were well tolerated and safe. Taken these findings together there is a sound rationale to study the long-term reno- and cardioprotective efficacy and safety of SGLT2 inhibitors in patients with severe CKD. There are two cardiac sub-studies: the cardiac MRI substudy and the echocardiography sub-study. The echocardiography sub-study is referred to as the "SGLT-2-inhibitors to Target Heart Failure in Peritoneal Dialysis" (STOP HF in PD) study. In STOP HF in PD the effect of dapagliflozin on cardiac function will be assessed in a subset of 100 patients treated with peritoneal dialysis.

NCT ID: NCT05373940 Recruiting - Heart Failure Clinical Trials

Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years

DILEMMA
Start date: June 29, 2022
Phase: N/A
Study type: Interventional

The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 75 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

NCT ID: NCT05369806 Completed - Depression Clinical Trials

Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya

AI-NEO
Start date: May 4, 2022
Phase: N/A
Study type: Interventional

Mobile health (mHealth) interventions such as interactive short message service (SMS) text messaging with healthcare workers (HCWs) have been proposed as efficient, accessible additions to traditional health care in resource-limited settings. Realizing the full public health potential of mHealth for maternal health requires use of new technological tools that dynamically adapt to user needs. This study will test use of a natural language processing computer algorithm on incoming SMS messages with pregnant people and new mothers in Kenya to see if it can help to identify urgent messages.

NCT ID: NCT05355324 Completed - Anemia Clinical Trials

Risk Factor for Readmission and Death of Lower Respiratory Infections in Older Adults

Start date: March 1, 2016
Phase:
Study type: Observational

Lower respiratory tract infection(LRTI) is a prevalent disease that threatens the health of older people worldwide. Anemia is also a common disorder in the elderly, and its prevalence increases significantly with age. Most factors that contribute to the development of anemia are improvable. Therefore, we investigated whether anemia was a risk factor for LRTI-caused readmission and death in the elderly occurring within 1 year of discharge from the hospital.