Clinical trials

1. Background \& Context The Challenge: Type 2 Diabetes (T2D) is a major public health burden. Lifestyle changes are effective, but little is known about how long it actually takes to make these changes stick. The Gap: Traditional trials look at outcomes at fixed time points (e.g., 12 weeks). We lack data on the specific timeline of habit formation, which is critical for designing scalable interventions. The Setting: This study aligns with Saudi Vision 2030 by leveraging digital health to improve population wellness. 2. Study Objectives Primary Aim: To determine if a structured digital intervention accelerates the time to habit adoption compared to standard education. Secondary Aims: To measure improvements in glucose control (HbA1c), overall physical activity levels, and quality of life. 3. Study Design \& Methods Design: Randomized Controlled Trial (RCT). Population: 222 adults at risk for diabetes. Intervention (12 Weeks): Group A (Experimental): Hybrid digital intervention with personalized support. Group B (Control): Standard lifestyle education. Follow-up: Total study duration of 24 weeks. Primary Endpoint: "Time to Habit." Defined as achieving ≥150 min/week of moderate-to-vigorous physical activity (MVPA) for four consecutive weeks (verified by wearables). 4. Statistical Analysis Primary Analysis: We will use Kaplan-Meier curves to visualize the probability of achieving the habit over time, and Cox Proportional Hazards models to calculate the "Hazard Ratio" (the speed of adoption between the two groups). Secondary Analysis: General linear models for continuous outcomes (HbA1c, IPAQ, SF-12

After a tooth is taken out, the empty socket needs to heal. Sometimes unhealthy soft tissue (called granulation tissue) is left behind and can slow down healing. This study compares two ways to clean the socket: 1. Manual method: a hand instrument (curette) 2. Rotary method: a small rotating dental bur Both methods are standard in dental practice. The study will see which method is faster, causes less pain, and leads to better bone healing. After cleaning, all patients will receive a routine bone graft to protect the jawbone for a possible future dental implant. The study will measure: * How long (in seconds) it takes to clean the socket * Whether the socket is completely clean, checked with a harmless blue stain (Toluidine Blue) * Changes in the bone at 3 and 6 months, measured by a special three-dimensional X-ray (cone-beam computed tomography, CBCT) * Pain and swelling reported by patients in the first week after the procedure * Any side effects or healing problems Patients are randomly assigned to one of the two cleaning methods (like flipping a coin). The surgeon knows which method is used, but the person analyzing the X-rays does not, to keep the results fair. The study will include 58-60 adult patients who need a tooth removed because of a long-term infection at the root. It is being conducted at the College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.

Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. This study evaluates restrictive versus liberal fluid management strategies in patients with acute VOC. This multi-center, open-label, non-inferiority RCT will enroll patients with SCD presenting with acute VOC. Participants will be randomized to either a restrictive or liberal intravenous fluid management protocol. Primary outcome is pain score reduction. Secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid dose, adverse events (incidence of fluid overload, pulmonary congestion), acute chest syndrome, incidence of acute kidney injury, revisit rates within 72 hours of ED discharge, need for intensive care or high-dependency unit admission, need for additional interventions, and 28 days overall mortality. Data will be analyzed using intention-to-treat principles. We hypothesize that a restrictive fluid strategy will achieve non-inferior pain control compared to a liberal strategy, while minimizing fluid-related complications. This study will provide evidence to inform clinical guidelines for fluid management in SCD patients experiencing VOCs.

Background: Obesity and mechanical low back pain (MLBP) are two major health problems negatively affecting the human body. Many studies have shown that obesity and MLBP are associated with negative effects on the respiratory system. There are many interventions to treat obesity and MLBP, such as aerobic exercise and diet programs. Moreover, the Inspiratory Muscle Trainer (IMT) significantly improved inspiratory muscle strength in patients with obesity. This study aims to investigate whether adding IMT to aerobic exercise will improve respiratory function, exercise capacity, and pain intensity in patients with obesity and MLBP. Materials and Methods: A total of forty-eight obese patients with MLBP will be equally and randomly assigned to the experimental group and control group. The experimental group will have training on IMT for 6 weeks, three days per week (two sessions daily, thirty breaths per session) using POWERbreathe IMT, starting at 40% of maximal inspiratory pressure with increasing training load at the third week, in addition to having aerobic exercise three times a week for 30 minutes and total body resistance. The control group will have the same training as the experimental group, except for IMT; they will have zero resistance. Main outcome measures: pulmonary function tests and maximal inspiratory pressures to assess respiratory function; VO2 to assess exercise capacity; pain intensity; and Oswestry Disability Index to determine functional disability. All the measurements will be done before and after the intervention in both groups. Paired and independent t-tests will be used to compare within- and between-group differences. A repeated-measures design will be used to determine significant differences before, during, and after the intervention within each group.

