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NCT ID: NCT05274269 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation

Start date: May 9, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.

NCT ID: NCT05267795 Completed - Pain Clinical Trials

Reducing Pain With Focused Music Listening

PainMusic
Start date: April 22, 2019
Phase: N/A
Study type: Interventional

Pain-reducing effects of music listening are well-established, but the effects are small and their clinical relevance questionable. Recent theoretical advances, however, have proposed that synchronizing to music, such as clapping, tapping or dancing, has evolutionarily important social effects that are associated with activation of the endogenous opioid system (EOS; which supports both analgesia and social bonding). Thus, active sensorimotor synchronization to music could have stronger analgesic effects than simply listening to music. However, to the best of the investigators' knowledge, the hypothesis of an EOS activation by sensorimotor synchronization to music has never been investigated. Accordingly, the investigators set up a test with the premise that if sensorimotor synchronization to music indeed activates the EOS, then it should have larger pain-reducing effects than simply listening to music. Using pressure algometry to the fingernails, specific amounts of pain were delivered to healthy adults either during music listening or silence, while either performing an active tapping task or a passive control task. As the dependent variable, perceived pain was rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong). In addition, to pain ratings, participants provided ratings of their emotional state in terms of pleasantness as well as arousal, and then rated their familiarity with the music (also on scales ranging from 1 to 9). Emotion ratings were obtained to explore whether the mechanisms driving pain-reducing effects of sensorimotor synchronization to music include emotion. At the end of the experiment, participants also rated their preference for the music on a scale ranging from 1 to 9 (see Method). Familiarity and preference ratings were obtained to elucidate possible contributions of these factors on pain reduction.

NCT ID: NCT05266118 Completed - Critical Illness Clinical Trials

Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge

Start date: April 19, 2022
Phase:
Study type: Observational

The overall objective of this study is a) to increase knowledge about ICU patient's symptoms and symptom clusters during the first week after ICU discharge, and b) to identify cognitive, psychological, and physical symptoms and health state at hospital discharge.

NCT ID: NCT05261126 Completed - Clinical trials for Hypercholesterolemia

A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Start date: March 10, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of MK-0616, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of MK-0616 tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.

NCT ID: NCT05259722 Completed - Chronic Hand Eczema Clinical Trials

A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

Start date: June 15, 2022
Phase: Phase 3
Study type: Interventional

This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

NCT ID: NCT05244928 Completed - Patient Safety Clinical Trials

Team Training and Medication Administration in an Ambulance Service

TEAM-AMB
Start date: January 24, 2022
Phase: N/A
Study type: Interventional

Medication administration events have the potential to cause patient harm. Frequency of medication administration events in the ambulance services is less known. Effective teamwork has been described as paramount for providing safe and effective patient care in the high-risk ambulance environment. "Team Strategies and Tools to Enhance Performance and Patient Safety®" is an evidence-based team training program released from the Agency for Healthcare Research and Quality. The aims of the study are: (1) to advance the knowledge of medication administration process in the ambulance services, and (2) to study the impact of a team training program on medication administration events, teamwork, and patient safety culture. To address the overall aims, the following research objectives will guide the study: Pre-study: To analyse and validate the psychometric properties of the Norwegian version of the Teamwork Perception Questionnaire for use in an ambulance service. Studies: 1. To determine the frequency of medication administration events in an ambulance service. 2. To describe the medication administration process in an ambulance service according to the "Systems Engineering Initiative for Patient Safety model". 3. To identify the impact of a team training program on the frequency of medication administration events in an ambulance service. 4. To explore ambulance professionals' experiences of teamwork before and after the implementation of a team training program and their experiences with the program. 5. To compare ambulance professionals' perceptions of teamwork and patient safety culture before and after implementation of a team training program. Post-study: To study the association between medication administration events and team training and patient safety culture in an ambulance service. A stepped wedge cluster randomized controlled trial provides the framework for the intervention of the team training program in two clusters including seven ambulance stations, in total.

NCT ID: NCT05227729 Completed - Clinical trials for Hemodynamic Instability

Descending Aorta Blood Flow to Guide Fluid Therapy During Surgery

Start date: October 18, 2022
Phase:
Study type: Observational [Patient Registry]

The investigators will perform a clinical observational study of patients undergoing abdominal surgery. The study will be performed at Sykehuset Telemark, Skien. The aims of the study are to compare suprasternal and transoesophageal Doppler (reference method) to measure blood flow in the proximal descending aorta and to explore the variability of hemodynamic variables during surgery.

NCT ID: NCT05226481 Completed - PTSD Clinical Trials

Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth

Start date: January 1, 2018
Phase:
Study type: Observational

Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based practice (EBP) for the treatment of posttraumatic stress disorder (PTSD) and posttraumatic stress symptoms (PTSS) among children and adolescents. In the current study, data were collected from youth receiving TF-CBT in specialized child and adolescent mental health services (CAMHS) and their caregivers in 2018-2021.

NCT ID: NCT05218876 Completed - Clinical trials for Breast Cancer Female

Effects of Moderate and High-intensity Exercise During Chemotherapy on Muscle Cells in Women With Breast Cancer

PhysCan
Start date: December 8, 2016
Phase: N/A
Study type: Interventional

(Neo-)adjuvant chemotherapy for breast cancer has deleterious effects on muscle tissue resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high intensity training vs. low-to moderate intensity training on muscle tissue cellular outcomes and function in breast cancer patients during chemotherapy. The present study aims to compare the effects of high vs. low-to moderate intensity training on its ability to counteract deleterious effects of chemotherapy on skeletal muscle in women diagnosed with breast cancer. Eighty newly diagnosed women with breast cancer planned to start (neo-)adjuvant chemotherapy will be randomized to either a group performing a combination of strength and endurance training with high intensity or a group performing training with low to moderate intensity. Muscle biopsies from m. vastus lateralis for assessment of muscular cellular outcomes will be collected and muscle function and cardiorespiratory fitness will be measured before the first cycle of chemotherapy (or, when not possible, one week after) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% will be willing to take muscle biopsies. The study will give important information about the effects of different training intensities for breast cancer patients during treatment and will contribute with knowledge about how to refine exercise programs that are effective and compatible with multidisciplinary management of breast cancer.

NCT ID: NCT05217797 Completed - COVID-19 Clinical Trials

Glasses Against Transmission of SARS-CoV-2 (COVID-19) in the Community

GLASSY
Start date: February 2, 2021
Phase: N/A
Study type: Interventional

In this trial the researchers plan to recruit 25,000 volunteers to be randomly allocated either wearing sunglasses or ordinary glasses in public spaces where they are close to other people, or not wear glasses in such circumstances. For each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about results of COVID-19 tests during the trial period.