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NCT ID: NCT05810311 Not yet recruiting - Clinical trials for Diabetes Complications

The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

FOXTROT
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

The study will investigate if treatment with Roxadustat improves kidney oxygenation in diabetic patients with nephropathy receiving treatment for renal anemia, compared to patients receiving treatment with darbepoetin alpha. Participants will be randomized to either treatment, and receive equal care for renal anemia. Kidney oxygenation will be examined before treatment start and after 24 weeks using BOLD-MRI (blood oxygen level-defendant MRI), a non-invasive method available for measurement of tissue oxygenation levels that is comparable with direct invasive measurement of partial oxygen pressure. Blood and urin samples will be collected in connection to these visits. The primary endpoint is the change in medullary and cortical R2* (inversely proportional to the tissue oxygenation content) after 24 weeks. Secondary endpoints will be albuminuria and urinary levels of ROS (evaluated by electron paramagnetic resonance (EPR) spectroscopy with CPH spin probes).

NCT ID: NCT05810155 Recruiting - Quality of Life Clinical Trials

Delayed Surgery in Inflammatory Bowel Disease

Start date: January 8, 2023
Phase:
Study type: Observational [Patient Registry]

The timing of elective surgery in inflammatory bowel disease (IBD) may be crucial according to progression of the disease. In most cases, medical treatment has failed when surgery is discussed. If treatment with surgery then is delayed, complications may arise, such as fistula, severe inflammation with risk of perforation or stenosis, nutrition problems i.e. This may affect quality of life, and also make the surgery more complicated, with higher risk of per- and postoperative complications. The COVID-19 pandemic led to a shift in resources where elective surgery has been postponed. The waiting time for elective surgery for IBD-patients at Sahlgrenska University Hospital/Östra is still affected which might have impact on patient health outcomes as well as health economics, due to the risk of complications and need of emergency and planned care while waiting for surgery. The primary object is to evaluate how long an IBD patient can wait for surgery before affecting health economy and quality of life. In the operation program Orbit, we identify all patients with ulcerative colitits (UC) and Crohn´s disease (CD) that stands in line for elective surgery (not including dysplasia/cancer). The date when operation was decided is registered including time of delay. Patient characteristics are registered in CRF, including diagnosis, age and reason for scheduled surgery. Number of hospital visits (planned/emergency visits) are registered during time of waiting for surgery. Days of sick leave is registered from the Swedish Social Insurance Agency. Questionnaires are sent to the patients for quality of life and bowel function (EQ5D and Short Health Scale). The primary endpoint in the first manuscript is how health economics is affected by the delay of elective care in IBD-patients, due to complications and extensive need of hospital visits while waiting for surgery, costs of medical material (stoma bandage i.e), costs of medical treatment and sick leave rates, including quality of life. Patients who have been operated for IBD will form the control group and comparison will be made in terms of complications, hospital visits, costs of medical material and medical treatment and sick leave rates, as well as quality of life.

NCT ID: NCT05809479 Active, not recruiting - Clinical trials for Chronic Diseases in Children

NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment

NICE
Start date: June 2015
Phase:
Study type: Observational

Role of the exposome on allergy, caries, and neurophysiological development in childhood.

NCT ID: NCT05808712 Recruiting - Clinical trials for Cancer, Gastrointestinal

Quality of Care in Relationship to Aborted Cancer Surgery

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

Surgery is often a central curative treatment for gastrointestinal tumors. Surgical treatment of diagnosed cancer tumors is decided after a comprehensive assessment of the patient's physical status, radiological assessments and after careful evaluation at the multidisciplinary conference. Despite the careful preoperative assessment of patients for curative surgery, the planned operation may unexpectedly need to be canceled. Of the patients who were planned for curative resection for pancreatic cancer in 2021 in Sweden, 90% received the intended surgery, and 10% of planned surgery was canceled. The reason for this was disseminated cancer or locally advanced disease in which radical resection is considered impossible to carry out. A systematic review of knowledge reveals a significant lack of evidence regarding patient-centered research and aborted cancer surgery. The studies in the project have different study designs and methods, and include focus group interviews with staff, translation and validation of a questionnaire to measure care needs, estimation of supportive care needs and patient experiences. An improved understanding and knowledge of patients' preferences and needs is needed to design interventions that can improve health-related quality of life. This project is dedicated to studying patients undergoing aborted cancer surgery, with the aim of improving the quality of care and meeting patients' care needs.

