[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Oman\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":731},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,42,67,100,125,147,180,207,230,260,283,309,339,377,408,433,457,489,522,553,578,607,631,661,696],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964",false,"NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye","ALL","18 Years",{"count":21,"type":22},230,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).",[28],"Metastatic Breast Cancer","RECRUITING","2026-08-21",{"date":32,"type":33},"2026-08-25","ACTUAL",{"date":35,"type":33},"2023-09-08",{"date":37,"type":22},"2032-12-28",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",192,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100609545","a-real-world-study-to-evaluate-luspatercept-in-adults-with-transfusion-dependent-beta-thalassemia-in-the-middle-east-100609545","NCT07215975","A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East","REal-World Application of Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East (RELATE): A Non-interventional Retrospective and Prospective Observational Study","Inclusion Criteria:\n\n* Male or female participants of any race aged at least 18 years at time of initiation of luspatercept treatment\n* Participants with documented diagnosis of transfusion-dependent β-thalassemia (TDT).\n* Participants who have been initiated on treatment with luspatercept as per the product's Summary of Product Characteristics (SmPC) no longer than 12 months prior to informed consent signature, and for whom therapy is ongoing.\n* Participants for whom the decision to prescribe luspatercept treatment is clearly separated from the physician's decision to include the participant in the current study.\n* Participants who have provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study\n\nExclusion Criteria:\n\n* Participants that meet any of the contraindications to the administration of luspatercept as outlined in the latest version of the locally approved SmPC.\n* Participants who are currently receiving or are planned to receive treatment with any investigational drug\u002Fdevice\u002Fintervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to luspatercept therapy initiation.\n* Participants who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.\n* Participants who have not provided signed informed consent for participating in the study and for collecting and analysing medical data pertinent to the objectives of this study.",{"count":50,"type":22},200,"OBSERVATIONAL","The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East",[54],"β-thalassemia",[56],"Transfusion-dependent β-thalassemia","2026-08-18",{"date":59,"type":33},"2026-08-19",{"date":61,"type":33},"2026-06-26",{"date":63,"type":22},"2031-04-17",{"name":65,"class":40},"Bristol-Myers Squibb",13,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100652415","single-fraction-and-multifraction-arc-based-radiotherapy-for-painful-bone-metastases-100652415","NCT07772206","Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases","The SMART Trial: A Randomised Feasibility Study Comparing Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases","SMART","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically proven malignancy\n* Radiological evidence of bone or spine metastases\n* Pain score ≥4 on Numeric Rating Scale (NRS-11)\n* ECOG Performance Status 0-3\n* Life expectancy ≥3 months.\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Spinal cord compression requiring emergency therapy\n* Previous radiotherapy to same site\n* Unstable pathological fracture requiring surgery\n* Pregnancy\n* Inability to provide consent\n* Oligometastatic bone metastases requiring Stereotactic Body Radiotherapy (SBRT)",{"count":76,"type":22},70,[78],"NA","This prospective randomised pilot feasibility study will compare single-fraction radiotherapy (8 Gy × 1) with multifraction radiotherapy (20 Gy in 5 fractions) for the palliation of painful bone metastases. The study will evaluate pain response at 4 weeks following radiotherapy, together with feasibility, treatment compliance, toxicity, pain flare, retreatment, patient convenience and resource utilisation. The study will generate preliminary data to inform the design of a future definitive randomised trial.",[81,82],"Bone Metastases of a Malignant Tumor","Cancer Pain",[84,85,86,87,88],"Bone Metastases","Feasibility","Single fraction radiotherapy","Multifraction radiotherapy","Pain response,","NOT_YET_RECRUITING","2026-08-14",{"date":59,"type":33},{"date":93,"type":22},"2026-09-01",{"date":95,"type":22},"2027-12-30",{"name":97,"class":98},"Oman Ministry of Health","OTHER_GOV",1,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100563138","phase-3-a-study-to-evaluate-how-well-etavopivat-works-in-people-with-sickle-cell-disease-100563138","NCT06612268","A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease","A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease","Hibiscus 2","Inclusion Criteria:\n\n* Male or female.\n* Age 12 years or above at the time of signing the informed consent.\n* Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.\n* Have 1-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g\u002FdL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 g\u002FL) at screening.\n\nExclusion Criteria:\n\n* More than 15 VOCs within the past 12 months prior to screening documented in the participant's medical record. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.\n* Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.\n* Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).\n* Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.\n* Receiving or use of concomitant medications that are strong inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.\n* Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.\n* Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).\n* Hepatic dysfunction characterized by:\n\n  * Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or\n  * Direct bilirubin greater than 3.0 × ULN.\n* Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.\n* Severe renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] at screening, calculated by the central laboratory greater than 30 mL\u002Fmin\u002F1.73 m\\^ 2) or on chronic dialysis.\n* Travelled distance on standardized 6MWT below 100m at screening.","12 Years",{"count":110,"type":22},408,[25],"This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.",[114],"Sickle Cell Disease","2026-08-12",{"date":117,"type":33},"2026-08-13",{"date":119,"type":33},"2025-02-17",{"date":121,"type":22},"2029-08-12",{"name":123,"class":40},"Novo Nordisk A\u002FS",175,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100562904","phase-3-a-research-study-looking-at-long-term-treatment-with-etavopivat-in-people-with-sickle-cell-disease-or-thalassaemia-100562904","NCT06609226","A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia","An Open-label, Multi-centre, Rollover Study to Characterise Long-term Safety and Efficacy of Etavopivat in Adults, Adolescents and Children Who Have Sickle Cell Disease or Thalassaemia and Have Completed a Treatment Period in an Etavopivat Study","FLORAL","Inclusion Criteria:\n\n* Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.\n* Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.\n* Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the full dose of etavopivat before transferring.\n* Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have been on a stable dose in the parent study as defined at the investigator's discretion. Necessary adjustments related to weight or age are accepted. Participants with temporary dose reductions or pauses due to medical reasons may still be considered to have a stable dose, as determined by the investigator, who will assess the impact of these adjustments based on clinical context and the participant's overall health status.