[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Nigeria\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":696},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,47,75,107,129,151,177,200,225,249,276,304,324,347,400,432,465,492,516,548,570,603,625,645,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100653200","a-combination-triple-pill-implementation-strategy-for-blood-pressure-control-100653200",false,"NCT07784647","A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol","A Low-Cost, Scalable Treatment Strategy for Improving Hypertension Control in Low and Middle-Income Settings: Formative Phase (Aim 1)","ACTION","SARA Facility Survey Inclusion Criteria:\n\n\\- primary care facility must be located in the Federal Capital Territory in Nigeria, and in the Gampaha District in Sri Lanka\n\nPatient Cross-Sectional Survey Inclusion Criteria:\n\n* adult (age ≥18 years)\n* hypertensive (defined as prior documented diagnosis of hypertension, or current use of BP-lowering drugs for hypertension, or SBP ≥140 mmHg, and\u002For DBP ≥90 mmHg measured on two separate occasions)\n\nPatient Cross-Sectional Survey Exclusion Criteria:\n\n* receiving BP-lowering drugs for conditions other than hypertension (e.g., benign prostate hyperplasia, migraine, etc)\n* normotensive",true,"ALL","18 Years",{"count":22,"type":23},1357,"ESTIMATED","OBSERVATIONAL","This study includes a survey of primary healthcare facilities in Nigeria and Sri Lanka. It will aim to assess the availability and readiness of hypertension care in primary healthcare facilities, and feasibility to conduct a future randomised controlled trial.\n\nThis study also includes a survey of patients with high blood pressure who will be recruited from primary care in Sri Lanka and Nigeria. Its aim is to understand the characteristics of patients with hypertension, hypertension management and control, including use of pharmacological interventions and lifestyle management. Patients will have their blood pressure, height and weight measured. They will also be asked about their age, sex\u002Fgender, socio-economic status, medical history, and health behaviours and lifestyle.\n\nAdditionally, this study includes focus group discussions and in-depth interviews with adults with high blood pressure and their carers; healthcare providers (community health workers, nurses, and doctors or physicians); clinic administrators; and policymakers. The discussions and interviews will aim to explore experiences, practices, and views on hypertension care and the new treatment strategies. Topics will cover experiences of current high blood pressure care; service availability, accessibility, and affordability; healthcare staff training and how well they follow medical guidelines for helping patients with high blood pressure; what works well and what are the problems with helping patients with high blood pressure; experiences of patients who need help with their high blood pressure; and how well new ways of helping people with high blood pressure are received.",[27,28],"Hypertension","Health Services Accessibility",[30,31,32,33],"service availability and readiness assessment","hypertension","health services accessibility","blood pressure","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-25","ACTUAL",{"date":40,"type":38},"2026-04-01",{"date":42,"type":23},"2026-08-31",{"name":44,"class":45},"Imperial College London","OTHER",2,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":19,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100472377","phase-2-a-phase-23-study-in-adult-and-adolescent-participants-with-scd-100472377","NCT05431088","A Phase 2\u002F3 Study of Osivelotor in Adult and Adolescent Participants With SCD","A PHASE 2\u002F3 RANDOMIZED, MULTICENTER STUDY OF OSIVELOTOR ADMINISTERED ORALLY TO ADULT AND ADOLESCENT PARTICIPANTS WITH SICKLE CELL DISEASE","Inclusion Criteria:\n\nPart A and Part B:\n\n* Male or female with SCD, HbSS and HbSB-zero\n* Participants with Hemoglobin ≥ 5.5 and ≤ 10.5 g\u002FdL during Screening and considered stable by the Investigator.\n* For participants taking hydroxyurea and\u002For L-glutamine, the dose must be stable for at least 90 days prior to signing the ICF or assent and with no anticipated need for dose adjustments during the study in the opinion of the Investigator.\n\nPart B:\n\n* Participants with SCD ages 12 years and older, inclusive at screening.\n* Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening.\n\nOLE:\n\n\\- Participants who have completed the Part B successfully will be eligible.\n\nExclusion Criteria:\n\nPart A and Part B:\n\n* Participants who had more than 10 VOC within 12 months of screening\n* Female participant who is breastfeeding or pregnant\n* Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1\n* Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF or anytime during the screening period.\n* Participants in Sub-Saharan Africa or who have relocated from Sub-Saharan Africa within 6 months.\n\nOLE:\n\n* Have any unresolved clinically significant adverse event, laboratory abnormality, or safety finding from Part B that, in the opinion of the Investigator, increases the risk of study drug administration.\n* Met permanent treatment discontinuation criteria during Part B.\n* Have withdrawn consent or are unable to comply with study procedure","12 Years",{"count":56,"type":23},389,"INTERVENTIONAL",[59,60],"PHASE2","PHASE3","The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.",[63],"Sickle Cell Disease","2026-08-14",{"date":66,"type":38},"2026-08-18",{"date":68,"type":38},"2022-09-22",{"date":70,"type":23},"2032-12-31",{"name":72,"class":73},"Pfizer","INDUSTRY",80,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":20,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":57,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100556002","phase-3-tranexamic-acid-for-anaemia-trial-100556002","NCT06519422","Tranexamic Acid for Anaemia Trial","The Effects of Tranexamic Acid on Anaemia, Menstrual Health and the Wellbeing of Women: an International Randomised, Placebo-controlled Trial Among Menstruating Women With Anaemia","WOMAN-3","Inclusion Criteria:\n\n* Adult women aged 18 years and older.\n* Currently menstruating, with menstrual periods occurring at least every 38 days and lasting ≥2 days.\n* Anaemia at screening, defined as hemoglobin (Hb) \\\u003C120 g\u002FL by point-of-care finger prick test.\n* Willing and able to provide informed consent.\n* Able to attend in-person follow-up visits during the trial period.\n\nIndividuals with known thalassaemia and sickle cell disease are eligible to participate and take the trial treatment but will not be given standard of care iron supplementation unless it is prescribed by their own treating clinician. They will continue to receive their usual standard care.