NCT ID: NCT05806593 Recruiting - Clinical trials for Spinal Stenosis Lumbar

Feasibility of a Person-centred Digital Program Targeting Physical Activity in Spinal Stenosis Surgery

GetBack
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

Spinal stenosis is the most common cause of degenerative spinal surgery. The majority do not achieve the global recommendations for health-promoting physical activity before or after surgery. Patients with a low level of physical activity and a high degree of fear of movement are at an increased risk of poorer health outcomes after surgery. Increasing the number of steps per day is a way to increase physical activity, which in long term can lead to health benefits. In addition, a digital format is a way to increase the availability of physiotherapy to strive for equal rehabilitation. The overall purpose of the research project is to improve health outcome and increase the availability of rehabilitation for patients at high risk of negative health outcomes after spinal surgery due to spinal stenosis through Get Back, a person-centered and digital program with a focus on physical activity. Before conducting a large-scale study, the investigators want to conduct a study that aims to investigate and develop the Get Back program regarding content and dose, treatment fidelity as well as feasibility in terms of study procedure, compliance, and acceptability. Approximately thirty patients with lumbar spinal stenosis and an identified risk profile for poorer postoperative outcomes will be recruited from two spine clinics in Sweden. The program involves meeting a physiotherapist digitally (through video call) approximately 1 week before surgery to formulate a person-centered health plan. The health plan is monitored and progressed by the physiotherapist by video until eleven weeks after surgery. The Get Back program includes 5 sessions (1 hour each) which are supplemented with 5 booster sessions (30 minutes) to reinforce the intervention. Get Back is based on three key components that run through all sessions. These are person-centeredness, behavioral medicine techniques to reduce fear of movement and worries about pain, as well as to optimize physical activity. The physiotherapist supports the participant's individual resources and abilities through validated behavioral medicine methods in combination with education/communication/knowledge support and behavior-strengthening tools (which are also used in-between sessions) to achieve the participant's personal goals linked to physical functioning, physical activity, and health. The program will be compared to standard physiotherapy.

NCT ID: NCT05806502 Completed - Type 2 Diabetes Clinical Trials

Arginase Inhibition in Type 1 and Type 2 Diabetes Mellitus

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

To evaluate the efficacy of arginase inhibition on endothelial function in patients with type 1 diabetes and type 2 diabetes.

NCT ID: NCT05805696 Recruiting - Hyperhidrosis Clinical Trials

Treatment and Mapping of Impostor Phenomenon

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate persons/patients with different skin diseases or pain to evaluate whether unhealthy perfectionism, stress, anxiety, impostor phenomenon (inability to realistically assess your competence and skills) and lack of self-compassion (a positive attitude towards ourselves), have impact on symptoms, handling, and treatment regarding some dermatological diseases/pain.

NCT ID: NCT05801653 Completed - Healthy Clinical Trials

Health Effects of Oat Bioactives (Betaglucan) in Human

Start date: March 8, 2023
Phase: N/A
Study type: Interventional

Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods.

NCT ID: NCT05801614 Recruiting - Clinical trials for Diabetes Mellitus Type 2 in Obese

Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction

CarborCal
Start date: February 28, 2022
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to determine whether a low-carbohydrate (LC) diet can lead to normalized blood glucose levels in patients with short duration of type 2 diabetes (T2D). Previous studies have shown that caloric restricted diet leading to weight loss can normalize blood glucose levels in approximately 50% of patients with a short duration of diabetes type 2. However, caloric restriction is difficult to maintain. Less restrictive approaches are needed. The hypothesis in this study is that Low carbohydrate diet can results in normalized blood glucose levels in T2D and can be an alternative to caloric restriction diet, both in the shorter term (3 months) and longer term (15 months). The outcome of this study leading to reduction of HbA1c is important for prevention of diabetes complications.

NCT ID: NCT05801185 Enrolling by invitation - Clinical trials for Unilateral Lower Limb Suspension

Single Nuclei Sequencing in Human Skeletal Muscle After Unloading

ULLS23
Start date: March 5, 2023
Phase: N/A
Study type: Interventional

Injuries often require people to undergo some degree of limb immobilization. This comes at a high cost in terms of muscle mass and function losses. At the molecular level, it is completely unknown how the different cells in the muscle respond to this complete lack of mechanical stimuli. The investigators will explore cell type specific changes in skeletal muscle after a short period of unloading, and specifically examine the behavior of myogenic stem cells with particular attention to potential unloading-induced maturation into fast- or slow-twitch muscle fibers. Ten healthy young participants will perform a 5-day Unilateral Lower Limb Suspension (ULLS) intervention, where one leg is continuously subjected to unloading, i.e., lack of mechanical stimuli. Before and after the ULLS period, participants will perform muscle function testing and MRI scans to assess muscle size in the lower limbs. Immediately after the ULLS, two muscle biopsies will be obtained, one from each leg. The tissue will be employed for single-nuclei RNA sequencing analysis and immunohistochemistry experiments. This project will be the first to analyze cell type specific changes induced by complete, short-term lack of mechanical stimuli in skeletal muscle. This will add a new dimension to the understanding of the processes directing this type of muscle atrophy (i.e., muscle loss in otherwise healthy individuals) and thus help to develop effective countermeasures to offset muscle changes.