There are about 11304 clinical studies being (or have been) conducted in Denmark. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The study is a single site parallel randomized controlled study. The study will be assessing the effect of approximately 10% weight loss intervention vs a control group among healthy females/couples where the prospective mother is overweight or obese (BMI 27-45 kg/m^2) and between 18-38 years. The investigators will recruit a total of 240 healthy females/couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI. The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight and adiposity and its complications compared to a control group. The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a reduction in offspring neonatal adiposity, reduced risk of being born large for gestational age (LGA) and with lower BMI z-score at 18 months.
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.
New treatment regimens with increased efficiency and reduced toxicities are being introduced in the treatment of Multiple Myeloma (MM). As a result, patients can expect increased survival, but also increased time on active treatment. Consequently, patients spend an increasing amount of time at the hospital and on transportation. This may not only expose the patients to unnecessary risks of infections, but will also reduce their available time to have a meaningful life. Carfilzomib is a drug used alone or in combination with other drugs for treatment of relapsed multiple myeloma. It is gives as an intravenous infusion day 1 and 2, day 8 and 9, and day 15 and 16 every 28th day. Thus, the patients have to show up at the hospital many times with the risk of acquiring infections. Likewise they sometimes live a long way from the hospital, and therefore spent a lot of time on transportation to and from treatment. The investigator wish to minimize the number of times the patients have to go to the hospital, by educating them to self-administer day 2, 9 and 16 in their own home. The investigator hope thereby to reduce their risk of hospital-acquired infections and to reduce the time spent on transportation to and from treatment. From a hospital point of view the investigator hope it will reduce the pressure on space in the outpatient clinic; that it will reduce the time a nurse spent on treatment. In the present project, intravenous Carfilzomib is administered in the hospital through a peripheral intravenous needle on day 1, 8, and 15 of a 28-day cycle and the treatment for the day after is handed to the patient in a cooling compartment. The next day the patient will load the Carfilzomib into the pump and attach it to the peripheral intravenous needle. Once the infusion if finished, the patient will remove the needle and the following week, bring the cooling compartment and the pump back to the hospital.
The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. The main goals are to identify if: - Results from a previous randomised controlled trail can be reproduced in real life. - Evaluate skills retention after program completion. - Assess real life implementation of the training program.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study.
Objective: The overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (PA) in response to acute moderate intensity continous exercise (MICE) and high intensity interval exercise (HIIE) among adolescents with type 1 diabetes (T1D) using automated insulin delivery (AID) systems (MiniMed 780G and Tandem Control-IQ). Methods: This study will be a two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities among a total of 24 age-, sex-, and insulin-dose-matched adolescents with T1D (12 using MiniMed 780G and 12 using Tandem Control-IQ). Endpoint: The primary endpoint is sensor-derived time in range (3.9 mmol/L-10.0 mmol/L) around exercise
Alcoholic hepatitis is a disease with a high mortality rate with few treatment options improving survival. Recently certain bacterial strains has been correlated to survival in patients with alcoholic hepatitis. In the BATTLE-trial the investigators will investigate if certain bacteria are correlated to decreased chance of survival in patients with alcoholic hepatitis.
Loss of muscle mass is common phenotypic trait of muscular disuse and ageing. The loss of muscle mass affects, among others, the ability to maintain homeostasis of glucose metabolism and the energy reservoir in catabolic conditions, while also affecting mechanical muscle function which can cause detrimental impairments in general functional status and hence quality of life. However, a limited amount of research has attempted to elucidate molecular regulators of muscle mass loss following bed rest in older individuals and across genders. Consequently, the mechanistic drivers are unresolved and there are currently no effective therapeutic strategies to counteract muscle wasting and loss of function in individuals submitted to bed rest e.g. during hospitalization. Purpose The purpose is to examine the effects of 5 days of bed rest on muscle mass, including myofibrillar protein synthesis and breakdown, and muscle function, and elucidate molecular regulators of muscle mass loss and metabolic pathways, while also investigating if potential negative effects can be counteracted by daily NeuroMuscular Electrical Stimulation (NMES) across different age and genders. Methods The study is designed as a randomized controlled cross-over 5-day bed rest study including a group of healthy young (18-30 years) and healthy old (65-80 years) men and women. Participants will receive daily electrical stimulation (NMES) of the thigh muscles (30 min x 3/day) on one leg (ES), while the other leg serves as a control (CON). Participants will be tested at baseline (pre) and after (post) intervention for muscle strength, muscle power, balance, and muscle activation. Blood samples are collected at several time points and muscle biopsies are sampled pre- and post-intervention along with assessment of whole-body muscle mass and thigh muscle mass. Scientific exposition The results from the study can potentially provide insight into the adaptive mechanisms associated with NMES training and muscular disuse on both cellular- and whole-body level. The understanding of the underlying mechanisms is crucial for the application of NMES in a therapeutic context and will furthermore help us understand the basic mechanism regulating the skeletal muscle mass during both training and muscular disuse. Overall, the results can potentially help establishing treatments to counteract loss of muscle mass, muscle function and muscle health during periods of muscular disuse.
The BrainDrugs-D study uses multimodal neuroimaging combined with self-report measures, clinical and molecular markers to identify clinically relevant predictors that can identify subtypes of major depressive disorder (MDD) and, in a naturalistic setting, predict treatment response to standard antidepressive treatment. The cohorts are followed in nationwide health registries.
The aim is to re-validate a FTIR spectroscopy test for measuring lung maturity/Respiratory Distress Syndrome (RDS) before conducting a RCT using this test to guide surfactant treatment of preterm infants. The test has been validated previously (NCT03235882) but needs re-validation due to continued improvement in accuracy and since the test is now developed into a Point of Care test (POC-test). The purpose is to accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio determined by a rapid FTIR in a newly developed point of care test (POC-test) on fresh gastric aspirates using retrospective analysis. The FAST 2 Validation Study is a part of the FAST 2 Trial consisting of a validation study and a subsequent randomized clinical trial, that will be registered separately on clinicaltrials.gov (NTC XXXXXXXXX)