\n\nExclusion Criteria:\n\n* Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.\n* Participants on permanent dose reduction (greater than \\[\\>\\] 28 days or more) or ongoing temporary treatment discontinuation.\n* Use of any of the following within the timeframes prior to the transfer visit as stated:\n* Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study.\n* Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.\n* Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need of such agents for a maintenance treatment during this study.\n* Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.\n* Current participation in a study that is not a designated parent study, or planned participation in any other clinical study, for the duration of FLORAL.","2 Years",{"count":135,"type":22},480,[25],"Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.",[114,139],"Thalassemia",{"date":117,"type":33},{"date":142,"type":33},"2025-01-10",{"date":144,"type":22},"2030-12-30",{"name":123,"class":40},106,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":99},"100651865","prospective-evaluation-of-stapled-intact-duodenum-bipartition-with-sleeve-gastrectomy-sibs-100651865","NCT07765758","Prospective Evaluation of Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)","Safety, Feasibility, and Clinical Outcomes of Laparoscopic Side-to-Side Duodenoileal Bipartition Without Duodenal Transection Using a Conventional Linear Stapler: A Prospective Interventional Study","SIBS","Inclusion Criteria\n\n* Age 18-65 years.\n* Body mass index (BMI) ≥35 kg\u002Fm², regardless of the presence or severity of obesity-associated medical conditions; or BMI 30.0-34.9 kg\u002Fm² with type 2 diabetes mellitus or another clinically significant obesity-associated medical condition and inadequate weight loss or improvement following appropriate nonsurgical management.\n* Eligible for metabolic and bariatric surgery following multidisciplinary clinical assessment.\n* Considered suitable for laparoscopic Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS) based on preoperative assessment.\n* For primary procedures, no previous metabolic or bariatric surgical procedure.\n* For revisional procedures, previous sleeve gastrectomy with a clinical indication for revisional metabolic\u002Fbariatric surgery and anatomy considered suitable for SIBS.\n* Able to understand the investigational nature of the SIBS procedure, its potential risks and benefits, and established alternative bariatric procedures.\n* Able and willing to provide written informed consent.\n* Willing and able to comply with the scheduled postoperative clinical, nutritional, laboratory, and study follow-up for at least 12 months.\n\nExclusion Criteria\n\n* Age \\\u003C18 years or \\>65 years.\n* Pregnancy or breastfeeding.\n* Planned pregnancy during the 12-month postoperative study period.\n* Contraindication to general anesthesia or laparoscopic metabolic\u002Fbariatric surgery.\n* Previous gastrointestinal surgery resulting in anatomy that precludes safe performance of the planned SIBS procedure, except previous sleeve gastrectomy in participants undergoing an eligible revisional procedure.\n* Intraoperative anatomy that prevents safe creation of a tension-free side-to-side duodenoileal anastomosis.\n* Active inflammatory bowel disease involving the small intestine.\n* Active gastrointestinal malignancy or other active malignancy for which the proposed operation or follow-up would be inappropriate.\n* Severe hepatic dysfunction, severe renal dysfunction, or another major systemic illness considered to confer an unacceptable operative or nutritional risk.\n* Pre-existing severe protein-calorie malnutrition or clinically significant nutritional deficiency that cannot be adequately corrected before surgery.\n* Active gastrointestinal ulceration or another gastrointestinal condition considered to substantially increase the risk of the planned procedure.\n* Uncontrolled psychiatric illness or cognitive impairment that precludes valid informed consent or adherence to postoperative care.\n* Active alcohol or substance use disorder considered incompatible with safe metabolic and bariatric surgery.\n* Inability or unwillingness to adhere to postoperative dietary recommendations, nutritional supplementation, or scheduled follow-up.\n* Any medical, surgical, anatomical, or psychosocial condition that, in the judgment of the multidisciplinary bariatric team, makes participation or performance of SIBS inappropriate or unsafe.","65 Years",{"count":157,"type":22},50,[78],"Obesity is a chronic disease that can be treated with metabolic and bariatric surgery when appropriate. This study will prospectively evaluate a new laparoscopic bariatric procedure called Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS).\n\nSIBS combines sleeve gastrectomy with a side-to-side connection between the first part of the duodenum and the ileum. Unlike standard single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S), the duodenum is not divided. Instead, the new connection is created while the duodenum remains intact, allowing food to continue through the normal duodenal pathway while also providing an additional pathway to the ileum. The connection is created laparoscopically using a conventional linear surgical stapler.\n\nThe main purpose of this prospective study is to evaluate the technical feasibility and short-term safety of the SIBS procedure in adults undergoing metabolic and bariatric surgery. The study will assess whether the planned procedure can be completed successfully and will record postoperative complications occurring within 30 days after surgery.\n\nParticipants will also be followed after surgery to evaluate weight loss, changes in body mass index, glycemic control and other obesity-associated medical conditions, nutritional status, gastrointestinal symptoms, hospital readmission, reoperation, and procedure-related complications. Follow-up assessments are planned for up to 12 months after surgery.\n\nThe study is intended to provide prospective evidence regarding the safety, feasibility, and early clinical outcomes of this surgical approach. Longer-term and comparative studies will be needed to determine how its outcomes compare with established metabolic and bariatric procedures",[161,162],"Obesity","Obesity Type 2 Diabetes Mellitus",[164,165,166,167,153,168,169,170,171],"Metabolic and Bariatric Surgery","Duodenoileal Bipartition","Duodenal Bipartition","Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy","Sleeve Gastrectomy","Side-to-Side Duodenoileal Anastomosis","Metabolic Surgery","Linear Stapler","2026-08-11",{"date":90,"type":33},{"date":175,"type":22},"2026-08-01",{"date":177,"type":22},"2027-12-31",{"name":179,"class":98},"Medical City for Military and Security Services",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":188,"minAge":19,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100640673","beyond-study-a-multicentre-prospective-observational-study-of-real-world-treatment-patterns-and-outcomes-of-trastuzumab-deruxtecan-in-patients-with-hr-positive-her2-low-or-ultra-low-metastatic-breast-cancer-previously-treated-with-endocrine-therapy-100640673","NCT07597993","BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy","A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy","BEYOND","Inclusion Criteria:\n\n* -Female patients aged ≥18 years old at the time of T-DXd initiation\n* Patients with a confirmed histological or cytologically based diagnosis of HR-positive mBC.\n* Patients who were classified as HER2-low or HER2-ultralow mBC confirmed by the closest locally obtained HER2 test prior to or on the index date, and who meet the following definitions:\n* HER2-low status defined as IHC scores 1+ and 2+ without ISH gene amplification based on the pathology report.