Jeddah

Researchers are studying the real-world effectiveness of pegcetacoplan in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This long-term, multicenter observational study aims to fill knowledge gaps about how pegcetacoplan works in routine medical practice. It also seeks to provide important information on red blood cell transfusions and healthcare resource use before and after starting pegcetacoplan treatment. Patients who have started pegcetacoplan treatment within the last 12 months or are prescribed it at enrollment will be followed for approximately 36 months. The study will collect both retrospective data from up to 12 months before treatment start and prospective data during treatment, with a total data collection period of up to about 48 months. After stopping pegcetacoplan, patients will remain in the study for 8 weeks to monitor for any adverse events. Participants will attend their usual medical visits, and data from these visits will be collected, including effectiveness measures, safety reports, patient- and clinician-reported outcomes, and healthcare use. The primary outcome includes changes in hemoglobin levels over 6 months from the start of pegcetacoplan treatment. The study plans to enroll about 200 patients across multiple countries, and data collection includes both retrospective and prospective periods, capturing comprehensive information on pegcetacoplan use in real-world settings.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Pressure injuries are common and preventable complications in critically ill patients, especially in intensive care units (ICUs). This research evaluates whether an artificial intelligence (AI)-assisted skin assessment tool can improve the accuracy of pressure injury staging by critical-care nurses. The study also explores if using AI increases nurses' knowledge and confidence in performing these assessments, addressing challenges in consistent and early detection of pressure injuries in ICU settings. The trial compares two groups of nurses: one using the AI-assisted mobile application that analyzes skin images for pressure injury staging based on established criteria, and another using standard visual and manual skin assessments. All nurses receive training on pressure injury prevention and assessment before the study, with additional training for the AI group on capturing standardized images. A blinded wound-care specialist reviews all assessments to serve as the gold standard for accuracy comparison. Participants will complete questionnaires about their knowledge and confidence before and after training. Nurses will perform skin assessments on ICU patients at risk for pressure injuries using their assigned method. Researchers will measure agreement between nurse assessments and expert evaluations over six months, track changes in nurse knowledge and confidence, and assess the feasibility of integrating AI into ICU care workflows. The study aims to improve early detection and staging accuracy to support better pressure injury prevention.

Researchers are evaluating how an art-based tool, called the Artistic Pain Exploration (APE) method, may help improve communication and understanding of pain in adults with early-stage temporomandibular disorders (TMD) who do not require surgery. This Phase 3 randomized controlled trial compares the standard care approach to the use of the APE method alongside standard care. The study aims to see if the art-based tool improves pain communication, jaw joint function, and reduces anxiety more effectively than usual assessment alone. Participants are randomly assigned to one of two groups. The control group receives standard TMD assessment and treatment, which includes physical evaluation and symptom management. The intervention group receives the same standard care plus the APE method, where participants view three expressive paintings and select one that resonates with their pain experience. A guided discussion using the chosen artwork explores the patient's physical and emotional pain and its impact on daily activities. Both groups undergo clinical exams and complete questionnaires assessing anxiety and depression. During the study, participants complete standardized questionnaires before and after two weeks to measure anxiety and report on their pain understanding. Clinical examinations assess jaw pain and function, and appropriate treatments and lifestyle advice are provided. The main outcome is patient-reported outcomes on pain understanding and communication. Safety is monitored, with support available for any emotional discomfort caused by discussing pain. The total participation lasts about two weeks, including follow-up assessments.

Researchers are exploring how intensive care unit (ICU) physicians experience and manage discussions about Do Not Attempt Resuscitation (DNAR) and end-of-life decisions with families of critically ill adult patients in a Muslim-majority healthcare setting. This observational study aims to understand the factors influencing DNAR decisions, including physician experience, family dynamics, religious views, and institutional support, to improve communication and care during these sensitive conversations. The study is conducted over 24 months at King Faisal Specialist Hospital & Research Centre in Jeddah. ICU physicians (residents, fellows, assistant consultants, and consultants) who routinely conduct DNAR discussions will complete a brief questionnaire immediately after each conversation. These responses will be linked anonymously to de-identified patient data extracted from electronic medical records. The study defines different DNAR levels and considers full resuscitation and various comfort-focused care options. Participants will be involved through these post-discussion questionnaires, with no direct contact with patients or families. Data collected include physician perceptions, family emotions, decision outcomes, and clinical patient information. Researchers will analyze these data to identify patterns and factors affecting DNAR decisions, aiming to enhance physician training and develop culturally sensitive policies for end-of-life care in Muslim-majority ICUs.

Researchers are assessing whether a special toothpaste containing nano-hydroxyapatite (Nano-HA) can help children aged 6 to 12 with Molar-Incisor Hypomineralization (MIH), a dental condition causing enamel defects. The study compares Nano-HA toothpaste to regular fluoridated toothpaste to see if it reduces cavities, improves tooth appearance, and decreases tooth sensitivity over time. The safety of the Nano-HA toothpaste is also being evaluated. Participants will be divided into two groups: one using Nano-HA toothpaste and the other using fluoridated toothpaste, both applied three times daily under parental supervision for 9 months. The study involves daily use of the assigned toothpaste and monitoring effects on affected teeth, such as the first permanent molars and permanent maxillary incisors. Treatment effects will be followed for 12 months with clinical evaluations at baseline and several intervals. Children will visit the clinic every 1 to 3 months for checkups and assessments, including tooth color changes and sensitivity. They will keep records of symptoms, tooth brushing compliance, and sensitivity levels. The main outcome measure is the change in enamel desensitization at 6 months, with continued follow-up to 12 months to monitor ongoing effects and safety.