\n\nExclusion Criteria:\n\n* Planning to get pregnant during the trial period\n* Already taking TXA\n* Known to have possible contraindications to TXA treatment (including allergy to TXA or its excipients, renal impairment, active thromboembolic disease, history of venous or arterial thrombosis, history of convulsion.)","FEMALE",{"count":85,"type":23},4000,[60],"Anaemia is when the body does not have enough healthy red blood cells to carry oxygen. It is common in women because they lose blood every month during their periods. Anaemia can womwn make feel tired, weak, dizzy and out of breath. It can also make it harder to study, work or look after their family. If woman become pregnant with anaemia, it can cause problems for both mother and baby, such as early birth or heavy bleeding when giving birth. It is best to treat anaemia in young women well before they get pregnant. Doctors treat anaemia with iron and vitamins. But some people get side effects when taking iron tablets and so they stop taking them. Tranexamic acid (TXA) is a medicine used to treat heavy periods. The investigators of this study would like to find out if taking TXA with the usual iron and vitamin supplements is better at treating anaemia than taking iron and vitamin supplements alone. (Lay Summary)",[89],"Anaemia",[91,92,89,93,94,95,96],"Tranexamic acid","Antifibrinolytic","Menstrual health","Menstruation","Bleeding","Iron Deficiency","2026-08-13",{"date":99,"type":38},"2026-08-17",{"date":101,"type":38},"2026-08-10",{"date":103,"type":23},"2028-09",{"name":105,"class":45},"London School of Hygiene and Tropical Medicine",3,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":19,"minAge":54,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":57,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"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.",{"count":116,"type":23},408,[60],"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.",[63],"2026-08-12",{"date":97,"type":38},{"date":123,"type":38},"2025-02-17",{"date":125,"type":23},"2029-08-12",{"name":127,"class":73},"Novo Nordisk A\u002FS",175,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":19,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":57,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"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":139,"type":23},480,[60],"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.",[63,143],"Thalassemia",{"date":97,"type":38},{"date":146,"type":38},"2025-01-10",{"date":148,"type":23},"2030-12-30",{"name":127,"class":73},106,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":158,"minAge":20,"maxAge":4,"enrollmentInfo":159,"targetDuration":161,"studyType":24,"phases":4,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"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":160,"type":23},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.",[164,165],"Benign Prostatic Hyperplasia","Lower Urinary Tract Symptoms",[167],"BPH, Registry, LUTS","2026-08-11",{"date":97,"type":38},{"date":171,"type":38},"2023-03-13",{"date":173,"type":23},"2028-12",{"name":175,"class":45},"Société Internationale d'Urologie",30,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":19,"minAge":185,"maxAge":20,"enrollmentInfo":186,"targetDuration":4,"studyType":57,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"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":187,"type":23},95,[59],"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.",[63],"2026-08-07",{"date":120,"type":38},{"date":194,"type":38},"2023-01-12",{"date":196,"type":23},"2029-08-08",{"name":198,"class":73},"Forma Therapeutics, Inc.",18,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":158,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":57,"phases":211,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100530732","combination-intervention-to-enhance-treatment-engagement-and-viral-suppression-among-sexual-and-gender-minority-youth-in-nigeria-100530732","NCT06190613","Combination Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria","Adapting and Testing a Combination Peer Navigation and mHealth Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria","Inclusion Criteria:\n\n* HIV seropositive\n* registered as a patient at one of the collaborating key population (KP)-focused community centers\n* male sex at birth\n* identify as YMSM or YTW (or report a history of sex with men)\n* understand and read basic English, Yoruba, or Pidgin English\n* intention to remain a patient at a collaborating clinic during the 24-week follow-up period\n* has a cellphone\n\nExclusion Criteria:\n\n* Unable to obtain parental permission if 15 years of age and not emancipated","15 Years","29 Years",{"count":210,"type":23},110,[212],"NA","The study will adapt and test a combination peer navigation and mHealth approach, Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria), to improve HIV treatment engagement, medication adherence and viral suppression among YMSM and YTW, ages 15-29.",[215],"HIV","2026-08-06",{"date":191,"type":38},{"date":219,"type":38},"2024-11-28",{"date":221,"type":23},"2026-12-31",{"name":223,"class":45},"Northwestern University",1,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":83,"minAge":20,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":57,"phases":234,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100547757","phase-4-study-evaluating-safety-tolerability-and-metabolism-of-niraparib-100547757","NCT06412120","Study Evaluating Safety, Tolerability, and Metabolism of Niraparib","Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance Following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry","Inclusion Criteria:\n\n1. Participant must be female ≥18 years of age, able to understand study procedures, and agree to participate in the study by providing written informed consent.\n2. Self-identify as Black. Please note that individuals who identify as Latino are eligible to participate so long as they also self-identify as Black.\n3. Participant has completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.\n4. Participant must have high-grade serous or high-grade endometrioid histology.\n5. Participant must provide saliva and\u002For blood specimens for assessment of germline mutation(s) in the Fanconi Anemia pathway.\n6. Participant must provide formalin-fixed, paraffin-embedded (FFPE) or fresh tumor specimen from initial cytoreductive surgery (primary debulking) or initial pre-treatment core biopsy (if neoadjuvant chemotherapy (NACT) received; tumor obtained from interval cytoreduction acceptable if pre-treatment biopsy not obtained).\n7. Participant must have had a complete or partial clinical response to adjuvant treatment as confirmed by CT scan within 8 weeks after completion of the last dose of platinum-based chemotherapy.\n8. Participant must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments.\n9. Participant must not have any known contraindication or hypersensitivity to niraparib or any of its excipients.\n10. Participants must be considered candidates for maintenance niraparib therapy by their treating physician.\n11. Participants should have adequate organ function as defined below:\n\n    * Platelets ≥ 100 platelets × 10\\^9\u002FL\n    * Hemoglobin ≥ 9 g\u002FdL or 5.6 mmol\u002FL\n    * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN), \\\u003C5× in patients with known liver metastases\n    * Serum total bilirubin ≤ 1.5 × ULN\n    * 1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg daily.\n    * Creatinine \\\u003C1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin by Cockcroft-Gault\n\n      * Depending on scenario, glomerular filtration rate (GFR) 30-49 mL\u002Fmin can be permissible.\n12. Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria:\n\n    * Cluster of differentiation 4 (CD4) ≥350\u002FμL and viral load \\\u003C400 copies\u002FmL\n    * No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months before enrollment\n    * No history of HIV-associated malignancy for the past 5 years. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started \\>4 weeks before study enrollment.\n13. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:\n\n    * Is not a woman of childbearing potential (WOCBP), or\n    * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year) from the Screening Visit through at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment, and\n    * A WOCBP must have a negative test result from a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 72 hours before treatment. Additional periodic testing should be carried out according to the protocol.\n\n    Note: The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n14. Participant must agree to complete HRQoL and patient reported outcomes (PRO) measures throughout the study period.\n\nExclusion Criteria:\n\n1. Any of the following histologies: low-grade serous carcinoma, grade 1 or 2 endometrioid adenocarcinoma, clear cell, mucinous, transitional cell, carcinosarcoma, undifferentiated, dedifferentiated\n2. Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)\n3. Primary progressive, platinum-refractory disease\n4. Participant is at an increased risk of bleeding due to concurrent conditions (eg, major injuries or major surgery within the past 28 days before start of study treatment).\n5. Current diagnosis of platelet disorder (eg, thrombotic thrombocytopenic purpura (TTP), immune thrombocytopenia (ITP))\n6. Inability to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication\n7. Participants that have systolic blood pressure (SBP\\])\\>140 mmHg or diastolic blood pressure (DBP)\\>90 mmHg that has not been adequately treated or controlled.\n8. Active second primary malignancy\n9. Participant is pregnant, currently breastfeeding an infant, or expecting to conceive children while receiving study treatment and\u002For for up to 180 days after the last dose of study treatment.\n10. Participant has received a live vaccine within 30 days of planned start of study therapy. Coronavirus disease 2019 (COVID-19) vaccines that do not contain live viruses are allowed.\n11. Participant has received a transfusion (platelets or red blood cells) or colony-stimulating factors (eg, granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks before the first dose of study treatment.\n12. Participant has had radiotherapy encompassing \\>20% of the bone marrow within 2 weeks or any radiation therapy within 1 week before Day 1 of protocol therapy.\n13. Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastasis, or radiographic signs of central nervous system hemorrhage.\n14. Participant has current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study.\n15. Participants with active hepatitis B or C infection.\n16. Patient with prior history of posterior reversible encephalopathy syndrome (PRES).\n17. Patients with impaired decision-making capacity.\n18. Participants have high medical risk due to a serious, uncontrolled medical disorder; non malignant systemic disease; or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent.\n19. Patient is currently receiving one or more cytotoxic, hormonal, or other medications to treat their cancer.",{"count":233,"type":23},70,[235],"PHASE4","The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.",[238],"Ovarian Cancer","2026-08-03",{"date":241,"type":38},"2026-08-05",{"date":243,"type":38},"2026-07-28",{"date":245,"type":23},"2031-07-28",{"name":247,"class":45},"University of Miami",4,{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":19,"minAge":257,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":57,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"100463298","phase-2-phase-23-adaptive-study-of-vx-147-in-adult-and-pediatric-participants-with-apol1-mediated-proteinuric-kidney-disease-100463298","NCT05312879","Phase 2\u002F3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease","A Phase 2\u002F3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease","AMPLITUDE","Key Inclusion Criteria:\n\nPart A:\n\n* APOL1 genotype of G1\u002FG1, G2\u002FG2, or G1\u002FG2\n* Proteinuric kidney disease\n\nPart B:\n\n\\- Completion of Treatment Period in Part A and no permanent discontinuation of study drug.\n\nKey Exclusion Criteria:\n\nPart A:\n\n* Solid organ or bone marrow transplant\n* Uncontrolled hypertension\n* History of diabetes mellitus\n* Known underlying cause of kidney disease including but not limited to sickle cell disease\n\nPart B:\n\n* ESKD (End Stage Kidney Disease) as defined in the protocol.\n* Any lab abnormality that may pose a safety risk to the participant, as judged by the investigator.\n\nOther protocol defined Inclusion\u002FExclusion criteria will apply.","10 Years","65 Years",{"count":260,"type":23},466,[59,60],"The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.",[264],"Proteinuric Kidney Disease",[266],"APOL1-mediated kidney disease (AMKD)",{"date":268,"type":38},"2026-08-04",{"date":270,"type":38},"2022-03-30",{"date":272,"type":23},"2030-05-07",{"name":274,"class":73},"Vertex Pharmaceuticals Incorporated",318,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":19,"minAge":282,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":57,"phases":285,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":224},"100537746","phase-1-dolutegravir-pharmacokinetics-during-weekly-rifapentineisoniazid-for-tb-prevention-100537746","NCT06281834","Dolutegravir Pharmacokinetics During Weekly Rifapentine\u002FIsoniazid for TB Prevention","Inclusion Criteria:\n\n* (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \\\u003C12 years of age;\n* (2) no evidence of active TB based on an appropriate clinical evaluation;\n* (3) negative TB diagnostic test if performed (other than tuberculin skin testing);\n* (4) weight of at least 4 kilograms; and\n* (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age).\n\nExclusion Criteria:\n\n* (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine;\n* (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or\n* (3) receipt of a medication that has drug-drug interactions with DTG or RPT.","4 Weeks","11 Years",{"count":7,"type":23},[286],"PHASE1","Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention\u002Flatent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.",[289,290],"Pediatric HIV Infection","Latent Tuberculosis",[292,293,294],"Pediatric HIV","rifapentine","TB prevention","2026-07-29",{"date":297,"type":38},"2026-07-30",{"date":299,"type":38},"2024-11-15",{"date":301,"type":23},"2027-06-01",{"name":303,"class":45},"Brigham and Women's Hospital",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":18,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":57,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":224},"100502062","implementation-of-anal-cancer-screening-and-treatment-in-nigeria-100502062","NCT05817370","Implementation of Anal Cancer Screening and Treatment in Nigeria","Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)","IMPACT","Inclusion Criteria:\n\n1. Possess a medical degree in medical sciences (MBBS or equivalent)\n2. At least 2-5 years of experience working with clinical HIV\u002FAIDS community\n3. Must be registered with the medical and dental council of Nigeria\n4. Possess a current medical practicing license\n5. Willing to work with the Sexual Gender Minority Community\n\nExclusion Criteria:",{"count":224,"type":23},[212],"The study is a feasibility pilot trial testing 2 types of training protocols on a single physician. The first training protocol is the current standard and was developed in high-income settings. The second training protocol will be developed so tailored to the Nigerian setting. Investigators will test if the physician performs differently in their ability to conduct anal cancer screening and treatment between the 2 training protocols.",[316],"Education, Medical",{"date":297,"type":38},{"date":319,"type":38},"2023-05-02",{"date":321,"type":23},"2027-08-31",{"name":323,"class":45},"University of Maryland, Baltimore",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":19,"minAge":282,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":57,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":224},"100444611","phase-1-dolutegravir-pharmacokinetics-among-hivtb-coinfected-children-receiving-standard-and-high-dose-rifampicin-100444611","NCT05069688","Dolutegravir Pharmacokinetics Among HIV\u002FTB Coinfected Children Receiving Standard and High-dose Rifampicin","Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV\u002FTB Cotreatment and TB Prevention","Inclusion Criteria:\n\n* ART-naïve or ART-experienced HIV-infected children between 4 weeks and \\\u003C6 years of age\n* Active TB diagnosis\n* Weight of at least 3 kilograms\n* Consent of the parent or legal guardian\n\nExclusion Criteria:\n\n* Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine\n* Suspected TB meningitis or presenting with acute respiratory distress or decompensation\n* Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin","5 Years",{"count":333,"type":23},20,[286],"Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV\u002FTB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV\u002FTB coinfected children receiving standard-dose and high-dose rifampicin.",[289,337],"Tuberculosis Infection",[339,340,341],"pharmacokinetic","dolutegravir","rifampicin",{"date":297,"type":38},{"date":344,"type":38},"2023-07-07",{"date":221,"type":23},{"name":303,"class":45},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":18,"sex":158,"minAge":20,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":57,"phases":356,"briefSummary":357,"conditions":358,"keywords":374,"overallStatus":391,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":224},"100649333","prostate-cancer-risk-calculator-for-actionable-clinical-decision-making-in-nigeria-100649333","NCT07733440","PROstate Cancer Risk Calculator for ACTionable Clinical Decision-making in Nigeria","Clinical Risk Calculator Validation and Implementation to Optimize Prostate Cancer Early Detection in Nigeria","PROACT","Inclusion Criteria:\n\n1. Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals.\n2. Supported Risk Assessment\n\n(i) Eligible key informants will be eligible primary care providers who were trained and implemented the supported risk assessment and the targeted population of patient participants who received the supported risk assessment.\n\n(ii) Eligible patient participants (for the collection of observation data) will be the target population of adult males 40 - 79 years accessing provider services.\n\nExclusion Criteria:\n\n\\-",{"count":5,"type":23},[212],"This study is a pilot trial that builds on findings from the validation of prostate cancer risk calculators in Nigerian men. The goal of the overall study is to improve the early detection of prostate cancer in a high-risk population.\n\nThe main questions the validation study aims to answer are:\n\n1. How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer?\n2. Will a new risk calculator designed for Nigerian men more accurately identify those with clinically significant prostate cancer?\n\nThe main questions the intervention study aims to answer is:\n\nWill the primary care provider-facing risk calculator be feasible and acceptable for primary care providers to implement?\n\nThe intervention trial will be piloted among participants in community-level hospitals in order to primarily assess implementation outcomes",[359,360,361,362,363,364,365,366,367,368,369,370,371,372,373],"Prostate Cancer","Risk Assessment","Clinical Decision Support Systems","Predictive Value of Tests","Models","Algorithms","Evidence-Based Practice","Implementation Research","Community Health Services","Primary Health Care","Biomarker","Prostate Specific Antigen","Global Health","Africa","Nigeria",[375,376,377,378,379,380,381,382,383,384,385,386,372,387,388,389,390,373],"Prostate cancer","early detection","prostate cancer screening","early diagnosis","prostate specific antigen","risk calculator","risk prediction model","diagnostic accuracy","validation","prostate biopsy","primary care","implementation science","precision prevention","clinically significant prostate cancer","clinical prediction model","community oncology","NOT_YET_RECRUITING","2026-07-24",{"date":295,"type":38},{"date":395,"type":23},"2029-03",{"date":397,"type":23},"2029-08",{"name":399,"class":45},"Ahmadu Bello University",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":18,"sex":19,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":431},"100399177","ppmi-clinical---establishing-a-deeply-phenotyped-pd-cohort-100399177","NCT04477785","PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort","The Parkinson's Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort","PPMI","7.1 Healthy Controls (HC) Note: Active Healthy controls previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.1.1 Inclusion Criteria (HC)\n\n1. Male or female age 57 years or older at Screening visit.\n2. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n3. Confirmation that participant is eligible based on Screening SPECT imaging.\n4. Able to provide informed consent.\n5. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.1.2 Exclusion Criteria (HC)\n\n1. First degree relative with PD (i.e., biologic parent, sibling, child).\n2. Current or active clinically significant neurological disorder (in the opinion of the Investigator).\n3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n4. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n5. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.\n6. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n7. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.2 Parkinson's Disease (PD) Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.2.1 Inclusion Criteria (PD)\n\n1. Male or female age 30 years or older at Screening Visit.\n2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.\n3. Not expected to require PD medication within at least 6 months from Baseline.\n4. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.\n5. Hoehn and Yahr stage I or II at Baseline.\n6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n7. Confirmation that participant is eligible based on Screening SPECT imaging.\n8. Able to provide informed consent.\n9. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.2.2 Exclusion Criteria (PD)\n\n1. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).\n2. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit.\n3. Has taken levodopa or dopamine agonists prior to Baseline visit for more than a total of 90 days.\n4. Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).\n5. A clinical diagnosis of dementia as determined by the investigator.\n6. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n7. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n8. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.\n9. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n10. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n11. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.3 Parkinson's Disease (PD) with LRRK2 or GBA variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.3.1 Inclusion Criteria (PD ¬- LRRK2 or GBA)\n\n1. Male or female age 30 years or older at Screening Visit.\n2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.\n3. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.\n4. Hoehn and Yahr stage I or II at Baseline.\n5. Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).\n6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n7. Confirmation that participant is eligible based on Screening SPECT imaging.\n8. Able to provide informed consent.\n9. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.3.2 Exclusion Criteria (PD - LRRK2 or GBA)\n\n1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.\n3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.4 Parkinson's Disease (PD) with SNCA or rare genetic variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.4.1 Inclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))\n\n1. Male or female age 30 years or older at Screening Visit.\n2. Parkinson's disease diagnosis at Screening Visit.\n3. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.\n4. Hoehn and Yahr stage I, II, or III at Baseline.\n5. Confirmation of causative SNCA or rare genetic variant (such as Parkin or Pink1) (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).\n6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n7. Confirmation that participant is eligible based on Screening SPECT imaging.\n8. Able to provide informed consent.\n9. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.4.2 Exclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))\n\n1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.\n3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.5 Prodromal Note: Active Prodromal participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\nThe specific predictive eligibility criteria for participants recruited through PPMI Remote to advance to PPMI Clinical will be iteratively optimized based on data collected from these studies.\n\n7.5.1 Inclusion criteria (Prodromal)\n\nFor Screening:\n\n1. Confirmation that participant is eligible based on centrally determined predictive criteria including the University of Pennsylvania Smell Identification Test (UPSIT).\n\n   * For participants in PPMI Remote, referral to the clinical site confirms predictive eligibility.\n   * For participants identified by the clinical site, predictive criteria are based on generalized risk such as first degree biologic relative, known risk of PD including RBD, or known genetic variants associated with PD risk.\n\n   Additionally, confirmation of UPSIT eligibility during the Screening visit prior to SPECT Imaging.\n2. Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic variants (such as Parkin or Pink1) participants).\n3. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n4. Able to provide informed consent.\n5. Either is male, or is female and meets additional criteria below, as applicable:\n\n   • Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n   For continuation to Baseline visit and ongoing follow-up:\n6. Confirmation that participant is eligible based on \\*Screening SPECT imaging.\n\n   * Screening SPECT Imaging eligibility:\n\nBased on the results of the SPECT imaging test, Prodromal participants eligible to continue their participation in PPMI Clinical will be asked to return for their PPMI Clinical baseline visit. Neither the participant nor the site investigator will be made aware of the participant's DAT status during the study.\n\n* It is anticipated that approximately 6,000 participants will complete a screening visit to undergo DAT imaging. Approximately 2,000 participants will be eligible to continue their participation in PPMI Clinical (those not eligible to proceed will remain in PPMI Remote, as applicable).\n* All participants with DAT deficit will be eligible to continue their participation in PPMI Clinical. It is estimated that about 75% of eligible participants will have a DAT deficit (defined by a hybrid of visual assessment and quantitative striatal specific binding analysis).\n* Some participants without DAT deficit will also be eligible to continue their participation in PPMI Clinical. These participants will be chosen based on DAT binding that is reduced from age expected but it not outside the normal range and\u002For from individuals with high-risk of PD including RBD, LRRK2, GBA, SNCA, or rare genetic variants (such as Parkin or Pink1) that do not demonstrate DAT deficit. It is estimated that about 25% of eligible participants will not have a DAT deficit.\n* It is anticipated that approximately 30% of the PPMI Clinical prodromal participants with DAT deficit will phenoconvert to motor parkinsonism during a 3 to 5-year follow-up.\n\n7.5.2 Exclusion Criteria (Prodromal)\n\n1. Clinical diagnosis of PD at screening, other parkinsonism, or dementia.\n2. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Baseline Visit.\n3. Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.\n4. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n5. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n6. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).\n7. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit. except for low-dose treatment of restless leg syndrome (with permission of medical monitor).\n8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.","30 Years",{"count":410,"type":23},4500,"The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls.\n\nThe overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.",[413],"Parkinson Disease",[415,416,417,418,419,420,421,422],"Parkinson","Bio-markers","Neurodegenerative disorder","Imaging","Prodromal","Genetics","At Risk","Loss of Smell",{"date":424,"type":38},"2026-07-27",{"date":426,"type":38},"2020-07-01",{"date":428,"type":23},"2033-12",{"name":430,"class":45},"Michael J. Fox Foundation for Parkinson's Research",50,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":440,"targetDuration":161,"studyType":24,"phases":4,"briefSummary":442,"conditions":443,"keywords":447,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":464},"100327946","icareme-global-registry-multinational-real-world-evidence-in-cardiorenal-and-metabolic-diseases-100327946","NCT03549754","iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases","Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and\u002For Chronic Kidney Diseases","iCaReMe","Inclusion Criteria:\n\n1. Being 18 years or older\n2. Having type 2 diabetes, Hypertension, Heart Failure and\u002For chronic kidney disease\n3. Providing written informed consent to participate in the registry\n\nExclusion Criteria:\n\n1. Having a life-threatening co-morbidity with life expectancy below 1 year\n2. Participating in an interventional trial requiring informed consent",{"count":441,"type":23},35000,"To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and\u002For Chronic kidney diseases",[444,27,445,446],"Type 2 Diabetes","Chronic Kidney Disease","Heart Failure",[448,444,449,445,450,27,451,452,446,453,454],"Registry","T2DM","CKD","HTN","Adult population","HF","Early cardiorenal complications","2026-07-20",{"date":457,"type":38},"2026-07-22",{"date":459,"type":38},"2018-02-17",{"date":461,"type":23},"2030-12-31",{"name":463,"class":73},"AstraZeneca",76,{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":18,"sex":19,"minAge":472,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":57,"phases":475,"briefSummary":476,"conditions":477,"keywords":480,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":490,"locationsCount":224},"100631238","digital-interventions-to-increase-hpv-vaccination-intentions-among-nigerian-caregivers-100631238","NCT07498075","Digital Interventions to Increase HPV Vaccination Intentions Among Nigerian Caregivers","A Randomized Trial of Digital Interventions to Increase HPV Vaccination Intentions Among Nigerian Caregivers","Inclusion Criteria:\n\n* Parent or primary caregiver of at least one girl aged 9-14 years\n* Parent states \"no\" or \"unsure\" to question asking if eligible daughter has received any doses of the HPV vaccine\n* Provides informed consent to participate\n\nExclusion Criteria:\n\n* Parent or caregiver of a girl who has already received one or more doses of the HPV vaccine\n* Does not meet age eligibility criteria for an eligible daughter\n* Fails Attention Checks","27 Years",{"count":474,"type":23},3340,[212],"This study evaluates whether different types of digital health communication can increase parents' intention to vaccinate their daughters against human papillomavirus (HPV) in Nigeria. HPV vaccination is recommended for girls aged 9-14 years and helps prevent cervical cancer, yet vaccination rates remain low.