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NCT ID: NCT06279975 Recruiting - Brain Death Clinical Trials

Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study

INSPECT
Start date: December 18, 2023
Phase:
Study type: Observational

The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.

NCT ID: NCT06277336 Recruiting - Hyponatremia Clinical Trials

Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD

ESCAPE
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia. The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin. The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia. The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia.

NCT ID: NCT06277115 Recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

Acute and Long-term Effects of CPAP in OSA

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

Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence).

NCT ID: NCT06274879 Not yet recruiting - Bile Duct Cancer Clinical Trials

Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer

Ablatio
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy. Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and CICI, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined. Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.

NCT ID: NCT06273176 Recruiting - Glioblastoma Clinical Trials

The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma

RECMAP
Start date: January 1, 2023
Phase:
Study type: Observational

Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma. This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).

NCT ID: NCT06269315 Not yet recruiting - Clinical trials for Hand Disinfectant Exposure

Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants

SBDDCP
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers. The main questions it aims to answer are: - How does exposure to household detergents and hand disinfectants impact skin barrier function? - Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants? Participants will: Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin. Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure. If there is a comparison group: Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact.

NCT ID: NCT06265168 Recruiting - Coma Clinical Trials

Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients

COMA
Start date: March 1, 2024
Phase:
Study type: Observational

This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient.

NCT ID: NCT06263712 Recruiting - Self Efficacy Clinical Trials

Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2

NePsyAssip HT
Start date: March 25, 2024
Phase: N/A
Study type: Interventional

The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment. The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland). At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2. Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1.

NCT ID: NCT06258616 Recruiting - Fluid Overload Clinical Trials

Fluid Administration and Fluid Accumulation in the Intensive Care Unit

FLUID-ICU
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this international inception cohort study is to describe fluid administration during admittance to the intensive care unit (ICU), and provide contemporary epidemiological data on fluid accumulation, risk factors, management and outcome in critically ill adult patients.

NCT ID: NCT06258291 Not yet recruiting - Septic Shock Clinical Trials

First in Human Trial to Assess the Safety of HemoSystem REBOOT in Patients With Sepsis-induced Immunosuppression

RESTORE I
Start date: October 15, 2024
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to restore immune function by selectively removing three mediators largely contributing to sepsis-induced immunosuppression from extracorporeal circulation.