Clinical trials

Breast cancer is the commonest cancer affecting women worldwide. Early breast cancer is treated surgically with wide local excision of tumor with axillary staging operations like sentinel node biopsy. Surgical adjuncts used in identifying and localizing the area for excision include metallic wire, radioactive or magnetic seeds and radiofrequency reflectors. These are placed in the lesion under image guidance by the breast radiologists, either on the day of surgery (wires) or prior (seeds). Bracketing localization is performed in case of multiple lesions or wide spread calcifications to aid the surgeons in performing wide local excision of all involved areas. This means placing multiple devices around the area of excision for accurate triangulation, which increase the costs significantly. Localization agents like radionucleotide labelled albumin, super paramagnetic iron oxide (SPIO) and colored dyes like methylene blue, isosulphane blue and indocyanine green are injected in the breast for identification of sentinel lymph nodes in the axilla. More recent studies have demonstrated successful use of SPIO in localization of small impalpable breast cancer lesions. This also raises the prospect of using SPIO for the dual purpose of lesion localization / bracketing and sentinel node biopsy. This study was designed to test this principle in patients requiring bracketing. This is a prospective proof-of-concept pilot study to evaluate the feasibility of SPIO (Magtrace®) as a single-agent solution for bracketing the excision area and localizing the sentinel lymph node for breast-conserving surgery. Patients with breast cancer requiring bracketing and sentinel node biopsy will be identified through multidisciplinary breast tumor board and invited to take part in the study. All patients who consent to participate will receive an injection of Magtrace® for bracketing (0.5ml each at four points around the excision area) one day before surgery under ultrasound guidance. Primary outcome will be successful localization of the Magtrace® signal in breast for bracketing and in the sentinel node, using a magnetic probe on the day of surgery. Clinical outcomes, complications and cost analyses will be performed as secondary outcomes. We anticipate a sample size of 35 patients to be recruited for the study.

This prospective comparative observational study will compare the incidence of true nephrotoxicity in adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem. Vancomycin plus piperacillin-tazobactam has been associated with a higher incidence of kidney injury based mainly on increases in serum creatinine. However, it remains uncertain whether these increases represent true kidney injury or pseudo-nephrotoxicity, in which serum creatinine increases without a corresponding decline in kidney function. To address this uncertainty, the study will prospectively assess kidney function using both serum creatinine and cystatin C. True nephrotoxicity will be identified when changes in both biomarkers meet the study criteria for acute kidney injury, while an increase in serum creatinine without a corresponding cystatin C increase will be considered pseudo-nephrotoxicity. The study will compare true nephrotoxicity between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem. It will also evaluate the timing, persistence, severity, and recovery of kidney injury. The results may help clarify whether the higher rates of nephrotoxicity reported with vancomycin plus piperacillin-tazobactam represent true renal injury and may help guide antibiotic selection when balancing antimicrobial coverage and kidney safety.

This study aims to evaluate whether incorporating FeNO monitoring into routine pediatric asthma care improves clinical outcomes relative to a historical cohort managed without FeNO

In this pilot randomized controlled trial (RCT), the investigators aim to explore the feasibility of conducting a powered RCT that examines the efficacy and safety of high flow tracheal oxygen (HFTO) in weaning critically ill tracheostomy patients from mechanical ventilation. Objective of the study 1. To assess the feasibility of conducting a larger RCT as primary objective. 2. To explore the effect of using HFTO in mechanically ventilated tracheostomized critically ill patients on ventilator-free days (VFD) compared to standard of care method using tracheal mask (TM) as secondary objective.

The Saudi Emergency Laparotomy Audit (SELA) is a national, multicenter observational clinical audit designed to evaluate outcomes and quality of care for patients undergoing emergency laparotomy in Saudi Arabia. The audit will collect standardized data on patient characteristics, comorbidities, perioperative processes, and postoperative outcomes through a retrospective baseline phase followed by a prospective registry phase. SELA aims to establish national benchmarks, assess applicability of international risk models, support development of a Saudi-specific risk prediction tool, and drive quality improvement through systematic feedback and benchmarking across participating hospitals.