\n\nParents of eligible, unvaccinated girls will be randomly assigned to receive one of several types of digital content delivered online. These include: (1) a short chatbot conversation based on motivational interviewing principles, (2) an interactive game designed to help parents recognize and resist common forms of vaccine misinformation, (3) a set of short edutainment videos about HPV vaccination, (4) standard informational infographics about HPV vaccination from a national public health agency, or (5) unrelated health content about menstruation.\n\nThe main outcome is parents' self-reported intention to vaccinate their daughter against HPV, measured immediately and one week after exposure to the assigned content. Additional outcomes include HPV-related knowledge, perceptions of vaccine safety, willingness to recommend the vaccine to others, and self-reported vaccine uptake at 1-week and 6 month follow-up. The results will help inform scalable communication strategies to improve HPV vaccination uptake in low- and middle-income settings.",[478,479],"HPV","HPV Vaccine",[478,479,481,482,483],"Chatbots","Misinformation","Pre-Bunking","2026-07-15",{"date":486,"type":38},"2026-07-16",{"date":488,"type":38},"2026-05-07",{"date":221,"type":23},{"name":491,"class":45},"University of Pennsylvania",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":57,"phases":501,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":106},"100556777","phase-2-tislelizumab-in-people-with-colorectal-cancer-100556777","NCT06529523","Tislelizumab in People With Colorectal Cancer","PD-1 (Programmed Cell Death Protein 1) Blockade in Mismatch-repair Deficient Colorectal Cancer in Nigeria","All subjects\n\nInclusion Criteria:\n\n* Age 18 years or older on date of signing informed consent\n* ECOG performance status of 0 or 1\n* Negative pregnancy test done within 72 hours prior to start of treatment for women of childbearing potential.\n\n  * Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab They must also have a negative urine or serum pregnancy test result ≤ 7 days before first dose of study drug.\n  * The Clinical Trials Facilitation Group recommendations related to contraception and pregnancy testing in clinical studies include the use of highly effective forms of birth control (Clinical Trials Facilitation Group 2014). These methods include the following:\n\n    * Oral, intravaginal, or transdermal combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation\n    * Oral, injectable, implantable progestogen-only hormonal contraception associated with the inhibition of ovulation Note: Oral birth control pills are not considered a highly effective form of birth control, and if they are selected, they must be used with a second, barrier method of contraception such as condoms with or without spermicide.\n    * An intrauterine device\n    * Intrauterine hormone-releasing system\n    * Bilateral tubal occlusion\n    * Vasectomized partner Note: This is only considered a highly effective form of birth control when the vasectomized partner is the sole partner of the study participant and there has been a medical assessment confirming surgical success.\n    * A sterile male is one for whom azoospermia, in a semen sample, has been demonstrated as definitive evidence of infertility.\n    * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) Note: Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle.\n\nPeriodic abstinence (eg, calendar, ovulation, sympto-thermal, postovulation methods), declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable methods of contraception.\n\nOf note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception; if used, this method must be used in combination with one of the highly effective forms of birth control listed above.\n\n°\"Women of non-childbearing potential\" are defined as female patients meeting any of the following criteria:\n\n* Surgically sterile (ie, through bilateral salpingectomy, bilateral oophorectomy, or hysterectomy)\n* Postmenopausal, defined as:\n\n  * ≥ 55 years of age with no spontaneous menses for ≥ 12 months OR\n  * \\\u003C 55 years of age with no spontaneous menses for ≥ 12 months AND with postmenopausal follicle-stimulating hormone (FSH) concentration \\> 30 IU\u002FmL and all alternative medical causes for the lack of spontaneous menses for ≥ 12 months have been ruled out, such as polycystic ovarian syndrome, hyperprolactinemia, etc.\n  * If an FSH measurement is required to confirm postmenopausal state, concomitant use of hormonal contraception or hormonal replacement therapy should be excluded.\n\n\\[Adapted from Clinical Trials Facilitation Group (CTFG) 2014.\\]\n\n* Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab\n\n  •A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility.\n  * Males with known \"low sperm counts\" (consistent with \"subfertility\") are not to be considered sterile.\n\n    \\- Demonstration of adequate organ function below within 14 days of cycle 1 day 1\n    * The ability to adhere to the study protocol and willingness to provide informed consent\n    * Cohort 1 subjects\n  * Histological confirmation of colorectal adenocarcinoma\n  * Confirmation of dMMR by immunohistochemistry\n  * Radiologically measurable metastatic disease as per RECIST 1.1, not eligible for potentially curative surgery -Cohort 2 subjects\n  * Histological confirmation of rectal adenocarcinoma\n  * Confirmation of dMMR by immunohistochemistry\n  * Rectal cancer stage II or III per AJCC 8 th edition criteria\n  * No evidence of distant metastases\n\n    * Hematological\n* Absolute neutrophil count (ANC) ≥1,500 \u002Fmm\\^3\n* Platelets ≥100,000 \u002F mcL\n* Hemoglobin \\>9 g\u002FdL or ≥5.6 mmol\u002FL\n\n  * Renal\n* Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥30 mL\u002Fmin for subject with creatinine levels \\> 1.5 × institutional ULN\n\n  * Hepatic\n* Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (\\\u003C 5 x ULN if hepatic metastases are present in cohort 1\n\n  * Coagulation\n* International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) INR \\\u003C1.5 or PT \\\u003C1.5 x ULN; and either PTT or aPTT \\\u003C1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5\n\nExclusion Criteria:\n\n* Presence of other active malignancy\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days prior to first dose of treatment\n* Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug. Inhaled or topical steroids, and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of an active autoimmune disease. Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:\n\n  1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)\n  2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption\n  3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen\n* Active autoimmune disease requiring systemic therapy within the 2 years prior to treatment initiation\n\n  o Well controlled hypothyroidism, diabetes, and skin conditions allowed\n* Untreated active Hepatitis B or Hepatitis C\n\n  o Patients actively on therapy with disease under control are allowed\n* Untreated Acquired Immunodeficiency Syndrome (AIDS)\n\n  o Patients with Human Immunodeficiency Virus (HIV) well controlled on anti-retroviral therapy are allowed\n* Infection (including tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before first dose of study drug\n* History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis.\n\n  o Patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening\n* Currently receiving other anticancer or experimental therapy\n* Has received prior therapy with an immune checkpoint inhibitor\n* Prior ≥ Grade 3 immune-related AE from previous immunotherapy\n* Pregnant women, women who are breast-feeding, or men expecting to conceive or father children during the trial period, through 120 days after last dose of medication\n* Receipt of live vaccine within 30 days of planned treatment start\n* Major surgical procedure or significant traumatic injury within 28 days prior to enrollment\n* Known hypersensitivity to Tislelizumab\n* Prior allogeneic stem cell or organ transplantation\n* Any of the following cardiovascular risk factors:\n\n  a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drug e. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug g. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before first dose of study drug h. Any episode of syncope or seizure ≤ 28 days before first dose of study drug\n* Cohort 1 subjects\n* Prior immunotherapy, chemotherapy, radiation therapy, or surgery for metastatic colorectal cancer\n\n  o Treatment with adjuvant therapy of prior localized tumor is allowable as long as it was completed at least 6 months prior to cycle 1 day 1\n* Known active central nervous system (CNS) metastasis and\u002For carcinomatous meningitis\n\n  o Patients with previously treated brain metastases may participate if the brain metastases are stable via MRI assessment, performed ≥ 4 weeks after treatment\n* Cohort 2 subjects\n* Prior immunotherapy, chemotherapy, radiation therapy, or surgery for localized rectal cancer\n* Presence of metastatic or recurrent disease",{"count":500,"type":23},40,[59],"The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug.\n\nAll participants in this study will be treatment naïve (they have not yet received treatment for their cancer), and their cancer will be mismatch repair deficient (dMMR). dMMR cancer can happen when your cells are unable to repair mistakes made during the cell division process.",[504],"Colorectal Cancer",[506,507,508],"Tislelizumab","PD-1 blockade","24-063",{"date":486,"type":38},{"date":511,"type":38},"2024-07-26",{"date":513,"type":23},"2028-07",{"name":515,"class":45},"Memorial Sloan Kettering Cancer Center",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":18,"sex":19,"minAge":331,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":57,"phases":526,"briefSummary":527,"conditions":528,"keywords":533,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":224},"100647299","expanding-access-to-preventive-chemotherapy-among-mobile-and-migrant-populations-100647299","NCT07707817","Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations","A Community Mapping and Participatory Research Protocol for Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations Through Social and Occupational Networks in Nigeria: MISSION Nigeria","MISSION","Inclusion Criteria:\n\nParticipants will be eligible for inclusion if they:\n\n1. Are children aged 5-14 years or adult heads of households residing in households identified as belonging to mobile or migrant populations.\n2. Reside permanently or semi-permanently within the study communities\n3. Have missed one or more previous rounds of onchocerciasis and\u002For lymphatic filariasis MDA.\n4. Are willing to provide the required biological specimens and participate in interviews, surveys, and participatory workshops or discussions as required by the study protocol.\n5. Provide informed consent or assent with parental\u002Fguardian consent where applicable for minors.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n1. Are temporary visitors without meaningful residence in the study communities.\n2. Do not belong to the identified mobile or migrant populations targeted by the study.\n3. Are unable or unwilling to provide the required biological specimens or participate in study procedures.\n4. Decline informed consent or assent, or whose parent or guardian declines consent for participation.\n5. Are severely ill or have medical conditions that, in the opinion of study personnel, would make participation unsafe or inappropriate.",{"count":525,"type":23},5760,[212],"Neglected Tropical Diseases (NTDs) are among the most common groups of diseases affecting over one billion people globally and are disproportionately concentrated in remote, underserved, and marginalized communities. Efforts toward NTD elimination have largely relied on preventive chemotherapy (PC), large-scale distribution of free, safe, and effective medicines to at-risk populations. One major challenge threatening elimination efforts is the poor participation of mobile and migrant populations (MMPs) in treatment programs. Despite this gap, few studies have explored strategies to improve access among these underserved populations.\n\nThis study aims to determine the burden of NTDs among MMPs and explore strategies for expanding access to preventive chemotherapy through social and occupational networks using community mapping and participatory action research approaches in Nigeria.\n\nThis project is a multi-site implementation research study involving 15 communities across three Nigerian states-Taraba, Akwa Ibom, and Ondo-representing pastoralist, fishing, and agrarian settings, respectively. The study comprises four phases. The first two formative phases will assess the baseline burden of NTDs and coverage of preventive chemotherapy interventions using community surveys, parasitological and serological assessments, mapping, and participatory workshops to identify migration patterns, anchor points, and social and occupational networks that could support expansion of PC. The third phase will use participatory approaches to co-construct context-specific strategies for expanding access to preventive chemotherapy among MMPs. In the fourth phase, the co-developed strategies will be implemented and evaluated for impact using established implementation research frameworks and mixed methods approaches.