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NCT ID: NCT05074862 Not yet recruiting - Critical Illness Clinical Trials

Effects of Ketosis on Muscle Kinetics and Signaling During Critical Illness.

KETO-ICU
Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

Background: Patients with critical illness in the intensive care unit (ICU) experience marked skeletal muscle weakness, muscle atrophy and disability in physical function, commonly termed ICU-acquired weakness (ICU-AW). The pathophysiology of ICU-AW is complex, but a key feature of skeletal muscle wasting is disturbed protein metabolism reflected in both increased rate of muscle protein degradation and reduced synthesis. Treatment with 3-OHB seems a promising new anticatabolic treatment in patients with critical illness, preventing ICU-AW. To date, no data exist on the clinical and functional effects of ketone body modulation in patients with critical illness. Objective: The aim to investigate the effect of exogenous 3-OHB administration on muscle protein kinetics and lipolysis in patients with critical illness, aiming towards preventing ICU-AW. Design: A randomized double-blind isocaloric placebo-controlled cross-over study in 10 mechanically ventilated patients with critical illness in the ICU. Methods: Evaluation of whole-body and focal leg protein kinetics using labeled phenylalanine and tyrosine tracers. Assessment of free fatty acid (FFA) turnover using a labeled palmitate tracer. Femoral arterial blood flow (assessed with pulsed-wave Doppler ultrasound) is evaluated once per study period. Blood- and urinary samples are collected routinely throughout the study day. Whenever feasible, muscle and fat biopsies will be taken for analysis of protein and adipocyte metabolic signaling and mitochondrial function. Perspectives: This investigation may grant essential knowledge on ketosis in critical illness. This may lead to larger clinical trials, and hopefully a new and better treatment strategy aimed at preserving muscle mass and function during and improving recovery after critical illness.

NCT ID: NCT05069753 Not yet recruiting - Bilateral Cataract Clinical Trials

Patient Reported Visual Satisfaction Following Same Day or Delayed Bilateral Cataract Surgery

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

Cataract is currently the leading cause of visual impairment worldwide with age being the most common cause of lenticular opacification. As cataract surgery is the most commonly performed elective surgery worldwide, forecasts of an increasing number of elderly individuals make it clear that efficient and evidence based models for managing cataract in the future need to be implemented to manage the broadening gap between intervention and available resources. Bilateral cataract is currently treated using same day separate surgical procedures (immediate sequential bilateral cataract surgery (ISBCS) or on separate days (delayed sequential bilateral cataract surgery (DSBCS). Whether one approach is more ideal than the other is an ongoing debate. There is, however, a clear advantage of same day surgery on resource management. The primary purpose of this clinical study is to measure the patient reported satisfaction regarding vision in a group of 300 participants following either same day or delayed bilateral cataract surgery.

NCT ID: NCT05050786 Not yet recruiting - Quality of Life Clinical Trials

Prophylactic Negative Pressure Wound Therapy for Patients Undergoing Incisional Hernia Repair

PROPRESS
Start date: January 2022
Phase: N/A
Study type: Interventional

The study will examine the effect of using Negative Pressure Wound Therapy (NPWT) compared with standard wound dressing among patients undergoing elective open surgery for incisional hernia. The study's main hypothesis is that NPWT will decrease the post-operative incidence of surgical site infections and also improve the patients' quality of life including less scar-related pain and higher cosmetic satisfaction.

NCT ID: NCT05038007 Not yet recruiting - Lung Cancer Clinical Trials

Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades

Start date: September 15, 2021
Phase: Phase 2
Study type: Interventional

To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.

NCT ID: NCT04996550 Not yet recruiting - Clinical trials for Chronic Heart Failure

Are Carvedilol and Metoprolol Succinate Comparable Treatments in Heart Failure Patients With Reduced Ejection Fraction

CROWD-COMPARE
Start date: January 3, 2022
Phase:
Study type: Observational [Patient Registry]

The objective of CROWD-COMPARE is to compare the efficacy of carvedilol and metoprolol succinate on all-cause mortality or first hospitalization for worsening heart failure in patients with heart failure with reduced ejection fraction with an indication for treatment with beta-blockers.

NCT ID: NCT04788927 Not yet recruiting - Clinical trials for Head and Neck Cancer

Development of a Predictive Model for the Risk of Metastatic Disease in PPGLs, a Retrospective Cohort Study

PPGL-Pred
Start date: October 1, 2023
Phase:
Study type: Observational

Phaeochromocytomas and paragangliomas (PPGLs) are tumours of the adrenal medulla and extra-adrenal sympathetic nervous system, some which can become metastatic. It is a very rare disease and the tumours are often detected late. Approximately 50 % of the tumours are caused by germline genetic variants screening programmes are recommended for patients and their family members; however, they are not yet well-targeted with respect to individual prognosis. In this study the investigatorscaim to characterize the genotype-phenotype associations in all Danish patients (n=400) diagnosed with PPGLs who have been followed in tertiary centres using medical records and national registries. To this end novel immunohistochemical, genetic, and epigenetic biomarkers in tumour tissues samples from biobank material (blood samples and tumour tissue) will be investigated to develop a comprehensive predictive algorithm for disease prognosis. The study will provide a clinical tool for an improved targeted screening program and subsequently prevention of disease development.

NCT ID: NCT04687384 Not yet recruiting - Inflammation Clinical Trials

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer

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

The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.

NCT ID: NCT04685239 Not yet recruiting - Dislocation, Hip Clinical Trials

Dual Mobility Cup Versus Unipolar Cup

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The general purpose of this study is to examine whether the dual mobility cup (Novae® Serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (>1 year) after primary THR compared with a conventional cup design (Trabecular MetalTM Modular Acetabular System).

NCT ID: NCT04600193 Not yet recruiting - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients

RCTOIP
Start date: March 17, 2021
Phase: N/A
Study type: Interventional

Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. But since phosphate exists in both organic and inorganic forms in the diet, this leads to several problems. Informations of the bioavability and furthermore the effect of plasma koncentrations of phosphate are lacking for both forms of phosphate.

NCT ID: NCT04585620 Not yet recruiting - Chronic Pain Clinical Trials

Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery

Start date: September 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic postsurgical pain following lung cancer surgery is common with and 20-60 % develop chronic pain which persists more than six months after surgery. Causes and health impact of this pain have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy. Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized controlled trials (RCT) have been executed to date. Study objectives: Determine recruitment potential among cured lung cancer patients with chronic postsurgical pain for an RCT and if the method of BTX-A administration is feasible and acceptable. Further more, this study will contribute to the stage testing of the hypothesis that chronic pain following thoracic surgery can be treated with BTX-A. Methods: Recruitment of test subjects: Participiants are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail. Randomization and blinding: Participants are randomized to receive a single series of subcutaneous injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo) at the former operation site. Neither participant nor investigator will know which treatment is given until the end of the trial. Data collection: Data is collected by questionnaires delivered and answered by mail or digitally. Data on the possible effects and possible adverse reactions are collected at multiple times until three months after treatment.