[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Lebanon\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":727},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,71,0,25,[9,47,74,98,125,147,173,207,231,265,293,324,355,391,419,457,480,505,539,567,595,617,648,672,697],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":7},"100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387",false,"NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","ALL","1 Month",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[25],"Perimembranous Ventricular Septal Defect",[27,28,29,30,31,32,33,34],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects","RECRUITING","2026-08-24",{"date":38,"type":39},"2026-08-25","ACTUAL",{"date":41,"type":39},"2025-01-01",{"date":43,"type":21},"2027-06-30",{"name":45,"class":46},"Fondation Hôpital Saint-Joseph","OTHER",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100652889","electromyographic-effects-of-postural-correction-exercises-in-individuals-with-forward-head-posture-100652889","NCT07780396","Electromyographic Effects of Postural Correction Exercises in Individuals With Forward Head Posture","Electromyographic Changes in Masticatory and Cervical Muscles Following a Structured 10-week Postural Correction Exercise Program in Individuals With Asymptomatic Forward Head Posture: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. Participants aged 18- 30 years. 2. Presence of forward head posture, defined as CVA of less than 50° with no symptoms of neck pain \\[18, 19\\]. 3. No treatment for TMD or cervical symptoms (e.g., medication, physical therapy, or intra-articular injection) within the previous 2 weeks.\n\nExclusion Criteria:\n\n* 1\\. Current or previous diagnosis of temporomandibular disorder (TMD), or the presence of TMD-related signs or symptoms (e.g., joint sounds, restricted mouth opening, or orofacial pain) during screening.\n\n  2\\. History of TMJ subluxation or dislocation that could interfere with mouth opening.\n\n  3\\. History of recent head or neck trauma. 4. Angle Class II or Class III malocclusion. 5. Postural abnormalities secondary to structural spinal deformities (e.g., scoliosis or kyphosis), rheumatic diseases, or other medical conditions affecting posture.\n\n  6\\. Missing posterior teeth, recent orthodontic treatment (within the previous 12 months), or dental restorations that altered occlusion.","18 Years","30 Years",{"count":57,"type":21},60,"INTERVENTIONAL",[60],"NA","This study investigates the effects of specific corrective exercises on EMG of masticatory and cervical muscles in individuals with forward head posture. The study's design will be a retrospective, double- blinded, randomized controlled trial. The participants will be randomly allocated to one of two groups: the exercise group and the control group. The training groups will perform a program consisting of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises. This exercise program will be repeated 4 times per week for 10 weeks, and each session lasted 30 minutes.\n\nThe pre\u002Fpost assessment of forward head posture will measure by using craniovertebral angle CVA. While the muscle activity EMG of the masseter, temporalis, splenius, upper trapezius, and SCM will measure pre and post-assessment using a biopic data acquisition system.",[63],"Forward Head Posture","2026-08-19",{"date":66,"type":39},"2026-08-21",{"date":68,"type":39},"2026-05-15",{"date":70,"type":21},"2026-10-30",{"name":72,"class":46},"Cairo University",1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":82,"targetDuration":83,"studyType":22,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100213888","prospective-global-registry-for-the-study-of-chronic-total-occlusion-intervention-100213888","NCT02061436","Prospective Global Registry for the Study of Chronic Total Occlusion Intervention","Multicenter Registry of Chronic Total Occlusion Interventions","PROGRESS-CTO","Inclusion Criteria:\n\n* Patients undergoing CTO PCI at each of the participating centers.\n\nExclusion Criteria:\n\n* None",{"count":20,"type":21},"1 Year","Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.",[86],"Coronary Artery Disease",[88],"chronic total occlusion, percutaneous coronary intervention","2026-08-17",{"date":64,"type":39},{"date":92,"type":39},"2012-01",{"date":94,"type":21},"2030-01",{"name":96,"class":46},"Minneapolis Heart Institute Foundation",48,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":58,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"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":108,"type":21},408,[110],"PHASE3","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.",[113],"Sickle Cell Disease","2026-08-12",{"date":116,"type":39},"2026-08-13",{"date":118,"type":39},"2025-02-17",{"date":120,"type":21},"2029-08-12",{"name":122,"class":123},"Novo Nordisk A\u002FS","INDUSTRY",175,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":58,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"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":21},480,[110],"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.",[113,139],"Thalassemia",{"date":116,"type":39},{"date":142,"type":39},"2025-01-10",{"date":144,"type":21},"2030-12-30",{"name":122,"class":123},106,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":154,"minAge":54,"maxAge":4,"enrollmentInfo":155,"targetDuration":157,"studyType":22,"phases":4,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100480992","bph-global-registry-100480992","NCT05543200","BPH Global Registry","A Global Registry of Treatments and Outcomes for Benign Prostatic Hyperplasia","Inclusion Criteria:\n\n* Primary diagnosis of BPH with LUTS with prescribed medical treatment or surgical intervention\n\nExclusion Criteria:\n\n* Non-symptomatic BPH\n* No treatment prescribed for BPH","MALE",{"count":156,"type":21},7500,"3 Years","Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.",[160,161],"Benign Prostatic Hyperplasia","Lower Urinary Tract Symptoms",[163],"BPH, Registry, LUTS","2026-08-11",{"date":116,"type":39},{"date":167,"type":39},"2023-03-13",{"date":169,"type":21},"2028-12",{"name":171,"class":46},"Société Internationale d'Urologie",30,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":58,"phases":183,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":73},"100651704","therapeutic-effects-of-music-on-procedural-outcomes-100651704","NCT07763860","Therapeutic Effects of Music on Procedural Outcomes","Effect of Intra-Procedural Low-Tempo Instrumental Music Plus Standard Sedation Versus Standard Sedation Alone on Sedative Requirements in Adults Undergoing Gastroscopy and\u002For Colonoscopy: a Single-Center, Parallel-Group, Randomized Superiority Trial With Blinded Outcome Assessors and Statisticians","TEMPO","Inclusion Criteria:\n\n* Age ≥18 years.\n* Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Emergency or urgent endoscopic procedure.\n* Hearing impairment that prevents adequate perception of the standardized test audio through the study headphones.\n* American Society of Anesthesiologists (ASA) Physical Status IV or higher.\n* Cognitive impairment, altered mental status, or another condition that prevents provision of informed consent or reliable completion of study assessments.\n* Any condition that prevents safe or appropriate use of the study headphones.",{"count":182,"type":21},180,[60],"This study will evaluate whether listening to low-tempo instrumental music during gastroscopy and\u002For colonoscopy can reduce the amount of sedative medication needed during the procedure. Adults undergoing elective gastroscopy and\u002For colonoscopy with sedation will be randomly assigned to one of two groups. One group will listen to low-tempo instrumental music (60-80 beats per minute) through headphones during the procedure in addition to receiving standard sedation. The other group will receive standard sedation without music.\n\nThe main outcome of the study is the amount of sedative medication required during the procedure. The study will also compare pain after the procedure, time until discharge, patient satisfaction, and changes in heart rate and blood pressure between the two groups. The researchers hypothesize that patients who listen to low-tempo music will require less sedative medication and may have improved recovery and patient-reported outcomes compared with patients receiving standard sedation alone.",[186,187,188],"Procedural Sedation","Gastrointestinal Endoscopy","Music Intervention",[190,191,192,193,186,194,195,196,197,198],"Music","Low-Tempo Music","Gastroscopy","Colonoscopy","Sedation","Propofol","Pain","Patient Satisfaction","Recovery Time","2026-08-09",{"date":116,"type":39},{"date":202,"type":21},"2026-08",{"date":204,"type":21},"2026-10",{"name":206,"class":46},"Bahaa Bou Dargham",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":215,"maxAge":54,"enrollmentInfo":216,"targetDuration":4,"studyType":58,"phases":218,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100531354","phase-2-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-etavopivat-in-pediatric-patients-with-sickle-cell-disease-100531354","NCT06198712","A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease","A Single Arm, Open Label, Phase 1\u002F2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease","HIBISCUS KIDS","Inclusion Criteria:\n\n* Type of Participant and Disease Characteristics\n\n  1. Patient's parent, legal guardian, or legal representative has provided documented informed consent and patients have provided age-appropriate assent\n  2. Age greater than or equal to (≥) 6 months and lesser than (\\\u003C) 18 years of age at time of enrollment, according to the enrolling cohort:\n\n     * Cohort 1: age 12 to \\\u003C 18 years (adolescents)\n     * Cohort 2: age 6 to \\\u003C 12 years\n     * Cohort 3: age 2 to \\\u003C 6 years\n     * Cohort 4: age 6 months to \\\u003C 2 years\n  3. Patient has confirmed diagnosis of SCD\n\n     • Documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing. Molecular genotyping is not required. SCD genotype may be determined from the results of Hb electrophoresis, high-performance liquid chromatography (HPLC), or similar testing. Note that Hb electrophoresis is performed by the local laboratory at Screening.