* Radiation dermatitis is a common side effect in head and neck cancer (HNC) patients receiving radiotherapy, especially with advanced techniques like TomoTherapy. The use of 6 MegaVoltage (MV) Flattening Filter-Free (FFF) beams and shorter Source to Skin Distance (SSD) in TomoTherapy may increase skin dose, leading to higher rates of skin reactions such as redness, irritation, and pain. These reactions can affect patient comfort, increase the risk of infection, and even interrupt treatment. * Although radiation dermatitis is frequent, there is no widely accepted standard for preventing or managing it. Supportive care programs, like the Dermatitis Control Program (DeCoP), and other supportive care programs using silicone-based semi-permeable barrier film have shown that simple measures-such as good skin hygiene and keeping the skin moist, can help reduce skin damage during treatment. * This study will evaluate the effectiveness of fragrance-free emollient (glycerol-based) + absorbent polyurethane foam dressing versus silicone-based semi-permeable barrier film dressing in preventing or reducing skin toxicity in HNC patients receiving TomoTherapy. These products are easy to apply, affordable, and widely available, making them practical options for routine care.

This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).

Background Rotator cuff tears (RCTs) are a common, costly, and often persistent musculoskeletal complaint, with an increasing number of shoulder pain patients undergoing surgical repair each year. Whereas many asymptomatic RCTs can be successfully managed non-surgically, when conservative treatment fails, surgery is recommended. However, there is a lack of consensus on the best approach to postoperative rehabilitation, an important factor in the recovery process of rotator cuff repairs. This study aims to investigate the effectiveness of early versus delayed rehabilitation following rotator cuff repairs. Objective This study aims to determine the effectiveness of early versus delayed rehabilitation following rotator cuff repairs. Method A two-armed, randomized controlled trial will be conducted in an outpatient physical rehabilitation department at a tertiary hospital. The sample will include 88 adults aged 18 years or older with RCTs. From the day after surgery, the intervention will engage in supervised passive range of motion (ROM) exercises, focusing on forward flexion and external rotation. They will receive daily exercise instructions, including table slides and active movements for the elbow, wrist, and hand, while also practicing passive shoulder flexion and abduction based on their pain limits. Participants are encouraged to do gentle pendulum exercises and passive movements three times daily to improve shoulder mobility. Active shoulder exercises will be restricted until six weeks post-surgery to ensure healing. Sling use will decrease by the sixth week, allowing for active ROM exercises to start. Participants in the control group will follow a delayed rehabilitation protocol, learning strict sling immobilization techniques for the first six weeks postoperatively. During this period, sling removal will be allowed only for basic exercises and daily activities, with no other shoulder movements encouraged initially. Sling use will end by the sixth week, followed by the start of active ROM exercises. Outcome measures will include shoulder ROM, muscle power, a numeric pain scale (NPS), shoulder pain disability index (SPADI), and EQ-5D-5L questionnaires assessed at 3, 6, and 12 months follow-up between the two groups. Rotator cuff integrity will be evaluated using MRI at baseline and at 12 months post-surgery. Conclusion We anticipate that this study will add to the body of knowledge required to make effective treatment choices on the management of patients following rotator cuff repairs. Ultimately, this trial aims not only to influence national rehabilitation guidelines but also to enrich the global evidence base concerning optimal rehabilitation strategies following rotator cuff repair, especially for populations in the Middle East and Gulf regions.

The goal of this clinical trial is to learn whether an artificial intelligence (AI)-assisted skin assessment tool can improve the accuracy of pressure-injury staging in critical-care nurses. The study also aims to understand whether the AI tool increases nurses' knowledge and confidence in performing skin assessments. The main questions it aims to answer are: Does AI-assisted assessment improve the accuracy of pressure-injury staging compared with standard visual assessment? Does the use of AI improve nurses' knowledge and confidence related to skin assessment and pressure-injury staging? Researchers will compare nurses who use an AI-assisted mobile application with nurses who perform standard manual assessments to see whether the AI tool improves staging accuracy and supports early identification of pressure injuries. Participants will: Complete brief questionnaires about their knowledge and confidence before and after training Perform skin assessments on their assigned ICU patients using either standard methods or the AI tool. Have their assessments compared with those of a blinded wound-care specialist, who will determine the most accurate staging

The Saudi CABG Audit and Registry (SCAR) is a prospective, multicenter national clinical quality registry designed to systematically collect perioperative and long-term outcome data for all patients undergoing coronary artery bypass grafting (CABG) in Saudi Arabia. The registry will begin with a pilot phase in selected tertiary cardiac centers and will progressively expand to national coverage. SCAR captures detailed information on patient demographics, cardiac status, operative techniques, postoperative outcomes, and 1-year follow-up, including patient-reported quality-of-life measures (EQ-5D and SF-36). The aim is to establish a standardized national platform for benchmarking, quality improvement, and real-world evidence generation to support clinical decision-making and health policy development in cardiac surgery. Data are collected prospectively through secure electronic systems, anonymized before central storage, and analyzed using standardized definitions aligned with international registries such as STS and E-CABG.

