[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sultan Qaboos University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":312},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,78,112,143,167,196,222,243,262,292],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644587","feasibility-and-effectiveness-of-an-ai-powered-carbohydrate-counting-educational-platform-to-support-parents-of-children-with-type-1-diabetes-100644587",false,"NCT07671053","Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes","Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes: A Multicentre Randomized Controlled Trial","CARB-AI","Inclusion Criteria:\n\n* Primary responsibility for carbohydrate counting and insulin dosing decisions for the child\n* English-speaking\n* Access to a smartphone (iOS or Android) with internet connectivity\n* Willing and able to provide informed consent and complete study procedures\n* Diagnosis of type 1 diabetes for at least 1 month\n* Receiving intensive insulin therapy (multiple daily injections or insulin pump)\n* Using carbohydrate counting for insulin dosing\n\nExclusion Criteria:\n\n* Child has significant developmental delay or a medical condition that substantially alters nutritional requirements or carbohydrate metabolism (e.g., celiac disease, cystic fibrosis)\n* Parent or caregiver has significant cognitive impairment that would preclude participation\n* Family plans to relocate from the study area during the study period\n* Participation in another diabetes intervention study","ALL",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to learn whether an AI-powered carbohydrate counting educational platform can help parents of children with type 1 diabetes improve their carbohydrate counting skills and diabetes management. The study will include parents or primary caregivers of children aged 2-12 years with type 1 diabetes.\n\nThe main questions it aims to answer are:\n\n* Is the AI-powered educational platform feasible, acceptable, and easy for parents to use?\n* Can the platform improve carbohydrate counting accuracy, parental confidence in diabetes management, and diabetes outcomes compared with usual education alone?\n\nResearchers will compare parents who receive access to the AI-powered carbohydrate counting educational platform plus usual diabetes education with parents who receive usual diabetes education alone to see whether the AI-supported approach provides additional benefits.\n\nParticipants will:\n\n* Complete baseline assessments, including questionnaires and a carbohydrate counting test.\n* Be randomly assigned to either the AI-supported education group or the usual education group.\n* Use the assigned educational resources for 12 weeks.\n* Complete a follow-up assessment at 6 weeks and a final assessment at 12 weeks.\n* Provide information about their child's diabetes management, including HbA1c and glucose monitoring data.\n* Complete questionnaires about confidence, usability, and satisfaction with the educational support they receive.\n\nThe AI platform is designed to provide educational support only and does not replace medical advice, insulin dosing decisions, or routine diabetes care provided by healthcare professionals.",[26],"Type 1 Diabetes Mellitus",[28,29,30,31,32],"Type 1 Diabetes","Carbohydrate Counting","Artificial Intelligence","AI-Powered Education","Digital Health","NOT_YET_RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":20},"2026-09-01",{"date":41,"type":20},"2027-12-31",{"name":43,"class":44},"Sultan Qaboos University","OTHER",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100625784","pediatric-insulin-plan-calculator-for-t1dm-management-100625784","NCT07427134","Pediatric Insulin Plan Calculator for T1DM Management","Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management","FLEXI-T1D","Inclusion Criteria:\n\n* Children and adolescents \\\u003C 12 years\n* Diagnosed with Type 1 Diabetes Mellitus (T1DM)\n* Duration of diagnosis \\> 1 year\n* Using a multiple daily injection (MDI) regimen\n* Practising carbohydrate counting for at least 1 month before enrolment\n\nExclusion Criteria:\n\n* Use of an existing insulin dose calculator (e.g., mobile application or bolus advisor) within the last 3 months\n* Diagnosis of other types of diabetes (e.g., Type 2 diabetes mellitus, monogenic diabetes)\n* Use of insulin regimens other than multiple daily injections (MDI) (e.g., insulin pump therapy)","1 Year","12 Years",{"count":57,"type":20},440,[23],"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.\n\nThe 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\u002Fkg\u002Fday), 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.",[26,61,62,63],"Type 1 Diabetes Mellitus (T1DM)","T1DM","T1DM - Type 1 Diabetes Mellitus",[26,65,66,67],"Clinical Decision Support Tool","Digital Health Intervention","Insulin Dose Calculator","RECRUITING","2026-06-06",{"date":71,"type":37},"2026-06-09",{"date":73,"type":37},"2026-05-03",{"date":75,"type":20},"2026-12-31",{"name":43,"class":44},2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100619295","phase-4-dapagliflozin-versus-metformin-for-the-management-of-antipsychotic-induced-weight-gain-a-pragmatic-pilot-randomized-controlled-trial-100619295","NCT07342764","Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial","Inclusion criteria:\n\n* Patients aged ≥16 years\n* Diagnosis according to DSM-5 criteria, including:\n\nSchizophrenia spectrum and other psychotic disorders, as summarized in the DSM-5 chapter Schizophrenia Spectrum and Other Psychotic Disorders, excluding:\n\nSubstance\u002Fmedication-induced psychotic disorder Psychotic disorder due to another medical condition Catatonia associated with another mental disorder Catatonic disorder due to another medical condition Unspecified catatonia Bipolar and related disorders, as summarized in the DSM-5 chapter Bipolar and Related Disorders Depressive disorders, as summarized in the DSM-5 chapter Depressive Disorders Obsessive-compulsive and related disorders, as summarized in the DSM-5 chapter Obsessive-Compulsive and Related Disorders Other psychiatric conditions for which antipsychotic treatment is clinically indicated, as judged by the investigator Other conditions where antipsychotics are indicated\n\n* Receiving stable antipsychotic treatment for ≥3 months prior to enrollment\n* Evidence of antipsychotic-induced weight gain (AiWG), defined as:\n\n  1. ≥7% increase in body weight from baseline following initiation of antipsychotic treatment, or\n  2. BMI \\>25 kg\u002Fm² with clinically established antipsychotic-associated weight gain\n* Able to understand and comply with study procedures, as judged by the investigator\n* Able to provide written informed consent. For participants aged 16-17 years, assent and\u002For guardian consent will be obtained according to local ethics committee requirements.\n\nExclusion criteria:\n\n* Diabetes mellitus\n* Diagnosed patients of polycystic ovarian syndrome (PCOS)\n* Renal impairment defined as estimated glomerular filtration rate (eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²)\n* Significant hepatic disease or other serious or unstable medical conditions that, in the opinion of the investigator, would make participation unsafe\n* Pregnant or breastfeeding females\n* Current use of metformin, dapagliflozin, or another sodium-glucose cotransporter 2 inhibitor.\n* Use of weight-loss medications or participation in structured weight-loss programs within the past 3 months\n* Recurrent genitourinary infections (if dapagliflozin is used)\n* Use of non-antipsychotic medications known to cause clinically significant weight gain, including but not limited to selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), mirtazapine, tricyclic antidepressants, valproate, lithium, corticosteroids, sedating antihistamines, or other medications as judged by the investigator\n* Unstable psychiatric condition or active substance use disorder that may impair the ability to adhere to study procedures, as judged by the investigator","16 Years","60 Years",{"count":87,"type":20},110,[89],"PHASE4","The goal of this clinical trial is to learn whether dapagliflozin can help manage weight gain caused by antipsychotic medications in people aged 16 years or older who are receiving antipsychotic treatment and have developed antipsychotic-induced weight gain.\n\nThe main questions it aims to answer are:\n\nCan dapagliflozin reduce body weight as effectively and safely as metformin over the study period?\n\nHow do dapagliflozin and metformin compare in their effects on body weight, body mass index, waist circumference, blood sugar, HbA1c, lipid profile, psychiatric symptoms, quality of life, medication adherence, and side effects?\n\nResearchers will compare dapagliflozin plus a common lifestyle program with metformin plus a common lifestyle program to see which treatment is more effective, better tolerated, and more acceptable for managing antipsychotic-induced weight gain.\n\nParticipants will:\n\nBe randomly assigned to receive either dapagliflozin or metformin. Receive lifestyle advice, including dietary counselling, physical activity counselling, and behavioural support.