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NCT ID: NCT06084091 Recruiting - Clinical trials for Coronary Artery Disease

Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

ECS
Start date: October 6, 2023
Phase:
Study type: Observational

The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients The main questions it aims to answer are: - The Devices can record myocardial spectrometric data for analysis, and - How these measures correlate with the occurring events, procedures, and clinical parameters during the operation. - Number of participants with device-related adverse events as assessed by CTCAE v4.0

NCT ID: NCT06083064 Recruiting - Appendicitis Clinical Trials

Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis

PROSECCO
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question[s] it aims to answer are: - Does protocol based selective imaging using clinical scoring affect clinical outcome? - Does protocol based selective observation combined with score based selective imaging affect clinical outcome? Participants will be randomized into three groups: - Selective imaging based on Adult Appendicitis Score - Selective observation based on Appendicitis Severity Score combined with selective imaging based on Adult Appendicitis Score - Routine imaging using ultrasound and/or computed tomography Researchers will compare selective imaging groups separately with routine imaging to see if number of negative appendectomies or number of complicated appendicitis is not significantly increased.

NCT ID: NCT06082037 Recruiting - Clinical trials for Lung Transplant Rejection

A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

ROCKaspire
Start date: October 10, 2023
Phase: Phase 3
Study type: Interventional

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.

NCT ID: NCT06079190 Recruiting - Alzheimer's Disease Clinical Trials

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

PROGRESS-AD
Start date: October 20, 2023
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

NCT ID: NCT06077864 Recruiting - Obesity Clinical Trials

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

Start date: November 17, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.

NCT ID: NCT06075147 Recruiting - Visual Impairment Clinical Trials

The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema

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

This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.

NCT ID: NCT06070038 Recruiting - Clinical trials for Inactivity, Physical

A Collaborative Theory-based Intervention to Promote Physical Activity Among Sedentary Parents and Their Children

ProAct
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

Insufficient physical activity in children and adults is linked to increased risk of physical and mental health conditions. Parents have an important influence on their children's activity, and preliminary aimed at promoting physical activity suggest the family unit as a potentially efficacious means of delivery. However, there is relatively little research examining the efficacy of family interventions aimed at promoting both parents' and children's physical activity. In addition, many family-based interventions are not guided by behavioral theory known to enhance intervention efficacy and reduce variability, and do not target low-active families. This project will therefore develop and test the efficacy of a theory-based behavioral intervention to increase physical activity engagement in low-active children and their parents. The intervention will adopt a randomized waitlist-controlled design with parents and their children allocated to an intervention group that receives theory-based content targeting changes in key behavioral determinants or to a waitlist control group that receives measurement only. The intervention will be delivered to parent-child dyads in a series of four online meetings with a trained facilitator, accompanied by web-based supporting materials, and a moderated social support online chat group. The primary dependent variable will be parents' and children's leisure time physical activity, and secondary outcomes will be device measured physical activity (intervention group only) and measures of key theory-based determinants of physical activity, including autonomous motivation, attitudes, subjective norms, self-efficacy, intentions, and perceived autonomy support. These outcomes will be measured at baseline and at 3, 6, and 12 months post-baseline. Parents and children allocated to the intervention group are expected to exhibit higher levels of physical activity and behavioral determinants. Intervention effects on physical activity change are expected to be mediated by the theory-based determinants, consistent with psychological theory. The project will contribute to research by testing the efficacy of a unique intervention based on behavioral theory expected to be effective in promoting physical activity in low-active parents and their children, and providing guidelines and materials that practitioners in health promotion and public health can use in campaigns and national strategies to promote physical activity in this population.

NCT ID: NCT06066528 Recruiting - Obesity Clinical Trials

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

SYNCHRONIZE™-2
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.

NCT ID: NCT06065748 Recruiting - Clinical trials for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

NCT ID: NCT06065540 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

REIMAGINE 2
Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).