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NCT ID: NCT04127669 Completed - Stroke Sequelae Clinical Trials

Study Evaluating Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke

OSU6162DB003
Start date: March 20, 2017
Phase: Phase 2
Study type: Interventional

Following stroke, a recovery process is promptly initiated, which leads to a partial rehabilitation. However, a number of disabling residual symptoms may persist for years and include mental fatigue, depression, cognitive deficits, neurological problems and more. In the lack of an effective treatment these symptoms will lead to major consequences for the individual and the surrounding society. OSU6162 has in earlier clinical studies of stroke patients shown evidence of a favorable effect on residual symptoms, especially mental fatigue, together with a mild side effect profile. In this phase II, randomized, placebo-controlled, two-armed study, a 16 week OSU6162 treatment will be compared to an equally long placebo treatment in patients with residual symptoms following stroke.

NCT ID: NCT04126330 Completed - Inflammation Clinical Trials

Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation

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

Study objectives: Immunity, Inflammation, and Brain Function To determine the effect of supplements with probiotics, Omega-3 and Vitamin D on the inflammatory marker highly sensitive CRP (primary outcome), markers of inflammation (secondary outcome), and gastrointestinal barrier function (secondary outcome) in elderly and obese cohorts that exhibit elevated inflammation at baseline. Mobility To determine the effect of supplements with probiotics, Omega-3 and Vitamin D on joints, bones, and muscles by means of the WOMAC questionnaire, sit/stand test (muscle function) and CTX-I (cartilage degradation) as secondary endpoints in elderly and obese cohorts that exhibit elevated inflammation at baseline.

NCT ID: NCT04123470 Completed - Malignant Melanoma Clinical Trials

A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma

Start date: January 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits (up to 57 weeks). The patients are then monitored for survival for maximum study participation of 48 months. The treatments will be given every 3 weeks. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival.

NCT ID: NCT04123327 Completed - Atrial Fibrillation Clinical Trials

Symptom Preoccupation in Atrial Fibrillation (AF) and Its Role in AF-related Disability

Start date: December 24, 2019
Phase:
Study type: Observational

A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

NCT ID: NCT04122846 Completed - Clinical trials for Somatic Symptom Disorder

Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder

MBS1
Start date: September 30, 2019
Phase: N/A
Study type: Interventional

The main purpose of the study is to conduct an initial feasibility evaluation of the new Internet-based EAET treatment manual. We will include 50 patients with somatic symptom disorder to take part of the treatment for nine weeks through the Internet. A within-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly. Feedback on content, process and potential caveats will be collected using surveys and written evaluations from the participants at post-treatment. Linear mixed models will be used to investigate trajectories of change in symptoms and processes.

NCT ID: NCT04121949 Completed - Angina, Stable Clinical Trials

Cost-effectiveness and Safety of the CADScorSystem in Patients With Symptoms Suggestive of Stable Coronary Artery Disease.

FILTER-SCAD
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery disease. Half of the patients will undergo stratification using a Diamond-Forrester score only, while the other half will undergo stratification using a Diamond-Forrester score and a CAD-score. The study hypothesis is that the addition of a CAD-score will reduce unnecessary testing without compromising patient safety.

NCT ID: NCT04121091 Completed - Anhedonia Clinical Trials

Pramipexole to Target "Anhedonic Depression"

PILOT-PRAXOL
Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

The heterogeneity of depression suggests that different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is an endophenotype within the depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic and antidepressant effects of add-on pramipexole using an "enriched population study design" including only depressed patients with significant anhedonia. To understand the neurobiology of anhedonia in depression and to identify treatment predictors, the investigators also do assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.

NCT ID: NCT04119843 Completed - Clinical trials for Severe Renal Impairment

Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

SPARKLE
Start date: February 19, 2020
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

NCT ID: NCT04119258 Completed - Depression Clinical Trials

Therapist Adherence to Cognitive-behavioral Therapy

Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

An observational web-based survey on therapist adherence to evidence-based cognitive-behavioral therapy (CBT) in the perspective of their patients with depression or anxiety disorders in psychiatric outpatient care in Stockholm, Sweden. Following completion of CBT, participants respond to questions including their age, gender, education, whether they have improved, whether they considered treatment helpful, and an instrument measuring therapist adherence to CBT procedures (e.g., setting agenda, follow up on home assignments) and CBT techniques (e.g., exposure, cognitive restructuring). The purpose of the study is to contribute to quality assurance of CBT in Stockholm Health Care Services.

NCT ID: NCT04117789 Completed - Clinical trials for Major Depressive Disorder

Feasibility of Internet-delivered CBT for Adolescents With Depression

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

Prior to a properly powered randomized controlled study, evaluating efficacy and cost-effectiveness of ICBT, we will conduct a pilot study to investigate if the trial design is feasible, if therapist-guided and self-guided internet-delivered cognitive behavioral therapy (ICBT) is acceptable for adolescents with depression and to provide preliminary clinical efficacy data.