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NCT ID: NCT04790370 Recruiting - Pulmonary Embolism Clinical Trials

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

HI-PEITHO
Start date: August 2, 2021
Phase: Phase 4
Study type: Interventional

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

NCT ID: NCT04790266 Recruiting - Cardiotoxicity Clinical Trials

Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients

CARDIOTOX
Start date: September 15, 2020
Phase:
Study type: Observational

To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%) measured on CMR and ECHO over the time window of 12 months from the end of radiation therapy.

NCT ID: NCT04790253 Recruiting - Clinical trials for Extensive-stage Small-cell Lung Cancer

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

PRIMALung
Start date: October 27, 2022
Phase: N/A
Study type: Interventional

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

NCT ID: NCT04789863 Active, not recruiting - Clinical trials for Stem Cell Transplantation

Implementation and Testing of an eHealth Integrated Model of Care for Patients Receiving Allogeneic Stem Cell Transplantation: The SMILe Project

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Numerous publications call for innovation based on integrated care principles, investment in self-management and use of eHealth to improve outcomes for allogeneic Stem Cell Transplant (alloSCT). While eHealth supported integrated care models are effective, real-world implementation remain elusive. The newly developed SMILe-Integrated Care Model (ICM) is the first theory-based eHealth supported integrated care model for alloSCT patients. SMILe-ICM includes four self-management modules (i.e., monitoring & follow-up, medication adherence, infection prevention, physical activity) and combines a human role, i.e., a Care Coordinator (CC), with a technological component (i.e., the SMILeApp). Patients monitor and transfer symptoms and health behaviours to their CC, who supports them in self-management and dealing with complications. Embedded in implementation science methodology, we aim to implement and test the SMILe-ICM at the University Hospital Basel (USB) in the first year post-alloSCT by evaluating effectiveness, implementation outcomes and implementation pathway. A hybrid 1 effectiveness-implementation randomized controlled trial will include 80 adult alloSCT patients who are transplanted and followed up at USB, have basic German proficiency and provide written informed consent. Patients with physical or mental conditions limiting the use of the SMILeApp will be excluded. About ten days before alloSCT, a stratified randomization based on participants' clinical risk scores will assign patients 1:1 to the control (CG) or intervention group (IG). The CG will receive usual care; the IG will receive the SMILe-ICM over one year with 12 CC visits and continuous use of the SMILeApp. Re-hospitalization rate (primary outcome), total healthcare utilization costs, acute and chronic GvHD episodes and survival will be assessed using medical records. Medication adherence will be assessed via the BAASIS© scale, treatment burden via the PETS©, health-related quality of life via the EQ-5D-5L©. Implementation outcomes will be assessed via questionnaires and the implementation pathway via qualitative focus groups, each from patient and CC perspectives. Patients will be followed up 3 months after the intervention ended. Intention-to-treat and per-protocol analyses will be conducted using the rate ratio by unconditional maximum likelihood estimation (Wald) for the primary outcome. Qualitative data will be analysed using mind-mapping techniques and thematic analysis.

NCT ID: NCT04788966 Completed - Diagnoses Disease Clinical Trials

Evaluation of an Innovative Speech-enabled Translator in Emergency Settings

Start date: November 29, 2018
Phase:
Study type: Observational

Survey-based satisfaction, performance and technical features evaluation of a speech-enabled fixed-phrase translation tool (BabelDR) in an emergency department.

NCT ID: NCT04788888 Recruiting - Clinical trials for Symptomatic Severe Aortic Stenosis

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

VANTAGE
Start date: June 13, 2021
Phase: N/A
Study type: Interventional

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

NCT ID: NCT04788836 Active, not recruiting - Obesity Clinical Trials

How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood)

BrainFood
Start date: November 1, 2021
Phase:
Study type: Observational

Obesity is currently one of the most substantial health burdens. Due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obesity and its comorbidities. Surgical rearrangement of the gastrointestinal tract remarkably alters metabolism and hormones acting on neurological and hypothalamic signalling, involved in food decision-making and eating behaviour. In this context, many patients who underwent bariatric surgery self-report changes in appetite, satiety and food preferences. Furthermore, new gut hormone-based (e.g. GLP-1 receptor agonist or GLP-1-RA) pharmacotherapies which mimic the effect of bariatric surgery show impressive efficacy on weight reduction by modulation of food behaviour. However, the mechanisms of such functional changes, and how they relate to food decision-making and food purchase behaviour remain unknown. In Part 2 of the BrainFood-project, the investigators propose a novel approach using digital receipts from loyalty card to unravel the effect of obesity treatments (surgical and non-surgical) on eating and food purchase behaviour in daily life.

NCT ID: NCT04786262 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Start date: March 29, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

NCT ID: NCT04784013 Completed - Atrial Fibrillation Clinical Trials

Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation

POWER-PLUS
Start date: March 24, 2021
Phase: Phase 4
Study type: Interventional

This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.

NCT ID: NCT04782102 Completed - Clinical trials for Social Anxiety Disorder

SOPHIE: Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents

SOPHIE
Start date: June 7, 2021
Phase: N/A
Study type: Interventional

This study's aim is to investigate the efficacy of the online-intervention SOPHIE. SOPHIE is an online-intervention for adolescents with social anxiety. In Switzerland, Germany, Austria and Liechtenstein, about one in 15 adolescents suffers from social anxiety. The SOPHIE intervention aims to help these adolescents to better understand and cope with their social anxiety symptoms and to feel more comfortable in social situations. The investigators intend to include 248 adolescents in the study. Stratified by subclinical and clinical level of social anxiety, participants will be randomly assigned to the SOPHIE group or the control group receiving care-as-usual. Both groups will complete online questionnaires and will be interviewed via telephone several times during the study. This allows to compare the two groups regarding their efficacy of the SOPHIE programme in terms of changes in social anxiety over time.