Clinical trials

This study aims to examine efficacy of The Expanded Health Belief model-based intervention in enhancing female high school students' adherence to polycystic ovary syndrome health-protective behaviors.

Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.

The goal of this clinical trial is to learn which distraction method works better to reduce needle pain in children aged 4-12 years during blood draws. The main questions it aims to answer are: * Does watching cartoon videos lower children's pain more than squeezing a stress ball? * Which method do parents prefer for their children? 120 children will be randomly assigned to watch cartoons or squeeze a ball while nurses draw blood. Pain will be measured using a 0-10 pain scale right after the needle. This study will help nurses choose the best way to make blood draws less painful for children.

This randomized controlled clinical study is designed to evaluate the clinical effectiveness of combining temporomandibular joint (TMJ) arthrocentesis with a single intra-articular injection of meloxicam in patients suffering from TMJ internal derangement. Temporomandibular disorders (TMD) are common conditions causing pain, restricted jaw movement, and joint sounds, which can significantly impair patients' quality of life. While conventional treatments include conservative approaches and arthrocentesis alone, finding optimal therapeutic protocols remains crucial for refractory cases. A total of 50 adult patients diagnosed with unilateral TMJ internal derangement (with or without reduction) who have failed at least one month of conservative therapy will be enrolled and randomly allocated into two equal groups: Study Group: Will undergo joint arthrocentesis followed by a single intra-articular injection of meloxicam (15 mg / 1.5 mL). Control Group: Will undergo joint arthrocentesis alone using Ringer's lactate solution. Patients will be evaluated across a 12-week postoperative period (at 2, 4, 8, and 12 weeks) to assess primary and secondary outcomes, including pain intensity (measured via a Numerical Rating Scale), maximum mouth opening (inter-incisal distance in millimeters), joint sounds (clicking, popping, or crepitus), and overall patient satisfaction. The findings aim to establish whether adding an intra-articular non-steroidal anti-inflammatory drug (NSAID) enhances the therapeutic benefits of standard TMJ arthrocentesis.

Goal To compare the effectiveness of a toy nebulizer versus distraction cards in reducing fear among children during nebulization therapy while improving parental satisfaction. Aim To evaluate and measure children's fear levels and parents' satisfaction when using toy nebulizers compared to distraction cards in nebulization sessions. Null hypothesis: (Hᴏ) There is no statistically significant difference in fear levels among children, and parental satisfaction scores in in the toy nebulizer, distraction cards, and control groups. Alternative hypothesis: (H₁) There is a statistically significant difference in fear levels among children, and parental satisfaction scores in the toy nebulizer, distraction cards, and control groups.

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

This study aims to evaluation of collegians adherence to oral health behavers and to examine the efficacy of the Expanded Health Belief Model-based intervention in enhancing oral health behaviors among collegians.

This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period. primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.

Patients with end-stage renal disease (ESRD) on maintenance hemodialysis experience chronic systemic inflammation, oxidative stress, and dyslipidemia, which together drive much of the excess cardiovascular morbidity and mortality seen in this population. Pumpkin seed oil is a nutraceutical rich in polyunsaturated fatty acids, phytosterols,and tocopherols, with documented antioxidant, anti-inflammatory, and antihyperlipidemic properties in preclinical and limited clinical studies. This study investigates the potential role of pumpkin seed oil as a nutraceutical on the clinical and biochemical outcomes of hemodialysis patients. It is a randomized, open-label, prospective interventional study in which daily oral supplementation with pumpkin seed oil (1000 mg once daily) for 3 months is evaluated against usual care. Eighty-five participants will be assigned to either an intervention group (n=45, pumpkin seed oil 1000 mg/day plus usual care) or a control group (n=40, usual care only). The biochemical outcomes assessed are changes in serum interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), lipid profile, malondialdehyde (MDA), and superoxide dismutase (SOD) from baseline to the end of the 3-month follow-up period. The study is being conducted at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq

This randomized controlled trial will evaluate the efficacy of a Transtheoretical Model (TTM)-based behavior-change intervention, delivered through stage-matched counseling sessions, on anabolic-androgenic steroid (AAS) use among gym-goers, compared with a control group receiving standard health education. Non-medical AAS use is a growing public health concern in gym and fitness settings and is associated with serious cardiovascular, endocrine, hepatic, and psychiatric harms. Participants will be randomly assigned to either a TTM-based intervention group or a control group. The intervention will tailor counseling content to each participant's stage of change (precontemplation, contemplation, preparation, action, or maintenance) regarding AAS use. The findings of this study will provide evidence on the effectiveness of stage-based behavioral counseling in reducing AAS use and progressing gym-goers toward safer, drug-free training practices.

This study aims to determine the effect of probiotics and Zn/CHx mouthwashes on plaque accumulation and halitosis in fixed orthodontic patients.

This study will compare the effect of standard-dose and micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) with a placebo control on dental implant stability in the posterior mandible. Sixty patients requiring a single dental implant will be randomly assigned to one of three groups: standard-dose rhBMP-2, micro-dose rhBMP-2, or sterile saline only. Implant stability will be measured using Resonance Frequency Analysis at baseline, 2 weeks, 4 weeks, and 12 weeks. Marginal bone loss, peri-implant bone density, ectopic bone formation, and postoperative sequelae including swelling, pain, trismus, and soft tissue healing will also be evaluated during follow-up. The aim is to determine whether micro-dose rhBMP-2 can improve implant stability while reducing postoperative complications compared with the standard dose.

This study is a multi-center, prospective, parallel-group randomized controlled trial designed to compare the orthodontic treatment outcomes of a passive self-ligating bracket system (Damon Ultima) versus a clear aligner system. The primary objective is to evaluate and compare the total orthodontic treatment duration between the two systems in patients with Angle Class I malocclusion and moderate crowding. Secondary objectives include assessing alignment efficiency, patient pain perception at multiple time intervals, dental arch dimension changes, root volume loss percentage, and overall treatment quality using the American Board of Orthodontics Objective Grading System (ABO-OGS).

This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Participants will be randomly assigned to either an intervention group receiving virtual reality-guided imagery in addition to routine care, or a control group receiving routine care

Randomized split mouth clinical trials study focused on comparing the efficacy of C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype.

Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy, with over 80,500 estimated new cases diagnosed in the United States in 20231. Diffuse large B-cell lymphoma (DLBCL) is the most frequent subtype of NHL, accounting for 30%-40% of cases2. DLBCL is an aggressive malignancy with heterogeneous biology and behavior. Disease risk stratification and treatment planning involve various patient and clinical characteristics (e.g., age, stage, and tumor bulk), prognostic indices (e.g., International Prognostic Index (IPI) score), and gene expression profiling. Patients typically present with nodal or extranodal disease, usually exhibiting rapid tumor growth and symptoms that are highly dependent upon the tumor localization. The diagnosis and subtyping of DLBCL have significantly advanced, from morphological assessment of tissue slide to numerous ancillary tests, including immunophenotyping performed by immunohistochemistry (IHC), cytogenetics, and detailed molecular testing to classify the disease based on cell of origin (COO). With the advent of novel therapeutic options, molecular subtyping of DLBCL at diagnosis is expected to allow prognostic stratification of patients into distinct subgroups. This stratification could provide a preclinical rationale for therapeutic targeting the involved pathways and paving the application of personalized treatment. DLBCL is a potentially curable disease with an overall 60-70% chance of achieving durable complete remission (CR) with the currently used standard first-line immunochemotherapy. However, 30-40% of patients are either refractory to first-line treatment or experience relapse and eventually will die of disease progression7. Although high-dose chemotherapy followed by autologous stem cell transplant (ASCT) is the recommended SOC for eligible patients in the second-line setting based on results from the pivotal PARMA study, real-world SOC in this setting remains less clearly defined. Patients not cured with ASCT or ineligible to ASCT or refractory to salvage chemotherapy may be considered for Chimeric Antigen Receptor (CAR) T cell therapy targeting CD1910. Although ASCT and CAR-T cell therapy offer patients an opportunity for durable remission, many patients may not be eligible for ASCT or CAR-T cell therapy or relapse after these treatments. In the last decade, the investigation of novel antigens, which can be targeted by immunotherapy and identified to eliminate malignant cells regardless of their molecular pathogenesis, has been constantly pursued. This study aims to address this need by examining the demographic, clinical characteristics, and treatment patterns and exploring access to novel therapies for diffuse large B-cell lymphoma (DLBCL) patients, both treatment naïve and relapsed/refractory patients, in the Middle East and Africa (MEA) region.