\n* HER2-ultralow status defined as IHC 0 with membrane staining based on the pathology report.\n* Patient who received at least one prior line of ET (± targeted therapy) in the metastatic setting.\n* Patients who are chemotherapy-naïve in the metastatic setting.\n* Patients who initiated T-DXd up to 30 days before the signature of the ICF. The decision to initiate T-DXd must be made independently by treating physicians as part of routine clinical practice.\n* Patients are willing to sign the written ICF, indicating that they understand the purpose of the study and procedures required for participation.\n\nExclusion Criteria:\n\n* -Patients with a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.\n* Patients who received prior chemotherapy in the metastatic setting.\n* Patients with Eastern Cooperative Oncology Group (ECOG) status ≥2 or missing ECOG status at the time of initiation of T-DXd (index date).\n* Patients with a history of participation in another clinical trial in the metastatic setting.\n* Female patient with current or planned pregnancy, or breastfeeding.","FEMALE",{"count":190,"type":22},109,"BEYOND study is designed to generate the first real-world data from GCC countries on the patient characteristics, treatment patterns, survival outcomes, and safety of T-DXd in patients with HRpositive,HER2-low or HER2-ultralow mBC previously treated with ET. The evidence generated will help to optimise treatment strategies, inform clinical guidelines, and ultimately improve outcomes for patients with mBC across the region.",[193],"Breast Cancer",[195,196],"breast cancer","Trastuzumab Deruxtecan","2026-08-06",{"date":199,"type":33},"2026-08-10",{"date":201,"type":33},"2026-07-12",{"date":203,"type":22},"2029-03-31",{"name":205,"class":40},"AstraZeneca",9,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":215,"maxAge":155,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100591087","phase-3-the-efficacy-and-safety-of-rilzabrutinib-in-participants-aged-10-to-65-years-with-sickle-cell-disease-100591087","NCT06975865","The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Flexible-adaptive, Group Sequential Study to Evaluate the Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","LIBRA","Inclusion Criteria:\n\n* Participants who have been diagnosed with SCD.\n* Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.\n* Participants who are either not on hydroxyurea and\u002For L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and\u002For L-glutamine for a minimum of 6 months. Participants on hydroxyurea and\u002For L-glutamine must have been on a stable weight-based dose level (mg\u002Fkg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons.\n* Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* For participants ≥10 to \\\u003C18 years of age: the parent(s)\u002Flegal guardian(s) must provide written informed consent prior to any study-related procedures being performed.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply: Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.\n* Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings.\n* Participants with history of stroke, or history of abnormal transcranial doppler.\n* Participants with uncontrolled or active HBV infection and\u002For HCV infection including those receiving antiviral therapy at the time of screening.\n* HIV infection.\n* A history of active or latent tuberculosis (TB)\n* Positive COVID-19 molecular test.\n* Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and\u002For voxelotor (OXBRYTA®) within 30 days prior to the Screening visit.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","10 Years",{"count":41,"type":22},[25],"This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and safety of rilzabrutinib in participants with sickle-cell disease (SCD).\n\nStudy details include:\n\n* Study duration: a 52-week double-blind period (Part A), followed by an open-label LTE period (Part B). Double-blind period has two parts, 50% (adult only) until the interim analysis (a proof-concept part analogous to a phase 2b study), and 50% (adult and children) after the interim analysis. Only the participants who complete double-blind treatment period (Part A) are eligible to continue to the LTE period. The duration of the LTE period (Part B) will be from the first-participant-in (FPI)-LTE (Part B) until the last participant who enters the LTE has completed 52 weeks.\n* Treatment duration: 52-week double-blind period (Part A); LTE period (Part B) from the (FPI until the last participant who enters the LTE has completed 52 weeks.\n* Visit frequency: Week visits based on the Schedule of Assessments.",[114],"2026-07-28",{"date":222,"type":33},"2026-07-29",{"date":224,"type":33},"2025-08-12",{"date":226,"type":22},"2028-12-29",{"name":228,"class":40},"Sanofi",53,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":18,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":99},"100649023","phase-2-nebulized-ketamine-for-severe-asthma-attacks-in-children-100649023","NCT07728851","Nebulized Ketamine for Severe Asthma Attacks in Children","Effectiveness and Safety of Nebulized Ketamine in Severe Pediatric Asthma: a Phase-2, Double-blind, Randomized, Placebo-controlled Pilot Trial","Inclusion Criteria:\n\n* Children aged 1 to 13 years.\n* Diagnosis of severe asthma exacerbation (PRAM score 8-12)\n* Prior treatment with standard first-line management (beta-2 agonist, corticosteroid, magnesium sulfate)\n\nExclusion Criteria:\n\n* Known allergy or adverse reaction to ketamine\n* Significant hemodynamic instability\n* Systemic hypertension \\>95th percentile for age\n* Cardiac arrhythmias\n* Congestive heart failure\n* Obstructive sleep apnea with AHI \\>5","1 Year","13 Years",{"count":240,"type":22},60,[242],"PHASE2","This is a double-blinded, randomised, placebo-controlled trial enrolling 60 children aged 1 to 13 years with severe asthma exacerbation. All participants will receive standard therapy. Children not responding to standard therapy will be randomised to intervention arms. Randomization will occur in a 1:1 ratio using a computer-generated Excel sequence with permuted blocks of four, stratified by age (1-5 and 6-13 years). Patients will receive either nebulized ketamine (1 mg\u002Fkg every 6 hours for 24 hours) or 0.9% normal saline placebo. Randomization codes will be maintained by the hospital pharmacy, which will prepare identical numbered packs. During working hours, the pharmacist will dispense the allocated medication; at nights and weekends, pre-prepared packs will be stored securely in the PHDU\u002FPICU under the supervision of the nursing in-charge. Blinding will be maintained for patients, clinicians, and outcome assessors. PRAM scores will be recorded at baseline and at 20, 60, 90, and 120 minutes post-dose. The primary outcome is pediatric respiratory assessment measure (PRAM) score change. Secondary outcomes include need for NIV or intubation and HDU\u002FPICU length of stay.",[245,246],"Asthma Acute","Exacerbation of Allergic Asthma",[248,249],"Asthma","Ketamine","2026-07-23",{"date":252,"type":33},"2026-07-27",{"date":254,"type":22},"2027-01-01",{"date":256,"type":22},"2029-12-31",{"name":258,"class":259},"Sultan Qaboos University","OTHER",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100583779","phase-3-study-of-plozasiran-in-adults-with-severe-hypertriglyceridemia-at-risk-of-acute-pancreatitis-100583779","NCT06880770","Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis","Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)","SHASTA-5","Inclusion Criteria:\n\n* Males, or nonpregnant (who do not plan to become pregnant) nonlactating females\n* Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg\u002FdL (≥ 10 mmol\u002FL)\n* Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening.\n* Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg\u002FdL (≤ 3.37 mmol\u002FL) at Screening\n* Screening hemoglobin A1c (HbA1c) ≤ 9.5%\n* Willing to follow diet counseling and maintain a stable low-fat diet\n* Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the Investigator)\n\nExclusion Criteria:\n\n* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and\u002For triglycerides within 365 days before Day 1, except inclisiran.\n* Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer.\n* AP ≤ 4 weeks prior to Randomization\u002FDay 1\n* Body mass index (BMI) \\> 45 kg\u002Fm\\^2\n* Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)\n* Planned coronary intervention (e.g. stent placement or heart bypass) during the study\n* History of arterial revascularization within 16 weeks of Screening\n* History of acute coronary syndrome event within 24 weeks of Screening\n* Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening\n* Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study\n* History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening\n* New York Heart Association Class III-IV heart failure or last known ejection fraction of \\\u003C 30%\n* Current diagnosis of nephrotic syndrome\n* Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2\n* Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5× Upper Limit of Normal (ULN) at Screening\n\nNote: Additional Inclusion\u002FExclusion Criteria may apply per protocol",{"count":269,"type":22},288,[25],"This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.",[273],"Severe Hypertriglyceridemia","2026-07-22",{"date":250,"type":33},{"date":277,"type":33},"2025-04-24",{"date":279,"type":22},"2029-06",{"name":281,"class":40},"Arrowhead Pharmaceuticals",102,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":308},"100540241","interstellar---international-study-evaluating-lupus-outcomes-after-anifrolumab-real-world-use-100540241","NCT06314282","INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use","INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice","INTERSTELLAR","Inclusion Criteria:\n\n1. Aged 18 years or older at study enrolment.\n2. Fulfilled the 2019 EULAR\u002FACR criteria1 for SLE at the time of study entry.\n3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.\n4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.\n5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.\n6. Provided informed consent to participate in the study.\n7. Willing and able to participate in all required study evaluations and procedures.\n\nExclusion Criteria:\n\n1. Currently participating in an anifrolumab early access\u002Fcompassionate use program or an interventional clinical trial with an investigational product.\n2. Previous exposure to anifrolumab as part of a clinical trial or early access program.\n3. Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \\[MMF\\]\u002Fcyclophosphamide \\[CYC\\] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.\n4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.",{"count":50,"type":22},"INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion\u002Fexclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.",[294],"Systemic Lupus Erythematosus (SLE)",[296,297,298,299,300],"SLE","Systemic lupus erythematosus","autoimmune disease","Lupus","Anifrolumab","2026-07-16",{"date":303,"type":33},"2026-07-17",{"date":305,"type":33},"2024-10-22",{"date":177,"type":22},{"name":205,"class":40},32,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":18,"minAge":317,"maxAge":215,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":325,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},"100646349","evaluation-of-virtual-reality-based-distraction-on-anxiety-and-pain-perception-in-paediatric-dental-extraction-100646349","NCT07693764","Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction","\"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial\"","VR-PED","Inclusion Criteria:\n\n* Children aged 6 to 10 years\n* Classified as ASA class 1 or 2 (healthy or with mild systemic disease)\n* Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures\n* Children with NO previous exposure to invasive dental procedure\n* No prior experience using VR glasses\n* Requiring extraction of mandibular deciduous molar under local anesthesia\n\nExclusion Criteria:\n\n* ASA 3 and above\n* Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures\n* Special needs ( intellectual and developmental)\n* Children on psychotropic medication\n* Children wearing glasses\n* Presence of intra-oral swelling","6 Years",{"count":319,"type":22},168,[78],"The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:\n\nDoes virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?\n\nDoes virtual reality distraction reduce pain perception during dental extraction?\n\nResearchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.\n\nParticipants will:\n\nWear VR glasses to watch immersive 3D cartoons, or\n\nWatch 2D cartoons with headset, or\n\nReceive the conventional tell-show-do technique with verbal distraction.\n\nOutcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).",[323,324],"Dental Anxiety in Children","Pain Perception",[326,327,328,329,330],"pediatric dentistry","dental anxiety","tooth extraction","virtual reality","VR","2026-07-03",{"date":333,"type":33},"2026-07-09",{"date":93,"type":22},{"date":336,"type":22},"2027-10-01",{"name":258,"class":259},2,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":346,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":352,"conditions":353,"keywords":356,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100429857","phase-4-asciminib-roll-over-study-100429857","NCT04877522","Asciminib Roll-over Study","An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment","Key Inclusion Criteria:\n\n1. Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.\n2. Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.\n\nKey Exclusion Criteria:\n\n1. Participant has been discontinued from parent study treatment.\n2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.\n3. Participant's ongoing treatment is currently approved and reimbursed at country level.\n4. Pregnant or nursing (lactating) women.\n5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.\n6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.\n7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:\n\n   * Asymptomatic (grade 2) pancreatitis if not resolved within 28 days\n   * QTcF\\>480msec or inability to determine QTc interval\n   * any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment\n\nOther protocol-defined Inclusion\u002FExclusion criteria may apply.","7 Years","100 Years",{"count":349,"type":22},347,[351],"PHASE4","This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment",[354,355],"Chronic Myelogenous Leukemia","Leukemia, Myelogenous, Chronic, BCR-ABL Positive",[354,357,18,358,359,360,361,362,363,364,365,366],"CML","CML-AP","CML-BP","CML-CP","myeloproliferative neoplasm","chronic phase","accelerated phase","blast phase","ABL001","asciminib","2026-07-01",{"date":369,"type":33},"2026-07-06",{"date":371,"type":33},"2022-08-30",{"date":373,"type":22},"2030-08-30",{"name":375,"class":40},"Novartis Pharmaceuticals",85,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":384,"minAge":237,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":393,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":407},"100450410","phase-3-open-label-extension-study-of-marstacimab-in-hemophilia-participants-with-or-without-inhibitors-100450410","NCT05145127","Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors","AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN SEVERE (COAGULATION FACTOR ACTIVITY \u003C1%) HEMOPHILIA A PARTICIPANTS WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS","Inclusion