\n  4. Hemoglobin ≥ 5.5 and lesser than or equal to (≤) 10.5 grams per deciliter (g\u002FdL)\n  5. Pediatric patients with severe SCD, as defined by at least 1 of the following:\n\n     * 2-15 episodes of documented VOC within the 12 months prior to screening. Documentation must exist in the patient's medical record prior to screening. Events based solely on patient recall without supporting documentation should not be counted towards eligibility.\n     * Hospitalization for any SCD-related complication in the last 12 months prior to starting study treatment\n     * Proteinuria, defined as an albumin:creatinine ratio (ACR) \\> 100 mg\u002Fg on 2 measures (separated by ≥ 1 month) as an indicator of early renal disease\n     * History of a conditional TCD in the last 12 months prior to starting study treatment, but not currently being treated with chronic transfusion therapy (applicable to participants \\> 2 years of age). Conditional TCD is defined as a TAMMV of 170-199 cm\u002Fs by TCD or 155-184 cm\u002Fs by imaging TCD (TCDi).\n  6. For participants taking hydroxyurea (HU), the dose of HU (mg\u002Fkg) must be stable (no more than a 20% change in dosing) for at least 90 days prior to start of study treatment with no anticipated need for dose adjustments during the study, in the opinion of the Investigator\n  7. Patients on crizanlizumab or L-glutamine treatment at the time of consent may be eligible if they:\n\n     * Have been on a stable dose for ≥ 12 months at the time of consent (ie, no changes to the dose except for changes to weight or for safety reasons)\n     * For patients on crizanlizumab, have been ≥ 80% compliant with the planned regimen during the 12 months prior to the time of consent\n  8. Female patients of childbearing potential who are using acceptable methods of contraception and agree not to donate ova from study start to 90 days after the last dose of study drug, and male patients who are willing to use acceptable methods of contraception and agree not to donate sperm, from study start to 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  1. Female who is breastfeeding or pregnant\n  2. More than 15 VOCs within the 12 months prior to starting study treatment that required a hospital, emergency room (ER), or clinic visit\n  3. Hospitalized for sickle cell crisis or other vaso-occlusive event occurring in the 14 days prior to starting study treatment\n  4. Abnormal TCD in the 12 months prior to starting study treatment\n\n     Prior\u002FConcomitant Therapy\n  5. Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)\n  6. Received any blood products within 30 days of starting study treatment\n  7. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4\u002F5 within 2 weeks of starting study treatment\n  8. Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study\n  9. Receipt of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study\n  10. Receipt of prior cellular based therapy (eg, hematopoietic cell transplant, gene modification therapy)","6 Months",{"count":217,"type":21},95,[219],"PHASE2","The purpose of this study is to evaluate the pharmacokinetics and safety of etavopivat in paediatric participants with sickle cell disease (SCD). Participants will receive etavopivat and will be enrolled in a staggered manner, starting with the oldest age group and followed sequentially by younger cohorts after review of pharmacokinetic and safety data from the preceding cohort. All participants will undergo a 24-week primary treatment period followed by a 72-week extension treatment period to further evaluate long-term safety and pharmacokinetics of etavopivat. The total duration of the study will be approximately 96 weeks.",[113],"2026-08-07",{"date":114,"type":39},{"date":225,"type":39},"2023-01-12",{"date":227,"type":21},"2029-08-08",{"name":229,"class":123},"Forma Therapeutics, Inc.",18,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":238,"sex":17,"minAge":54,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":58,"phases":242,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100647858","puff-topography-and-sensory-effects-across-iqos-device-generations-100647858","NCT07712887","Puff Topography and Sensory Effects Across IQOS Device Generations","Puff Topography and Sensory Effects Across IQOS Device Generations: A Randomized Crossover Study","Inclusion Criteria:\n\n* Current IQOS user (at least 3 days per week in the past 30 days)\n* Age 18 to 65 years\n* Generally healthy\n* Willing to provide informed written consent\n* Willing to attend all laboratory visits\n* Willing to abstain from all nicotine and tobacco products for at least 12 hours before each visit\n\nExclusion Criteria:\n\n* Use of any tobacco products other than IQOS in the past 30 days\n* Chronic cardiovascular conditions, seizures, or abnormal blood pressure\n* Current psychiatric disorder requiring active treatment, including major depressive disorder\n* Regular use of prescription medications that may influence cardiovascular function, respiratory function, or nicotine metabolism (excluding vitamins or birth control)\n* Use of cocaine, opioids, benzodiazepines, or methamphetamines in the past month\n* Marijuana use on more than 15 days per month\n* Current pregnancy or breastfeeding\n* Plans to quit nicotine or tobacco products within the next 30 days",true,"65 Years",{"count":241,"type":21},50,[60],"The goal of this clinical trial is to learn how people use two generations of IQOS heated tobacco devices and how each device affects their smoking behavior and sensory experience.\n\nThe main questions it aims to answer are:\n\n* Do participants puff differently when using the newer IQOS Iluma i compared to the older IQOS 2.4?\n* Does the flavor of the tobacco stick (preferred flavor vs. standard tobacco flavor) affect puffing behavior or sensory experience?\n* What are the differences in throat hit, mouthfeel, and satisfaction between the two devices?\n\nParticipants will:\n\n* Attend 2 laboratory visits at the American University of Beirut\n* Use both the IQOS Iluma i and IQOS 2.4 devices during each visit\n* Have their puffing behavior recorded automatically during device use\n* Provide a breath sample before and after each use session\n* Complete short questionnaires about how each device felt and their urge to smoke",[245,246],"Nicotine Dependence","Tobacco Use",[248,249,250,251,252,253,254],"Heated Tobacco Products","IQOS","Puff Topography","Electronic Nicotine Delivery Systems","Nicotine","Subjective Effects","Tobacco Harm Reduction","2026-07-29",{"date":257,"type":39},"2026-07-30",{"date":259,"type":39},"2026-07-27",{"date":261,"type":21},"2027-12-15",{"name":263,"class":46},"American University of Beirut Medical Center",2,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":238,"sex":17,"minAge":54,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":58,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":264},"100649455","the-addition-of-core-muscle-training-on-tennis-serve-speed-in-tennis-players-100649455","NCT07733869","The Addition of Core Muscle Training on Tennis Serve Speed in Tennis Players","The Effect of Adding Core Muscle Training With Shoulder Strengthening in Tennis Players: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Healthy adults aged 18-35 years\n* Recreational to competitive non-professional tennis players (currently playing ≥2 sessions\u002Fweek for ≥1 year; NTRP 3.0-5.0 or equivalent ITN; no professional ranking or tour-level competition history)\n* Right- or left-hand dominant (serve arm recorded)\n* Able to perform a full flat serve without pain\n* Willing to maintain current tennis training routine and refrain from starting other new strength\u002Fconditioning programs during the study\n\nExclusion Criteria:\n\n* Current or history of shoulder pain\u002Finjury in the past 6 months (e.g., rotator cuff pathology, labral injury, impingement)\n* Low back pain or lumbar spine pathology in the past 6 months\n* Prior shoulder or spine surgery\n* Systemic conditions affecting neuromuscular function (e.g., uncontrolled diabetes, neurological disorders)\n* Pregnancy\n* Current participation in a structured core or shoulder strengthening program","35 Years",{"count":274,"type":21},120,[60],"Compared with shoulder-only training and with continued tennis training alone, will the addition of core strengthening to shoulder training produce significantly greater improvements in flat serve ball speed in healthy tennis players?\n\nSecondary Hypothesis:\n\n* Combined core + shoulder training will produce greater improvement in serve accuracy than shoulder-only training or tennis training alone.\n* Combined core + shoulder training will produce greater improvement in TGAR than shoulder-only training or tennis training alone.\n* Combined core + shoulder training will produce greater improvement in core strength\u002Fendurance and shoulder rotational strength than the comparator groups.",[278,279],"Tennis","Tennis Serve Performance",[281,282,283,284,285],"Serve Speed","Core Training","Shoulder training","strengthening","total glenohumeral arc of rotation","2026-07-24",{"date":255,"type":39},{"date":289,"type":39},"2026-06-15",{"date":291,"type":21},"2026-09-20",{"name":72,"class":46},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":58,"phases":304,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":314,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":73},"100648261","clinical-radiographic-histological-and-patient-reported-experience-outcome-measures-of-endoscopically-monitored-graftless-transcrestal-sinus-floor-elevation-with-simultaneous-multiple-implant-placement-using-osseodensificationod-versus-osteotomes-ot-in-subsinus-bone-height-of-4-5-mm-an-rct-100648261","NCT07719283","Clinical, Radiographic, Histological, and Patient-reported\u002F Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT","Clinical, Radiographic, Histological, and Patient-reported\u002F Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification Versus Osteotomes in Subsinus Bone Height of 4-5 mm: A Randomized Controlled Trial","OD - OT - RCT","Inclusion criteria:\n\n* \\>18 years old\n* Ability and willingness to comply with the study protocol and scheduling\n* Unilateral or bilateral absence of 2-3 consecutive teeth posterior to maxillary the 1st premolar (excluding 3rd molars)\n* Missing teeth extracted or lost \\> 6months prior to surgery\n* Subsinus residual bone height 4-5 mm\n* Alveolar ridge bucco-palatal width allowing placement of implants with at least 3.7-mm diameter leaving \\>1.5 mm at the buccal and palatal aspects of the implants\n* Narrow-medium sinus cavities with bucco-palatal width ≤ 15 mm at the 10-mm level including the residual alveolar crest\n* Sinus membrane thickness \\\u003C 2 mm\n\nExclusion criteria:\n\n* Smoking \\> 10 cigarettes\u002Fday\n* Absolute contraindications to implant therapy\n* Pregnancy or lactation\n* Systemic conditions\u002F medications affecting bone healing\n* Ongoing or history of head and neck irradiation therapy\n* Uncontrolled diabetes with HbA1c \\> 7%\n* Alcohol or drug abuse\n* Ongoing or history of benign paroxysmal positional vertigo\n* Severe parafunctional habits (clenching and bruxism)\n* Maxillary sinus infection or pathology\n* Previous bone augmentation at the planned implant sites\n* Osseous lesions or infections at the planned implant sites\n* Sinus bony septa in line with the planned implant sites\n* Untreated periodontal disease","75 Years",{"count":303,"type":21},44,[60],"Study title: Comparison of clinical, radiographic, histological, and patient-reported outcome\u002F experience measures of endoscopically-monitored graftless transcrestal sinus floor (TSFE) elevation with 1-stage simultaneous multiple implant placement using osseodensification versus osteotomes in subsinus bone height of 4-5 mm: An 18-month double-arm randomized controlled trial.\n\nPrincipal investigator: Georgina El-Ghoul, DDS, MSc. Contact: georginaelghoule@gmail.com Institution: Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University of Beirut, Lebanon.\n\n1. Introduction You are being asked to participate in a research study comparing 2 different procedures used in graftless TSFE with simultaneous implant placement in areas where there is limited amount of bone (4-5 mm) over a period of 18 months. TSFE is used to elevate the sinus membrane to allow new bone formation under the elevated membrane. TSFE can be achieved using either mechanical tools (osteotome) or specially designed burs (osseodensification burs). Currently, the 2 procedures are used by clinicians worldwide with excellent short- and long-term outcomes.\n\n   You fit the selection criteria of patients enrolled in the study because you have partial posterior edentulism with more than one tooth missing and limited bone height below the maxillary sinus, a condition that is typically treated with graftless TSFE and simultaneous implant placement.\n2. Purpose of the study The goal is to evaluate which technique, osseodensification or osteotomes, provides better bone healing, implant stability, and a more comfortable experience for the patient. TSFE procedures are blindly performed without direct intra-operative visualization of the sinus membrane. Since intra-operative sinus membrane perforation has been suggested to increase the risk of implant failure, the incorporation of endoscopy in TSFE provides a real-time magnified intra-operative view of the sinus membrane throughout the entire TSFE and implant placement, thus allowing a precise and controlled sinus elevation with minimal or no risks of perforation.\n3. Procedures involved in this study\n\n   If you agree to participate, you will be randomly assigned to one of 2 groups:\n   * test group (osseodensification): sinus floor elevation using rotating burs; or\n   * control group (osteotomes): sinus floor elevation using manual surgical instruments.\n\n   The following will occur for all participants:\n   * CBCT: pre-surgically, immediately at the end of the surgery, 6 and 12 months following delivery of the definitive prosthesis;\n   * surgery: sinus floor elevation with simultaneous multiple implant placement using either osseodensification or osteotomes under local anesthesia;\n   * endoscopic monitoring: TSFE is conventionally performed blindly without direct visualization of the delicate sinus membrane during the procedure. In this study, we will use a small specialized camera- an endoscope- through a very small bony hole located either within the surgical area or at a close separate location. This will allow us to enhance the procedure by visualizing the sinus interior and sinus membrane in real-time on a screen during the entire surgery. This monitoring technology will ensure that the sinus membrane stays intact while we create space for your implants, and therefore reduce the risk of implant failure;\n   * biopsy (histomorphometric analysis): when possible, a small bone or implant-bone core that include osseointegrated non-strategic implants (prepared with the OD and OT approaches) along with a thin layer of surrounding bone will be retrieved and analyzed. The non-strategic implant is placed only for research purposes during the same appointment as your planned implants. It is not intended to support your planned bridge. The retrieval of this non-strategic implant involves a second minor and fast flapless procedure 6 months following the main surgery. This test implant will be sent to a laboratory to examine the bone-to-implant connection under a microscope. This will allow us to better understand how quickly and strongly the bone heals around implants using TSFE; and\n   * follow-up (18 months): regular visits for evaluation and tooth cleaning at intervals of 3 months following delivery of the definitive prosthesis.\n\n   You will be asked to complete surveys about your post-operative course and your overall treatment experience.\n4. Risks involved Beyond the normal post-operative course which include potential discomfort, swelling, and hematoma, infrequent complications may occur such as post-surgical infection, bleeding, vertigo, and muscle spasms related to mouth opening. The CBCT radiation dose used each time is roughly equivalent to 6-9 months of natural background radiation (rocks, sun, air, flights).\n5. Expected benefits to the patient Sinus augmentation will help generate bone around the implants that replace your missing teeth. Your participation will help improve future treatments for other",[307],"Osseodensification Drilling Technique",[309,310,311,312,313],"Transcrestal sinus floor augmentation","Endoscopy","Dental implants","Sinus membrane perforation","Implant survival","NOT_YET_RECRUITING","2026-07-17",{"date":317,"type":39},"2026-07-22",{"date":319,"type":21},"2026-09-30",{"date":321,"type":21},"2029-09",{"name":323,"class":46},"Saint-Joseph University",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":332,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":58,"phases":336,"briefSummary":337,"conditions":338,"keywords":344,"overallStatus":314,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":73},"100618145","effect-of-mental-arithmetic-priming-on-gait-and-balance-in-stroke-100618145","NCT07327814","Effect of Mental Arithmetic Priming on Gait and Balance in Stroke","Mental Calculus Can Enhance Gait Performance in Post-Stroke Patients: A Randomized Controlled Trial","MA-Stroke","Inclusion Criteria:\n\n* Diagnosis of stroke.\n* Mini-Mental State Examination (MMSE) score ≥ 23.\n* Ability to walk 10 meters independently (with or without assistive device).\n\nExclusion Criteria:\n\n* Hemianopia.\n* Wernicke's aphasia or Global aphasia.\n* Orthopedic injuries or recent surgeries affecting the lower limbs.","60 Years","80 Years",{"count":335,"type":21},17,[60],"This study investigates the effect of cognitive priming through mental arithmetic on functional mobility in post-stroke patients. It hypothesizes that performing mental calculations (addition, subtraction, multiplication) prior to movement stimulates frontoparietal networks, thereby improving gait speed and dynamic balance compared to a passive control condition.",[339,340,341,342,343],"Stroke","Hemiparesis","Gait Disorders","Posture","Disorders",[339,340,342,345,341],"Balance","2026-07-15",{"date":348,"type":39},"2026-07-16",{"date":350,"type":21},"2026-09-01",{"date":352,"type":21},"2027-01-01",{"name":354,"class":46},"Lebanese University",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":133,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":58,"phases":365,"briefSummary":366,"conditions":367,"keywords":370,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100513799","phase-3-a-study-of-roxadustat-to-treat-anemia-in-children-and-teenagers-with-chronic-kidney-disease-100513799","NCT05970172","A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease","A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease","Inclusion Criteria:\n\n* Participant has a diagnosis of anemia in CKD Kidney Disease Outcomes Quality Initiative stages 3 or 4 or 5. This can include participants not on dialysis or dialysis dependent (DD) participants (including hemodialysis, peritoneal dialysis and hemodiafiltration participants).\n* Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of \\\u003C 60 mL\u002Fmin per 1.73 m\\^2.\n* ESA-treated participants should have a screening Hb level, assessed via HemoCue, between 10.0 and 12.0 g\u002FdL; ESA-naïve participants can have a Hb level ≤ 11 g\u002FdL.\n* Participant has a ferritin level \\> 100 ng\u002FmL or a transferrin saturation (TSAT) value \\> 20%.\n* Participant has an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) and total bilirubin (TBL) ≤ 1.5 x ULN at enrollment visit.\n* Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as:\n\n  * ESA-treated: Participant is taking a stable dose of an ESA for at least 4 weeks prior to screening.\n  * ESA-naïve: Participant has no prior ESA exposure OR participant's total prior ESA exposure ≤ 3 weeks within the preceding 4 weeks from screening OR participant was previously treated with and discontinued an ESA ≥ 8 weeks prior to screening.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 4 weeks after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening and throughout the study and for 4 weeks post-last roxadustat dose.\n* Female participant must not donate ova starting at first administration of roxadustat and throughout the study period and for 4 weeks post-last roxadustat dose.\n* Male participants with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 4 weeks post-last roxadustat dose.\n* Male participants must not donate sperm during the treatment period and for 4 weeks post-last roxadustat dose.\n* Male participants with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 4 weeks post-last roxadustat dose.\n* Participant and\u002For participant's parent or legal guardian agrees for the participant not to participate in another interventional study while participating in the present study.\n\nExclusion Criteria:\n\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has any medical condition, including active, systemic or clinically significant infection which may pose a safety risk to a participant in this study, which may confound the safety or activity assessment or may interfere with study participation making the participant unsuitable for study.\n* Participant has a known or suspected hypersensitivity to roxadustat, related hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI), or any components of the formulation used.\n* Participant has uncontrolled hypertension (defined as ≥ 95th percentile + 12 mm Hg or ≥ 140\u002F90 mm Hg \\[whichever is lower\\] for participants \\\u003C 13 years of age and ≥ 140\u002F90 mm Hg for participants ≥ 13 years of age measured 3 times at the same visit) in the 2 weeks prior to screening.\n* Participant has a known hematologic disease other than anemia secondary to renal disease,(e.g., history of sickle cell disease, sickle cell anemia, hemoglobin sickle cell disease, or hemoglobin sickle cell beta thalassemia).\n* Participant has untreated hypothyroidism.\n* Participant has severe hyperparathyroidism defined as serum parathyroid hormone (PTH) levels above 1000 pg\u002FmL intact PTH within 4 weeks of screening.\n* Participant has a functioning kidney allograft.\n* Participant has a folate or B12 or carnitine deficiency. Acceptable if treated to normal values within 4 weeks of screening.\n* Participant has a known active malignancy or malignancy within 18 months before the screening visit. Radiation or chemotherapy must be completed at least 12 months before the screening visit.\n* Participant has a scheduled living donor organ transplantation date within 12 weeks of screening. If participant becomes eligible for a kidney transplant during study conduct, the participant should be discontinued.\n* Participant has a whole blood or packed red blood cells (pRBC) transfusion during the 8 weeks prior to screening.\n* Participant has any current condition leading to active significant blood loss in the past 4 weeks.\n* Participant has a diagnosis of hemolytic uremic syndrome within 12 weeks prior to screening.\n\n  * Participant who has a previous diagnosis of atypical hemolytic syndrome must be relapse-free (stable hemoglobin (Hb), normal platelet count, normal serum lactate dehydrogenase, and normal haptoglobin level) for more than 12 weeks prior to screening.\n* Participant has a history of chronic liver disease, including comorbidity with autosomal recessive polycystic kidney disease, cystinosis, and primary hyperoxaluria.\n* Participant had an episode of peritonitis within 30 days of screening.\n* Participant has active inflammation such as glomerulonephritis flare (i.e., lupus nephritis, immunoglobulin A (IgA) nephritis, rapidly progressive glomerulonephritis, membranoproliferative glomerulonephritis, antineutrophil cytoplasmic antibodies vasculitis) requiring pulse corticosteroid treatment or induction treatment with an immunosuppressive agent (i.e., cyclophosphamide, rituximab, or another monoclonal antibody) within 6 weeks of screening visit. Receipt of monoclonal antibody or biologic for maintenance treatment of underlying condition is acceptable.\n* Participant has a known history of human immunodeficiency virus infection.\n* Participant has rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or is allergic to peanut or soya.","17 Years",{"count":364,"type":21},100,[110],"Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help the bone marrow make more red blood cells. These are often given together with iron. This treatment is also available to children and teenagers with CKD. However, there are some safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option for treating anemia in children and teenagers with CKD. In this study, children and teenagers with CKD and anemia will take roxadustat for up to 52 weeks to treat their anemia.\n\nThe main aim of the study is to learn how roxadustat affects anemia in children and teenagers with CKD.\n\nThis is an open-label study which means the children and teenagers in the study and the clinic staff know they will be taking roxadustat. In this study, the children and teenagers with CKD who need treatment for anemia can take part. Those currently being treated with an ESA will be switched to roxadustat. Those who have not been treated with an ESA can start on roxadustat straight away. All children and teenagers in the study will take roxadustat 3 times a week for up to 52 weeks (1 year). They will start on a fixed dose of roxadustat for 4 weeks. Blood samples will be taken regularly to check hemoglobin levels. The roxadustat dose may be changed if the blood levels of hemoglobin are too high, too low, or change too quickly. After 4 weeks the dose may be changed, if needed, to keep blood levels of hemoglobin in the blood to just below the normal range.\n\nFirstly, teenagers will take roxadustat. 10 teenagers will take their fixed dose of roxadustat for 4 weeks. They will give blood samples to help the researchers work out the most suitable dose for the rest of the teenagers in the study. When the rest of the teenagers start taking roxadustat at the most suitable dose for teenagers, 10 children will take roxadustat for 4 weeks. These 10 children will give blood samples to help the researchers work out the most suitable dose for the rest of the children in the study. Then, the rest of the children will take roxadustat at the most suitable dose for children.