\n\nAttend clinic visits at baseline, Week 12, and Week 26 for weight, waist circumference, blood tests, medication review, and other assessments.\n\nReceive telephone follow-up at Week 2, Week 6, and Week 18 to check medication adherence, side effects, tolerability, and lifestyle progress.\n\nComplete questionnaires and clinical assessments related to physical activity, quality of life, psychiatric symptoms, and treatment tolerability.",[92,93],"Antipsychotic-induced Weight Gain (AIWG)","Antipsychotic-induced Weight Gain",[95,96,97,98,99,100,101,102,103],"Dapagliflozin","Metformin","Antipsychotic-induced weight gain","Psychotic disorders","Randomized controlled trial","Weight management","Metabolic side effects","Lifestyle intervention","SGLT2 inhibitor",{"date":105,"type":37},"2026-06-10",{"date":107,"type":20},"2026-09",{"date":109,"type":20},"2028-12",{"name":43,"class":44},1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100629392","phase-3-investigating-the-efficacy-of-tranexamic-acid-as-a-prophylactic-agent-in-reducing-postpartum-hemorrhage-among-patients-undergoing-cesarean-section-in-squh-100629392","NCT07474077","Investigating the Efficacy of Tranexamic Acid as a Prophylactic Agent in Reducing Postpartum Hemorrhage Among Patients Undergoing Cesarean Section in SQUH","PROPHYLACTIC TRANEXAMIC ACID IN REDUCING POSTPARTUM HEMORRHAGE IN CESAREAN SECTIONS","Inclusion Criteria:\n\nPregnant woman with risk factors for postpartum haemorrhage undergoing elective and emergency caesarean section in SQUH.\n\n* Previous Caesarean Section\n* Multiple pregnancy,\n* Polyhydramnios,\n* Fetal macrosomia (BW \\>4kg),\n* Anemia\n* Booking BMI\\>30\n* Previous history of postpartum hemorrhage\n* Fibroids,\n* Adenomyosis,\n* Placenta previa (non- accreta),\n* Chorioamnionitis.\n\nExclusion Criteria: Woman with conditions like\n\n* Placenta accreta spectrum,\n* Contraindications to tranexamic acid (e.g., hypersensitivity to tranexamic acid), -History of seizure disorders,\n* Kidney disease,\n* Thromboembolic disease,\n* Medical conditions or treatments associated with a high risk of thrombosis",true,"FEMALE","18 Years","45 Years",{"count":124,"type":20},88,[126],"PHASE3","Investigating the efficacy of tranexamic acid (TXA) as a prophylactic agent in reducing postpartum haemorrhage (PPH) among patients undergoing cesarean section (CS) in SQUH: a prospective randomized controlled trial.",[129],"Post Partum Haemorrhage",[131,132,133,134],"Post partum haemorrhage","tranexamic acid","Caesarean section","Pregnancy","2026-03-26",{"date":137,"type":37},"2026-04-01",{"date":139,"type":20},"2026-05-01",{"date":141,"type":20},"2028-03-31",{"name":43,"class":44},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":150,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100617563","virtual-reality-for-patient-preparation-before-cardiac-catheterization-in-oman-100617563","NCT07320248","Virtual Reality for Patient Preparation Before Cardiac Catheterization in Oman","Evaluating the Efficacy of Virtual Reality in Patient Preparation for Cardiac Catheterization Procedures in Oman: A Randomized Controlled Trial","Inclusion Criteria:\n\n* • Adult patients (aged 18 years and above)\n\n  * Scheduled for first-time elective cardiac catheterization\n  * Able to understand Arabic or English\n  * Capable of providing informed consent\n\nExclusion Criteria:\n\n* • Individuals with cognitive impairment or psychiatric conditions that may interfere with their ability to engage in the VR intervention\n\n  * Patients requiring emergency or urgent catheterization","19 Years",{"count":152,"type":20},120,[23],"Background: Cardiovascular disease is considered one of the most prevalent diseases in recent times, and cardiac catheterization is widely used to diagnose and treat cardiovascular disease. However, patients often experience significant anxiety before the procedure due to fear of the unknown, potential complications, and concern about discomfort.Aim: To evaluate the efficacy of virtual reality technology to reduce anxiety and improve patient satisfaction, attitude, and usefulness in individuals undergoing first-time cardiac catheterization procedures in Oman.Method: A mixed-method randomized control trial will be used with approximately 120 patients from different tertiary hospitals in Oman. The experimental group will experience a virtual reality simulation of the catheterization process before providing informed consent, while the control group will receive the standard pre-procedure