Criteria:\n\n* All participants will have a minimum body weight as defined by parent studies\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Participants have successfully completed participation in parent studies, defined as did not require \"Early Termination\"\n\nExclusion Criteria:\n\n* Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade \\>3), or ischemic disease (except catheter-associated thrombosis)\n* Abnormal renal function as defined by eGFR \\\u003C30 mL.min\u002F1.73 m(2)\n* Known planned surgical procedure during the planned study period\n* Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study\n* For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available CD4 count (if available), which would make the participant inappropriate for the study\n* Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)\n* Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study\n* Participation in other study involving investigational drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in parent studies\n* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members","MALE","74 Years",{"count":387,"type":22},245,[25],"Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require \"Early Termination\" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008.\n\nStudy B7841005: approximately 145 adolescent and adult participants 12 to \\\u003C75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity \\\u003C1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab).\n\nStudy B7841008: this is an ongoing Phase 3, open-label study in pediatric participants \\\u003C18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity \\\u003C1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to \\\u003C18 years and at least 80 participants will be aged ≥1 to \\\u003C12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to \\\u003C18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit\u002Frisk assessment in support of dosing participants aged ≥6 to \\\u003C12 years. Based on the positive benefit\u002Frisk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to \\\u003C12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to \\\u003C6 years.\n\nAll participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.",[391,392],"Hemophilia A","Hemophilia B",[394,395,396,397,398],"Factor VIII Inhibitor","Factor IX Inhibitor","PF-06741086","Marstacimab","Anti-TFPI","2026-06-30",{"date":367,"type":33},{"date":402,"type":33},"2021-11-17",{"date":404,"type":22},"2030-07-31",{"name":406,"class":40},"Pfizer",75,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":430,"leadSponsor":431,"locationsCount":432},"100644587","feasibility-and-effectiveness-of-an-ai-powered-carbohydrate-counting-educational-platform-to-support-parents-of-children-with-type-1-diabetes-100644587","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",{"count":417,"type":22},80,[78],"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.",[421],"Type 1 Diabetes Mellitus",[423,424,425,426,427],"Type 1 Diabetes","Carbohydrate Counting","Artificial Intelligence","AI-Powered Education","Digital Health",{"date":399,"type":33},{"date":93,"type":22},{"date":177,"type":22},{"name":258,"class":259},3,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":443,"conditions":444,"keywords":447,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":456},"100597965","a-multicenter-observational-study-to-understand-the-clinical-characteristics-treatment-patterns-and-access-to-novel-therapies-of-patients-with-diffuse-large-b-cell-lymphoma-in-the-mea-region-100597965","NCT07065344","A Multicenter Observational Study to Understand the Clinical Characteristics, Treatment Patterns and Access to Novel Therapies of Patients With Diffuse Large B-Cell Lymphoma in the MEA Region","A Multicenter Observational Study to Understand the Clinical Characteristics, Treatment Patterns and Access to Novel Therapies of Patients With Diffuse Large B-Cell Lymphoma in the MEA Region A Cross-sectional Multi-center, Observational Study to Describe the Disease Characteristics and Treatment Patterns and Explore Access to Novel Therapies for Diffuse Large B-Cell Lymphoma (DLBCL) Patients for Both Treatment naïve and Relapsed\u002FRefractory Patients in the Middle East & Africa (MEA) Region.","DOMAIN","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or older at diagnosis.\n2. Patients who have confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) according to the investigator's decision and\u002For histopathological diagnosis.\n3. For Cohort 1: DLBCL patients who are eligible to start treatment\\* according to the investigator's decision.\n4. For Cohort 2: patients who are diagnosed with DLBCL and have failed at least one prior line of therapy.\n5. Patients willing to sign the written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.\n\nExclusion Criteria:\n\n1. Patients who are not eligible for treatment for any reason, according to the investigator's judgment and decision\n2. Patients with concurrent active malignancies other than DLBCL.\n3. Patients who are actively participating in any other clinical trial.",{"count":442,"type":22},500,"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.\n\nThe 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.\n\nDLBCL 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.\n\nPatients 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.\n\nThis 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\u002Frefractory patients, in the Middle East and Africa (MEA) region.",[445,446],"Hematology","Diffused Large B Cell Lymphoma",[446],"2026-06-17",{"date":450,"type":33},"2026-06-18",{"date":452,"type":33},"2025-07-23",{"date":454,"type":22},"2027-01-31",{"name":205,"class":40},21,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":473,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":99},"100641488","the-effect-of-using-weighted-blanket-on-anxiety-stress-depression-and-comfort-level-among-patients-with-cancer-undergoing-intravenous-anticancer-therapy-and-its-feasibility-of-use-by-nurses-compared-to-routine-care-100641488","NCT07653035","The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care","The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care; a Randomized Controlled Study (CALM-WB)","CALM-WB","Inclusion Criteria: for patients\n\n* Newly diagnosed cancer patients aged 18 years and older.\n* Receiving first-line intravenous anticancer therapy (chemotherapy or immunotherapy or a combination of both) in the daycare unit (adjuvant, neoadjuvant, or palliative).\n* Weighting at least 55 kg during obtaining the informed consent. (At least 54 kg before the intervention).\n* Able to complete study assessments.\n* Speaks Arabic or English.\n* Signs Informed consent.\n\nExclusion Criteria for patients:\n\n* Prior psychological treatment or psychotherapy (confirmed psychological diagnosis, history of psychotropic medications and previous psychotherapy).\n* Currently hospitalized in inpatient units.\n* Patients on daily anticancer infusions.\n* Positive fall risk assessment.\n* Open wounds and recent surgeries\u002F stoma.\n* Enrolled in any other device study or clinical trial during data collection.\n* History of:\n\n  * Diabetes mellitus\n  * Respiratory disorders,\n  * Claustrophobia (Miller et al 2003) Because of the possibility for altered sensory perception,\n  * Patients who had a diagnosis of peripheral neuropathy or fibromyalgia (Vinson et al. 2020)\n  * Cognitive impairment\n\nEligibility criteria for the nurse's population:\n\nDay Care Unit nurses will be recruited by convenient sampling and feedback will be sought per patient per visit. The reason to this is because the same nurses maybe caring for multiple patients using the WBs and each patient will provide a different experience for the nurses caring for those patients. Only nurses who agree to complete the study questionnaire will be included.",{"count":466,"type":22},152,[78],"Protocol Title: Protocol Title: The Effect of using Weighted Blanket on anxiety, stress, depression and comfort level among Patients with cancer undergoing intravenous (IV) anticancer therapy and its feasibility of use by nurses compared to routine care; a Randomized controlled study.