\n\nThere will be many clinic visits during the study. Overnight hospital stays are not expected. There will be 1 visit every 2 weeks for the first 4 weeks of taking roxadustat, then every 4 weeks until the end of treatment. Finally there is 1 visit 4 weeks after treatment has finished.\n\nDuring most visits, the children and teenagers will have their vital signs checked (blood pressure, body temperature and heart rate). Fluid status (how much water is in the body) will also be checked for those who need dialysis. The children and teenagers will also have blood tests and the study doctors will check for any medical problems. The children and teenagers will have a medical examination before their first dose of roxadustat and again at about 24-week (6-month) and 52-week (13-month) visits. They will have an electrocardiogram (ECG) before their first dose of roxadustat and again at the 12-week, 24-week, 36-week, and 52-week visit. They will also have urine tests at the 4-week, 24-week and 52-week visits. At the 52-week visit, the children and teenagers will also have blood tests for hemoglobin and iron levels. The study doctors will also check for any medical problems.",[368,369],"Chronic Kidney Disease","Renal Anemia",[371,372,373,369,374,368,375,376,377,378,379,380,381],"Roxadustat","ASP1517","Pediatric","Chronic renal failure","Renal Insufficiency, Chronic","Anemia","Open-label","Uncontrolled","Safety","Pharmacokinetics","Pharmacodynamics","2026-07-14",{"date":346,"type":39},{"date":385,"type":39},"2024-01-16",{"date":387,"type":21},"2027-10-30",{"name":389,"class":123},"Astellas Pharma Global Development, Inc.",47,{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":398,"maxAge":362,"enrollmentInfo":399,"targetDuration":4,"studyType":58,"phases":401,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":418},"100373538","phase-2-study-of-safety--pk-of-luspatercept-ace-536-in-pediatric-participants-with-beta--thalassemia-100373538","NCT04143724","Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia","A Phase 2a Study to Evaluate the Safety and Pharmacokinetics of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia","Inclusion Criteria\n\n* Participants must be 6 years to \\\u003C 18 years of age at the time of signing the informed consent form (ICF)\u002Finformed assent form (IAF).\n* Participants (and when applicable, parent\u002Flegal representative) must understand and voluntarily sign an ICF\u002FIAF prior to conducting any study-related assessments\u002Fprocedures.\n* Participants (and when applicable, parent\u002Flegal representative) is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Participants must have documented diagnosis of β-thalassemia or Hemoglobin E\u002Fβ-thalassemia.\n* Transfusion dependence (TD):\n\n  1. TD participant i. Participant is regularly transfused, defined as: ≥ 4 RBC transfusion events in the 24 weeks prior to enrollment with no transfusion-free period ≥ 42 days during that period.\n\n     Note: For the purpose of the study, transfusions administered over 2 or 3 consecutive days are considered as part of a single transfusion event. Participant must have a history of regular transfusions for at least 2 years.\n  2. NTD participant (ex-US sites only) i. Participant must have received \\\u003C 4 RBC transfusion events in the 24 weeks prior to enrollment.\n\nii. Participant must not be on a regular transfusion program and must be RBC transfusion-free for at least 8 weeks prior to enrollment.\n\niii. Participant must have mean baseline hemoglobin ≤ 10 g\u002FdL, based on a minimum of 2 measurements ≥ 1 week apart within the 12-week screening period; at least 1 measurement should be collected within 4 weeks prior to enrollment; hemoglobin values within 21 days post-transfusion will be excluded.\n\n* Participants have Karnofsky (age ≥16 years) or Lansky (age \\\u003C 16 years) performance status score ≥ 50 at screening.\n* Female children of childbearing potential (FCCBP), individuals of childbearing potential (IOCBP), and male (as assigned at birth) participants that have reached puberty (and when applicable, parent\u002Flegal representative) must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction.\n* Female children of childbearing potential, defined as females who have achieved menarche with or without breast development in Tanner Stage 2 or greater and have not undergone a hysterectomy or bilateral oophorectomy and IOCBP defined as a sexually mature woman who has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must meet the following conditions below (Note: Secondary amenorrhea from any cause does not rule out childbearing potential. Breast development at Tanner Stage ≥2 alone does not reliably indicate reproductive potential):\n* Medically supervised serum pregnancy tests with a sensitivity of at least 25 mIU\u002FmL must be conducted in Female children of childbearing potential (FCCBP)\u002F individuals of childbearing potential (IOCBP), including those who commit to complete abstinence. Female children of childbearing potential\u002F individuals of childbearing potential (IOCBP) must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy (one of these tests should be performed by central laboratory). Female children of childbearing potential\u002F individuals of childbearing potential (IOCBP) must agree to ongoing pregnancy testing during the course of the study at the End of Treatment (EOT) visit and at the 9-week Safety Follow-up visit.\n* Female participants must, as appropriate to age and at the discretion of the site Investigator, either commit to true abstinence\\* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective\\*\\* contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 12 weeks (approximately 5 times the mean terminal t1\u002F2 of luspatercept based on multiple-dose PK data) after discontinuation of study therapy.\n* Male (as assigned at birth) participants, as appropriate to age and the discretion of the study physician:\n* Must practice true abstinence\\* (which must be reviewed on a monthly basis) or agree to use a synthetic or latex condom during sexual contact with a pregnant female or a Female children of childbearing potential (FCCBP)\u002F IOCBP while participating in the study, during dose interruptions and for at least 12 weeks (approximately 5 times the mean terminal t1\u002F2 of luspatercept based on multiple-dose PK data) following IP discontinuation, even if he has undergone a successful vasectomy.\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the participant. \\[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\\] \\*\\* Agreement to use highly effective methods of contraception that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly throughout the course of the study. Such methods include: Combined (estrogen and progesterone\u002Fprogestin containing) hormonal contraception: Oral; Intravaginal; Transdermal; Progestogen\u002Fprogestin only hormonal contraception associated with inhibition of ovulation: Oral; Injectable hormonal contraception; Implantable hormonal contraception; Placement of an intrauterine device (IUD); Placement of an intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner; Sexual Abstinence.\n\nExclusion Criteria\n\n* Participant has a diagnosis of Hemoglobin S\u002Fβ-thalassemia or alpha (α)-thalassemia (eg, Hemoglobin H); β-thalassemia combined with α-thalassemia is allowed.\n* Participant has of active hepatitis C (HCV) infection, as demonstrated by a positive HCF-ribonucleic acid (RNS) test of sufficient sensitivity, or active infectious hepatitis B (as demonstrated by the presence of hepatitis B surface antigen (HBsAG) and\u002For hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) positive, or known positive human immunodeficiency virus (HIV).\n\nNote: Participants receiving antiviral therapies should have 2 negative HCV-RNA tests 3 months apart before ICF\u002FIAF signature, ie, one test at the end of the antiviral therapy and the second test 3 months following the first test.\n\n* Participant has deep vein thrombosis (DVT), stroke, or other thromboembolic event(s) (except clogged indwelling catheter) requiring medical intervention ≤ 24 weeks prior to enrollment.\n* Participant has platelet count \\> 1000 x 109\u002FL.\n* Participant has treatment with another investigational drug or device ≤ 28 days prior to enrollment.\n* Participant has prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536).\n* Participant underwent or is scheduled for HSCT or gene therapy (candidates for HSCT or gene therapy with anticipated waiting period of ≥ 12 months are eligible).\n* Participant use of iron chelation therapy (ICT), if initiated ≤ 8 weeks prior to enrollment (allowed if initiated \\> 8 weeks before or during treatment).\n* Participant received treatment with hydroxyurea immunomodulatory drugs IMiDs (such as thalidomide), other fetal Hb (HbF) inducers or erythropoiesis-stimulating agents (ESAs) ≤ 12 weeks prior to enrollment for NTD participants and ≤ 24 weeks for TD participants.\n* Participant is pregnant or breastfeeding female or plan to get pregnant during the study.\n* Participant has uncontrolled hypertension. Controlled hypertension for this protocol is considered: blood pressure value corresponding to ≤ Grade 1 according to NCI CTCAE version 5.0 with or without pharmacological treatment.