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NCT ID: NCT05862571 Recruiting - Brain Concussion Clinical Trials

Screening Instruments for Measuring Visual Symptoms in Victims of Concussion

VISCOM
Start date: December 1, 2022
Phase:
Study type: Observational [Patient Registry]

Visual dysfunction after mild traumatic brain injury (mTBI) is common but often remain undiscovered during longer periods of time. No valid, reliable and easy-to-use screening instrument for uncovering visual dysfunction exists. Furthermore, it is unknown whether optometric measurements currently used in assessing vision problems are consistent with patients' subjective complaints experienced in everyday life. A better understanding of patients' visual challenges combined with objective measurements, will contribute to a better and more efficient diagnostic investigation and treatment. The aim of this study is to get a better understanding of patients who are suffering from visual dysfunction after mTBI. This understanding will be gained by: 1. developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI. 2. developing eye tracking based screening tools applicable both in- and outside of optometry clinics 3. examining relationships between self-reported data, eye tracking measurements and optometric measurements. The study will consist of N = 200 subjects. N = 100 of the subjects are suffering from mTBI (commotio group). The second group N = 100 is the non-injured group that preferably will consist of relatives to the subjects in the commotio group. The subjects in both groups have to answer the questionnaires regarding subjective visual complains, undergo optometric tests and undergo eye tracking measurements.

NCT ID: NCT05858359 Recruiting - Clinical trials for Cognitive Impairment

Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

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

The aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.

NCT ID: NCT05857761 Recruiting - Concussion, Mild Clinical Trials

GAIN Symptoms: Post-traumatic Headache

Start date: August 28, 2023
Phase: N/A
Study type: Interventional

The overall aim of the study is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent post-traumatic headache (PTH) with a direct impact on the ability to diagnose and manage PTH effectively. The investigators also aim to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS), a novel intervention on PTH.

NCT ID: NCT05856799 Recruiting - AV Block Clinical Trials

Danish Randomized Trial on Leadless vs Transvenous Pacing

DANVERS
Start date: August 25, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.

NCT ID: NCT05855031 Recruiting - Clinical trials for Alcohol Use Disorder

The Liver Care Trial

Start date: May 8, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.

NCT ID: NCT05852704 Recruiting - Atrial Fibrillation Clinical Trials

SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF

STENOTYPE
Start date: April 4, 2024
Phase: Phase 3
Study type: Interventional

The goal of this randomized, double-blinded, controlled clinical trial is to investigate if treatment with an sodium-glucose cotransporter-2 inhibitor (SGLT2) during the unique time window before coronary artery bypass surgery (CABG), can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury in patients with chronic coronary syndrome. The main questions it aims to answer are: - Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of new onset atrial fibrillation compared to placebo? - Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of acute kidney injury before hospital discharge compared to placebo? Participants will be administered dapagliflozin 10 mg once daily or placebo for a minimum of seven days while awaiting scheduled CABG and up until discharge, with a short interruption for surgery. The active arm will be compared to the placebo arm to see if dapagliflozin can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury.

NCT ID: NCT05852691 Recruiting - Breast Cancer Clinical Trials

A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Start date: July 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).

NCT ID: NCT05851950 Recruiting - Psychotic Disorders Clinical Trials

RUFUS - Group Rumination-focused CBT for Negative Symptoms

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

Abstract - -- Introduction: Psychosis spectrum disorders are characterized by both positive and negative symptoms, but whereas there is good effect of treatment on positive symptoms, there is still a scarcity of effective interventions aimed at reducing negative symptoms. Rumination has been proposed as an important and fundamental factor in the development and maintenance of symptoms across psychiatric diagnoses, and there is a need to develop effective interventions targeting rumination behaviors and negative symptoms in patients with psychotic disorders. The aim of the current study is to investigate the feasibility and acceptability of group rumination-focused cognitive behavioral therapy (RFCBT) in the treatment of young people with psychosis spectrum disorders as well as investigating potential indications of treatment efficacy. Methods and analysis: The study is a mixed-method clinical randomized controlled pilot trial with a target sample of 60 patients, who are randomized to either receive 13 weeks of group CFCBT or 13 weeks of treatment as usual (TAU). All patients are examined at the start of the project and at the 13-week follow-up. The researcher will compare changes in outcomes from baseline to posttreatment between group CFCBT and TAU. In addition, qualitative analyzes are carried out to explore feasibility and acceptability and to uncover the patients' experience of receiving the intervention.

NCT ID: NCT05846620 Recruiting - Healthy Clinical Trials

Pulmonary Immune Cell-microbiome Interactions in the Healthy Lung

ILLUMINA-2
Start date: April 17, 2023
Phase:
Study type: Observational

The overall aim is to to provide a normal material for the composition and spatial heterogeneity of the following in the healthy lung: i) immune cell populations and their activation patterns, ii) the surrounding cytokine-chemokine milieu, including trans-compartmental fluxes of these mediators between the lung and bloodstream, and iii) the lung microbiome. Main hypotheses: - Absolute and relative immune cell counts in bronchoalveolar lavage fluid (BALF) are similar to those previously reported by other methods6,7. - No trans-compartmental flux of cytokines between the lungs and bloodstream is present, but cytokine concentrations (notably IL-6 and IL-8) vary with the immune-cell-microbiome composition. - Immune cell (mainly T cell) activation, differentiation, and gene expression patterns are expected to differ between blood and BALF in a manner that depends on the regional diversity of the pulmonary microbiome.

NCT ID: NCT05846256 Recruiting - Infertility, Male Clinical Trials

Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

Start date: April 25, 2023
Phase:
Study type: Observational

The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.