Background: The core has two functions, both critical to soccer performance. The first is to provide proximal stability, allowing efficient mobility at the distal parts. This function requires a submaximal contraction of core muscles for as long as the movement takes. It was reported that core endurance is the construct most closely representing this function. The second function is generating and transferring forces from one extremity to another. This function operates via the kinetic chain theory, which implies that various body parts are connected through myofascial kinetic chains, and that a defect in one part of the chain can lead to faulty mechanics and balance, potentially causing injuries in other parts of that chain. Aim: To investigate the efficacy of core stability training on core endurance, lower limb kinetic chain function, and lower limb dynamic balance in professional, healthy young adult soccer players. Methods: This is a randomized, controlled trial with a parallel, two-arm, pre- and post-design. After screening for eligibility and obtaining participants' consents, at least 28 male and female soccer players will be randomly assigned to intervention and control groups and tested before and after eight weeks of core training intervention. The outcome measures include the Sport-specific Endurance Plank test, the Closed Kinetic Chain Lower Extremity Stability test, and the modified Star Excursion Balance test. Data Analysis: The Shapiro-Wilk test, Q-Q plots, and Box plots will be used to evaluate the normality of the data. Lavan's test will check the homogeneity of variances. Based on the normality results, parametric or non-parametric tests will be implemented to compare within and between groups. A P-value of \<0.05 will be used to reflect the significance of the results. An intention-to-treat (ITT) analysis will be employed to address potential missing data. Keywords: core stability, endurance, kinetic chain, athletes, soccer.

Rationale Bleeding after cardiac surgery is a complication that might result in increased morbidity, mortality, and cost of cardiac surgery by 1.76 (confidence interval (CI), 1.64-1.90) times and a median increase in costs by Australian $33,338 (CI, $21,943-$38,415) \[1\]. Strategies and techniques to reduce postoperative bleeding in identified high-risk patients for bleeding after cardiac surgery might improve outcomes and resource utilization. Desmopressin (DDAVP) is used as a hemostatic agent to prevent and treat bleeding in patients with mild hemophilia patients with von Willebrand's deficiency through stimulating the release of von Willebrand factor from endothelial cells. Previous studies showed controversial results in terms of reduced transfusion requirements in patients with low risk for bleeding with post cardiopulmonary bypass (CPB) bleeding following prophylactic infusing desmopressin over 10 to 15 minutes after induction of anesthesia or protamine administration due to its positive effects on the coagulation system responsible for such bleeding. Contradictory, prophylactic desmopressin use demonstrated fewer transfusion requirements in patients treated with antiplatelets, which raises the need to examine its efficacy in high-risk cardiac surgery patients for perioperative bleeding. These controversial results might be attributed to delayed administration of desmopressin after evolving CPB-associated thrombocytopenia, platelet dysfunction, coagulation factor consumption and dilution, hyperfibrinolysis, and hypofibrinogenemia \[2\] Concerns were raised about the associated transient decreases in systemic vascular resistance and blood pressure after desmopressin administration following discontinuing CPB and administering protamine, which might be related to the rapid infusion rate during the critical surgery stage. The cost of a single dose of Desmopressin 0.3 ug/kg for a patient with an average weight of 70 Kg is about 82US$ which is cheaper than the alternative hemostatic agents proved to be effective in reducing bleeding and transfusion needs after cardiac surgery (e.g., fibrinogen concrete (average of 3 g = 1,167US$) and prothrombin complex concentrate (6,255US$ considering low fixed dosfixed-doseof 1040 IU F IX). It is yet unclear if extended infusions of desmopressin started earlier before the development of CPB-associated coagulopathy and platelets dysfunction from anesthesia induction time and continued to the end of CPB before protamine administration would offer an "efficacy," "safety, and "cost-effective" benefits over placebo in patients with high risks for bleeding after cardiac surgery terms of the need for transfusion, cumulative postoperative 48-hour chest tube outputs, need for reoperation, thrombotic complications, 30-day mortality, hemodynamic stability, and urine output during and after completing infusion, and costs of the study drug and allogenic transfusion requirement. That raises the need to examine its impact on these crucial clinical outcomes. Objective The primary objective of this prospective multicentre randomized clinical trial (RCT) is, compared with placebo, to examine the impact of prolonged infusion desmopressin on reducing postoperative bleeding and the need for allogenic allogeneic transfusion in high-bleeding-risk cardiac surgery patients scheduled for elective cardiac surgical procedures using CPB. Secondary objectives include comparing placebo and desmopressin in terms of safety and cost-effectiveness. Hypothesis It is hypothesized that extended 'desmopressin' infusion compared to 'placebo' results in less postoperative bleeding and transfusion needs (more effective) and leads to less hemodynamic compromise (safer) and cheaper (cost-effective) in high-risk cardiac surgery patients.

