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NCT ID: NCT06409234 Not yet recruiting - Clinical trials for Elective Surgical Procedure

Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients

Start date: June 30, 2024
Phase:
Study type: Observational

In August 2022 the European Society of Cardiology published updated guidelines including recommendations on preoperative transthoracic echocardiography. The update resulted in broadened criteria for preoperative transthoracic echocardiography. The impact of preoperative transthoracic echocardiography on outcome is controversial and the evidence was mostly derived from administrative databases. Also there is also a knowledge gap in terms of what changes in perioperative managements are derived from transthoracic echocardiography information in current daily practice in Europe and what their impact on outcome may be. Further, a secondary analysis in a large international cohort suggests that the criteria endorsed by the guidelines to define the class of recommendation of transthoracic echocardiography may not be efficient.

NCT ID: NCT06402123 Not yet recruiting - Clinical trials for Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)

A Phase 2b Study of Zagociguat in Patients With MELAS

PRIZM
Start date: July 15, 2024
Phase: Phase 2
Study type: Interventional

PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.

NCT ID: NCT06390384 Not yet recruiting - Clinical trials for Blended-care Counselling

Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.

STEPS@SCHOOL
Start date: August 1, 2026
Phase: N/A
Study type: Interventional

The objectives of this two-arm phase-IIa randomized, controlled study are: - to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital and mental health literacy only (treatment as usual) concerning the reduction of psychiatric burden in adolescents. - to improve the well-being and level of participation in adolescents at risk for psychiatric disorders. - to reduce the expression of psychiatric symptoms in adolescents with enhanced psychiatric burden. - to test whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support is well accepted by students, their parents, and teachers. - to identify individual factors predicting the improvement of well-being and level of participation in adolescents as well as the acceptance of the prevention program in all subjects involved (students, parents, teachers, psychologists). - to investigate whether the clinic-guided personal counseling with a therapy-assistive digital support causes reduction of primary and secondary costs in the psychosocial support system and represents an economic advantage.

NCT ID: NCT06388382 Not yet recruiting - Clinical trials for Implantable Defibrillator User

Investigation of the Audible ICD Alert Tone

Start date: May 15, 2024
Phase:
Study type: Observational

Ability of ICD patients to hear the audible ICD alert is being assessed.

NCT ID: NCT06388369 Not yet recruiting - Clinical trials for Very High Risk Prostate Carcinoma

Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer

NEPI
Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

A randomized, open-label Phase I/II study of neoadjuvant treatment with [177Lu]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.

NCT ID: NCT06388187 Not yet recruiting - Obesity Clinical Trials

A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

NCT ID: NCT06382675 Not yet recruiting - Autoimmune Diseases Clinical Trials

Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

plasmaFlux
Start date: April 2024
Phase: N/A
Study type: Interventional

The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process. The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment.

NCT ID: NCT06381427 Not yet recruiting - Heart Failure Clinical Trials

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

PeriOP-CARE HF
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery.

NCT ID: NCT06380686 Not yet recruiting - Clinical trials for Squamous Cell Carcinoma of the Oral Cavity

Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome

HEAT
Start date: May 2024
Phase:
Study type: Observational [Patient Registry]

Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients.

NCT ID: NCT06379828 Not yet recruiting - Self-Assessment Clinical Trials

Self-assessment Tool for Implementing the ESCNH

Start date: June 3, 2024
Phase:
Study type: Observational

This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability.