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NCT ID: NCT06051968 Enrolling by invitation - Hearing Loss Clinical Trials

Effects of an Online Hearing Support for First-time Hearing Aid Users

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.

NCT ID: NCT06044337 Enrolling by invitation - Clinical trials for Subacute Cutaneous Lupus Erythematosus

A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

AMETHYST LTE
Start date: October 3, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

NCT ID: NCT06022068 Enrolling by invitation - Alzheimer Disease Clinical Trials

Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography

ERAP
Start date: September 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This single-center, uncontrolled pilot study aims to evaluate the efficacy, safety, and tolerability of six months of intermittently dosed oral rapamycin (sirolimus) in subjects with early-stage Alzheimer's disease. Fifteen participants will be recruited. Following a set of baseline measurements, all participants will receive a weekly oral dose of 7 mg rapamycin for six months. Participants will be continuously monitored for safety and side effects. At the termination of the treatment, follow-up measurements will be taken. The primary endpoint will be change in cerebral glucose metabolism, measured using 18F labeled fluorodeoxyglucose ([18F]FDG) positron emission tomography (PET). In addition to the registered outcome measures this pilot trial will explore the feasibility of acquiring data on the effect of sirolimus treatment on age-related tissue changes in the body using a variety of imaging modalities, such as bone mineral density assessed using quantitative computed tomography, retinal structures assessed using optical coherence tomography, periodontal tissue assessed using MRI and FDG-PET, cardiac function assessed using MRI, vessel wall in large arteries using MRI and [18F]FDG PET.

NCT ID: NCT06019364 Enrolling by invitation - Blood Transfusion Clinical Trials

Transfusion of Whole Blood in Acute Bleeding

HEPEP
Start date: September 10, 2023
Phase:
Study type: Observational

Blood collected from blood donors is routinely divided into its different components, red blood cells, plasma and platelets. These components are stored under different storage conditions and their maximum storage time before transfusion is different. Platelets are stored at a maximum of 7 days and at a temperature of 22°C to best preserve their function. Research has been conduction on blood stored and transfused as whole blood (without separation into the various components), particularly in situations of acute trauma. Region Örebro län will therefore start transfusion of whole blood in such situations. The whole blood units will be stored at 4°C for a maximum of 14 days. This means that the platelets will be stored at a lower temperature than standard and for a longer time period. The research on how this will affect platelet function is limited. This project aims to determine how the patients are affected regarding coagulation, hemolysis, renal function, immunisation, transfusion reactions and the effect of substances released from the blood cells in the whole blood units during the storage period and if there is an impact on mortality.

NCT ID: NCT05979870 Enrolling by invitation - Clinical trials for Magnetic Resonance Imaging

Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease

AI-CMR
Start date: October 1, 2022
Phase:
Study type: Observational

The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates. The main question[s] it aims to answer are: - [question 1]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve - [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term. Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.

NCT ID: NCT05889416 Enrolling by invitation - Clinical trials for Myocardial Infarction

The Perfect-CR Implementation Study

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this open-label cluster-randomized effectiveness-implementation hybrid trial is to study whether a) audit and feedback of cardiac rehabilitation service delivery within a national quality registry and b) structured implementation support can improve center-level adherence to guidelines and short and long-term patient-level outcomes.

NCT ID: NCT05877534 Enrolling by invitation - COVID-19 Clinical Trials

Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study

Start date: May 25, 2023
Phase: N/A
Study type: Interventional

Covid-19 has the potential to affect physical, cognitive and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post COVID-19 condition (defined by WHO) is used to describe the wide range of prolonged symptoms following the infection. Patients may need specialized rehabilitation to be able to meet the complex symptoms and problems that may arise. A more specific syndrome that seems to occur more frequently than expected in the group of non-hospitalized patients with post COVID-19 condition is the postural orthostatic tachycardia syndrome (POTS). A randomized controlled design will be used to evaluate the effects of individual tailored physical exercise in patients with POTS after Covid-19. Participants: Adults (>18 years) with post COVID-19 condition and diagnosed with POTS (n=60) will be included. Exclusion criteria: known pregnancy, cancer, already ongoing individual physical exercise (specific for POTS), or not able to perform measurements and/or intervention. Procedure and outcomes: The primary outcomes are objectively measured time in upright position and health-related quality of life. Secondary outcomes are: physical activity, physical capacity, work ability and disease specific symptoms measured with tests and questionnaires. Prior to randomization baseline measurements will be performed, aswell as after 16 weeks, 6 months and 12 months. Intervention: Participants randomized to intervention will receive standard care and undergo a individually designed physical exercise program during 16 weeks, supervised and guided by a physiotherapist. The intervention will consist of different exercises to enhance muscle strength and endurance. Progression will be according to a program (based on previous feasibility studie) but should be halted if post exertional malaise (PEM) or other problems occur. Controls: Participants randomized to control will receive standard care during 16 weeks. Measurements of both groups (control and intervention) will be repeated after completion of a period of 16 weeks.

NCT ID: NCT05876169 Enrolling by invitation - Clinical trials for Cleft Lip and Palate

How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Start date: September 6, 2022
Phase: N/A
Study type: Interventional

In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. The results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. We will have blinded evaluation of outcomes.

NCT ID: NCT05874804 Enrolling by invitation - Clinical trials for End Stage Renal Disease

Carry Life@ UF System Clinical Study

Start date: September 19, 2023
Phase: N/A
Study type: Interventional

The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the device. By maintaining a stable glucose concentration in the intraperitoneal fluid during the 5-hour treatment, the ultrafiltration can be increased compared to a standard CAPD dwell.

NCT ID: NCT05853809 Enrolling by invitation - Asthma Clinical Trials

Cluster-Randomized Asthma FeNO Trial

CRAFT
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Asthma is a chronic inflammatory respiratory disease that affects people of all ages and of both sexes. It is a common disease and is present in 8-10 % of the population. Despite drug treatment, many patients have poor control of their asthma with an impact on quality of life and restriction of daily activities. The purpose of this study in primary care is to investigate if measurement of airway inflammation (FeNO) can improve the treatment results and the overall care of adult patients with asthma. The main question in the study is whether the use of FeNO measurements can reduce the number of deterioration periods. The study is conducted under real clinical conditions where the effect of the intervention is measured (pragmatic intervention study). Eight to twelve primary health care centers with functional asthma / COPD clinics are selected within the Stockholm County and are randomly assigned to two groups with four to six primary health care centers each, an active group and a control group (cluster randomization). Instruments for FeNO measurements are made available to the active group and this group is also trained on FeNO measurements and how the value should be interpreted and used to control the treatment, while the control group continues to take care of their asthma patients as usual. The study can lead to improved treatment decisions and patients gaining an increased understanding of their asthma by being informed on the actual degree of inflammation in the airways. Optimized treatment can provide better asthma control with increased quality of life and fewer periods of deterioration, which results in reduced burden on healthcare and lower costs for patients and society.