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NCT ID: NCT06455449 Not yet recruiting - Clinical trials for Polymyositis, Dermatomyositis

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

JASMINE
Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

NCT ID: NCT06454227 Not yet recruiting - Clinical trials for Surgical Site Infection

Subcutaneous Lavage in Cesarean Section

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection. intraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section. The main questions we aim to answer are: Does subcutaneous antiseptic washing reduce the rates of surgical site infection? Does antiseptic washing improve scar healing? Does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases? Researchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce Participants will: consent to participate in the trial Visit the postpartum clinic 30 days after surgery

NCT ID: NCT06453473 Not yet recruiting - Older Adults Clinical Trials

Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills

BiPerAge
Start date: September 2024
Phase: N/A
Study type: Interventional

The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while sitting. With this system, unexpected perturbations can be provided under controlled and safe conditions. Within the BiPerAge-project it will be evaluated if 20 training sessions (20 minutes each) on the PerStBiRo system will lead to transfer effects on safe cycling skills of community-dwelling older adults (age 65 years and older). The ability to cycle safely will be tested prior and after the training period using a cycling course, which consists of variant tasks requiring motor and cognitive skills.

NCT ID: NCT06452277 Not yet recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

SOHO-02
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: - BAY 2927088 twice every day as a tablet by mouth, or - Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment. During the study, the doctors and their study team will: - take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer - check the overall health of the participants by performing tests such as blood and urine tests, and checking - heart health using an electrocardiogram (ECG) - perform pregnancy tests for women - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06451562 Not yet recruiting - Scoliosis Clinical Trials

Effect of Regional Anesthesia or Intravenous Infusion of Lidocaine on Morphine Use After Scoliosis Repair Surgery

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of the surgical correction of scoliosis is to prevent progression of the curve or progression of restrictive lung disease. After scoliosis surgery, patients experience severe pain. The standard treatment for pain relief after scoliosis surgery is the administration of opiates. However, treatment with these substances involves side effects such as respiratory depression, nausea and vomiting, inhibition of bowel activity and itching. To lower the dose of opiates, different types of painkillers and other techniques can be added. The purpose of the study is to compare the effect of instillation of lidocaine (which is an analgesic and anti-inflammatory) or regional anesthesia using Erector spinae plane on the dose of morphine consumption, the intensity of pain, the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis.

NCT ID: NCT06443502 Not yet recruiting - Pouchitis Clinical Trials

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

When some people have their large bowel removed, a surgeon can make a "pouch" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab. Participants will receive up to 6 infusions of vedolizumab. First 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in total. After completing treatment with vedolizumab, participants will visit their clinic for a health check at Week 34. One final health check will be scheduled 4.5 months (18 weeks) after the last vedolizumab infusion. Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study (Vedolizumab-3042).

NCT ID: NCT06439277 Not yet recruiting - Obesity Clinical Trials

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.

NCT ID: NCT06431308 Not yet recruiting - Obesity; Drug Clinical Trials

Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews. A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy©. The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM. Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© titration phase [20 weeks (T1)] and weekly during the study period (for GI symptoms assessment).

NCT ID: NCT06423690 Not yet recruiting - Lung Cancer Clinical Trials

First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection

NCT ID: NCT06415344 Not yet recruiting - Angelman Syndrome Clinical Trials

Long-term Extension of GTX-102 in Angelman Syndrome

Start date: August 2024
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety profile of GTX-102 in participants with Angelman Syndrome (AS)