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NCT ID: NCT04790136 Completed - Clinical trials for Comparative Bioavailability

Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

Glatt Pharmaceutical Services GmbH & Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions. The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution. Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.

NCT ID: NCT04788641 Completed - Hyperkalaemia Clinical Trials

Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

Start date: March 30, 2021
Phase: Phase 1
Study type: Interventional

This study will be an open-label, randomised sequence, 2-period, 2-cohort, 2-treatment in each cohort, cross-over study in healthy subjects (males and females of non-childbearing potential), performed at a single study centre.

NCT ID: NCT04788511 Completed - Obesity Clinical Trials

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

STEP-HFpEF
Start date: March 16, 2021
Phase: Phase 3
Study type: Interventional

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity. The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04784884 Completed - Tissue Oxygenation Clinical Trials

Hyperspectral Imaging in Thoracic Surgery

PILOT-Tx-HSI
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to find out whether hyperspectral imaging enables bronchus stump and bronchus anastomosis oxygenation.

NCT ID: NCT04783935 Completed - Multiple Sclerosis Clinical Trials

Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

Start date: March 10, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

NCT ID: NCT04782648 Completed - Clinical trials for Bariatric Surgery Candidate

Transit Bipartition After Sleeve Gastrectomy

TB-LSG
Start date: November 1, 2017
Phase:
Study type: Observational

Retrospective analysis of 100 morbidly obese patients who underwent a transit bipartition (TB) procedure ("Single Anastomosis Sleeve Ileal bypass") for inadequate weight loss or weight recidivism after a previous sleeve gastrectomy. Data were collected prospectively in strictly pseudonymous form. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux) as well as safety.

NCT ID: NCT04782570 Completed - Phobia Clinical Trials

Psychotherapy of Anxiety Disorders With Noninvasive Brain Stimulation - Using Virtual Reality

Start date: May 12, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to transfer the rTMS stimulation protocol by Raij et al. (2018) into a therapeutic setting to improve exposure therapy in acrophobic patients. The quasi-randomized, placebo-controlled and double-blinded study will include 88 patients with height phobia (according to DSM 5). All participants will perform two exposure sessions in virtual reality (VR). Before exposure therapy, one group will receive verum rTMS of the left frontal cortex, which is indirectly functionally linked to the ventromedial prefrontal cortex (Raij et al., 2018). The control group will receive sham stimulation. A structural MRI and a TMS navigation system will be used for precise localization of the left FC. Anxiety symptoms will be measured using subjective ratings (e.g. Acrophobia Questionnaire) and the behavioural approach task (BAT) in VR and in real life before and after the treatment, and at 6 months follow-up. Furthermore, blood samples will be collected before rTMS and after exposure treatment to assess epigenetic and gene expression based changes.

NCT ID: NCT04780295 Completed - Covid19 Clinical Trials

Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications

CORE-THROMB
Start date: April 15, 2020
Phase:
Study type: Observational

This online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (Covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of imaging tests for the detection of cardiovascular events in patients with Covid19. This will also facilitate and constitute the basis for the conduction of interventional thromboprophylaxis studies in patients with Covid19.

NCT ID: NCT04780165 Completed - Demodex Blepharitis Clinical Trials

Efficacy and Tolerability of Blephademodex Wipes

Start date: September 11, 2019
Phase: N/A
Study type: Interventional

Primary Objective - To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS). Secondary Objectives - To evaluate the efficacy of Blephademodex eyelid hygiene wipe treatment in Demodex blepharitis as assessed by the change alone and in combination with a subsequent maintenance period of treatment with Blephaclean eyelid cleansing wipes ocular symptoms by: adapted TOSS; SANDE; specific blepharitis symptoms; Demodex count; ocular surface redness (Efron scale); lid margin redness/swelling (Efron / custom scale); Dandruff coverage at bases of eyelashes; ocular surface staining (Oxford scale; corneal only) - To evaluate subject and physician satisfaction with Blephademodex eyelid hygiene wipes - To evaluate ease of use for Blephademodex eyelid hygiene wipes - Adverse events are documented and analyzed.

NCT ID: NCT04779437 Completed - Depression Clinical Trials

Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work

Start date: March 17, 2021
Phase: N/A
Study type: Interventional

The study is an initial investigation of the feasibility of applying Bayesian sequential analyses to individual participant single-case data for rapid detection of whether or not the individual is benefitting from a low-intensity computerized cognitive training intervention for depression. Patients waiting for, or in follow-up from, outpatient psychological therapy will complete first a two-week period of daily symptom monitoring, followed by two different two-week cognitive training interventions. Data collected will be used to assess feasibility of a future formal case series using Bayesian sequential analyses to determine switching of interventions, and inform the analysis parameters for such a future study.