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NCT ID: NCT05052125 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)

Start date: December 16, 2021
Phase: Phase 4
Study type: Interventional

As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.

NCT ID: NCT05048797 Recruiting - Clinical trials for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

NCT ID: NCT05046262 Recruiting - Clinical trials for Basal Cell Carcinoma

Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study

Start date: January 8, 2020
Phase: Phase 3
Study type: Interventional

25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation

NCT ID: NCT05043207 Recruiting - Clinical trials for Hearing Loss, Sensorineural

A Study Protocol for the Validation of UAud in a Clinical Setting.

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

The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

NCT ID: NCT05043116 Recruiting - Asthma in Children Clinical Trials

High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children

COPSACvitd
Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

To investigate whether high-dose vitamin D supplementation may have a beneficial effect on secondary prevention in preschool children (1-5 years of age), with respiratory infections being the primary cause of acute exacerbations with asthma-like symptoms.

NCT ID: NCT05042973 Recruiting - Obesity Clinical Trials

The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure

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

The aim of this trial is to assess the effect of Empagliflozin on lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed. The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.

NCT ID: NCT05042180 Recruiting - Addiction, Alcohol Clinical Trials

Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR)

Start date: October 6, 2021
Phase: Phase 2
Study type: Interventional

The study is a single-blinded, randomized, controlled, 12 months clinical trial. The objective is to investigate the feasibility, effects and side-effects of virtual reality-assisted cognitive behavioral therapy (VR-CBT) vs. cognitive behavioral therapy (CBT) in patients with a diagnosis of alcohol dependence.

NCT ID: NCT05039398 Recruiting - Safety Issues Clinical Trials

'Dialogue and Guidance' - a Policy Intervention for Improved OHS Among Workplaces With WEA Violations

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

With the aim to inspire and motivate workplaces in their work to prevent and reduce occupational health and safety hazards, the Danish Working Environment Authority (WEA) developed the intervention 'Dialogue and Guidance' aimed at workplaces receiving notices (prohibition notice, immediate improvement notice and notice with time limit) from WEA during inspections. At present, WEA gives dialogue and guidance as standard practice during WEA inspections to all workplaces receiving a notice with the purpose to help workplaces resolve the occupational health and safety problem that led to the notice. In the intervention 'Dialogue and Guidance' the experimental groups are receiving additional dialogue and guidance at a subsequent meeting (over the telephone or physical presence) that takes place after the inspection and after the deadline for appealing the notice has expired. The control group is receiving dialogue and guidance during inspection as usual. The aim of this RCT study is to evaluate the policy-developed intervention with additional 'Dialogue and Guidance' in regards to the effect on motivation and priority of occupational health and safety work at the workplace after 6 months follow-up and for WEA notices by next WEA inspection (approx. follow-up by 12-18 months). Study is risk assessed and approved under Danish Data Protection Agency via the National Research Centre for the Working Environment's umbrella approval.

NCT ID: NCT05038930 Recruiting - Clinical trials for Subarachnoid Hemorrhage

Mobilising Patients With Severe Brain Injury in Intensive Care

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

Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. The Sara Combilizer® is an easy and efficient tool for mobilising patients with severe injuries, including brain injury. Through a randomised cross-over trial the investigators will investigate the impact of early mobilisation on patients with severe acquired brain injury caused by traumatic brain injury, subarachnoid brain injury or intracranial haematoma. The investigators hypothesise that mobilisation using the Sara Combilizer® does not affect partial oxygenation of brain tissue.

NCT ID: NCT05038735 Recruiting - Breast Cancer Clinical Trials

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

EPIK-B5
Start date: November 29, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.