education. The Arabic version of the DASS-21 scale will be used to assess anxiety level pre- and post-intervention, while patient satisfaction will be measured through qualitative interviews with a subset of 10 participants.Result: ANOVA will be conducted to examine differences in anxiety and satisfaction scores between groups, and Pearson's correlation (r) will assess relationships between anxiety levels and satisfaction scores, while paired t-tests will be applied to compare anxiety levels before and after the intervention within groups. Additionally, multiple regression analysis will be employed to identify predictors of patient satisfaction and anxiety reduction, with a significance level set at p ≤ 0.05 for all statistical tests.Conclusion: The expected outcome of this study is that virtual reality-based education will significantly reduce pre-procedure anxiety and enhance patient satisfaction compared to standard education. Findings from this research may contribute to improving patient-centered care and developing innovative strategies to optimize emotional preparedness before cardiac catheterization procedures.",[156,157,158],"Coronary Artery Disease","Ischaemic Heart Desease","Cardiac Catheterization","2025-12-21",{"date":161,"type":37},"2026-01-06",{"date":163,"type":20},"2026-03-05",{"date":165,"type":20},"2027-06-30",{"name":43,"class":44},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":77},"100555215","phase-2-the-use-of-melatonin-for-delirium-prevention-in-medically-hospitalized-patients-100555215","NCT06509191","The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients","Effect of Melatonin Versus Placebo for Prevention of Delirium Among Medically Hospitalized Patients: Study Protocol for a Single-Center, Double-Blinded, Randomised Controlled Trial","RESTORE","Inclusion Criteria:\n\n* Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit\n\nExclusion Criteria:\n\n* Patients admitted to the ward, however meeting requirement for vasopressors or non-invasive ventilation.\n* Patient admitted through emergency to Intensive Care Unit (ICU) or High Dependency Unit (HDU).\n* Aphasic patients.\n* Patients with language barriers.\n* Already taking melatonin or ramelteon at the time of randomization.\n* Presence of delirium at the time of randomization.\n* If enteral medications are contraindicated due to gastrointestinal conditions.\n* If enteral medications are not allowed due to unavailability of nasogastric tube\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (liver function tests) \\> 3 times the upper limit of normal.\n* Patient on strong cytochrome P450 1A2 (CYP1A2) inhibitors (namely: fluvoxamine and viloxazine) .\n* Patient with active alcohol drinking or admitted with alcohol withdrawal syndrome.\n* Subject or proxy unable to provide informed consent within 24 hours of admission.\n* Patients with the following autoimmune diseases (Rheumatoid arthritis, inflammatory bowel disease and systemic lupus erythematosus).\n* Allergy to melatonin.","65 Years",{"count":177,"type":20},240,[179,126],"PHASE2","The high prevalence of delirium in hospitalized older adults, with significant associated morbidity and mortality, emphasize the need for effective prevention strategies. Limited trials have explored melatonin's potential in preventing delirium among patients admitted to general medical wards. Previous trials on melatonin's preventive role in medical wards had limitations, necessitating a robust, double-blinded, placebo-controlled design with a larger sample size. This randomized, double-blind study of melatonin versus placebo aims to investigate the efficacy of melatonin, a neurohormone regulating the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 or older. Given the high prevalence of delirium in this population and its association with adverse outcomes, the study seeks to contribute valuable insights into an effective preventive strategy.",[182],"Delirium",[184,185,186,187],"delirium","melatonin","Hospitalized","Medical","2025-01-11",{"date":190,"type":37},"2025-01-14",{"date":192,"type":37},"2024-09-30",{"date":194,"type":20},"2025-06",{"name":43,"class":44},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":4},"100565642","phase-4-effective-of-transcranial-magnetic-stimulation-tms-vs-treatment-as-usual-for-first-episode-depression-in-adults-100565642","NCT06644833","Effective of Transcranial Magnetic Stimulation (TMS) vs Treatment as Usual for First-Episode Depression in Adults","Effectiveness of Transcranial Magnetic Stimulation (TMS) Versus Treatment as Usual for First-Episode Depression in Adult Patients. An Open-Label Randomised Controlled Trial","Inclusion Criteria:\n\n* Adults (≥18 years old till 64 years) diagnosed with a first or second episode of unipolar major depressive disorder (MDD).