\n* Participant has major organ damage, including:\n\n  1. Symptomatic splenomegaly\n  2. Liver disease with alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\> 3X the upper limit of normal (ULN) for age\n  3. Heart disease, heart failure as classified by the New York Heart Association (NYHA) classification 3 or higher, or significant arrhythmia requiring treatment, or recent myocardial infarction within 6 months of enrollment\n  4. Lung disease, including pulmonary fibrosis or pulmonary hypertension of Grade ≥ 3 according to NCI-CTCAE version 5.0.\n  5. Renal insufficiency defined as:\n* A serum creatinine based on age\u002Fgender based on threshold derived from Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control.\n* Participant has proteinuria ≥ Grade 3 according to NCI CTCAE version 5.0 (which is equivalent to a urine protein\u002Fcreatinine ratio \\> 215 mg\u002Fmmol of creatinine), or a urine albumin\u002Fcreatinine ratio \\> 129 mg\u002Fmmol of creatinine.\n* Participant use high dose long-term therapy with systemic glucocorticoids ≤ 12 weeks prior to enrollment (physiologic replacement therapy for adrenal insufficiency is allowed). Low-dose long-term (defined as ≤ 0.2 mg\u002Fkg\u002Fday or ≤ 10 mg\u002Fday of prednisone equivalent), short treatment, single doses of systemic glucocorticoids (eg, for prevention or treatment of transfusion reactions), inhaled, intranasal and topical corticosteroids are allowed.\n* Participant has history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the IP (refer to the IB).\n* Participant use of cytotoxic agents, immunosuppressants ≤ 28 days prior to enrollment (ie, antithymocite globulin (ATG) or cyclosporine).\n* Participant has history of malignancy with the exception of:\n\n  1. Curatively resected nonmelanoma skin cancer.\n  2. Curatively treated carcinoma in situ.\n  3. Other solid tumor with no known active disease in the opinion of the Investigator.\n* Participant who has extramedullary hematopoiesis (EMH) complications or requires treatment to control the growth of EMH masse(s) during the screening period.\n* Any medical or psychiatric condition that in the opinion of the investigator would put the participant at unacceptable risk of participating in the study or may impact interpretation of the study results.\n* Use of herbs or food supplements (eg, Chinese traditional medicine), if, per investigator's judgment, likely to impact the safety and efficacy assessment, for 24 weeks before initiating the study treatment for TD participants, and 12 weeks for NTD participants.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","6 Years",{"count":400,"type":21},99,[219],"This is a Phase 2a study to evaluate the safety and pharmacokinetics (PK) of luspatercept in pediatric participants with β-thalassemia.\n\nThe study will be conducted in 2 parts for both transfusion-dependent (TD) and non-transfusion-dependent (NTD) β-thalassemia participants: TD Part A will be in adolescent participants aged 12 to \\\u003C18 years with two dose escalation cohorts, followed by a dose expansion cohorts. NTD Part A will be conducted in the same age group participants as TD Part A with dose confirmation and expansion cohorts. After Part A TD participants have completed at least one year of treatment, all available safety data from Part A adolescent participants will be evaluated before initiating TD and NTD Part B in the age group from 6 to \\\u003C12 years old. Part B will consist of two dose escalation cohorts for TD and two dose escalation cohorts for NTD.\n\nUpon completion of the Treatment Period, participants of any cohort who are benefiting from the study treatment, will be offered the opportunity to continue luspatercept treatment in the Long-term Treatment Period for up to 5 years from their first dose.\n\nParticipants who discontinue study treatment at any time will continue in the Posttreatment Follow-up Period for at least 5 years from their first dose of luspatercept, or 3 years from their last dose, whichever occurs later, or until they withdraw consent\u002Fassent, are lost to follow-up, or the End of Trial, whichever occurs first. If neither commercial treatment nor an LTFU (long-term follow-up) protocol is available at that time, continued treatment will be provided within this study or via an alternative mechanism, at the Sponsor's discretion.",[404],"Beta-Thalassemia",[406,407,380,404,408],"ACE-536","Luspatercept","Red Blood Cell Transfusion","2026-07-08",{"date":411,"type":39},"2026-07-10",{"date":413,"type":39},"2019-11-07",{"date":415,"type":21},"2035-08-31",{"name":417,"class":123},"Celgene",26,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":426,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":58,"phases":430,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":456},"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":429,"type":21},347,[431],"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",[434,435],"Chronic Myelogenous Leukemia","Leukemia, Myelogenous, Chronic, BCR-ABL Positive",[434,437,17,438,439,440,441,442,443,444,445,446],"CML","CML-AP","CML-BP","CML-CP","myeloproliferative neoplasm","chronic phase","accelerated phase","blast phase","ABL001","asciminib","2026-07-01",{"date":449,"type":39},"2026-07-06",{"date":451,"type":39},"2022-08-30",{"date":453,"type":21},"2030-08-30",{"name":455,"class":123},"Novartis Pharmaceuticals",85,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":465,"maxAge":54,"enrollmentInfo":466,"targetDuration":4,"studyType":58,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":73},"100583472","effect-of-pediatric-lung-ultrasound-on-antibiotic-prescriptions-in-hospitalized-children-and-adolescents-with-lower-respiratory-tract-infections-a-randomized-controlled-trial-100583472","NCT06876766","Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections. A Randomized Controlled Trial.","Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections.","PLUS-AP","Inclusion Criteria:\n\n* Age between 3 months and 17 years old inclusive\n* Currently admitted to the pediatric Ward or boarding in the Emergency Department within 24 hours of admission order due to lower respiratory tract infections.\n\nExclusion Criteria:\n\n* Sickle cell disease (SCD).\n* On chemotherapy or any other immunosuppressive therapy except systemic corticosteroids use of ≤ 5 days duration.\n* Cystic fibrosis and other chronic lung diseases except asthma\n* Pre-existing and\u002For congenital neurologic, metabolic, and cardiac conditions\n* Hospitalized within the previous month\n* Patients with suspected foreign body aspiration -Received antibiotic therapy within the previous week\n* Patients admitted under PI's care","3 Months",{"count":467,"type":21},176,[60],"Title: Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents with Lower Respiratory Tract Infections (PLUS-AP Trial)\n\nPurpose of the Study:\n\nThis study is being done to find out if a type of imaging called lung ultrasound (LUS) can help doctors decide when to stop antibiotics in children and teens who are in the hospital with lung infections, like pneumonia. Antibiotics are often given to these patients, but sometimes they are used for longer than necessary, which can be harmful. The investigators want to see if using LUS helps doctors make decisions that reduce unnecessary antibiotic use, which can help prevent antibiotic resistance and other complications.\n\nWhat is Lung Ultrasound (LUS)? Lung ultrasound is a safe, non-invasive, and painless test that uses sound waves to look at the lungs. It doesn't involve radiation like chest X-rays. It is already being used to help doctors understand lung conditions, and this study will test if it can also help in deciding when to stop antibiotics.\n\nHow the Study Works:\n\nParticipants: Children and adolescents (ages 3 months-18 years) who are admitted to the hospital with a lung infection.\n\nGroups:\n\nLUS Group: These patients will have a lung ultrasound within 24 hours of enrollment. The results will help guide decisions about when to stop antibiotics.\n\nStandard Care Group: These patients will receive regular hospital care, which may include chest X-rays and other tests to guide their treatment.\n\nWhat Will Be Measured?\n\nPrimary Goal: The study will measure how long children and teens stay on antibiotics. The investigators are testing whether LUS can help shorten this time without affecting their recovery.\n\nSecondary Goals: Investigators will also look at how long patients stay in the hospital, whether they need further treatment or care after leaving.\n\nWhy is This Important? If this study shows that LUS can safely reduce the use of antibiotics, it could change how doctors treat lung infections in children. Reducing unnecessary antibiotic use can help fight antibiotic resistance and protect children from side effects of unnecessary treatments.",[471],"Lower Resp Tract Infection","2026-06-30",{"date":474,"type":39},"2026-07-02",{"date":476,"type":39},"2025-04-02",{"date":478,"type":21},"2027-06",{"name":263,"class":46},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":58,"phases":489,"briefSummary":490,"conditions":491,"keywords":495,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":504},"100367421","phase-3-a-study-to-evaluate-long-term-safety-in-participants-who-have-participated-in-other-luspatercept-ace-536-clinical-trials-100367421","NCT04064060","A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be enrolled in this study:\n\n1. Participant is ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:\n\n   1. Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR\n   2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR\n   3. Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).\n4. Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.\n5. Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.\n6. Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who:\n\n1\\) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must:\n\n1. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence from heterosexual contact.\n2. Agrees to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.\n\n   7\\. Applies to on treatment participants only- Male participants must:\n\na. Agrees to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a participant from enrollment:\n\n1. Applies to on treatment participants only- Concomitant use of any medications\u002Fprocedures that are prohibited in the parent luspatercept protocol.\n2. Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.\n3. Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.\n4. Applies to on treatment participants only- Pregnant or breastfeeding females.\n5. Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study.\n6. Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study.\n7. Participant has any condition that confounds the ability to interpret data from the study.",{"count":488,"type":21},665,[110],"A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:\n\n* Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept\n* Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met\n* The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase\n* Transition Phase is defined as one Enrollment visit\n* Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol\n* Follow-up Phase includes:\n\n  \\- 42 Day Safety Follow-up Visit\n* During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting\n\n  \\- Long-term Post-treatment Follow-up (LTPTFU) Phase\n* Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies\u002Fpre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule\n\nParticipants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.\n\nThe ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.",[492,493,494],"Myelodysplastic Syndromes (MDS)","Beta-thalassemia","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis",[406,407,496,493,497],"MDS","Myeloproliferative neoplasm (MPN)-associated myelofibrosis",{"date":447,"type":39},{"date":500,"type":39},"2019-08-12",{"date":502,"type":21},"2028-05-12",{"name":417,"class":123},143,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":513,"enrollmentInfo":514,"targetDuration":4,"studyType":58,"phases":516,"briefSummary":517,"conditions":518,"keywords":525,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":538,"locationsCount":73},"100644562","effects-of-kinesio-taping-versus-mcconnell-taping-on-clinical-outcomes-in-patients-with-patellofemoral-pain-syndrome-100644562","NCT07671482","Effects of Kinesio Taping Versus McConnell Taping on Clinical Outcomes in Patients With Patellofemoral Pain Syndrome.","Effects of Kinesio Taping Versus McConnell Taping on Clinical Outcomes in Patients With Patellofemoral Pain Syndrome. A Randomized Clinical Trial.","PFPS","Inclusion Criteria:\n\n* Anterior or retropatellar pain for a minimum of 3 months during functional activities.\n* 18-50 years of age.\n* Minimum pain of 3\u002F10 on the VAS score.\n* No LL physical therapy in the past 3 months.\n\nExclusion Criteria:\n\n* Meniscal or ligamentous injury\n* Neurological or systemic conditions affecting proprioception, coordination and balance.\n* Spinal referred pain or rheumatoid arthritis.\n* Hip and ankle disorders.","50 Years",{"count":515,"type":21},80,[60],"The primary goal of this randomized clinical trial (RCT) is to evaluate whether Kinesio Taping versus McConnell Taping, when integrated into a standardized hip-knee strengthening and neuromuscular control program, produces significant effects in individuals aged 18-50 with patellofemoral pain syndrome (PFPS).\n\nThe main question it aims to answer is: Does Kinesio Taping compared with McConnell Taping when both combined with a standardized hip-knee exercise program, produce different effects on quadriceps neuromuscular activation (VMO-VL sEMG), pain, functional knee pain, and dynamic knee valgus over a 6 week period intervention?\n\nParticipants will be divided into three groups for comparison: the control group will receive a structured hip-knee physical therapy exercise program without any taping intervention, Kinesio Taping group with a standardized exercise program, and a McConnell Taping group with a standardized exercise program.",[519,520,511,521,522,523,524],"Patello Femoral Pain Syndrome","Anterior Knee Pain Syndrome","Patellofemoral Pain Syndrome","Patellofemoral Disorder","Patellofemoral Pain, PFP","Patellofemoral Pain (PFPS)",[526,527,528,529,530,521,531],"Electromyography","EMG","Kinesio Taping","McConnell Taping","Exercise Therapy","Single-Leg Squat","2026-06-25",{"date":534,"type":39},"2026-06-26",{"date":536,"type":21},"2026-06",{"date":204,"type":21},{"name":72,"class":46},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":239,"enrollmentInfo":546,"targetDuration":4,"studyType":58,"phases":548,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":314,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":563,"leadSponsor":565,"locationsCount":73},"100643946","peri-implant-soft-tissue-augmentation-using-microneedling-with-i-prf-vs-connective-tissue-graft-100643946","NCT07667855","Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft","Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Systemically healthy adults (Between 18 and 65) with one or more dental implants requiring second-stage surgery in the esthetic zone (Anteriors and Premolars).\n* Thin soft tissue phenotype: mucosal thickness or KTW \\\u003C2 mm buccally.\n* Stable osseointegrated implant, adequate restorative space, and healthy adjacent teeth.\n* Good oral hygiene (PI ≤10%), with peri-implant maintenance.\n* Signed consent + willingness for 1-year follow-up.\n\nExclusion Criteria:\n\n* Heavy smokers (≥10 cig\u002Fday); light smokers only if reduced.\n* Systemic\u002Fhealing issues: uncontrolled diabetes, immunocompromise, bleeding disorders, anticoagulants, steroids.\n* Pregnancy or breastfeeding.\n* Active infection (periodontal or peri-implant).\n* No residual keratinized mucosa on buccal side.\n* Previous graft\u002Faugmentation at the site or recent surgery (\\\u003C6 months).\n* Allergies to anesthetics\u002Fmaterials.\n* Non-compliance with instructions or follow-up.",{"count":547,"type":21},24,[60],"This randomized controlled clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Patients with thin peri-implant soft tissue requiring implant second-stage surgery in the esthetic zone will be randomly assigned to receive either CTG harvested from the palate or a series of microneedling and i-PRF treatments. Clinical outcomes including mucosal thickness, keratinized tissue width, peri-implant health parameters, volumetric soft tissue changes, esthetic outcomes, and patient-reported measures of pain and satisfaction will be evaluated during follow-up. The study aims to determine whether microneedling with i-PRF can provide comparable soft tissue augmentation while reducing patient morbidity associated with connective tissue graft harvesting.",[551],"Thin Peri-implant Mucosal Phenotype",[553,554,555,556,557,558,559],"Microneedling","Injectable Platelet-Rich Fibrin","i-PRF","Peri-implant soft tissue augmentation","Implant Esthetics","Mucosal Thickness","Connective Tissue Graft","2026-06-19",{"date":532,"type":39},{"date":534,"type":21},{"date":564,"type":21},"2027-03-26",{"name":566,"class":46},"Beirut Arab University",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":574,"targetDuration":575,"studyType":22,"phases":4,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":594},"100075056","pompe-disease-registry-protocol-100075056","NCT00231400","Pompe Disease Registry Protocol","Pompe Disease Registry","Inclusion Criteria:\n\nAll patients with a confirmed diagnosis of Pompe disease who have signed the informed consent and authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as documented GAA enzyme deficiency from blood, skin, or muscle tissue and\u002For documentation of 2 GAA gene mutations.\n\nExclusion Criteria:\n\nThere are no exclusion criteria in this Registry",{"count":20,"type":21},"5 Years","The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development\u002Freimbursement, and for other research and non-research related purposes.\n\nThe objectives of the Registry are:\n\n* To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention.\n* To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.\n* To characterize the Pompe disease population.