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NCT ID: NCT05534386 Recruiting - Neoplasms Clinical Trials

A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

This study, using a sequential multiple assessment randomized controlled trial (SMART) approach, will evaluate a cancer survivorship care intervention on physical symptom distress, weight management, self-efficacy in managing cancer and health-related quality of life among Chinese patients recently completed curative cancer treatment.

NCT ID: NCT05562492 Recruiting - Clinical trials for Cystic Fibrosis-related Diabetes

Closed-loop for People Living With Cystic Fibrosis Related Diabetes

CL4P-CF
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The main objective of this study is to determine whether closed-loop glucose control is superior to standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with cystic fibrosis (CF) related diabetes. This is an open-label, multicentre, randomised, single-period, two-arm parallel design study, involving a run-in period followed by a 26 week intervention period during which glucose levels will be controlled either by a hybrid closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 128 young people and adults (aiming for 114 completed participants) with CF related diabetes using insulin will be recruited through outpatient CF and diabetes clinics and other established methods at participating centres. Participants who drop out of the study within the first 4 weeks of the intervention period will be replaced. Participants will receive appropriate training in the safe use of the CGM and closed-loop devices. Participants will have access to the study team during the intervention phase with 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM over the 26 week period. Other key endpoints include time above target glucose range (>10mmol/L), mean glucose, and HbA1c. Secondary outcomes include time spent with glucose levels below target as recorded by CGM, and other CGM-based metrics in addition to percent of predicted FEV1, body mass index, fasting C-peptide levels, insulin requirements and number of pulmonary exacerbations and hospitalisations. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Psychosocial outcomes include CGM & closed-loop usage, health-related quality of life questionnaires, burden of diabetes management assessment and semi-structured interviews after participants have had at least three months experience of using the technology. Data will be collected for future health economic analysis.

NCT ID: NCT05564026 Recruiting - Germ Cell Tumor Clinical Trials

Molecular Epidemiology of Pediatric Germ Cell Tumors

Start date: April 12, 2023
Phase:
Study type: Observational

A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.

NCT ID: NCT05567640 Recruiting - Depressive Symptoms Clinical Trials

Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale. The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers. A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.

NCT ID: NCT05568069 Recruiting - Heart Failure Clinical Trials

RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

BRITISH
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries. Participants will be randomised into two groups. Half the participants will receive an Implantable Cardioverter-Defibrillator (ICD) and the other half will not. The aim of the study will be to compare all-cause mortality (death from any cause) between these two groups at 36 months, and longer-term to 10 years. The study has the potential to change international heart failure treatment guidelines and to improve how patients with this condition are managed.

NCT ID: NCT05619289 Recruiting - Chronic Pain Clinical Trials

Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

Start date: April 12, 2023
Phase: Phase 2
Study type: Interventional

The goal of this pilot clinical trial is to learn whether vitamin D is able to prevent chronic pain following burn injury and to determine what biological mechanisms are engaged by Vitamin D following burn injury. The main question[s] it aims to answer are: - Is the clinical trial protocol feasible? - Is Vitamin D administration following burn injury safe? - How does vitamin D cause changes in the immune system in the aftermath of burn injury? Following informed consent, participants will be asked to: - Take 6 capsules by mouth one time following burn injury (Vitamin D or Placebo) - Provide a blood sample at baseline and 6 weeks following injury - Fill out surveys daily while in the hospital, weekly through 6 weeks, and at 3 months and 6 months. Researchers will compare Vitamin D and placebo groups to see if there are differences in adverse effects (side effects), chronic pain, and profiles of immune cells from collected blood samples.

NCT ID: NCT05629052 Recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

TrEatment Approach in the Multimodal Era Registry

TEAM
Start date: April 12, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: - surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) - the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) - drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: - How many patients receive a given kind of treatment? - How do expert centers combine the different treatments? - Are patients doing better after they receive a given kind of treatment? - How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.

NCT ID: NCT05630586 Recruiting - Clinical trials for Acute Ischemic Stroke

Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

ASSET
Start date: April 12, 2023
Phase: Phase 2
Study type: Interventional

Can Semaglutide help reduce the damage caused by a stroke? ASSET trial is a national, multicenter, clinical trial, investigating the safety and efficacy of Semaglutide in non-diabetic patients with acute ischemic stroke. Stroke is a worldwide leading cause of long-term disability and death. In the most common type of stroke (ischemic stroke), a blood clot obstructs an artery in the brain, and thereby prevents oxygenated blood from reaching an area of the brain. Brain cells are particularly vulnerable to the lack of oxygen. In the areas most severely affected by a stroke, brain cells die after 5 minutes. As more time pass, the affected area expands, and more brain cells perish. Today, efficient treatments aiming at reestablishing the flow of blood by either breaking down the blood clot (thrombolysis) or removing the clot (thrombektomi) are used. However, a significant amount of patients undergoing succesful treamtent, still suffer permanent disability following an ischemic stroke. Semaglutide mimics a naturally occurring hormone (glucagon-like peptide-1) and is currently used to treat diabetes and obesity. However, semaglutide has also been shown to possess neuroprotective abilities in recent animal studies, where it reduced the damage caused by ischemic stroke in rats. This study sets out to investigate if it's possible to utilize Semaglutide, to increase the resilience of brain cells in patients with an acute ischemic stroke, with the aim of bettering their outcome. The participants consist of non-diabetic patients with acute ischemic stroke, who will be randomized to: - Treatment with subcutaneous Semaglutide, or - No additional treatment (control group) Both groups will be treated according to the standard national guidelies for acute ischemic stroke. The two groups will then be compared to see, if patients in the group treated with Semaglutide are less impacted by their stroke.

NCT ID: NCT05661201 Recruiting - Solid Tumor Clinical Trials

NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors

Start date: April 12, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about the safety of NEROFE and doxorubicin and how well it works in patients with advanced/unresectable or metastatic solid KRAS-mutated and ST-positive solid tumors. The main question it aims to answer is to find the recommended dose and scheduled for the combination of NEROFE and doxorubicin. Participants will receive weekly doses of NEROFE and doxorubicin.

NCT ID: NCT05667324 Recruiting - Clinical trials for Deviated Nasal Septum

Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

Start date: April 12, 2023
Phase: Phase 4
Study type: Interventional

Maxillary nerve blocks have been shown to significantly reduce post-operative pain and analgesic intake during the 24-hour period following sinus surgery. This randomized, double-blinded, placebo-controlled study will investigate blocks of the pterygopalatine fossa using a suprazygomatic approach during septorhinoplasty surgery. It is the investigator's hypothesis that this technique will result in decreased post-operative pain and opioid use, and the morbidity associated with it.