\n\nStudy Tools: VAS-A, ESAS-R, DASS-21 and comfort level scale will be used to study the patients' population. A survey will be used to assess the feasibility of using the weighted blankets on patients receiving IV anticancer therapy.\n\nMethodology: Consented patients will be stratified per gender then randomized to either ARM1: The interventional arm, Weighted blanket, or ARM2: The control arm, Standard of care. (Regular blanket). The weighted blanket will be administered in the two cycles of IV anticancer therapy for the interventional arm, exploring the temporal trajectory of anxiety, depression, and psychological distress, and investigating the potential of a weighted blanket intervention to mitigate these symptoms. The tools will be administered according to the study protocol. Day Care Unit nurses will be assessed on how feasible they think the blankets are for patients. Expected Outcome: WB is expected to reduce the anxiety in patients undergoing IV anticancer therapy and reduce the nurses' burden when caring for those patients.",[470,471,472],"Solid Cancers","Anxiety Depression","Stress",[474,475,476,477,478,479,480],"blankets","cancer","anxiety","depression","comfort","intravenous infusion","non-pharmacological intervention","2026-06-14",{"date":448,"type":33},{"date":484,"type":33},"2025-12-25",{"date":486,"type":22},"2027-07",{"name":488,"class":259},"Sultan Qaboos Comprehensive Cancer Center",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":495,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":504,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":99},"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":498,"type":22},110,[351],"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.",[502,503],"Antipsychotic-induced Weight Gain (AIWG)","Antipsychotic-induced Weight Gain",[505,506,507,508,509,510,511,512,513],"Dapagliflozin","Metformin","Antipsychotic-induced weight gain","Psychotic disorders","Randomized controlled trial","Weight management","Metabolic side effects","Lifestyle intervention","SGLT2 inhibitor","2026-06-06",{"date":516,"type":33},"2026-06-10",{"date":518,"type":22},"2026-09",{"date":520,"type":22},"2028-12",{"name":258,"class":259},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":529,"maxAge":347,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":5},"100412996","phase-4-rollover-study-for-patients-with-sickle-cell-disease-who-have-completed-a-prior-novartis-sponsored-crizanlizumab-study-100412996","NCT04657822","Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study","An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study","Inclusion Criteria:\n\n1. Written informed consent\u002Fassent, according to local guidelines, signed by the adult patients. In the population under 18 years, it will be signed by the patient and\u002For by the parents or legal guardian prior to enrolling in the rollover study and receiving study medication\n2. SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements in the parent study. Patient is currently benefiting from the treatment with crizanlizumab as determined by the investigator and has completed the treatment schedule as planned in the parent study\n3. Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and ability to comply with future visit schedules\n\nExclusion Criteria:\n\n1. Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion\n2. Ongoing\u002Funresolved treatment-related Grade 3 or higher AEs, and\u002For any ongoing AE requiring dose interruption. Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved unless those toxicities were grade 4\n3. Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial\n4. Pregnant or nursing women\n5. Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab\n6. SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab","6 Months",{"count":531,"type":22},130,[351],"This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.",[114],[536,537,538,539,540,541,542,543,544],"SCD","Vaso-occlusive Crisis","crizanlizumab","SEG101","Sickle cell disease","Sickle cell disorder","VOC","P-selectin","Sickle cell anemia","2026-06-04",{"date":547,"type":33},"2026-06-08",{"date":549,"type":33},"2021-06-10",{"date":551,"type":22},"2031-06-10",{"name":375,"class":40},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":560,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":99},"100639203","development-and-validation-of-an-e-learning-module-on-systemic-anticancer-therapy-and-its-effectiveness-on-the-knowledge-attitude-and-practice-of-nurses-in-administering-systemic-anticancer-agents-at-a-specialized-cancer-centres-in-oman-100639203","NCT07600853","Development and Validation of an E-learning Module on Systemic Anticancer Therapy and Its Effectiveness on the Knowledge Attitude and Practice of Nurses in Administering Systemic Anticancer Agents at a Specialized Cancer Centres in Oman.","SACT -KAP","Inclusion Criteria:\n\n* Nurses who are willing to participate in the study\n\n  * Nurses who speaks and understand English.\n  * Nurses who administer systemic anti-cancer treatment in oncology units.\n  * Nurses who are administering systemic anticancer treatment to the adult oncology patient through IV piggyback\n  * Nurses who are willing to attend the orientation meeting getting familiarity with the study purpose and e- learning module.\n  * Nurses who completed baseline training in systemic anticancer therapy.\n\nExclusion Criteria:\n\n* Nurses who are not willing to participate in the study\n* Nurses who are administering systemic anticancer therapy to the pediatric patients\n* Nurses who are administering systemic anticancer therapy to the non-oncology patient.\n* Nurses who are not completed baseline training in systemic anticancer therapy.\n* Nurses who are pregnant and breast feeding.",true,{"count":562,"type":22},238,[78],"Cancer is becoming more common worldwide. In countries like the United States, cases of breast and colorectal cancer have increased in recent years. A similar pattern is seen in Oman, where breast cancer is the most common cancer among women, and colorectal cancer is the most common among men. As more people are diagnosed with cancer, there is a growing need for safe and effective cancer treatment.\n\nOne important type of treatment is systemic anticancer therapy (SACT), which includes medications such as chemotherapy, immunotherapy, and targeted therapy. These treatments are powerful and can cause serious side effects if not given correctly. Because of this, nurses who administer these treatments need special knowledge and skills to ensure patient safety.\n\nThis study aims to develop an online learning (e-learning) program to help nurses improve their knowledge, skills, and confidence in safely administering systemic anticancer therapy. The study will also evaluate whether this e-learning program is effective compared to routine education.\n\nThe study will be conducted in two major cancer care centers in Oman: the National Oncology Centre at Royal Hospital and the Sultan Qaboos Comprehensive Cancer Care and Research Centre. Nurses working in oncology and hematology units in these centers will be invited to participate.\n\nParticipants will be divided into two groups. One group will receive access to the e-learning program (intervention group), while the other group will continue with their usual training (control group). The assignment to these groups will be done randomly to ensure fairness.