\n* To evaluate the long-term effectiveness of alglucosidase alfa.",[578,579],"Glycogen Storage Disease Type II","Pompe Disease",[581,582,579,583,584,585],"Glycogen Storage Disease Type II (GSD-II)","GSD-II","Pompe Disease (late-onset)","Acid Maltase Deficiency Disease","Glycogenosis II",{"date":587,"type":39},"2026-06-23",{"date":589,"type":39},"2004-09-15",{"date":591,"type":21},"2034-01-31",{"name":593,"class":123},"Genzyme, a Sanofi Company",272,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":58,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":73},"100487538","phone-enabled-implementation-of-cessation-support-100487538","NCT05628389","Phone Enabled Implementation of Cessation Support","PHOENICS","Inclusion Criteria:\n\n* Age 18+\n* A current daily cigarette smoker and\u002For a regular waterpipe smoker (smokes at least 1-2 times\u002Fweek).\n* Not pregnant\n* Reachable by phone\n* Interested in quitting\n* Lives in Greater Beirut Area\n\nExclusion Criteria:\n\n* Patients who use other tobacco products including vape exclusively.\n* Any patient below 18 years old.\n* Cigarette smokers who do not smoke on daily basis.\n* Waterpipe smokers who smoke less than once\u002Fweekly",{"count":603,"type":21},1500,[60],"The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.",[607],"Smoking Cessation","2026-06-10",{"date":610,"type":39},"2026-06-12",{"date":612,"type":39},"2024-03-06",{"date":614,"type":21},"2027-08-31",{"name":616,"class":46},"University of Florida",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":215,"maxAge":427,"enrollmentInfo":624,"targetDuration":4,"studyType":58,"phases":626,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":647},"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",{"count":625,"type":21},130,[431],"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.",[113],[630,631,632,633,634,635,636,637,638],"SCD","Vaso-occlusive Crisis","crizanlizumab","SEG101","Sickle cell disease","Sickle cell disorder","VOC","P-selectin","Sickle cell anemia","2026-06-04",{"date":641,"type":39},"2026-06-08",{"date":643,"type":39},"2021-06-10",{"date":645,"type":21},"2031-06-10",{"name":455,"class":123},31,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":238,"sex":17,"minAge":54,"maxAge":333,"enrollmentInfo":655,"targetDuration":4,"studyType":58,"phases":657,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":73},"100636109","erector-spinae-block-versus-paravertebral-block-on-chronic-pain-after-mastectomy-100636109","NCT07561411","Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy","The Effect of Erector Spinae Block Versus Paravertebral Block on the Incidence of Chronic Pain After Mastectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients between 18 and 80 years old.\n* Scheduled to total mastectomy with or without axillary dissection\n* Willing to receive regional anesthesia in addition to GA\n* ASA classification 1-3\n\nExclusion Criteria:\n\n* Previous thoracic surgery with an incision of \\>2 cm\n* Patient's refusal\n* Allergy to local anesthetics\n* Pregnant women\n* Any contraindications to thoracic PVB, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy; anticoagulants intake.\n* American Society of Anesthesiologists (ASA) classification of 4 or higher,\n* History of chronic pain or untreated clinical severe depression",{"count":656,"type":21},132,[60],"The goal of this clinical trial is to learn if the erector spinae block can reduce the incidence of chronic pain compared to the paravertebral block in adult patients undergoing total mastectomy. The study includes patients aged 18 to 80 years scheduled for mastectomy, with or without axillary dissection. The main questions it aims to answer are:\n\n* Does erector spinae block reduce the incidence of chronic pain at 3 months after mastectomy compared to paravertebral block?\n* Does erector spinae block affect postoperative outcomes such as opioid consumption at 48 hours, pain scores (in PACU, 24 and 48 hours), block performance time, and the incidence of complications, anxiety or depression, and pain intensity at 3 months?\n\nResearchers will compare patients receiving erector spinae block to those receiving paravertebral block to determine if erector spinae block provides equivalent or improved outcomes in terms of chronic pain and perioperative measures.\n\nParticipants will:\n\n* Be randomly assigned to receive either erector spinae block or paravertebral block prior to surgery\n* Undergo total mastectomy (with or without axillary dissection)\n* Have their pain assessed in the PACU and at 24 and 48 hours postoperatively\n* Have opioid consumption measured during the first 48 hours after surgery\n* Be followed up at 3 months to assess chronic pain, pain intensity, and psychological outcomes (anxiety or depression)",[660,661,662,663],"Mastectomy; Lymphedema","Chronic Pain","Regional Anesthesia Morbidity","Opioid Use","2026-06-01",{"date":666,"type":39},"2026-06-02",{"date":668,"type":39},"2026-05-19",{"date":670,"type":21},"2028-05-01",{"name":263,"class":46},{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":4,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":679,"enrollmentInfo":680,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":73},"100563769","assessing-the-enhanced-precision-the-value-of-impedance-in-ultrasound-guided-nerve-blocks-axillary-interscalene-popliteal-sciatic-an-exploratory-prospective-observational-study-100563769","NCT06620471","Assessing the Enhanced Precision: The Value of Impedance in Ultrasound-Guided Nerve Blocks (Axillary, Interscalene, Popliteal Sciatic), an Exploratory Prospective Observational Study","Assessing the Enhanced Precision: The Value of Impedance in Ultrasound-Guided Nerve Blocks, an Exploratory Prospective Observational Study","Inclusion Criteria:\n\n* Individuals aged 18 years to 90 years old\n* No infection at the injection site\n* Patient signed the study consent form\n* No contraindications for nerve block\n* No allergies to any of the drugs used\n* Patient able to communicate effectively\n\nExclusion Criteria:\n\n* Patients not meeting the inclusion criteria\n* Patients with bleeding disorders or undergoing anticoagulation therapy\n* Pregnant patients\n* Patients with mental incapacity\n* Any medical conditions posing severe risks during the procedure","90 Years",{"count":364,"type":21},"Impedance can have an impact on nerve block during loco-regional anesthesia, particularly when using techniques such as nerve stimulation or ultrasound guidance to locate and block specific nerves. Impedance refers to the resistance to electrical current flow within tissue, and it can affect the ability to stimulate nerves or visualize them using ultrasound. The aim of this research is to assess the impedance across different tissue type during an axillary peripheral nerve block (skin, fat, fascia, muscle, nerve proximity). The results of this study would help clinicians performing nerve block to enhance the precision of needle placement, thus increase the success rate of nerve block and reduce adverse events such as intraneural or intravascular injections.",[683,684,685,686,687],"Impedance","Axillary Nerve Block","Ultrasound-Guided Nerve Blocks","Interscalene Nerve Block","Popliteal Sciatic Nerve Block","2026-05-18",{"date":690,"type":39},"2026-05-20",{"date":692,"type":39},"2024-06-10",{"date":694,"type":21},"2026-12",{"name":696,"class":46},"Lebanese American University",{"id":698,"slug":699,"hasResults":12,"nctId":700,"briefTitle":701,"officialTitle":702,"acronym":703,"eligibilityCriteria":704,"healthyVolunteers":12,"sex":17,"minAge":106,"maxAge":427,"enrollmentInfo":705,"targetDuration":4,"studyType":58,"phases":707,"briefSummary":708,"conditions":709,"keywords":711,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":719,"lastUpdatePostDateStruct":720,"startDateStruct":721,"completionDateStruct":723,"leadSponsor":725,"locationsCount":726},"100491688","phase-3-long-term-safety-and-tolerability-of-inclisiran-in-participants-with-hefh-or-hofh-who-have-completed-the-pediatric-orion-16-orion-13-orion-20-or-orion-19-studies-100491688","NCT05682378","Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies","An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20 or ORION-19 Studies (VICTORION-PEDS-OLE)","V-PEDS-OLE","Key inclusion:\n\n* Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16, ORION-13, ORION-20 or ORION-19 studies\n* Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16, ORION-13, ORION-20 or ORION-19 studies\n\nKey exclusion:\n\n* Participants who in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies either screen failed or permanently discontinued from the treatment\u002Fstudy for any reason or had serious safety or tolerability issues related to inclisiran treatment\n* Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and\u002For put the participant at significant risk",{"count":706,"type":21},195,[110],"The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.",[710],"Heterozygous or Homozygous Familial Hypercholesterolemia",[712,713,714,715,716,717,718],"KJX839","heterozygous familial hypercholesterolemia","homozygous familial hypercholesterolemia","familial hypercholesterolemia","FH","inclisiran","pediatric","2026-05-13",{"date":68,"type":39},{"date":722,"type":39},"2023-02-10",{"date":724,"type":21},"2032-03-28",{"name":455,"class":123},52,""]