Makkah

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are studying adolescent idiopathic scoliosis, a common spinal curvature disorder during adolescent growth spurts that can lead to serious physical and psychological problems if untreated. This research aims to develop a neuromuscular corrective treatment approach that may better manage and reduce spinal curvature in affected adolescents. The study evaluates a soft, breathable orthotic undergarment called TheraTogs with a strapping system designed to gently correct spinal deformities, compared to exercise alone. Participants are divided into two groups. One group receives a scoliosis-specific exercise program consisting of frontal plane correction exercises conducted three times a week for one hour each session over 12 weeks. The other group receives the same exercise program combined with wearing the soft orthosis with external strapping for 12 hours daily during the same 12-week period. This approach is intended to control and modulate the degree of scoliosis more effectively. Throughout the study, researchers measure changes in spinal curvature using X-rays, focusing on the Cobb's angle, pelvic obliquity, vertebral rotation, and coronal imbalance at the start and after 12 weeks of treatment. Participants' health, posture, and scoliosis progression are monitored closely during the treatment period. The study tracks the impact of interventions on spinal deformity and overall physical function over the 12-week timeline.

The International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry is an ongoing global observational program tracking routine clinical outcomes in patients diagnosed with Gaucher disease. It includes patients regardless of their treatment status and aims to improve understanding of the variability, progression, and natural history of Gaucher disease. The Registry also seeks to support the medical community by developing monitoring recommendations, characterizing the patient population, and evaluating long-term treatment effectiveness of imiglucerase and eliglustat. The Registry involves no experimental treatments; patients receive clinical assessments and care as directed by their treating physicians. Additionally, there is a Gaucher Pregnancy Sub-registry that monitors pregnancy outcomes, complications, and infant growth up to 36 months postpartum for women with Gaucher disease. This Sub-registry collects medical and obstetric history and pregnancy data for participants who consent, without altering their standard care. Participants provide data through routine clinical visits, and researchers collect medical information to better understand patient outcomes and optimize care. The Registry tracks outcomes over long periods, including up to 42 years, to support ongoing care improvements. Women in the Pregnancy Sub-registry have additional data collected on pregnancy and infant growth, contributing to comprehensive monitoring of Gaucher disease impacts during and after pregnancy.

Researchers are evaluating two types of dressings to prevent pressure ulcers in patients undergoing cardiac surgery at King Abdullah Medical City's cardiac center. This randomized control clinical trial compares polyurethane foam (Pink Pad) and Mepilex Border Sacrum dressings to see which is more effective during surgical procedures, especially in patients positioned in the Trendelenburg position. Both dressings are used alongside standard pressure ulcer prevention care based on international guidelines and risk assessments using the Braden Scale at hospital admission. Patients receive one of the two dressings during surgery in the operating room. The polyurethane foam system includes a pink foam pad, lift sheet, body straps, head rests, and boot liners, while the Mepilex dressing is a multilayer foam designed for the sacrum area. After surgery, patients are examined by the head nurse of the wound management team immediately, and then again on day 3 and day 7 post-operation. Dressings are removed after 7 days or earlier if clinically needed. If a patient is discharged before day 7, examination occurs before discharge. Follow-up lasts up to 7 days post-operation for each participant. Participants will be monitored for pressure ulcer development during the 7-day follow-up period. Assessments include clinical examinations by nursing staff to detect any skin changes or pressure ulcers. Patients unable to continue due to death or change in care setting are excluded from continuing. The main outcome measured is the incidence of pressure ulcers within 7 days after surgery. This study aims to provide evidence on which dressing better supports pressure ulcer prevention in cardiac surgery patients.

The Pompe Registry is a global, multicenter, international program that follows patients with Pompe disease over time. It is an observational and voluntary study designed to track the natural history and outcomes of Pompe disease in both treated and untreated patients. The registry aims to improve understanding of the disease's variability, progression, identification, and natural history, with the goal of guiding and assessing therapeutic interventions. It also supports the Pompe medical community in developing monitoring recommendations and reporting patient outcomes to optimize care. Additionally, the registry helps characterize the Pompe disease population and evaluates the long-term effectiveness of alglucosidase alfa. This study collects data retrospectively and prospectively from patients worldwide diagnosed with Pompe disease. It does not involve any specific interventions or treatments but gathers comprehensive clinical information over time. Data collection includes medical history, diagnosis details, treatment status, and other relevant health information to better understand the disease and patient experiences. Participants contribute data through regular updates that capture their disease progression and treatment outcomes. Researchers use this information to study how Pompe disease manifests and changes over time, with a maximum follow-up period of 30 years. The registry helps fulfill regulatory commitments, supports product development and reimbursement, and provides valuable information for research and patient care improvements.

Researchers are evaluating the management and outcomes of patients with Idiopathic Intracranial Hypertension (IIH) undergoing venous sinus stenting in the Middle East and North Africa (MENA) region. This multicenter observational study aims to assess clinical characteristics, treatment effectiveness, safety, and the role of venous sinus stenting as a treatment option for IIH, a condition marked by elevated pressure in the brain without an identifiable cause. The study is especially focused on patients who do not respond well to medical treatments or cannot tolerate certain medications. Participants receive a venous sinus stenting procedure performed under general or local anesthesia, targeting narrowed areas in the brain's venous sinuses such as the right or left transverse sinus or sigmoid sinuses. Various stents like Venous Sinus Stent (CWS), CASPER, and PRTCS are used, sometimes more than one if needed. After the procedure, patients are given antiplatelet therapy and undergo routine follow-up assessments to monitor their progress. During the six-month study period, participants are closely monitored through clinical evaluations, imaging studies, and assessments of symptoms like headaches and vision problems. Researchers measure improvements in symptoms, changes in papilledema (swelling of the optic nerve), and quality of life from baseline to six months after the procedure. Safety and effectiveness data are collected throughout to better understand the benefits and risks of venous sinus stenting for IIH in this region.

Researchers are conducting a randomized control trial to evaluate and compare the effectiveness of zinc oxide and moist exposed wound ointment (MEBO) in treating second stage pressure ulcers, also known as stage 2 pressure injuries or bedsores. This Phase 4 study focuses on patients diagnosed with second stage pressure ulcers according to established guidelines, aiming to assess wound healing outcomes within a month. Participants will be randomly assigned in equal numbers to one of two groups. One group will receive topical zinc oxide applied twice daily every 12 hours, while the other group will receive topical MEBO ointment on the same schedule. Treatment will continue daily, with patients being examined until their pressure ulcers fully heal or for a maximum of 30 days. The Bates-Jensen Wound Assessment Tool (BWAT), a validated clinical tool, will be used to monitor and evaluate wound healing progress throughout the study. During the study, patients will undergo daily examinations to assess wound status and healing using the BWAT. Data will be collected using a patient assessment sheet specifically designed for second stage pressure ulcers. The primary outcome measure is wound healing within 30 days. Safety monitoring will include checking for adverse reactions or signs of infection. The total participation period will last up to one month or until the pressure ulcer completely heals, whichever comes first.