Orthodontic treatment often requires moving the upper canine teeth (the pointed teeth) into the spaces left after removing premolar teeth. This process is usually slow and can take many months, making the total treatment time longer.This study will compare two techniques that may speed up this tooth movement: Micro-osteoperforation (MOP): A minimally invasive procedure in which a small device is used to create tiny holes in the jawbone near the canine tooth under local anesthesia. These micro-perforations stimulate the bone to remodel faster, which allows the tooth to move more quickly. Photobiomodulation therapy (PBMT) / Low-Level Laser Therapy (LLLT): A painless, non-invasive technique that uses a low-power laser light applied to the gum tissue near the canine tooth. The laser energy stimulates cells in the bone and supporting tissues to accelerate tooth movement without any cutting or drilling. This trial will randomly assign eligible patients into one of three groups: MOP, LLLT, or a control group receiving standard orthodontic treatment only. Each group will contain 25 participants (75 total). The main goal is to measure and compare how fast the upper canine tooth moves in each group over the first month and until the space is fully closed. The study will also measure the effect of age and sex on the results. The findings will help orthodontists choose the best, fastest, and most comfortable method for each patient to shorten overall treatment time

The goal of this clinical trial is to learn if an Arabic-language mobile application that uses artificial intelligence (AI) can help women with breast cancer during chemotherapy. The app is designed to give personalized support by reminding participants about their medications, teaching them how to manage treatment side effects, and alerting their healthcare team about serious symptoms. The main questions this study aims to answer are: 1. Does the AI-based mobile app provide accurate and safe recommendations for the patients? 2. Does using the AI-based mobile app help lower treatment-related symptoms and side effects compared to usual care? 3. Does the app help participants take their medications more regularly? 4. Does it increase participants' understanding and satisfaction with the information they receive about their treatment? Researchers will compare two groups: Group 1: Participants who use the AI-based mobile app plus usual oncology care. Group 2: Participants who receive usual care only. Participants will: 1. Use the mobile app daily for 12 weeks while receiving chemotherapy. 2. Complete short questionnaires about symptoms, medication use, and quality of life at the start and end of the study. 3. Report any problems or feedback about using the app. The AI app is for support and education only. It does not make treatment decisions. All information from the app will be reviewed by oncologists and pharmacists to ensure participant safety.

This is a multi-centre, prospective, randomized, open-label controlled trial designed to evaluate the effectiveness of a flexible digital insulin dose calculator in children under 12 years of age with Type 1 Diabetes Mellitus (T1DM) managed with multiple daily injections (MDI). Participants will be stratified by continuous glucose monitoring (CGM) use and baseline HbA1c, and randomised to receive either standard care alone or standard care plus the insulin dose calculator tool for 6 months. The primary outcome is the change in HbA1c from baseline to 6 months. Secondary outcomes include CGM-derived glycaemic metrics (Time in Range, Time Below Range, Time Above Range, and Coefficient of Variation), total daily insulin dose (units/kg/day), healthcare provider contact frequency, and caregiver-reported usability and satisfaction. The study aims to determine whether the use of a structured digital decision-support tool improves glycaemic control and supports safer insulin dosing in paediatric patients with T1DM.