\n* Moderate to severe depressive symptoms based on clinical assessment and validated scales (e.g., Hamilton Depression Rating Scale (HDRS)).\n* Willingness to participate and provide written informed consent.\n* Outpatient setting (not currently hospitalized for psychiatric reasons).\n\nExclusion Criteria:\n\n* Current episode is not the first or second episode of MDD.\n* Substance dependence or abuse within the last 6 months.\n* Diagnosed with psychotic depression, bipolar disorder, or catatonic features.\n* Severe depression requiring electroconvulsive therapy (ECT).\n* High suicidal risk as determined by clinical assessment.\n* History of unsatisfactory responses to prior TMS treatments.\n* Diagnosis of Epilepsy and Epilepsy high risk group\n* Pregnant or breastfeeding women, unless cleared by a neurologist for TMS treatment.","64 Years",{"count":152,"type":20},[89],"This clinical trial aims to assess the effectiveness of Transcranial Magnetic Stimulation (TMS) compared to Treatment as Usual (TAU) in adult patients experiencing their first or second episode of unipolar major depressive disorder (MDD). The primary end point is to determine whether TMS leads to higher rate of remission, response and greater reductions in depression severity, and improved functional outcomes compared to standard pharmacological and psychotherapeutic interventions. The trial will also explore the impact of TMS on quality of life and anxiety symptoms. Participants will be randomly assigned to either the TMS or TAU group, and outcomes will be assessed at multiple time points over a 3-year period. The trial will be conducted at Sultan Qaboos University Hospital's Department of Behavioural Medicine in Muscat, Oman, and is expected to contribute important evidence on the role of non-invasive brain stimulation in treating early-stage depression.",[208],"Major Depressive Disorder",[210,211,212,213],"Transcranial Magnetic Stimulation,","Antidepressants","iTMS","rTMS","2024-10-24",{"date":216,"type":37},"2024-10-28",{"date":218,"type":20},"2025-01-01",{"date":220,"type":20},"2029-06-01",{"name":43,"class":44},{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":85,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":4},"100539379","phase-4-tizanidine-vs-zolpidem-in-primary-insomnia-a-randomized-trial-100539379","NCT06303076","Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial","Efficacy of Tizanidine (0.1 mg\u002FKg\u002FHS) Versus Zolpidem 10 mg HS in Primary Insomnia: Double Blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Age and Gender Adult participants of either gender, aged 18-60 years old.\n* Diagnosis: Diagnosed with primary insomnia by a psychiatry specialist, based on DSM-5 criteria.\n* Consent: Able to provide written informed consent.\n* Compliance: Willing to comply with study procedures and follow-up assessments.\n* Medical Clearance: Participants must undergo a medical checkup by a medical officer affiliated with Al-Masarah Hospital before the randomization process. This checkup includes:\n* Medical history review.\n* Physical examination, including ECG.\n* Vital signs check.\n* Random blood sugar test.\n* Laboratory evaluation (CBC, LFT, RFT, TFT, Lipid profile).\n* Enrollment: Receiving medical clearance for enrollment in the study.\n\nExclusion Criteria:\n\n* Secondary Insomnia: Individuals diagnosed with secondary insomnia.\n* Substance Abuse History: Those with a history of substance abuse.\n* Significant Medical or Psychiatric Disorders: Individuals diagnosed with significant and\u002For unstable medical or psychiatric disorders or mental retardation.\n* Pregnancy or Lactation: Pregnant or lactating mothers, or those of childbearing potential not using an adequate method of contraception (excluding natural birth spacing methods).\n* Drug Allergy: Known hypersensitivity or allergy to Tinazidine or Benzodiazepines.\n* Communication Barriers: Individuals unable to understand or communicate with researchers.\n* Recent Participation in Clinical Trials: Those who have participated in other clinical trials involving investigational drugs within the past 30 days before participation.\n* Recent Use of Sleep Medication: Participants must not have taken any over-the-counter or prescription sleep medication within the past 30 days before participation.