Makkah

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are studying real-world treatment patterns, patient characteristics, survival outcomes, and safety of Trastuzumab Deruxtecan T-DXd in women with hormone receptor-positive metastatic breast cancer mBC that is HER2-low or HER2-ultralow. This study focuses on patients previously treated with endocrine therapy and aims to provide data from Gulf Cooperation Council countries to improve treatment strategies and clinical guidelines for mBC in the region. This observational study monitors patients who have initiated T-DXd treatment as part of routine care, including those who started the drug up to 30 days before consenting to participate. It includes women aged 18 years or older with confirmed HR-positive, HER2-low or ultralow metastatic breast cancer who have not received chemotherapy in the metastatic setting. The study collects data over 18 months on treatment patterns, safety, and progression-free survival. Participants are observed while receiving their usual medical care with T-DXd, without additional intervention by the study team. Researchers collect information on patient characteristics, treatment details, safety events, and time to next treatment. The main outcome measured is real-world progression-free survival at 18 months, along with safety profiles and treatment patterns. The study is expected to last until March 2029, supporting improved outcomes through real-world evidence.

Idiopathic scoliosis is a common spinal deformity affecting adolescents during their growth spurts, characterized by an abnormal curvature of the spine. The cause is unknown but may involve neuromuscular issues. The study aims to develop a neuromuscular corrective treatment to improve conservative management of adolescent idiopathic scoliosis and potentially provide a more effective approach than current methods. Participants will be divided into two groups. The control group will receive a scoliosis-specific exercise program consisting of three one-hour sessions per week over 12 weeks focused on correcting posture. The experimental group will follow the same exercise program combined with wearing a soft orthotic undergarment with external strapping for 12 hours daily over the same 12-week period. This soft orthosis is designed to provide gentle, passive compression to help correct spinal deformities. During the study, researchers will measure changes in the degree of spinal curvature, pelvic alignment, vertebral rotation, and coronal imbalance at the start and after 12 weeks of treatment. Participants will undergo X-rays to assess these outcomes. The study focuses on monitoring the effectiveness of these interventions in controlling scoliosis progression over the 12-week timeframe.

Researchers are tracking the natural history and clinical outcomes of patients with Gaucher disease through the ICGG Gaucher Registry, an international, multi-center observational program. This registry does not involve any experimental treatments, but collects information to better understand the variability, progression, and identification of Gaucher disease, aiming to improve patient care and therapeutic guidance. It also evaluates the long-term use of treatments like imiglucerase and eliglustat. The study includes two groups patients with Gaucher disease who receive routine clinical assessments and standard care as determined by their physicians, and a Pregnancy Sub-registry for women with Gaucher disease who are pregnant or have been pregnant. The Pregnancy Sub-registry collects information on pregnancy outcomes, complications, and infant growth up to 36 months postpartum, regardless of whether the women receive disease-specific therapy. Participants undergo clinical assessments and receive care according to their treating physicians decisions. Data collected includes medical history, pregnancy and birth details for the sub-registry, and patient outcomes over time. The primary goals are to provide recommendations for monitoring Gaucher disease patients, report outcomes to optimize care, and track pregnancy and infant growth outcomes. This ongoing registry allows long-term follow-up without experimental interventions.

Researchers are comparing two types of dressings, polyurethane foam Pink Pad and Mepilex Border Sacrum dressings, to prevent pressure ulcers in patients undergoing cardiac surgery at King Abdullah Medical City. The study focuses on patients at risk for pressure ulcers, using standard hospital protocols based on international guidelines to assess risk and provide prevention. This randomized clinical trial aims to evaluate which dressing may better help prevent pressure ulcers during surgery, especially for patients positioned in ways that increase risk, such as the Trendelenburg position. The study involves two intervention groups one using a single-use polyurethane foam system including a pink foam pad and related supports, and the other using self-adherent multilayer foam dressings applied to the sacrum. Both interventions are applied by operating room nurses during surgery. Patients will be examined by the wound management team after surgery and again at 3 and 7 days post-operation. Dressings are removed after 7 days or earlier if clinically needed. If patients are discharged sooner, they are examined before discharge. Follow-up lasts up to 7 days post-operation. Participants will be monitored through scheduled examinations and assessments by the wound management team to check for pressure ulcer development. The study measures the incidence of pressure ulcers within 7 days after surgery as its primary outcome. Any patient unable to continue due to death or changes in care setting will be excluded. Researchers will use risk assessment scales and clinical evaluations to track outcomes, ensuring patient safety and adherence to hospital protocols throughout the study period.

This research aims to collect detailed information about Pompe disease, a rare genetic disorder also known as Glycogen Storage Disease Type II. The study is a global, long-term observational program designed to better understand the diseases progression, variability, and identification in patients who are either treated or untreated. It also supports regulatory requirements, product development, reimbursement, and other research purposes. Participants in the Pompe Registry are tracked over many years, up to 30 years, to observe the natural history of the disease and evaluate long-term outcomes, including the effects of treatments like alglucosidase alfa. This observational study does not involve experimental treatments but gathers data from patients worldwide to improve care strategies and recommendations. During the study, participants health information is collected retrospectively and prospectively, including clinical outcomes and disease manifestations. Researchers analyze these data to understand patient variability, disease progression, and treatment effectiveness. The registry helps develop guidance for monitoring patients and provides valuable insights to optimize Pompe disease care over an extended period.

Researchers are evaluating the effectiveness of zinc oxide compared to moist exposed wound ointment MEBO in treating second stage pressure ulcers. This randomized controlled trial aims to determine which topical treatment better supports healing of these ulcers, which are common in patients with prolonged pressure on the skin. The study is sponsored by King Abdullah Medical City and uses a validated wound assessment tool to measure healing progress. Participants will be randomly assigned to one of two groups one receiving topical zinc oxide twice daily every 12 hours, and the other receiving topical MEBO ointment with the same frequency. The treatment period will last up to one month or until the ulcer completely heals. Daily examinations will be conducted to monitor wound status using the Bates-Jensen Wound Assessment Tool BWAT. During the study, participants will undergo daily wound assessments until healing is complete or for a maximum of 30 days. Researchers will collect data on wound healing and recovery time. The study includes regular monitoring to track treatment effects and safety. Participation involves applying the assigned ointment twice daily and attending daily evaluations throughout the treatment period.