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NCT ID: NCT04579497 Completed - Clinical trials for Autonomic Nervous System

Temperature-dependent Changes in Cardiovascular Parameters During Warm Water Footbaths in Healthy Women

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

A study to explore whether different temperatures of warm water footbaths have different effects on the cardiovascular system, the autonomic nervous system and the general well-being of healthy women.

NCT ID: NCT04579354 Completed - Anxiety Clinical Trials

Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia

VR OP- tour
Start date: September 7, 2020
Phase: N/A
Study type: Interventional

Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Patients are not confronted with the real stimuli or situations that trigger the branches, but with virtual representations of them. Virtual reality (VR) makes it possible to create scenarios that would not be possible in reality because of the organisational, time or financial expenditure involved.The effectiveness of virtual stimulus exposure is well documented, especially in the case of object or situation-related fears in the context of specific phobias. It is therefore obvious that virtual stimulus exposure could also be suitable for minimising operation-associated fears.The research project described is designed to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this purpose, a virtual tour of the operating setting has been created, which enables patients to explore the surroundings in detail by means of VR glasses.

NCT ID: NCT04579159 Completed - Atrial Arrhythmia Clinical Trials

The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9)

Smart in OAC
Start date: January 26, 2021
Phase: N/A
Study type: Interventional

This feasibility study will develop and evaluate pathways to identify participants with wearable-detected absoulute Arrhythmia (AA) and to enable local study teams to contact them regarding participation in a controlled trial of oral anticoagulation in this population, which will be conducted after the feasibility study.

NCT ID: NCT04578314 Completed - Schizophrenia Clinical Trials

RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations

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

Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities.

NCT ID: NCT04578288 Completed - Clinical trials for Acute Ischemic Stroke

Individualized Blood Pressure Management During Endovascular Stroke Treatment

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

Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. Low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. Retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. Some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. Intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. We aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. For this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (PROBE).

NCT ID: NCT04577404 Completed - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Start date: October 29, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

NCT ID: NCT04577352 Completed - Friedreich Ataxia Clinical Trials

A Study to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Participants With Friedreich Ataxia

MOVE-FA
Start date: December 17, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy (using the modified Friedreich Ataxia Rating Scale [mFARS]) and safety of vatiquinone in participants with Friedreich ataxia (FA).

NCT ID: NCT04576988 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.

NCT ID: NCT04575597 Completed - Clinical trials for Coronavirus Disease (COVID-19)

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

Start date: October 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29

NCT ID: NCT04575181 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine

Start date: October 21, 2020
Phase: Phase 1
Study type: Interventional

The study will look at the efficacy and safety of NNC0268-0965 (referred to as insulin 965). The study aims to show that insulin 965 has positive effects on the blood vessels. Participants will get either the new insulin 965 or insulin glargine - a medicine that doctors already can prescribe (Lantus®). Which treatment participants get is decided by chance. Participants will self-administer 2 injections per day under the skin of the thighs for 26 weeks. Study participation will last for about 32 weeks. Participants will have 15 clinic visits, 2 magnetic resonance imaging (MRI) visits and 14 phone calls with the study doctor. There will be a number of in-house assessments to study the effect of the new insulin. The assessments will be explained later in detail. The treatment of disease is not an aim of this study. Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are not able to become pregnant.