\n* Use of Substances Affecting CNS: No intake of any substance with central nervous system (CNS) effects known to affect sleep within 30 days before participation.",{"count":230,"type":20},90,[89],"The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg\u002FKg\u002FHS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout\u002Flost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia.",[234],"Depressive Disorder, Major","2024-03-04",{"date":237,"type":37},"2024-03-12",{"date":239,"type":20},"2024-09",{"date":241,"type":20},"2026-12",{"name":43,"class":44},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":175,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100510984","phase-4-effectiveness-of-cariprazine-monotherapy-for-treatment-of-major-depressive-disorder-100510984","NCT05933538","Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder","Effectiveness and Safety of Cariprazine Monotherapy Versus Treatment as Usual for Major Depressive Disorder: A Pragmatic Open Label Randomized Controlled Trial at Sultan Qaboos University Hospital Department of Behavioral Medicine","Inclusion Criteria:\n\n* Subjects meeting criteria for Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) currently in a Major Depressive Episode (MDE) as confirmed by the MINI International Neuropsychiatric Interview (MINI).\n* A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and at randomization, with no more than 20% improvement between these two visits.\n* Female subjects of childbearing potential must have a negative urine pregnancy test at enrolment (Visit 1) and be willing to use a reliable method of birth control (i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during the study.\n* Be able to understand and comply with the requirements of the study, as judged by the investigator(s).\n\nExclusion Criteria:\n\n* Presence of a current or past history of psychotic symptoms or a diagnosis of schizophrenia or bipolar disorder.\n* History of non-response or intolerance to Cariprazine or other antipsychotic medications.\n* Concurrent use of other antipsychotic medications or medications known to interact with Cariprazine.\n\n  --Significant medical conditions or unstable medical conditions that could interfere with participation in the study or pose a risk to the participant's safety.\n* Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the study.",{"count":87,"type":20},[89],"This trial protocol aims to evaluate the effectiveness and safety of cariprazine monotherapy compared to treatment as usual for major depressive disorder (MDD) in a pragmatic open-label randomized controlled trial (RCT) conducted at Sultan Qaboos University Hospital Department of Behavioral Medicine. The protocol adheres to the guidelines outlined in Good Clinical Practice (GCP) and will be submitted to the Institutional Review Board (IRB) for approval. The trial will assess the efficacy of cariprazine in improving depressive symptoms and overall functioning, as well as its safety profile in patients with MDD.",[234],"2023-07-05",{"date":256,"type":37},"2023-07-07",{"date":258,"type":20},"2024-08",{"date":260,"type":20},"2030-12",{"name":43,"class":44},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":273,"conditions":274,"keywords":279,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100500606","the-impact-of-using-a-smartphone-health-application-in-the-improvement-of-cardiovascular-disease-risk-factors-100500606","NCT05798442","The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors","The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors in the Omani Population; Prospective Randomized Clinical Trial","Inclusion Criteria:\n\n* Presentation with at least one of the following metabolic abnormalities:\n* Hypertensions (systolic blood pressure ≥ 130 mmHg and\u002For diastolic blood pressure ≥ 85 mmHg)\n* Obesity (waist circumference ≥ 80 cm (women) or ≥ 94 cm (men) and BMI ≥ 25 kg\u002Fm2)\n* Dyslipidemia (triglycerides ≥ 1.7 mmol\u002FL or\u002Fand HDL-cholesterol ≤ 1.29 mmol\u002FL (women) or ≤ 1.02 mmol\u002FL (men) or\u002Fand LDL-Cholesterol \\> 5.18 mmol\u002FL, serum total cholesterol ≥ 5.2 mmol\u002Fl)\n* Impaired glycemia\u002Ftype 2 diabetes (fasting plasma glucose ≥ 5.6 mmol\u002FL)\n* Arabic or English language speaking and able to read and write in one of these languages\n* Possession of a smart mobile phone Willing to utilize a mobile application for CVD management.