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NCT ID: NCT04254315 Completed - Clinical trials for Ischemic Heart Disease

OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in psychological distress with HADS over time in order to optimize time of measuring HADS. (3) To investigate if the intervention can be implemented to other cardiac rehabilitation sites with the same effect as on BFH (that it is not person dependent).

NCT ID: NCT04252846 Completed - Clinical trials for Partial Onset Seizures

A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Start date: July 20, 2020
Phase:
Study type: Observational

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

NCT ID: NCT04250987 Completed - Compliance, Patient Clinical Trials

Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter

Start date: March 23, 2019
Phase: N/A
Study type: Interventional

The purpose of the investigational device in the proposed clinical investigation is to capture pressure data prior to and during voiding using a CE-marked commercially available catheter.

NCT ID: NCT04250207 Completed - Clinical trials for Fuchs' Endothelial Corneal Dystrophy

Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

Start date: June 23, 2020
Phase: Phase 2
Study type: Interventional

The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.

NCT ID: NCT04249388 Completed - COPD Clinical Trials

Characteristics of People With Advanced Chronic Obstructive Pulmonary Disease (COPD) - A Multicenter Study

REPORT
Start date: February 1, 2020
Phase:
Study type: Observational

Pulmonary rehabilitation (PR) is a cornerstone of care for people with COPD. There is robust evidence that PR improves exercise capacity, enhances health-related quality of life (QoL) and reduces healthcare utilization. PR is strongly recommended in guidelines for COPD management. Despite the compelling evidence for its benefits, PR is delivered to less than 30% of people with COPD. Access is particularly challenging, an especially for those with the most progressed disease stages. We recently completed a randomized clinical trial, showing that approximately 1.100 patients annually are offered conventional hospital-based PR during routine consultations in the Capital Region of Denmark, but at least 700 patients declines participation. No major cohort studies have been published from people with severe and advanced COPD who opt out of traditional pulmonary rehabilitation. By establishing such cohort study, objective and qualitative knowledge from assessments and patient interviews is collected in patients we have very limited access to and knowledge of. Additionally, the collected data will give a deeper insight and understanding and possibly enable us to design new delivery models to be tested in proper study designs.

NCT ID: NCT04248842 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - Validation Study

Start date: January 23, 2020
Phase:
Study type: Observational

For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 27/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. As part of the WARD-COPD project, this validation study aim to assess the accuracy of physiologic parameters derived from standard and wireless patient monitors

NCT ID: NCT04248179 Completed - Breast Cancer Clinical Trials

The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.

Start date: November 29, 2019
Phase: Phase 4
Study type: Interventional

The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia golden standard for anesthesia of the hemithorax - but hypothetically without the risks of adverse events associated with the TPVB (i.e. pneumothorax, risk of bleeding in the thoracic paravertebral space, random and unmanageable epidural spread etc.). The investigators have already tested the anatomical- and block execution hypothesis in a randomized cadaveric study, and the investigators now have anatomical proof of concept for the functionality of the block technique. The investigators have also conducted a small clinical pilot study with very promising results. The investigators wish to conduct a randomized, placebo controlled and double-blind study, comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB) vs. placebo. The aim with this study is to investigate the efficacy of the MICB vs. placebo in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast cancer or ductal carcinoma in situ. The hypothesis is, that the unilateral MICB will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale pain score (0-10) and opioid related side effects.

NCT ID: NCT04247399 Completed - Education Clinical Trials

Simulation-assisted Teaching in Learning Gastroscopy

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

This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.

NCT ID: NCT04246853 Completed - Pain Clinical Trials

Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain

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

Non invasive brain stimulation (NIBS) of the primary motor cortex (M1) through transcranial direct current stimulation (tDCS) has been widely investigated in research and clinical settings in order to modulate brain plasticity and improve clinical pain. Interestingly, newly developed paradigms i.e. tDCS of the resting state motor network have proved higher modulatory effects in terms of corticospinal excitability when compared to traditional M1 tDCS. However, little is known about the effects of tDCS on the frequency changes of alpha oscillations (alpha peaks). Interestingly, previous studies show a correlation between reduced frequencies of alpha peaks during 1-hour experimental pain in comparison to baseline. The present study aims to investigate the effects of tDCS of the resting state motor network on the frequency and power of alpha peaks during prolonged experimental pain during 24 hours.

NCT ID: NCT04243603 Completed - Clinical trials for Non-suicidal Self-injury

Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial

Start date: May 11, 2020
Phase: N/A
Study type: Interventional

There has been a significant increase in non-suicidal self-injury the last decades especially among young people and treatment initiative are sparse. We aim to assess the feasibility of methods, procedures, and safety of internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as add on to treatment as usual (TAU) in 13-17-year-old patients with non-suicidal self-injury referred to psychiatric services.