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NCT ID: NCT05655260 Recruiting - Clinical trials for Endometrial Adenocarcinoma

PErsonalized TReatment for Endometrial Carcinoma

PETREC
Start date: February 8, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare: - Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas. - Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup. - Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.

NCT ID: NCT05654623 Recruiting - Clinical trials for Advanced Breast Cancer

A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

VERITAC-2
Start date: March 3, 2023
Phase: Phase 3
Study type: Interventional

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

NCT ID: NCT05649384 Recruiting - Clinical trials for NSTEMI - Non-ST Segment Elevation MI

Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)

PRESC1SE-MI
Start date: December 1, 2020
Phase:
Study type: Observational

The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.

NCT ID: NCT05646303 Recruiting - Clinical trials for Alcohol Use Disorder

Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

Start date: May 2, 2022
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are: - Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? - Is treatment with psilocybin and therapy safe for participants? Participants will - Attend 13 study visits - Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo - Record their daily alcohol consumption on study specific device Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.

NCT ID: NCT05637294 Recruiting - Clinical trials for Carpal Tunnel Syndrome

Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome

FINCROSS
Start date: February 15, 2023
Phase: N/A
Study type: Interventional

Carpal tunnel syndrome is a common compression neuropathy of upper extremities. Its usual symptoms are pain, numbness and tingling of fingers, which tend to be worse at night. Splinting the wrist with an external orthosis is usually a first-line treatment provided to most people with mild to moderate disease. The FINCROSS trial (randomized cross-over trial) aims to assess the effect of night-time and full-time splinting in comparison with no-treatment. It also aims to identify possible subgroups of people who would benefit from splinting, as well as assess if positive response to splinting is associated with subsequent lower need of surgery. The trial will recruit 110 people with carpal tunnel syndrome in Finland. Each participant will undergo all three treatment periods in a randomised order: 1) splinting at night-time for six weeks, 2) splinting both day and night for six weeks; and 3) be assessed under a six weeks long control period of no-treatment. Each treatment period will be separated with a three-week washout period. Therefore, the whole treatment sequence for each participant lasts 24 weeks after randomization. The participant will be followed-up to 1 year after the randomisation. Additionally, the participants will get instructions for self-administered stretching exercises to perform throughout the study. All participants will be asked to avoid any intervention administered or supervised by medical personnel (such as structured supervised exercises, manual therapy, steroid injections, surgery, etc.).

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05634239 Recruiting - Clinical trials for Cardiovascular Diseases

Senior Health Clinic Study

Start date: January 2, 2020
Phase: N/A
Study type: Interventional

Turku Senior Health Clinic study The Turku Senior Health Clinic Study was targeted to 75-year-old citizens with an underlying idea that at that age it would be almost the last moment to nudge people towards healthy lifestyle and taking care of their health and functional ability to maintain independent living. The short-term aims of the Turku Senior Health Clinic Study are to survey health and functional statuses and prevalence of specified risk factors for CVDs, dementia, frailty, and functional decline of 75-year-old independently home-dwelling citizens of the city of Turku. The aims also include assessment the frequency of follow-up treatments needed, and recommendations given for lifestyle changes and evidence-based drug treatment, as well as fulfillment of these recommendations. Also, participants feedback on the Turku Senior Health Clinic will be assessed. In addition, based on the results, recommendation for the content and implementation of preventive health clinic targeted to older people will be provided. The long-term aim of the research project is to assess the effects of the Turku Senior Health Clinic on the need of institutional care and home care as well as the cost-effectiveness of the clinic during the 10-year follow-up. For this purpose, participants of the Senior Health Clinic Study will be compared to that of non-participants and earlier cohorts of 75-year-olds in terms of the use of home care and institutional care.

NCT ID: NCT05632432 Recruiting - Clinical trials for Coronary Artery Disease

Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery

AAMS2
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF). The atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing. In this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy. In our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit. Based on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery. The trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.

NCT ID: NCT05625399 Recruiting - Melanoma Clinical Trials

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

RELATIVITY-127
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

NCT ID: NCT05621798 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements (REM) for Hearing Aid Fitting

BREM
Start date: September 7, 2022
Phase: N/A
Study type: Interventional

Adjusting hearing aid user's real ear performance by using probe-microphone technology (real ear measurement, REM) has been a well-known procedure that verifies whether the output of the hearing aid at the eardrum matches the desired prescribed target. Still less than half of audiologists verify hearing aid fitting to match the prescribed target amplification with this technology. Recent studies have demonstrated failures to match the prescribed amplification targets, using exclusively the predictions of the proprietary software. American Speech-Language-Hearing Association (ASHA) and American Academy of Audiology (AAA) have created Best Practice Guidelines that recommend using real-ear measurement (REM) over initial fit approach and also the recent ISO 21388:2020 on hearing aid fitting management recommends the routine use of REM. Still audiologists prefer to rely on the manufacturer's default "first-fit" settings because of the lack of proof over cost-effectiveness and patient outcome in using REM. There are only few publications of varying levels of evidence indicating benefits of REM-fitted hearing aids with respect to patient outcomes that include self-reported listening ability, speech intelligibility in quiet and noise and patients' preference. Our main research question is whether REM-based fitting improves the patient reported outcome measures - PROMs (SSQ, HERE) and performance-based outcome measures (speech-reception threshold in noise) over initial fit approach. An additional research question is whether REM-based fitting improves hearing aid usage (self-reported & log-data report). Eventually, the investigators will calculate the cost-effectiveness of REM-based fitting.