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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: NCT04118556 Recruiting - GVHD, Acute Clinical Trials

Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT

2017-00355
Start date: December 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A two-stage design. An open, non-randomized, 3+3 dose escalating scheme will be used in the first stage of the study. A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease in the second part of the study. Patients in each phase will receive 2 doses of DSC. In the second part (Phase II) additional doses (up to 6 doses) may be given depending on response. No cross-over are planned in the second stage of the study.

NCT ID: NCT04117854 Recruiting - Clinical trials for Spinal Cord Injuries

Spinal Cord Injury in the Pediatric Population - an International Multicenter Study

SINpedSCI
Start date: October 1, 2018
Phase:
Study type: Observational

INTRODUCTION: Due to the low incidence of pediatric spinal cord injury (SCI) and the high demand for knowledge and research, international cooperation is needed to build a solid and shared understanding of the extent of the problem, and also uniformity in treatment and measurement methods. The aim of the study is to map organization of care and rehabilitation of children and adolescents < 18 years of age with SCI, to explore qualitatively psychosocial aspects of individuals and to establish use of common outcome measures in 10 rehabilitation units from seven countries, cooperating within the Sunnaas International Network in Rehabilitation (SIN); China, USA, Russia, Israel, Palestine, Norway and Sweden. METHOD: In Phase I two cross-sectional studies will be conducted to set the scene for the outcome studies following in Phase II (2020-2022). Phase I consists of a quantitative descriptive study using a websurvey to describe and compare the systems of care and delivery of inpatient rehabilitation services for pediatric SCI patients. In addition, a qualitative study will explore the psychosocial aspects of living with a childhood acquired SCI. Two adolescents, aged 13-17 years and at least 6 months post-acute treatment, from each unit will interviewed using a semi-structured interview guide. Ethical approval has been applied for in each unit, and the study is registered at ClinicalTrial-gov. A workshop for the 24 study team members, where the main focus was to ensure that data collection is conducted in a good manner, was held in May 2018, and data collection is expected finalized by 2020. Phase II (planning stage) will consist of methodological outcome studies. DISCUSSION: Phase I of the study will broaden the body of knowledge on pediatric SCI internationally, thus enabling comparison, discussion and development of organizational models and quality of care and rehabilitation for young persons with SCI. Phase II will contribute to the use of common and reliable outcome measures for these patients.

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.

NCT ID: NCT04117672 Recruiting - Clinical trials for Traumatic Brain Injury

Antisecretory Factor In Severe Traumatic Brain Injury

AFISTBI
Start date: March 10, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates the addition of Salovum, an egg yolk powder enriched for antisecretory factor, to standard care of participants with severe traumatic brain injury. Half of the participants will be administered Salovum while the other half will be given a placebo egg yolk powder, not enriched for antisecretory factor. Intracranial pressure (ICP), partial brain oxygen pressure (PtbO2), microdialysis of metabolites and inflammatory mediators and trauma intensity level (TIL) will be assessed in all patients.

NCT ID: NCT04117568 Terminated - Sepsis Clinical Trials

The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients

Start date: September 4, 2019
Phase:
Study type: Observational

Surgical trauma elicits an immune response aiming to initiate healing and remove debris and damaged tissue locally at the wound site (1). This local reaction includes a considerable production of cytokines and chemokines that enters the circulation and initiate a systemic inflammatory response mediated by circulating cytokines and chemokines. This response is called systemic inflammatory immune response (SIRS) and is an aseptic systemic inflammation. Postoperative inflammation produces proinflammatory cytokines, mainly IL-6, IL1 beta, and tumor necrosis factor alfa (2). Neutrophils and emergency granulopoesis Polymorphonuclear neutrophils constitute the most abundant population of white blood cells. Their main task is to provide innate immune protection of the host from microbial attack, migrating to the site of infection, engulfing the microbes by phagocytosis, and killing the prey through attack by reactive oxygen species (ROS) and antimicrobial granule pro¬teins (22). Upon systemic infection or inflammation, e.g., sepsis or trauma, the bone marrow enters a state of emergency granulopoiesis, drenched in cytokines that augment production and survival of neutrophils for rapid delivery to the blood (23-25). Recently, advanced techniques have evolved that al¬low the isolation of different developmental stages of steady-state and emergency neutrophils, and characterization of these has just begun (26). Glycans Glycans (polysaccharides) attached to proteins and lipids on the surfaces on immune cells serve as ligands for glycan-binding proteins, lectins. Several neutrophil processes are directed by gly¬can - lectin interactions; selectin-directed rolling on the endothelium, siglec-mediated in¬hibitory signals, and activation of effector function by galectins. Many of the proteins that end up in neutrophil intra-cellular granules are highly glycosylated, but not much is known about if and how the neutrophil glycome evolves during the 'targeting-by-timing' process of differentiation and how this is affected by emergency granulopoiesis during systemic infection and inflammation. Here is a clear knowledge gap.

NCT ID: NCT04116411 Recruiting - Clinical trials for Glioblastoma Multiforme

A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients

VIGAS2
Start date: September 4, 2019
Phase: Phase 2
Study type: Interventional

This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Valganciclovir is approved for treatment of cytomegalovirus (CMV) infections, but may also have anti-tumoral effects. Current evidence imply that most glioblastomas are CMV positive and that the virus can affect tumor aggressiveness.