Anterior cruciate ligament (ACL) injuries are among the most common knee ligament injuries, causing joint instability and impairments. Besides being challenging, this type of injury greatly affects the athlete's passion and wellbeing, and it is associated with several risk factors. Injuries to the ACL are estimated to occur within 80,000 to 250,000 young, active and healthy athletes each year. This cross-sectional observational study aimed at translating, adapting cross-culturally, and investigating the psychometric properties of the Marx Activity Rating Scale (MARS) and the Knee Stability in Sports/Cutting-Pivoting Ability (KSS/CPA) scale in Saudi patients with anterior cruciate ligament injuries. For this study, a convenient sample size of 100 athletes with ACL injuries and healthy participants will be selected from different Saudi hospitals and clubs. Study participants will be informed about the study and a consent form will be obtained before they participate. A number of scales will be used as outcome measures, including the MARS, KSS/CPA scale, Knee Injury, and Osteoarthritis Outcome Score, Lysholm Knee Score, and International Knee Documentation Committee Subjective Knee Form. Internal consistency of both the MARS and KSS/CPA scales will be tested using Cronbach's alpha. A construct's validity will be measured by Spearman's correlation coefficient. Content validity can be determined by examining whether there are floor and ceiling effects. A significance level of 0.05 will be used to determine whether the data is significant. Ultimately, the study will help patients with ACL injuries to make informed decisions about their treatment, empower healthcare professionals to understand patients' concerns, and facilitate research.

The purpose of this study is to determine whether telerehabilitation is as effective as in-person rehabilitation in treating patients with chronic back pain in actual clinical practice settings.T he study will recruit eighty-four individuals with chronic LBP, who will be randomly assigned to one of two groups: telerehabilitation (TR) or the control group, who will receive standard clinic therapy. The TR group will be treated remotely via phone calls and the Zoom platform. The intervention program will be customized according to the requirements and abilities of each patient. It will include self-management skills, education and support, including Pain Neuroscience Education , and customized exercises.

This clinical trial aims to Compare the effectiveness of lower limb CIMT and the Strength Training of the Non-Hemiplegic lower limb on motor performance in hemiplegic children with CP. Participants will: diagnosed with hemiplegic cerebral palsy treated with CIMT or Strength training (cross-education) for a non-hemiplegic limb for 8 weeks. 3 sessions per week. Measurements will be taken at baseline and then at the end of the 8 weeks.

Background: Soccer is a prevalent sport worldwide; most soccer players are under 18. Soccer has benefits for your health, but there is also a chance that you could get injuries occasionally. High injury rates have been observed in both adult and young players, which has prompted the development of various preventive measures. FIFA recently introduced the FIFA 11+ Kids program for children under 14 to prevent soccer injuries and enhance kids' performance. To date, no studies have been done to determine whether adding the FIFA 11 + kids program for young players under 14 will enhance soccer-specific skills. Objective: To investigate the efficacy of FIFA 11+ Kids on soccer-specific skills among young soccer players. Methods: Thirty six young soccer players (aged 7-13) will be assigned randomly to the following groups: the control group (n =18) and the FIFA 11+ Kids program (n = 18). The experimental group will perform eight weeks of FIFA 11+ kids program (3/week). The control group will be instructed to continue their regular training . Three soccer specific skills tests : the Slalom dribble test, Harre circuit test, and Loughborough soccer passing test, will be done before and after eight weeks of training. Statistical analysis: IBM SPSS software (version 20) will be used for all statistical analyses. Data will be summarized in terms of mean and SD. Normality is checked with the Shapiro-Wilk test and homogeneity with Levene's tests. If the data are normally distributed, a paired t-test will be used for within-group difference comparison, and an independent t-test will be used for between-group comparison. If the data are not normally distributed, the Wilcoxon-Signed rank and Mann-Whitney U tests will be used.