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NCT ID: NCT05997693 Not yet recruiting - Clinical trials for Chronic Coronary Disease

One-Month DAPT in CABG Patients

ODIN
Start date: October 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with chronic coronary disease undergoing coronary artery bypass grafting.

NCT ID: NCT05992025 Recruiting - Myasthenia Gravis Clinical Trials

Digital Phenotyping and Lifestyle Intervention in Patients With Myasthenia Gravis

DIG-MG
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Myasthenia Gravis (MG) is a chronic autoimmune neurological disorder where an antibody attack of muscle receptors causes fatigable skeletal muscle weakness. In addition to fatigue, several MG patients experience general fatigue. Small supervised studies during 12 weeks of physical exercise interventions have indicated safety and beneficial neuromuscular outcomes in MG patients. Longer and unsupervised studies are required to obtain guidelines for physical activity in MG patients. Further, the development of smart rings enables remote digital supervision of physical activity, sleep, and biological parameters such as heart frequency, number of steps, and temperature. These parameters could add to the lack of biomarkers in MG. The project design is a randomized controlled trial with a lifestyle intervention to improve fatigue in the autoimmune neuromuscular disease Myasthenia Gravis (MG). The intervention includes digital group counseling regarding physical activity, sleep, general health, and digital follow-up with a "smart ring" (OURA).

NCT ID: NCT05990634 Active, not recruiting - Melanoma (Skin) Clinical Trials

LifeChamps Feasibility Study

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

The purpose of this study is to collect data from various sources (PROM / PREM, sensors, journal data) to train AI based models in the LifeChamps digital platform in a pre-pilot, as well as partly implement a pilot/feasibility study to examine the applicability of the digital technology developed in LifeChamps, as well as the usability for patients (cancer survivors) and health care professionals

NCT ID: NCT05988073 Recruiting - Clinical trials for Multifocal Motor Neuropathy

A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy

Start date: November 29, 2023
Phase:
Study type: Observational

This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. Participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. No IMP will be administered.

NCT ID: NCT05986032 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia

REACT
Start date: July 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The main question it aims to answer is if the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry measurements at 7 ± 2 postnatal days.

NCT ID: NCT05985915 Recruiting - Sjogrens Syndrome Clinical Trials

A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

NEPTUNUS-Ext
Start date: October 27, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection. All participants will receive ianalumab either monthly or every 3 months. - The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. - The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: - ianalumab 300 mg monthly or - ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe. Participants will be given the opportunity to self-inject at home on some visits after receiving training.

NCT ID: NCT05985668 Recruiting - Platelet Disorder Clinical Trials

Towards Improved Diagnostics for Suspected Platelet Function Disorders

Start date: September 5, 2023
Phase:
Study type: Observational

This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.

NCT ID: NCT05985551 Active, not recruiting - Breast Cancer Clinical Trials

Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment

MagNeo
Start date: January 1, 2020
Phase:
Study type: Observational

The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration. For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST. The main points to investigate are: 1. If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection 2. If the nodal yield and the accuracy of the procedure are affected

NCT ID: NCT05983705 Recruiting - Quality of Life Clinical Trials

The Effect and Experience of the Parental Program AFFEKT

Start date: August 23, 2023
Phase: N/A
Study type: Interventional

This project is the first to evaluate the effect and experience of the parent program AFFEKT, through a randomized controlled trial and qualitative study, within primary health care. The project will recruit 200 parents of children with externalizing behaviors, and evaluate the effect of AFFEKT and psychoeducation versus psychoeducation alone, on children's behaviors and mental health, and the parent's strategies and mental health. Through interviews the experience of AFFEKT will be investigated.

NCT ID: NCT05983419 Recruiting - Clinical trials for Barretts Esophagus With Dysplasia

Complete Resection of Barrett's Esophagus Harboring Neoplasia With Endoscopic Submucosal Dissection.

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

Patients with Barrett's esophagus (BE) have a change in the lining of the esophagus. The normal one the lining of the esophagus changes to a lining similar to that of the intestine. The new mucosa has increased the risk of developing cancer. Usually this type of cancer is detected in a late phase and the patients' survival is low (less than 25% at 5 years). In daily practice, we strive to detect early cancerous lesions in order to treat them and cure them the patients. It has been widely demonstrated in BE patients that if cancer or precursor lesions are detected in an early phase, patients can be cured with endoscopic treatment. Endoscopic treatment of BE is based on endoscopic resection of the lesions / early cancer. After resection, patients have a 20-47% risk of developing cancer later in the remaining Barrett's esophagus. So there is a need to remove the remaining Barrett's mucosa that has not been resected. Several techniques can be used for removal of remaining BE: radiofrequency ablation, argon plasma, cryotherapy or endoscopic resection. The goal is to after resection of cancer and removal of residual Barrett's mucosa, a normal esophageal epithelium will cover the esophagus and dramatically reduce the risk for cancer development. The most widely used strategy for removal of residual Barrett's mucosa is radiofrequency ablation. It is an easy technique to perform, but it is hindered by some factors: 1) it requires several treatment sessions; 2) is associated with complications in 11% of patients, such as severe pain, bleeding, stricture and perforation 3) Barrett's mucosal glands may grow under the new epithelium after treatment; 4) there is no histological assessment of what is ablated; 5) there is a need for continuous follow-up; 6) it there are high costs associated with this strategy; 7) This approach may cause physical and physiological burdens on patients due to continuous follow-up and lack of complete histological assessment. Endoscopic submucosal dissection (ESD) is an advanced endoscopic technique that enables resection of lesions or cancer in one piece and has been used extensively along the gastrointestinal tract. Studies have showed good effect of ESD for neoplastic BE. Karolinska has a lot of experience with ESD and has one of the largest the cohorts of ESD on BE patients. ESD of BE can be associated with complications such as bleeding and perforation in 2-3% in most published studies and in less than 1% each in our series. Another complication that can occur is narrowing of the the esophagus during the healing process after ESD. That risk was historically high and increased with the increase in the size of the resected specimen. The high risk of crowding out was the main inhibiting factor the development of ESD in the esophagus. With the introduction of steroid therapy to prevent narrowing a paradigm shift was formed and the corresponding narrowing risk was drastically reduced to between 2-33% in according to the size of the resections. In our series of 132 ESDs on Barrett's esophagus, 103 cases corresponded resections up to 75% of the luminal(?) circumference of the esophagus, in these only 4/103 (3.9%) had strictures and all were successfully treated with endoscopic balloon dilatation. In the remaining 29 ESDs: included resection more than 75% of the luminal circumference. In these, there was narrowing in 10/29 cases, all patients was successfully treated with endoscopic treatment. So preventive measures and thorough follow-up are associated with good results and safety profile, even in large ESD on BE. Several years ago did not perform ESD for the treatment of BE, due to the need for skilled endoscopists and the potential the risks of this procedure such as bleeding, perforation and strictures. Full resection of the BE mucosa allows complete resection of all mucosa at risk, with complete histological assessment and virtually no risk of lesion presence in the margins or development of buried glands. It leads to complete removal of BE and may lead to the need for additional follow-up. With this study, we want to test the efficacy and safety of ESD for the removal of all Barrett's mucosa, instead of the more common approach of resection of Barrett's cancer followed by ablation of the remaining BE.