This observational study aims to explore the real-time experiences, perceptions, and challenges faced by intensive care unit (ICU) physicians during goals-of-care discussions-specifically Do Not Attempt Resuscitation (DNAR) and end-of-life decision-making conversations-with families of critically ill patients in a Muslim-majority healthcare setting. The study seeks to identify factors that influence whether a DNAR decision is reached after physician-family discussions, and how physician experience, family dynamics, religious perspectives, and institutional support affect communication outcomes and care transitions. Participants will include ICU physicians (residents, fellows, and consultants) who routinely conduct DNAR discussions as part of clinical care. After each discussion, physicians will complete a brief structured questionnaire about their perceptions of the interaction, family emotions, and decision outcomes. These responses will be anonymously linked to limited, de-identified patient-level data (e.g., diagnosis, ICU course, and outcome) extracted retrospectively from the electronic medical record. No patients or family members will be contacted directly. Data collection will occur prospectively over two years at King Faisal Specialist Hospital \& Research Centre-Jeddah. Findings from this study are expected to provide culturally grounded insights that inform physician training, enhance family-centered communication, and guide policy development for DNAR and end-of-life discussions in Muslim-majority intensive care units.

Cardiac surgery patients often experience elevated blood glucose levels, which can lead to poor surgical outcomes and increased postoperative complications. Therefore, tight blood glucose control during surgery is important. Currently, there is no consensus on the best method for blood glucose control during cardiac surgery. This proposal aims to perform a randomized controlled trial to compare blood glucose control intraoperatively using an insulin drip versus insulin boluses. The primary objective of the study is to compare blood glucose control intraoperatively between patients who receive insulin drip and patients who receive insulin boluses during adult cardiac surgery. This study will be a randomized controlled trial in which adult patients undergoing cardiac surgery will be randomized into two groups: insulin drip and insulin boluses. Patients with a history of diabetes or those currently taking antidiabetic medications will be included in the study. This randomized controlled trial will provide valuable information on the optimal method for achieving blood glucose control intraoperatively. The results of this study may help improve patient outcomes and reduce the incidence of postoperative complications.

Acute lymphoblastic leukemia (ALL) is a malignant proliferation of immature lymphoid cells within the bone marrow, blood, and extramedullary sites. According to the SEER Cancer Statistics Review, the incidence was estimated to be at around 1·6 per 100000 people in 2014, with around 6000 new cases diagnosed in 2018. This disease is more frequent in children aged 1-4 years, then drops reaching the lowermost point between 25 years and 45 years. Generally, around 60% of ALL cases are diagnosed before the age of 20 years. Despite significant improvements in 5-year overall survival reaching around 90% in children, only 25% of patients older than 50 years old were alive 5 years after diagnosis1,2. These survival figures are much worse when dealing with relapsed disease. Cases of relapsed or refractory ALL are usually offered allogeneic stem cell transplantation that can establish meaningful disease control after achieving the best disease control depicted in lack of measurable residual disease3. However, the inability of performing allogeneic stem cell transplantation in some patients, especially elderly patients, represents unmet needs for advancing treatment for these challenging ALL cases. Cellular immunotherapy with CD19-directed chimeric antigen receptor (CAR) T-cells has demonstrated encouraging results for the treatment of B-cell ALL (B-ALL). Currently used CAR T-cells are genetically engineered autologous T cells that express the antigen-binding domain linked to a costimulatory molecule and an intracellular T-cell receptor signaling domain. CAR T-cells function in a major histocompatibility complex-independent manner. Because of its expression on nearly all B-ALL, CD19 became the most sensible target. This paved the way for using tisagenlecleucel and brexucabtagene autoleucel in patients with B-ALL with astonishing outcomes4-6. However, the dependence on expression of the antigen of target can be an "Achilles' heel" for CAR T-cells similar to monoclonal antibodies, and loss of this target is a major escape mechanism by which cancer cells can evade immunotherapy. Mechanisms of antigenic loss may include genetic modulations, epitope masking, or a cell lineage switch with secondary loss of the target epitope7. Cell plasticity is the ability of cells to be reprogrammed and to alter their fate and identity, which can enable homeostasis and restoration following injury. Pathological plasticity allows cancer cells to acquire new phenotypic and/or functional features leading to disease progression and resistance to therapy8. One of the most studied and established phenotypic and functional plasticity is KMT2A-r ALL9. The seminal work of Dr. John Dick and his lab in establishing the concept of leukemia stem cell was instrumental to the field. Transplantation of human ALL into NOD/SCID mice generates a disease in these mice that is reminiscent of the human disease10. The attributes of self-renewal and clonogenic proliferation are considered "functional" markers for stemness of these leukemia initiating cells. Because some of these functional assays are laborious, multiple efforts have been exerted to uncover the most accurate markers to label these cells that cab reliably predict this unique cellular population. In addition to cell-intrinsic factors for plasticity that are mentioned above, cell-extrinsic or "niche" elements can fuel cellular plasticity when they occur. Despite these limitations, CD34+CD38- cell fraction is most likely to harbor the most primitive and quiescent cells that can fuel disease existence11. King Faisal Specialist Hospital and Research Center is one of the leading hospital in the region in providing novel CAR T-cell therapy for management of challenging cases of relapsed and or refractory B-ALL, and has delivered a large number of products given its excellence reputation and the large number of cases treated at the center. We aim through our study to analyze the correlation between CD19 expression across the realm of B-ALL hierarchy using samples from relapsed B-ALL patients who underwent CAR T-cells therapy at our center and weigh this against their outcomes in relation to the percent expression of CD19 at each cellular faction: CD34+CD38-, CD34+CD38+, and CD34-CD38+.

