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NCT ID: NCT04351789 Recruiting - COVID-19 Clinical Trials

Impact of a Minimal Psychoeducational Intervention on Anxiety Among Hospitalized COVID-19 Patients in Denmark

PISCA
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

Background: There is limited knowledge on the psychological implications of COVID-19 among hospitalized patients and their close relatives. Moreover, evidence-based psychological interventions targeting hospitalized COVID-19 patients and their relatives are currently lacking. Objective: To test a minimal psychoeducational intervention versus standard of care for reducing anxiety among hospitalized COVID-19 patients. Methods and analysis: The trial is a Randomized Controlled Trial (RCT) with a 1 month and 3 month follow-up. Hospitalized COVID-19 patients are consecutively included at admission and randomized 1:1 to either an intervention or control group. Patients randomized to the intervention group will receive a minimal psychoeducational intervention just prior to discharge from the hospital. The goal of the intervention is that patients will be prepared and learn to interpret and react to physical and psychological symptoms that are related to recovering from a COVID-19 infection. Data is collected using standardized and validated patient reported outcome measures (PROMs) to assess mental health outcomes. The primary outcome is patient reported anxiety as assess by the Hospital Anxiety and Depression Scale. Perspectives: This study will provide a comprehensive understanding of the psychological implications of the COVID-19 outbreak. If successful, the minimal intervention is easily implemented in daily clinical practice.

NCT ID: NCT04348253 Recruiting - Ligament Injury Clinical Trials

Danish Multicenter Scapholunate Ligament Study

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.

NCT ID: NCT04341181 Recruiting - Cancer Clinical Trials

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

ProTarget
Start date: August 24, 2020
Phase: Phase 2
Study type: Interventional

The ProTarget study is a phase II, prospective, non-randomized clinical trial with the primary purpose of investigating the safety and efficacy of commercially available cancer drugs that target specific changes in cancer cell DNA to treat patients with advanced cancer. The primary endpoint is anti-tumor activity or stable disease documented after 16 weeks of experimental drug treatment. The drugs used in the trial have been approved by EMA/FDA for the treatment of certain cancers. Choice of drug is based on whether the patient's cancer cells contain precisely the DNA change (i) targeted by the EMA/FDA-approved drug or (ii) related to sensitivity to the EMA/FDA-approved drug. The trial drug is thus not approved by the EMA/FDA or in Denmark for the treatment of the patient's cancer - it is so-called "off-label use". The secondary purposes are: - To detect side effects in patients treated with commercially available targeted cancer drugs. - Performing biomarker analyzes, including (but not limited to) whole-genome analysis (WGS) on a fresh tumor tissue sample (biopsy) at baseline and progression. - To investigate mechanisms of resistance using recurrent / serial fresh tumor biopsies for WGS and so-called liquid biopsies, which are blood samples in which the cancer cell DNA is analyzed. The secondary endpoints include response duration, progression-free survival, and overall survival.

NCT ID: NCT04340817 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Fatty Liver Disease in Nordic Countries

FLINC
Start date: September 1, 2017
Phase:
Study type: Observational

A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH.

NCT ID: NCT04336228 Recruiting - Healthy Individuals Clinical Trials

The Role of Serotonin in Compulsive Behavior in Humans: Underlying Brain Mechanisms

Start date: April 1, 2020
Phase: Phase 4
Study type: Interventional

The aim of this project is to investigate: - The status of the central serotonin (5-hydroxytryptamine, 5-HT) system in compulsive behaviour and how it is affected by sub-chronic escitalopram administration - The mechanisms underlying how sub-chronic administration of escitalopram affects the central 5-HT system - How changes in cognitive performance, including the balance between habitual and goal-directed mechanisms, are affected in compulsive behaviour by boosting 5-HT function - How functional brain changes in cognitive function measured with magnetic resonance imaging relate to altered 5-HT function following escitalopram administration.

NCT ID: NCT04335669 Recruiting - Breast Cancer Clinical Trials

NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

Primary aim: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer. Pembrolizumab is allowed in both arms after approval for TNBC 2022.

NCT ID: NCT04332822 Recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

POLAR BEAR
Start date: August 19, 2020
Phase: Phase 3
Study type: Interventional

This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.

NCT ID: NCT04331821 Recruiting - Sleep Apnea Clinical Trials

READ-ASV Registry - Phase II

READ-ASV
Start date: May 1, 2019
Phase:
Study type: Observational

The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.

NCT ID: NCT04331522 Recruiting - Allergy in Children Clinical Trials

Allergen Provocations- HCA Children's Hospital

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.

NCT ID: NCT04330729 Recruiting - Clinical trials for Erythropoietin Adverse Reaction

The Effect of Salicylate on Platelet Function in CKD (Chronic Kidney Disease) Patients Treated With Aranesp

EPOASA
Start date: April 15, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to 1. To determine whether treatment with Erythropoiesis-stimulating agents (in the form of Aranesp®) affects platelet function, and how. 2. To determine whether salicylate treatment changes the effect of EPO (erythropoietin) on platelet function.