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NCT ID: NCT05665595 Active, not recruiting - Melanoma Clinical Trials

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Start date: January 19, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

NCT ID: NCT05652634 Active, not recruiting - Long COVID Clinical Trials

Chronic Stress as a Risk Factor for Long COVID

StressLoC
Start date: February 9, 2023
Phase:
Study type: Observational

The disease caused by the pathogen SARS-CoV-2 is known as coronavirus disease with the acronym COVID-19. The acute phase of this condition typically lasts one to two weeks and usually results in a full recovery. However, in about 10-30% of those affected, the symptoms persist for more than four weeks after the onset of the disease. In this case, there is an ongoing COVID-19 illness known as long COVID. Long COVID can persist for many months and cause significant distress and limitations to those affected due to the long-term health consequences. The causes of long COVID are still unclear and, accordingly, therapeutic measures are still insufficiently developed. It is assumed that long COVID can in principle affect anyone. Age, gender, obesity and the number of symptoms during an acute COVID-19 illness are discussed as risk factors for long COVID. Another potential risk factor for developing long COVID could be chronic stress, which has been shown to put a strain on the immune system. It is known from infections with other coronaviruses and other viral respiratory diseases that chronic stress can lead to prolonged illness and limited recovery. The aim of this study is to systematically examine chronic stress, as it existed before infection with the coronavirus, as a possible risk factor for long COVID. For this purpose, 600 people who have been proven to be infected with SARS-CoV-2 and have developed symptoms of COVID-19 will be included in this study.

NCT ID: NCT05621187 Active, not recruiting - Heart Failure Clinical Trials

Post Market Clinical Follow-up Study for the Pamira ICD Lead Family

Start date: November 30, 2022
Phase: N/A
Study type: Interventional

Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by - demonstrating clinical safety - evaluating performance based on sensing and pacing assessment - collecting additional data of interest to assess other aspects such as the handling and usability

NCT ID: NCT05587296 Active, not recruiting - Hot Flashes Clinical Trials

A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer

OASIS-4
Start date: October 14, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy. VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer. It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy. The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment. To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment. The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant. All participants will continue taking the anti-cancer therapy they have been using when entering the study. Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks. Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152. During the study, the participants will: - record information about their hot flashes - answer questions about their quality of life and other symptoms. The doctors and their study team will: - check the participants health and vital signs - take blood and urine samples - examine heart health using electrocardiogram (ECG) - examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs - make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable) - check the health of the participant's cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable) - take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis. - ask the participants questions about what medicines they are taking and if they are having adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants' health.

NCT ID: NCT05582395 Active, not recruiting - Clinical trials for Cardiomyopathy, Hypertrophic

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

ODYSSEY-HCM
Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

NCT ID: NCT05581303 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

NCT ID: NCT05565170 Active, not recruiting - Dementia Clinical Trials

Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults

LETHE
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

Previous research has shown that a healthy lifestyle, including a balanced diet, physical and social activity, and management of vascular risk factors can support both cardiovascular and brain health. In a landmark Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a multimodal lifestyle programme had clear benefits on older adults' cognition, functioning, and quality of life. The LETHE study utilises novel technologies and digital tools to deliver an optimised and more personalised FINGER-type multimodal lifestyle intervention. A total of 160 digitally skilled older adults (age 60-77) with risk factors for dementia but without substantial cognitive impairment will be recruited in Austria, Finland, Italy, and Sweden. Participants will be randomly assigned in a 1:1 ratio to the structured ICT-assisted multimodal lifestyle program (intervention group) or a self-guided lifestyle program (control group). Duration of the study and the intervention is 24 months. The multimodal lifestyle program covers the following domains: physical activity, nutrition, cognitive activity, vascular risk management, social interaction, sleep, and relaxation. The structured intervention program follows a hybrid model where regular in-person, individual and group-based intervention activities led by professionals are supported with activities in the LETHE mobile phone application. The self-guided (control) group receives relevant health advice and is recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Control group will have access to a simplified version of the LETHE app without any structured, scheduled activities or personalized content. The primary objective of the LETHE trial is to test the feasibility of a digitally supported multimodal lifestyle program (i.e., retention rate, adherence to intervention), and assess change in dementia risk based on validated risk scores (CAIDE, LIBRA). Other objectives include testing the intervention effects on lifestyle and risk factors, cognition, function, health-related quality of life, health literacy, physical functioning, and dementia-related biomarkers. To this aim, a range of personal, lifestyle, and health-related data will be collected both actively and passively with the help of digital devices. Attitudes towards digital tools and experiences of trial participation will also be explored.

NCT ID: NCT05556512 Active, not recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

SURMOUNT-MMO
Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

NCT ID: NCT05536297 Active, not recruiting - Clinical trials for Age-Related Macular Degeneration

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Start date: September 26, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

NCT ID: NCT05501873 Active, not recruiting - Atrial Fibrillation Clinical Trials

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

FARADISE
Start date: March 24, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSEā„¢ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSEā„¢ pulsed field ablation System is used per hospitals' standard of care.