Clinical trials

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.

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).

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.

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.

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.

The goal of this randomised clinical trial study is to investigate 3D-printed shape memory aligners in the treatment of anterior dental open bite adult patients. The main questions it aims to answer are: 1. Do 3D-direct-printed shape memory aligners demonstrate potentiality in the management of AOB? 2. What is the effect of 3D-direct printed shape memory aligners on molar intrusion? 3. Can the 3D-direct printed shape memory aligners extrude anterior teeth without the use of attachments? 4. Do 3D-direct printed shape memory aligners generate greater/higher stress distribution and initial teeth displacement compared to conventional clear aligners? Researchers will compare three groups: Group I: Patients treated with conventional clear aligners with attachments; Group II: Patients treated with 3D direct-printed shape-memory aligner without attachment; Group III: Patients treated with 3D direct-printed shape memory clear aligners with attachments and see its effect on anterior open bite treatment. Participants will wear a clear aligner for about 6-8 months. Then

This study examines the effects of coughing exercises and incentive spirometry (IS) on lung function and recovery in children who undergo heart surgery. The main goals are to see: How coughing exercises and IS affect breathing and lung function after surgery? How these exercises influence overall recovery after surgery? Children who participate will be randomly assigned to one of three groups: coughing exercises, IS, or standard care. Those in the exercise groups will perform their assigned breathing exercises every 3 hours for the first 3 days after surgery. Daily check-ups will be conducted to monitor their progress, lung function, and oxygen levels. The study will measure breathing ability, oxygen levels, and recovery milestones to find out which method is most effective in preventing lung complications and helping children recover faster.

This randomized controlled trial will evaluate the effect of Virtual Reality (VR) and tablet-based distraction techniques on children's behavioral distress during urinary catheterization, compared with a control group receiving standard care. Urinary catheterization is a painful and distressing procedure for children that requires effective non-pharmacological interventions to manage anxiety and pain. Participants will be randomly assigned to one of three groups: VR distraction, tablet-based distraction, or control. The findings of this study will provide evidence on the effectiveness of digital distraction methods in reducing behavioral distress and improving the overall experience for pediatric patients undergoing invasive procedures at specialized pediatric centers.

This randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.

Title Comparative Evaluation of Treatment Outcomes between Damon Ultima and Pitts 21 Pro Bracket Systems; A Randomized Clinical Trial Abstract Background: The primary advantages of self-ligation brackets include faster archwire removal and ligation, reduced or eliminated need for chairside assistance, secure archwire engagement, and lower bracket-archwire friction, which collectively contribute to a substantial reduction in resistance to sliding and are theorized to enhance the efficiency of initial tooth alignment. This randomized controlled trial (RCT) will be conducted to assess differences in treatment outcomes with these two different self-ligation bracket systems. Subjects/Materials and Methods: This randomized clinical trial included 40 participants with full permanent dentition (excluding third molars) exhibiting Angle Class I malocclusion with moderate crowding. Patients who were scheduled to undergo orthodontic treatment were allocated into two groups: Damon Ultima and Pitts 21 Pro. The total treatment duration will be measured in months from the bonding day to the completion of treatment, in addition to the number of visits. Pre-treatment, post-alignment, and post-treatment records were obtained, including intraoral scans (IOS) for assessing alignment efficiency and arch parameters. Periapical radiographs of the upper and lower incisors were taken before and after treatment to measure the amount of root resorption. Treatment outcomes were evaluated using the American Board of Orthodontics (ABO) grading system. Additionally, pain perception and patient treatment perception were assessed.

The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients. Does applying this natural gel reduce the incidence of pressure injuries compared to standard care? participants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.

This study is a randomized controlled trial designed to evaluate the effects of high-calorie diets and specialized nutritional formulas on weight gain and clinical outcomes in underweight children aged 1 to 5 years with congenital heart disease (CHD). Children with CHD often experience growth failure due to increased energy needs and feeding difficulties, which can negatively impact their recovery, development, and overall health. Seventy-five children will be randomly assigned to one of three groups: a control group receiving a standard diet, a group receiving a high-calorie diet made from energy-dense foods, and a third group receiving both the high-calorie diet and a specialized high-calorie pediatric formula. The study will measure changes in weight, appetite, feeding tolerance, and other growth indicators over an 8-week period. The goal is to determine whether enhanced nutritional support can improve weight gain and health outcomes in this high-risk population.

This randomized controlled trial will evaluate the effect of simulation-based and video-based training on nurses' confidence, satisfaction, and clinical practice related to nasogastric tube care, compared with a control group receiving routine training or usual practice. Nasogastric tube care is an essential nursing procedure that requires adequate knowledge, practical skills, and confidence to ensure safe and effective patient care. Participants will be randomly assigned to one of three groups: simulation-based training, video-based training, or control. The findings of this study will provide evidence on effective educational methods to improve nurses' performance in nasogastric tube care and support better quality of care.

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.

This study evaluates the effect of non-surgical periodontal therapy on salivary biomarkers (Dkk-1, Sclerostin, and PLAP-1) and clinical periodontal parameters in patients with periodontitis. Periodontitis is a chronic inflammatory disease that destroys tooth-supporting tissues. Smoking is a significant risk factor that worsens periodontal destruction and reduces the effectiveness of standard therapies. * The trial is a non-randomized comparative clinical study. * It includes 44 adult patients diagnosed with Stage II and III periodontitis. * The participants are divided into two equal groups: 22 current smokers and 22 non-smokers. * Participants will undergo a baseline examination, followed by standardized non-surgical periodontal therapy consisting of scaling and root planing. * A follow-up visit will be conducted six weeks post-therapy to repeat clinical measurements and saliva collection. * The primary objective is to evaluate changes in salivary biomarker levels and clinical parameters (Plaque Index, Gingival Index, bleeding on probing, Probing Pocket Depth, Clinical Attachment Level) after treatment.

This study aims to compare the effectiveness and safety of High-Intensity Laser Therapy (HILT) with conventional physical therapy treatments in patients with knee osteoarthritis. Knee osteoarthritis is a common condition, especially in older adults, causing pain, stiffness, reduced movement, and difficulty performing daily activities. Current treatments focus on reducing pain and improving joint function. In this study, 100 patients with knee osteoarthritis will be divided into two groups. One group will receive HILT combined with therapeutic exercises, while the other group will receive conventional physical therapy modalities along with the same exercises. The treatment outcomes will be evaluated over time. The main outcomes include pain reduction (measured by pain scales such as WOMAC and VAS), improvement in joint function, and structural changes in the knee assessed by MRI. In addition, laboratory tests will be used to measure inflammation, cartilage health markers, and oxidative stress before and after treatment. The goal is to determine whether HILT provides better pain relief, improves joint function, and is safe compared to standard therapy. The results may help improve rehabilitation strategies for patients with knee osteoarthritis.