The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners. The main question it aims to answer is: Does the use of in-office direct-printed shape-memory aligners result in superior clinical effectiveness, compared to established multilayer thermoformed aligner systems? Researchers will compare a Direct-Printed Aligner (DPA) group using Senertek Clear-A V2 resin to a Thermoformed Aligner (TFA) group using Zendura FLX multilayer sheets to see if the additive manufacturing process improves clinical outcomes and patient satisfaction. Participants will: * Undergo initial records including intraoral digital scans, photos, and a panoramic radiograph for treatment planning. * Wear their assigned clear aligners (either direct-printed or thermoformed) for at least 22 hours per day, changing them every 7 days. * Attend follow-up appointments every 5 weeks.

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.

1. To evaluate the effect of a medication adherence-based digital intervention on fatigue severity in patients with hypothyroidism. 2. To assess the effect of a medication adherence-based digital intervention on weight in patients with hypothyroidism. 3. To investigate the effect of a medication adherence-based digital intervention on thyroid hormone regulation in patients with hypothyroidism.

Clear orthodontic aligners are widely used due to their esthetics and patient comfort; however, prolonged wear may promote biofilm accumulation and enamel demineralization. This laboratory-based (in vitro) study aims to develop and evaluate a novel directly 3D-printed orthodontic aligner resin modified with antimicrobial and remineralizing agents. The study will investigate the incorporation of dimethylaminohexadecyl methacrylate (DMAHDM) as an antibacterial agent and amorphous calcium phosphate (ACP) as a remineralizing component into a 3D-printed aligner resin. Modified and unmodified resin specimens will be fabricated and assessed for antimicrobial activity, ion release, and enamel remineralization potential using extracted human teeth. In addition, the mechanical and physical properties of the experimental aligner materials, including shape memory behavior, deflection, tensile strength, translucency, and water sorption, will be evaluated to ensure clinical suitability. This study does not involve human participants and is conducted entirely in vitro. The findings are expected to contribute to the development of biofunctional orthodontic aligners that actively inhibit bacterial growth and support enamel health without compromising material performance

Open heart surgery is often associated with postoperative pulmonary complications, reduced lung expansion, dyspnea, and impaired cardiopulmonary function. Breathing exercises are commonly used after surgery to improve lung ventilation, enhance oxygenation, and support respiratory recovery. However, limited evidence is available comparing the effectiveness of segmental breathing exercises and active cycle breathing technique (ACBT) in patients after open heart surgery. This randomized controlled trial will compare the effects of segmental breathing exercises and ACBT on dyspnea and cardiopulmonary parameters in adults undergoing open heart surgery. Participants will be randomly assigned to either the segmental breathing exercise group, the ACBT group, or the standard care group during the postoperative period following extubation. Cardiopulmonary parameters, including oxygen saturation, respiratory rate, heart rate, and blood pressure, as well as dyspnea severity and postoperative pulmonary complications, will be assessed before and after the interventions. The findings of this study may help identify the most effective breathing exercise technique for improving respiratory outcomes, reducing postoperative pulmonary complications, and supporting evidence-based postoperative rehabilitation after cardiac surgery.

Post-stroke hemiplegia frequently results in impaired upper limb function, which significantly affects independence and quality of life. Various rehabilitation approaches have been developed to improve motor recovery, including mirror therapy and robotic-assisted training. Mirror therapy uses visual feedback to stimulate neural plasticity and enhance motor recovery, while soft robotic gloves assist repetitive hand movements and facilitate functional training. This randomized controlled trial aims to investigate the effect of combining mirror therapy with a soft robotic glove on hand function recovery in patients with post-stroke hemiplegia. Participants will be randomly assigned to different intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation. The primary outcome will assess improvement in upper limb motor function using validated clinical assessment tools. Secondary outcomes will evaluate functional hand performance and activities of daily living. The findings of this study may contribute to improving rehabilitation strategies for stroke survivors and provide evidence for integrating innovative rehabilitation technologies into clinical practice.