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NCT ID: NCT05993026 Enrolling by invitation - Mental Health Clinical Trials

A School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade

Start date: August 15, 2023
Phase: N/A
Study type: Interventional

The present study is an evaluation of school-based intervention. The intervention aims to strengthen students' well-being and increase their mental health through training in tools that increase self-efficacy and ability to understand themselves and others. The Danish Committee for Health Education is responsible for developing and implementing the intervention and for recruiting schools, while the the Danish National Institute of Public Health at University of Southern Denmark is responsible for the evaluation of the intervention, including data collection, analysis and reporting.

NCT ID: NCT05982600 Enrolling by invitation - Melanoma (Skin) Clinical Trials

Safety and Avoidance of Futile Excisions Through Skin Tele-triage

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

The goal of this study is to estimate the triage values, efficiency and safety of tele-dermoscopic triage of skin lesions suspected of melanoma. The main question[s] it aims to answer are: - What is the rate of correct patient management by a single, 2, 3 and 5 dermatologists. - What is the consequence for the patients if teledermoscopic triage is implemented, in termes of missed melanomas and reduced unnecessary excisions/biopsies. Retrospectively included patients will have their skin lesions re-examined by setups of 1, 2, 3 and 5 tele-dermoscopists who will assign a tentative diagnosis and a recommended clinical action. The investigators will compare the rate of correct patient management between the different setups.

NCT ID: NCT05929807 Enrolling by invitation - Achondroplasia Clinical Trials

A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia

AttaCH
Start date: June 21, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

TransCon CNP administered once-weekly in children and adolescents with achondroplasia who have completed a prior TransCon CNP clinical trial. Participants who complete a prior TransCon CNP trial and meet all eligibility criteria will be invited to continue into the long-term open label extension trial to receive 100 µg CNP/kg/week of TransCon CNP. Trial treatment will be completed when the participant reaches 16 years of age for females and 18 years of age for males and have femur and tibial epiphyseal closure. TransCon CNP treatment will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years for females, and 18 years for males. Treatment with TransCon CNP will be completed once femur and tibial epiphyseal closure is confirmed by radiographic imaging. The trial duration is individual for each trial participant. Visits will occur every 12-14 weeks throughout the trial.

NCT ID: NCT05921097 Enrolling by invitation - Diabetes Clinical Trials

Comparison of Histamine and Local Heating for Evoking the Axon-reflex Flare Response in Diabetes

HistaHeat
Start date: June 17, 2023
Phase:
Study type: Observational

Diabetic peripheral neuropathy is the most common complication to diabetes mellitus affecting as much as 50% of the population with diabetes. Symmetrical sensory neuropathy is by far the most common pattern, which often progress slowly over many years, although some individuals experience faster and more severe courses. Despite the frequent occurrence, the causes of diabetic peripheral neuropathy are largely unknown, which is reflected in the fact that no disease-modifying treatments are available for preventing, treating or even halting the progression of the disease. The consequences can be dire, as neuropathy frequently leads to foot ulcers, amputations or intolerable neuropathic pain in the lower extremities. Sensory loss may go completely undetected in diabetes, as there often are literally no symptoms. For many individuals, the development of diabetic peripheral neuropathy can therefore proceed completely unnoticed, making regular screening the most important tool for diagnosing the condition. Unfortunately, unlike nephropathy or retinopathy, diabetic peripheral neuropathy is not easily screened for, as the condition lacks reliable markers for early- or progressing disease. Therefore, screening for diabetic peripheral neuropathy currently revolves around diagnosing loss of protective sensation, judged by the inability to feel vibration or light touch. However, in their most recent guidelines, the American Diabetes Association has included screening for small fibre neuropathy using either the cold- and heat perception thresholds or pinprick as a clinical standard. Although this acknowledgement of the importance of assessing not only large- but also small nerve fibres is a huge step towards early detection of diabetic peripheral neuropathy, the overriding issue of insensitive, unreproducible, and inaccurate bedside tests for small nerve fibres remains. While cold- and heat perception and pinprick sensation are indeed mediated by small nerve fibres, the sensitivity of these methods, outside of extreme standardization only achievable in dedicated neuropathy research-centres, remain poor and not usable on an individual level. This lack of sensitivity has also become apparent in several large clinical trials, where the methods have continuously failed as robust clinical endpoints. Due to this, the hunt for a sensitive and reproducible method for adequate assessment of the small nerve fibres have begun. Amongst several interesting methods, two have gained particular interest (corneal confocal microscopy and skin biopsies with quantification of intra-epidermal nerve fiber density), due to their diverse strengths, although clinical application is currently limited to a few specialized sites. Furthermore, both methods suffer several inherent issues including that fact that they only provide information about the structure of the nerves and not the function. One method to assess the function of small cutaneous C-fibers is the assessment of the axon reflex flare response using laser doppler imaging (LDI) or Full-field laser perfusion imaging (FLPI), which has classically been studied using local heating. Unfortunately, this method is limited in clinical usage due to time-consumption. The investigators recently published an alternative method using a simple skin-prick application of histamine to evoke the response, which reduced the examination-time markedly. Before claiming the method to be a better alternative, the investigators do however need to prove that the method is as good as the original. In addition to the direct comparison of the histamine-induced and the heating-induced axon-reflex flare response the study will also assess spatial acuity in the same cohort as a secondary aim. Spatial acuity is considered as a measure of the sensory systems ability to code spatial information regarding an external stimulus. To investigate the spatial acuity, the 2-point discrimination task (2PDT) is often used. Spatial acuity has been shown to be impaired in several chronic pain condition. Additionally, it has been shown that the 2PDT may be a useful tool to understand the sensory changes in diabetes[8].

NCT ID: NCT05915260 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

CMR in T2DM: The NSR Cohort

Start date: April 1, 2023
Phase:
Study type: Observational

This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI. The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI. Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes. The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.

NCT ID: NCT05908669 Enrolling by invitation - Clinical trials for Glioblastoma Multiforme

Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme

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

This is a feasibility single arm study designed for obtaining early data for optimization and evaluation of the clinical potential for a new MR technique using deuterated glucose. The purpose of the study is to investigate whether this technique is useful in metabolic imaging of glioblastoma multiforme (GBM) and whether radiochemotherapy (RCT) induced changes in the brain metabolism can be detected and might be predictive for treatment response. The study will include 10 patients with histologically verified GBM scheduled for standard RCT. Patients will have MRI scan performed before and within 8 weeks after starting RCT. The scans will include imaging after oral intake of deuterated glucose, so called deuterium metabolic imaging (DMI). Based on this study, the most optimal scanning technique, output variables of highest discriminative power with respect to RCT, and potential predictive markers for response will be selected for further clinical investigation.

NCT ID: NCT05775614 Enrolling by invitation - Catheter Blockage Clinical Trials

UROtainer for Bladder Catheter Maintenance, Infection Prevention and Quality of Life

UROBIQ
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage. In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH.

NCT ID: NCT05770934 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

Late-initiated Blood Flow Restricted Rehabilitation Exercises After Total Knee Replacement

EXKnee2
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

This trial will investigate the effectiveness of applying low-load blood flow restricted exercise 12 months after receiving a total knee replacement to achieve a functional capacity-level similar to healthy peers. Participants will be allocated to either an exercise group performing a sit-to-stand exercise 4/weekly with concurrent partial restriction of the blood flow to the limbs or a usual care.

NCT ID: NCT05760755 Enrolling by invitation - Clinical trials for Breast Cancer Female

Stick Together - Pilot Intervention Study

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

This pilot study investigates the acceptability and feasibility of 'Stick Together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners.

NCT ID: NCT05712551 Enrolling by invitation - Melanoma (Skin) Clinical Trials

Dermoscopy Augmented Histology Trial, Consensus Agreement Diagnosis Made by Dermatopathology Experts

Start date: April 1, 2023
Phase:
Study type: Observational

It has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in-vivo clinical and dermoscopic images of melanocytic tumors. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images. The primary outcome of the upcoming DAHT RCT (Dermoscopy Augmented Histology Trial, a randomized controlled trial) is the diagnostic value (accuracy, sensitivity, and specificity) for the intervention and control group. For this purpose, we need an irrefutable gold standard diagnosis for all DAHT cases. The DAHT consensus trial strives to establish this gold standard through a four-phased Delphi-like process. Aim: To establish a gold-standard diagnosis for all DAHT cases. Data collection of DAHT cases: Department of plastic surgery, Herlev hospital, year 2020-2021 DAHT platform: Made in 2021-2023 by Melatech Consensus agreement: Four dermatopathologists assess all DAHT cases, year 2023