\n\nExclusion Criteria:\n\n* A history of stroke, myocardial infarction or any related cardiovascular complications Complicated diabetes mellitus e.g., Proliferative diabetic retinopathy, end-stage renal disease\n* Unavailability of a smartphone or any reason that will not allow the participant to use the app properly. (such as; difficulty or inability to use mobile applications, unavailability of network services…etc.).\n* Medical conditions that restrain the participant to be physically active.\n* High chance of loss to follow up at the FAMCO clinic (due to upcoming travel, temporary employment and thus eligibility to be treated at the clinic, irregular visits due to distance from home…etc.)","55 Years",{"count":271,"type":20},410,[23],"This study investigates the effectiveness of Mobile health application (mHealth apps) in the improvement of cardiovascular disease risk factors including metabolic and behavioral factors. The app will be tested on patients with any of the modifiable risk factors of CVD such as hypertension, obesity, hyperlipidemia, and impaired glycemic control\u002Ftype 2 diabetes mellitus .",[275,276,277,278],"Hypercholesterolemia","Obesity","Diabetes Mellitus","Hypertension",[280,281,282,283],"Mobile health application","Cardiovascular disease prevention","Metabolic risk factors","Behavioral risk factors","2023-03-23",{"date":286,"type":37},"2023-04-04",{"date":288,"type":20},"2024-01-30",{"date":290,"type":20},"2027-12-30",{"name":43,"class":44},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":150,"maxAge":85,"enrollmentInfo":299,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":4},"100495923","phase-4-efficacy-of-hydroxyzine-for-patients-with-panic-disorder-100495923","NCT05737511","Efficacy of Hydroxyzine for Patients With Panic Disorder","Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial.","Inclusion Criteria:\n\n* The study will recruit adult patients (18 years and older)\n* Confirmed diagnosis of the panic disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n* Participants will be included if they have had at least one panic attack per week for the last four weeks,\n* Have not received any pharmacological treatment for panic disorder in the past four weeks,\n* Willing to discontinue any current benzodiazepine or SSRI treatment for the duration of the study.\n\nExclusion criteria:\n\n* Current substance abuse or dependence,\n* Medical diseases\n* Psychiatric comorbidities,\n* Pregnancy or lactation.",{"count":19,"type":20},[89],"The aim of this study is to evaluate the efficacy of hydroxyzine compared to treatment as usual (TAU) for patients with panic disorder. By conducting a pilot study, we hope to provide initial data on the feasibility and potential impact of hydroxyzine for this population. This will inform the design and power calculations of a larger, more comprehensive study in the future.\n\nObjectives:\n\nTo assess the feasibility of conducting a randomized controlled trial (RCT) of hydroxyzine for panic disorder.\n\nTo evaluate the effectiveness of hydroxyzine compared to TAU in reducing panic symptoms in patients with panic disorder.\n\nTo explore the potential side effects and tolerability of hydroxyzine in this population.\n\nMethods:\n\nThis will be a single-center, open-label, randomized pilot study. A total of 30 patients with a primary diagnosis of panic disorder will be recruited from a psychiatric outpatient clinic. Participants will be randomly assigned to receive either hydroxyzine or TAU for 8 weeks. The primary outcome measure will be the change in panic symptoms as assessed by the Panic Disorder Severity Scale (PDSS). Secondary outcome measures will include the Hamilton Anxiety Rating Scale (HAM-A) and the Clinical Global Impression-Severity (CGI-S) scale. Participants will be assessed at baseline, 4 weeks, and 8 weeks. Adverse events will be monitored throughout the study.\n\nExpected Results:\n\nThis pilot study is expected to provide preliminary data on the feasibility and potential efficacy of hydroxyzine for panic disorder. The results will inform the design of a larger RCT to further evaluate the efficacy of hydroxyzine for this population.\n\nSignificance:\n\nThere is a need for effective and well-tolerated treatments for panic disorder. If found to be effective, hydroxyzine could provide a new option for patients with this condition, potentially improving their quality of life and functioning. The results of this pilot study will inform the design of future studies and contribute to the development of evidence-based treatments for panic disorder.",[303],"Panic Disorder","2023-02-20",{"date":306,"type":37},"2023-02-21",{"date":308,"type":20},"2023-12-30",{"date":310,"type":20},"2026-12-30",{"name":43,"class":44},""]