\n\nBefore starting the program, all participants will complete a questionnaire to assess their current knowledge, attitude, and practices related to systemic anticancer therapy. They will also provide basic information such as their age, years of experience, and previous training.\n\nThe e-learning program will be developed based on the learning needs of nurses and reviewed by experts in oncology to ensure accuracy and quality. Nurses in the intervention group will be given time to complete the online training.\n\nAfter the training period, all participants (both groups) will complete the same questionnaire again. This will help researchers compare the results before and after the training, as well as between the two groups, to see if the e-learning program made a difference.\n\nThe study will also assess how satisfied the nurses are with the e-learning program, as learner satisfaction is important for the success of educational interventions.\n\nParticipation in this study is voluntary. All participants will provide written informed consent before joining the study. They will be informed about the purpose of the study, what they need to do, and their right to withdraw at any time without any negative consequences. All information collected will be kept confidential and used only for research purposes.\n\nAt the end of the study, nurses in the control group will also be given access to the e-learning program to ensure fairness.\n\nThe results of this study are expected to show that the e-learning program improves nurses' knowledge, attitudes, and clinical practices in administering systemic anticancer therapy. This may help improve patient safety and the quality of cancer care in Oman.",[566,567,568,569],"E-learning","Knowledge","Attitude","Practice","2026-05-14",{"date":572,"type":33},"2026-05-22",{"date":574,"type":22},"2026-06-01",{"date":576,"type":22},"2027-12-01",{"name":488,"class":259},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":585,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":604,"leadSponsor":606,"locationsCount":99},"100624701","phase-3-comparative-efficacy-of-4-mg-vs-8-mg-submucosal-dexamethasone-in-postoperative-pain-management-after-dental-implant-surgery-a-randomized-double-blind-controlled-clinical-trial-100624701","NCT07413055","Comparative Efficacy Of 4 mg VS. 8 mg Submucosal Dexamethasone In Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial","Comparative Efficacy of 4 mg vs. 8 mg Submucosal Dexamethasone in Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial","Inclusion Criteria:\n\n* Males \\& females\n* Age range (21-80)\n* ASA I \\& II according to (American Society of Anesthesiologists) classification\n* Single tooth implant\n* Type 3 \\& type 4 implant placement timing (Chen and Buser, 2009)\n\nExclusion Criteria:\n\n* Any known allergy to any medications which will be used in the study\n* Smokers\u002F Alcoholics\n* Pregnant and lactating women\n* Bone augmentation\u002F sinus lifting required during the surgery\n* The need of antibiotic prophylaxis","21 Years","80 Years",{"count":588,"type":22},138,[25],"This study aims to compare the effectiveness of 4mg and 8mg dexamethasone administered submucosally in reducing postoperative pain after dental implant surgery. Participants will be randomly assigned to receive either 4mg dexamethasone, 8mg dexamethasone, or a placebo (normal saline) at the surgical site.\n\nLater, postoperative pain will be assessed using a Visual Analog Scale at 6 hours after the surgery and daily for the next 6 days. Also the number of pain-relief tablets consumed after the surgery will be recorded.\n\nPreoperative anxiety will be assessed using Generalized Anxiety Disorder-7 (GAD-7) questionnaire to assess its association with postoperative pain scores.\n\nThe results of this study will help determine the optimal dose of dexamethasone that is effective for postoperative pain control following dental implant surgery.",[592],"Postoperative Pain",[594,595,596,597,598,599],"Dexamethasone","Dental implants","Postoperative pain","Submucosal injection","Analgesic consumption","Anxiety","2026-03-25",{"date":602,"type":33},"2026-03-30",{"date":600,"type":22},{"date":605,"type":22},"2026-12-01",{"name":97,"class":98},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":238,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":99},"100630697","impact-of-sglt2-inhibitors-on-chronic-peritoneal-dialysis-patients-100630697","NCT07491042","Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.","Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients: A Six-month Prospective .Study","Inclusion Criteria:\n\n* o age equal to or more than13 years.\n\n  * All genders.\n  * All patients undergoing chronic Peritoneal Dialysis.\n  * Urine output equal or more than 150 ml\u002F24 hours.\n\nExclusion Criteria:\n\n* o Age less than 13 years\n\n  * Patients with type I diabetes mellitus.\n  * Patients with recurrent urinary tract infection (UTI) or peripheral vascular diseases (P.V.D).\n  * Patients with urine output less than 150 ml\u002F24hours.\n  * Patients with recurrent hypoglycemic episodes\n  * Patients with acute or chronic liver disease,\n  * Patients who refuse to participate in the study.\n  * peritoneal Dialysis catheter (PDC) related peritonitis in last 3 months",{"count":615,"type":22},38,[78],"This project aims to examine the effects of six-month treatment with selective SGLT2 inhibitor dapagliflozin in patients with end-stage kidney disease on chronic peritoneal dialysis.\n\nMethods: A prospective, open label, single-arm interventional clinical trial, will conduct at Nizwa Hospital from March 1st, 2026, to August 31th , 2026, and includes thirty (30) end-stage kidney disease diabetic and non-diabetic patients on chronic peritoneal dialysis, will receive selective SGLT2i Dapagliflozin 10 mg once daily (OD). Clinical and laboratory parameters will be assessed at baseline, then three and six months after drug initiation.\n\nThe primary outcomes are:1- change in ultrafiltration volume, 2- change in Kt\u002FV (dialysis adequacy), 3. Change in the mean 24-hour urine volume.",[619],"End Stage Chronic Renal Failure",[621,622,623],"SGLT-2 inhibitor","Peritoneal Dialysis","urine volume","2026-03-19",{"date":626,"type":33},"2026-03-24",{"date":628,"type":22},"2026-04-01",{"date":454,"type":22},{"name":97,"class":98},{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":638,"maxAge":238,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":645,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":99},"100624406","the-use-of-an-audio-visual-method-in-counseling-for-pediatric-lumbar-puncture-procedure-100624406","NCT07409220","The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure","The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.","Inclusion Criteria:\n\n* All Parents\u002Flegal guardians of 0-13 years old children who were identified to get an emergent lumbar puncture procedure, as decided by the attending physician during the Emergency Department shift.\n* Participants who speak Arabic or English\n\nExclusion Criteria:\n\n\\- Participants who are not Arabic nor English speakers.","12 Hours",{"count":640,"type":22},154,[78],"The goal of this clinical trial is to compare the use of usual verbal counseling supported by a video illustration comparing to the use of usual verbal counseling alone prior to obtaining spinal fluid ( Lumbar puncture - LP ) procedure, from children suspected to have brain infection in the Emergency department settings.\n\nThis trial is trying to answer if use of video illustration is associated with higher acceptance rate for the procedure by the parents of children who are suspected to have brain infection (meningitis) in the pediatric emergency room settings at a tertiary hospital.