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NCT ID: NCT06302283 Enrolling by invitation - Bereavement Clinical Trials

Collateral Effects of Pandemics - Care for Informal Caregivers

COLLPAN-3A
Start date: March 2024
Phase:
Study type: Observational

The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics.

NCT ID: NCT06261333 Enrolling by invitation - Clinical trials for Hereditary Hemorrhagic Telangiectasia

Quality of Life in Patients With Hemorrhagic Telangiectasia

Start date: January 22, 2024
Phase:
Study type: Observational

Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established. Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used.

NCT ID: NCT06256497 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient With Type 2 Diabetes

Start date: June 27, 2023
Phase:
Study type: Observational [Patient Registry]

The Revita DMR Post Market Pilot Clinical Registry is a post-market, prospective, observational, noninterventional clinical registry in patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.

NCT ID: NCT06237673 Enrolling by invitation - Clinical trials for Coronary Artery Disease

The "CAD-Man" EXTEND Study

CAD-Man-EXTEND
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

CAD-Man Extend is the long-term follow-up (clinical, laboratory, and computed tomography (CT) imaging) of a single-center, randomized, controlled CAD-Man trial comparing a CT-first strategy with a direct- invasive coronary angiography (ICA) diagnostic and management strategy, in 329 patients clinically referred for ICA with atypical angina or chest pain. Overall goal: The extension of CAD-Man follow-up (clinical, laboratory, and CT imaging) to approximately 10 years will provide the opportunity to compare plaque burden with CT-guided management versus direct-ICA at long-term and other endpoints.

NCT ID: NCT06223126 Enrolling by invitation - Clinical trials for Hormonal Contraception

Stress Reactivity and Hormonal Contraception

Start date: January 22, 2024
Phase:
Study type: Observational

For almost 60 years, millions of women globally have relied on oral contraceptive (OC) pills for pregnancy prevention and addressing menstrual irregularities. However, 4-10% of users experience mood-related side effects such as depression and anxiety, often leading to discontinuation of OC use. Previous studies also indicate that OC usage may lead to chronic alterations in brain structure and the regulation of the hypothalamic-pituitary-adrenal axis, a system involved in regulating stress responses. In the proposed study the investigators aim to investigate in more detail how women who start taking oral contraception (OC) and women who stop taking OC differ in their stress reactivity and their mood from long-term OC users. Furthermore, assessing hormones will help to shed light on the connection between OC, stress reaction, sex hormones and the brain. To achieve this, individual biomarkers will be evaluated, including changes in brain anatomy, functional responses and connectivity during acute psychosocial stress and early changes in mood and well-being through ambulatory assessment.

NCT ID: NCT06212050 Enrolling by invitation - Aortic Stenosis Clinical Trials

Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis

Neo2BAV
Start date: September 15, 2023
Phase:
Study type: Observational

The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis. The clinical, procedural, and imaging characteristics will be collected from patients with severe BAV stenosis, regardless of the phenotype, and treated with TAVI using the ACURATE neo2 bioprosthesis worldwide.

NCT ID: NCT06185777 Enrolling by invitation - Cancer Clinical Trials

Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients

MOVE-ONKO
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible. The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients

NCT ID: NCT06164951 Enrolling by invitation - Achondroplasia Clinical Trials

A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

PROPEL3
Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

NCT ID: NCT06144008 Enrolling by invitation - Clinical trials for Delivery of Health Care

ESCAPE (Evaluating Surge Capacity And PrEparedness)

ESCAPE
Start date: September 26, 2023
Phase:
Study type: Observational

The ESCAPE study intends to assess the possibility of recruiting students as surge capacity work force in hospitals in the event of a major medical incident such as an epidemic or pandemic.

NCT ID: NCT06138808 Enrolling by invitation - Clinical trials for Epilepsy Intractable

5-SENSE Score Validation Study

Start date: January 9, 2024
Phase:
Study type: Observational

The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.