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NCT ID: NCT06318299 Not yet recruiting - Ketosis Clinical Trials

Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid

KetoBrain
Start date: March 2024
Phase: N/A
Study type: Interventional

It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies. Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier. To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study. Aims: - The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint - The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling - If concentration measurements by point-of-care testing are non-inferior to mass spectrometry - If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels

NCT ID: NCT06314061 Not yet recruiting - Diabetes Mellitus Clinical Trials

The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes.

WARD-glucose
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients. The main question it aims to answer is: • Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes? Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge.

NCT ID: NCT06312254 Not yet recruiting - Clinical trials for Peripheral Neuropathy

Pharmacological Modulation of Peripheral Nerve Excitability

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

The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model. The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).

NCT ID: NCT06312202 Not yet recruiting - Drowning Clinical Trials

Drowning Incidents in Danish Harbours

DROWN_HARBOR
Start date: May 1, 2024
Phase:
Study type: Observational

A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning.

NCT ID: NCT06310499 Not yet recruiting - Drowning Clinical Trials

Primary or Secondary Drowning

DROWN_COD
Start date: August 1, 2024
Phase:
Study type: Observational

According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated. Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment.

NCT ID: NCT06310486 Not yet recruiting - Drowning Clinical Trials

The Emergency Call on Drowning

DROWN_CALL
Start date: May 1, 2024
Phase:
Study type: Observational

This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy.

NCT ID: NCT06306274 Not yet recruiting - Lymphedema Clinical Trials

Topical Tacrolimus for Breast Cancer-related Lymphedema

Start date: May 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are: - How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life). - If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.

NCT ID: NCT06303752 Not yet recruiting - Anal Fistula Clinical Trials

Tissue Therapy of Transsphincteric Anal Fistula

REP-PAF
Start date: May 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

NCT ID: NCT06300229 Not yet recruiting - Infertility, Male Clinical Trials

NAPO - Novel Approach for Oligospermia

NAPO
Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL).

NCT ID: NCT06300086 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease

NUDGE-CKD
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines. This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters.