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NCT ID: NCT05993728 Recruiting - Eating Disorders Clinical Trials

Virtual Body Project Groups Led by Peers Versus Clinicians

v-BP
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).

NCT ID: NCT05993468 Completed - Clinical trials for Complex Post-Traumatic Stress Disorder

A Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention

Start date: January 1, 2019
Phase:
Study type: Observational

This mixed-methods pilot study aim to assess the changes in symptoms of post-traumatic stress disorder (PTSD), complex post-traumatic stress disorder (CPTSD), dissociative symptoms, self-critique, and self-compassion following participation in a 16-week trauma-sensitive mindfulness and compassion (TMC) intervention. Adverse experiences of participation are also explored explicitly.

NCT ID: NCT05987618 Completed - Clinical trials for Sleep Apnea, Obstructive

Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial

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

The goal of this randomized crossover trial is to investigate the effect of elastic bands attached to oral appliances to minimize mouth opening during sleep in obstructive sleep apnea (OSA) patients. The main questions it aims to answer are: - Are the success rates (>50% reduction of AHI) of oral appliances with elastic bands superior to oral appliances treatment without elastic bands in treatment of moderate and severe OSA? - Are there predictors that can identify patients that will benefit from use of elastic bands in oral appliance treatment of OSA? - Are there predictors that can identify patients that are classified as non-responders to oral appliance treatment in general, both with and without elastic bands? Participants will be treated with oral appliances with and without elastic bands for 3 weeks, in randomized order. At the end of each 3-week period, the effect of the treatment will be investigated with sleep registrations and questionnaires. After the completion of both 3-week periodes, patients will continue using their preferred treatment modality (with or without elastic bands) and the oral appliance will be titrated if suboptimal treatment effect.

NCT ID: NCT05984797 Recruiting - Cancer Clinical Trials

Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

INSPIRE
Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The goal of this intervention trial is to determine if palliative rehabilitation in addition to usual care is more effective than usual care at improving health-related quality of life in patients with incurable solid cancer.

NCT ID: NCT05982340 Recruiting - Clinical trials for Acute Kidney Injury Due to Sepsis

Endogenous Lithium Clearance in Acute Kidney Injury

Start date: August 1, 2023
Phase:
Study type: Observational

Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. The investigators hypothesized that endogenous lithium reabsorption is impaired in the early stages of critical illness. Investigators would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10 healthy controls.

NCT ID: NCT05970172 Recruiting - Clinical trials for Chronic Kidney Disease

A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help the bone marrow make more red blood cells. These are often given together with iron. This treatment is also available to children and teenagers with CKD. However, there are some safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option for treating anemia in children and teenagers with CKD. In this study, children and teenagers with CKD and anemia will take roxadustat for up to 52 weeks to treat their anemia. The main aim of the study is to learn how roxadustat affects anemia in children and teenagers with CKD. This is an open-label study which means the children and teenagers in the study and the clinic staff know they will be taking roxadustat. In this study, the children and teenagers with CKD who need treatment for anemia can take part. Those currently being treated with an ESA will be switched to roxadustat. Those who have not been treated with an ESA can start on roxadustat straight away. All children and teenagers in the study will take roxadustat 3 times a week for up to 52 weeks (1 year). They will start on a fixed dose of roxadustat for 4 weeks. Blood samples will be taken regularly to check hemoglobin levels. The roxadustat dose may be changed if the blood levels of hemoglobin are too high, too low, or change too quickly. After 4 weeks the dose may be changed, if needed, to keep blood levels of hemoglobin in the blood to just below the normal range. Firstly, teenagers will take roxadustat. 10 teenagers will take their fixed dose of roxadustat for 4 weeks. They will give blood samples to help the researchers work out the most suitable dose for the rest of the teenagers in the study. When the rest of the teenagers start taking roxadustat at the most suitable dose for teenagers, 10 children will take roxadustat for 4 weeks. These 10 children will give blood samples to help the researchers work out the most suitable dose for the rest of the children in the study. Then, the rest of the children will take roxadustat at the most suitable dose for children. There will be many clinic visits during the study. Overnight hospital stays are not expected. There will be 1 visit every 2 weeks for the first 4 weeks of taking roxadustat, then every 4 weeks until the end of treatment. Finally there is 1 visit 4 weeks after treatment has finished. During most visits, the children and teenagers will have their vital signs checked (blood pressure, body temperature and heart rate). Fluid status (how much water is in the body) will also be checked for those who need dialysis. The children and teenagers will also have blood tests and the study doctors will check for any medical problems. The children and teenagers will have a medical examination before their first dose of roxadustat and again at about 24-week (6-month) and 52-week (13-month) visits. They will have an electrocardiogram (ECG) before their first dose of roxadustat and again at the 12-week, 24-week, 36-week, and 52-week visit. They will also have urine tests at the 4-week, 24-week and 52-week visits. At the 52-week visit, the children and teenagers will also have blood tests for hemoglobin and iron levels. The study doctors will also check for any medical problems.

NCT ID: NCT05964764 Recruiting - Clinical trials for Brain Injuries, Traumatic

Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

SHIPP
Start date: April 1, 2018
Phase:
Study type: Observational [Patient Registry]

Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed. The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department. The main research question is: - Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes? Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group. The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records >1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (>6 months).

NCT ID: NCT05961761 Recruiting - Clinical trials for Undifferentiated Pleomorphic Sarcoma

Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients

PROPANE
Start date: August 17, 2021
Phase: Phase 2
Study type: Interventional

The goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. The main questions aims to answer: - Primary: determine the progression-free survival rate (PFSR) at 3 months Secondary: determine the objective response rate (ORR), duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS). Ensure the safety and tolerability, Determine Quality of Life (QoL) • Exploratory: Characterize the TME Participants will be asked to ensure - Baseline biopsy and further optional biopsies - Treatment propranolol 40 mg BID and pembrolizumab 2 mg/kg Q3 weeks - Evaluation, blood counts, QoL and blood samples for biomarkers according to schedule

NCT ID: NCT05960565 Recruiting - Type 1 Diabetes Clinical Trials

Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Start date: June 20, 2023
Phase: Phase 2
Study type: Interventional

The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection. The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

NCT ID: NCT05955807 Active, not recruiting - Suicide Prevention Clinical Trials

Momentary Assessment.Tracking Suicidal Ideation

Start date: August 15, 2022
Phase:
Study type: Observational

The goal of this observational study is to increase the knowledge base about fluctuations in suicide ideation and its association with relational and contextual factors after hospital discharge in patients with high risk of suicide. Patients hospitalized due to severe risk of suicide (recent suicide attempt or due to acute suicidality) are invited to participate in the study. Researchers will investigate how psychological, relational and contextual factors trigger as well as protect against escalating suicide ideation in this period in the post discharge period. Information will be retrieved from multiple sources (eg. by Ecological Momentary Assessment Method (EMA), regular patient interviews and questionnaires in addition to information from Electronic Patient Registry) to; a) delineate fluctuations in suicide ideation, b) identify factors that are associated with/ influence suicide ideation in the EMA assessment period, c) explore associations with relational and contextual measures during EMA assessment, d) generate profiles for subgroups and investigate how participants experience and evaluate their participation and completion of the EMA assessment protocol.