\n\nWho is suitable to participate? Parents\u002Flegal guardians of all children aged between 1day to 12 years, who are suspected to have brain infection (meningitis) attending the Pediatric emergency room at the Royal Hospital.\n\nParticipants will:\n\nBe counseled using verbal snd video method = Intervention group OR verbal method only = Control group The Researchers will collect the acceptance rate in performing LP in both groups.",[644],"Meningitis in Children",[646,647,648,649,650,651,652],"lumbar puncture","counseling","audiovisual aids","verbal","video","emergency","pediatrics","2026-02-11",{"date":655,"type":33},"2026-02-13",{"date":657,"type":33},"2025-01-31",{"date":659,"type":22},"2026-07-30",{"name":97,"class":98},{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":560,"sex":18,"minAge":19,"maxAge":669,"enrollmentInfo":670,"targetDuration":4,"studyType":23,"phases":672,"briefSummary":673,"conditions":674,"keywords":677,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":99},"100611703","aescin-based-herbal-extract-reparil-for-postoperative-sequelae-after-mandibular-third-molar-surgery-100611703","NCT07244029","Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery","Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled Trial","Reparil","Inclusion Criteria:\n\n* Patients indicated for surgical removal of impacted mandibular third molars according to National Institute for Health and Care Excellence (NICE) guidelines.\n\nAge between 18 and 40 years.\n\nImpacted mandibular third molars with similar anatomical position and difficulty level as classified by Pell and Gregory and Pederson scoring.\n\nHealthy individuals (ASA I-II) with no significant systemic illness.\n\nWilling to provide written informed consent and attend all follow-up visits (Day 2 and Day 7 post-surgery).\n\nExclusion Criteria:\n\n* Recent use (within three weeks preoperatively) of anti-inflammatories, corticosteroids, or antibiotics.\n\nKnown allergies or hypersensitivity to Aescin, Ibuprofen, rescue medications, or local anesthetics.\n\nPregnant or lactating women.\n\nPatients with contraindications to NSAIDs (e.g., asthma, bleeding disorders, chronic kidney disease, active peptic ulcer, or cardiovascular disease).\n\nRecent use of substances that may affect surgery or interact with study drugs (e.g., contraceptives, alcohol, or tobacco).\n\nSurgical time exceeding 30 minutes or cases with intraoperative complications requiring non-study medications.","40 Years",{"count":671,"type":22},100,[78],"This randomized, single-blind, controlled clinical trial aims to evaluate the efficacy and safety of Aescin-based herbal extract (Reparil®) compared with Ibuprofen in managing postoperative sequelae following surgical removal of impacted mandibular third molars. A total of 100 participants aged 18-40 years will be enrolled at the Dental Center, Medical City Hospital for Military and Security Services (MCMSS), Al Khoud, Oman. Participants will be randomly assigned to receive either Reparil® (Aescin 20 mg, three times daily for five days) or Ibuprofen (400 mg, three times daily for five days) following standardized third molar extraction procedures. Postoperative outcomes including pain (VAS), facial swelling (3D facial scanner), and mouth opening (digital caliper) will be assessed preoperatively, on day 2, and day 7 post-surgery. The study aims to determine whether Aescin offers comparable analgesic and anti-edematous effects to Ibuprofen with fewer adverse events.",[592,675,676],"Facial Swelling","Trismus",[678,679,667,680,681,682,683,684,685,686],"Aescin","Escin","Ibuprofen","Herbal anti-inflammatory","Postoperative sequelae","Third molar extraction","Oral surgery","Phytotherapeutic agents","Pain management","2026-01-13",{"date":689,"type":33},"2026-01-15",{"date":691,"type":33},"2026-01-01",{"date":693,"type":22},"2026-09-30",{"name":695,"class":98},"Oman Medical Speciality Board",{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":701,"acronym":4,"eligibilityCriteria":702,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":703,"targetDuration":215,"studyType":51,"phases":4,"briefSummary":705,"conditions":706,"keywords":709,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":721,"lastUpdatePostDateStruct":722,"startDateStruct":724,"completionDateStruct":726,"leadSponsor":728,"locationsCount":730},"100539330","propel---a-prospective-observational-patient-registry-to-evaluate-enpp1-and-abcc6-deficiency-100539330","NCT06302439","PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency","A Prospective Observational Patient Registry to Evaluate Disease Progression in Patients With ENPP1 Deficiency and Infantile-Onset ABCC6 Deficiency (GACI Type 2)","Inclusion Criteria:\n\nIndividuals eligible to participate must meet all the following inclusion criteria:\n\n1. Must provide written or electronic consent after the nature of the registry has been explained, and prior to any research-related procedures, per International Council for Harmonisation (ICH) Good Clinical Practice (GCP)\n2. Agree to provide access to relevant medical records\n3. One of the following genetic or clinical criteria\n\n   1. A confirmed prenatal or postnatal molecular genetic diagnosis of ENPP1 Deficiency with biallelic mutations (ie, homozygous or compound heterozygous) performed by a College of American Pathologists\u002FClinical Laboratory Improvement Amendments (CAP\u002FCLIA) certified laboratory or regional equivalent\n\n      OR\n   2. Monoallelic ENPP1 mutation confirmed by a certified CAP\u002FCLIA laboratory or regional equivalent and any of the following clinical symptoms:\n\n   i. ≥ 1 traumatic vertebral fracture\n\nii. ≥ 2 fractures as an adult (eg, long-bones, digits, vertebrae)\n\niii. Low bone mineral density (dual-energy X-ray absorptiometry \\[DXA\\] Z-score \\\u003C1.5) and \\\u003C55 years of age\n\niv. Bone or joint pain interfering with movement or daily activities\n\nv. History of myocardial infarction (MI), unstable angina, transient ischemic attack (TIA) or low cardiac output before the age of 40 yrs.\n\nvi. History of rickets or bone deformity\n\nvii. Diagnosis of ossification of the posterior longitudinal ligament (OPLL)\n\nviii. Other clinical symptoms, with approval by Inozyme\n\nOR\n\nc. A confirmed prenatal or postnatal molecular genetic diagnosis of ABCC6 Deficiency with biallelic mutations confirmed by a certified CAP\u002FCLIA laboratory or regional equivalent, and \\\u003C18 years of age\n\nExclusion Criteria:\n\nIndividuals who meet the following exclusion criteria will not be eligible to participate:\n\n1. Participant or their legally designated representative does not have the cognitive capacity to provide informed consent\n2. Patients who are currently participating in an INZ-701 interventional clinical study, with the exception of expanded access programs and long-term safety follow-up studies\n\n   1. Participants in interventional studies may be approached for inclusion in the registry once their involvement in the treatment period of the clinical study has been completed",{"count":704,"type":22},1000,"The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase\u002Fphosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes \\[PROs\\]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease.",[707,708],"Ectonucleotide Pyrophosphatase\u002FPhosphodiesterase 1 Deficiency","ATP-Binding Cassette Subfamily C Member 6 Deficiency",[710,711,712,713,714,715,716,717,708,718,719,720],"Ectonucleotide pyrophosphatase","ENPP1","Generalized Arterial Calcification of Infancy","GACI","Autosomal Recessive Hypophosphatemic Rickets Type 2","ARHR2","Observational","Registry","ABCC6","PROPEL","Phosphodiesterase 1","2025-12-15",{"date":723,"type":33},"2025-12-22",{"date":725,"type":33},"2024-07-25",{"date":727,"type":22},"2034-05",{"name":729,"class":40},"Inozyme Pharma",14,""]