The goal of this clinical trial is to compare two treatments for regulating blood flow in small liver grafts during living donor liver transplantation (LDLT). The main questions it aims to answer are: * Is octreotide (a medication) as effective or better than splenic artery ligation (surgery) in reducing complications after transplantation? * Which treatment better controls blood flow while causing fewer side effects? Researchers will compare octreotide (given through an IV) to splenic artery ligation (performed during surgery) to see which approach works best for patients receiving small liver grafts. Participants will: * Be randomly assigned to receive either octreotide or splenic artery ligation during their transplant surgery * Have their liver blood flow monitored closely during and after surgery Be followed for 90 days and 1 year to track complications, hospital stay, recovery, and survival. This study may help doctors choose safer, more effective treatments for patients needing small liver grafts.

This randomized clinical trial will evaluate two approaches of GvHD prophylaxis; the standard of care GVHD prophylaxis regimen (methotrexate/calcineurin inhibitors) and post-transplant cyclophosphamide with calcineurin inhibitors for their efficacy as a new GVHD prophylaxis strategy.

Cardiovascular disease (CVD) and Type 2 diabetes mellitus (T2DM) are major global health challenges with significant morbidity and mortality. In Saudi Arabia, the prevalence of CVD and T2DM is increasing. This poses a significant burden on the healthcare system. Despite extensive global research, there remains a lack of comprehensive studies examining the combined impact of CVD and T2DM in the Saudi population, particularly in the Western region. Objectives: The primary objectives of the study are: (1) quantify the incidence and mortality rates of CVD and T2DM across various demographics in the Western region of Saudi Arabia; (2) analyse the demographic, clinical, and lifestyle factors contributing to cardiovascular risk in individuals with both conditions; (3) understand the influence of cultural, social, and religious beliefs on health behaviours related to CVD and T2DM using social media and survey data; (4) develop a predictive model for forecasting future cardiovascular events in the Saudi population; and (5) evaluate the impact of the ICD11 classification of CVD. Methodology: The project will include team of experts from King Faisal Specialist Hospital and Research Centre, Madinah, Taibah University, Islamic University of Madinah, University of Prince Mugrin, and King's College University, London. We will work under four workstreams (WS) which are: WS 1: This group will supervise the data collection, analysis and ensure efficient running of the project. WS 2: In year 1, retrospective data will be collected on the service needs, long term outcomes, and mortality of patients with CVD and T2DM, CVD only, T2DM only, and neither. Between Year 1 to 5, we will collect data prospectively using the new ICD-11 criteria. Both, retrospective and prospective data will be used to develop an artificial intelligence (AI) based predictive model. WS 3: Social media survey will be undertaken to understand health beliefs and behaviours influencing health related outcome to CVD and T2DM. WS 4: Undertake economic analyses into long-term resource utilisation and cost of care for CVD and T2DM. Expected Outcomes: The study is expected to provide a detailed incidence and all-cause mortality CVD and T2DM in the Western region of Saudi Arabia. This will help in identifying risk factors and predictive for CVD and understand health beliefs and behaviours in Saudi Arabia. The data will help in developing policies, guidelines and awareness programmes in collaboration with policy makers. In conclusion, this study will impact by improving epidemiological knowledge and understanding of CVD and T2DM in Saudi Arabia. The project will support the overall mission of Saudi Vision 2030 with regard to increasing the health and well-being of the population.