\n\nThrough this project, investigators will develop and evaluate a novel strategy for expanding access to PC among MMPs. The study will generate evidence on the feasibility, acceptability, reach, and sustainability of the proposed approach and is expected to inform adaptable implementation models for inclusive NTD programming in Nigeria and similar endemic settings.",[529,530,531,532],"Onchocerciasis (River Blindness)","Schistosomiasis","Soil Transmitted Helminth (STH) Infections","Lymphatic Filariasis",[534,535,536,537,373,538,539],"Neglected Tropical Diseases","Mobile and Migrant populations","Participatory Research","Implementation Science","Mass Drug Administration","Mass Administration of Medicines","2026-07-14",{"date":486,"type":38},{"date":543,"type":38},"2026-07-01",{"date":545,"type":23},"2027-11-30",{"name":547,"class":45},"Uwemedimo Friday Ekpo",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":18,"sex":19,"minAge":555,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":57,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":224},"100540538","managing-sickle-cell-disease-through-increased-adoption-of-hydroxyurea-in-nigeria-100540538","NCT06318143","mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria","ACCELERATE","Inclusion Criteria:\n\n* SCD patients18 years older that have provided consent;\n* Pediatric SCD patients aged 12 months to 17 years with an accompanying guardian and have provided informed consent or assent;\n* Registration in the electronic medical records (EMR) database with clinical charts and received care at the local clinical sites or health facilities and not on HU therapy;\n* Hb Genotype: SCD-SS, SCD-Sβo thal, SCD-SOArab (On a case by case basis, a severely affected person with SCD-SC may be offered HU therapy under a modified treatment protocol)\n\nExclusion Criteria:\n\n* Any SCD patient not registered in the EMR database without informed consent or assent;\n* Physically unable to participate in study activities;\n* An SCD patient on HU","12 Months",{"count":557,"type":23},900,[212],"Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is \\\u003C1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers\u002Fproviders to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria.",[63],"2026-07-06",{"date":563,"type":38},"2026-07-07",{"date":565,"type":38},"2024-07-01",{"date":567,"type":23},"2028-05-31",{"name":569,"class":45},"New York University",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":19,"minAge":578,"maxAge":207,"enrollmentInfo":579,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":581,"conditions":582,"keywords":588,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":106},"100522799","evaluation-of-a-multi-country-medical-oxygen-program-100522799","NCT06087315","Evaluation of a Multi-country Medical Oxygen Program","Realist Evaluation and Learning in a Multi-country Medical OXYgen Program (REAL-MOXY)","REAL-MOXY","Sub-study 1:\n\nResearch Question: What are the baseline pulse oximetry and oxygen practices for children admitted to participating health facilities, and what is the level of institutional readiness for oxygen service delivery? Which facilities, representative of high- and low-performing facilities and different levels of care and facility types, can be selected for additional investigation to understand current functioning of oxygen systems?\n\nSetting and Population: The broader MOXY program baseline cross-sectional assessments involve 9 countries. We have selected 6 MOXY countries for the mixed methods studies outlined in this protocol - Nigeria, Uganda, Liberia, Rwanda, Cambodia and Lao PDR - based on pre-existing research collaborations, and with the aim of representing broadly different geographical contexts.\n\nBaseline assessments are being conducted in all facilities participating in the MOXY program in each of the 6 study countries. From this data set, we will analyse primary and secondary outcomes for wards caring for children \\\u003C15 years (including neonatal wards where relevant).\n\nAnalysis\u002Foutcomes: Primary - proportion of admitted children (\\\u003C15 years, including neonates) screened with pulse oximetry. Secondary - proportion of admitted children with hypoxaemia (\\\u003C15 years, including neonates) treated with oxygen. For Real-Moxy the secondary outcome will inform identification of facilities for inclusion.\n\nSub-study 2:\n\nResearch question: Where and how are patients managed from arrival to admission and discharge (or transfer), and how does oxygen equipment move within and between clinical areas? How do process maps vary for different clinical scenarios representing different patient groups: i) pneumonia with and without hypoxaemia; ii) severe, acute illness syndrome with WHO emergency signs (e.g., shock, multi-trauma, seizures); iii) surgical condition and iv) neonatal illness (inborn and outborn)?\n\nSetting and Population: This will be conducted in 10 health facilities in each of the 6 countries (Nigeria, Uganda, Liberia, Rwanda, Lao PDR, Cambodia), selected to represent high and low functioning facility oxygen systems and include secondary and tertiary health facilities from government and non-governmental sectors (identified in sub-study 1). We will focus on admitted children (\\\u003C15 years, including neonates) with (i) pneumonia, (ii) other acute illness with WHO emergency signs, (iii) surgical conditions, and (iv) neonatal illness. We have chosen these conditions to represent diagnoses with a high prevalence of hypoxaemia, and to capture the nuances of how pulse oximetry and oxygen practices are adapted (or not adapted) to clinical scenarios (e.g., having a lower threshold to provide oxygen to a patient in shock; or targeting safe oxygen saturations in neonates).\n\nAnalysis\u002Foutcomes: Facility maps of patient and equipment flow.\n\nSub-study 3:\n\nResearch question: What is the sequence of emergency care for an unwell child in the first 4 hours, and how are decisions made - particularly relating to oxygen (when to start, stop, how much, what delivery modality, etc.)? What are the points of delays to appropriate care (including pulse oximetry and oxygen) and at what points in time and location could pulse oximetry and oxygen be used better for emergency care of children?\n\nSetting and Population: facilities are same as sub-study 2). Children (\\\u003C15 years, including neonates) presenting with each of 4 acute illness syndromes: (i) pneumonia, (ii) other acute illness with WHO emergency signs, (iii) surgical conditions, and (iv) neonatal illness.\n\nAnalysis\u002Foutcomes: Patient journey maps.\n\nSub-study 4:\n\nResearch question: How do healthcare workers use pulse oximetry and oxygen for admitted patients, and how does this change over time and vary between patient groups, facility type, and location? How do practices compare with treatment guidelines and where are the priority areas for improving oxygen care?\n\nPopulation and setting: Facilities are same as sub-studies 2\\&3.\n\nAnalysis\u002Foutcomes: Narrative descriptions of handover, ward rounds, and nursing rounds, with specific emphasis on how pulse oximetry is used, and decision making for oxygen therapy.\n\nSub-study 5: Indepth interviews and focus group discussions Research questions: 5a) How do patients\u002Fcaregivers perceive pulse oximetry and oxygen therapy within their broader care experience? 5b) How do healthcare workers, managers and technicians perceive oxygen therapy and the provision of oxygen-related care within the broader care provision experience?\n\nPopulation:\n\n* Patients and caregivers enrolled in sub-study 3 (patient journey mapping).\n* Healthcare workers (bedside), managers (including clinical and non-clinical managers) and technicians in each health facility. We will select staff with direct responsibility for wards caring for children \\\u003C15 years.\n\nAnalysis\u002Foutcomes: Reflexive thematic analysis of interviews and focus group discussions.","0 Years",{"count":580,"type":23},1200,"REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for beneficiaries, users and managers.",[583,584,585,586,587],"Hypoxemia","Neonatal Disease","Pneumonia","Sepsis","Morality",[589,590,591,592,593,594],"Oxygen systems","Pulse oximetry","Low middle income countries","Global health","Mixed-methods evaluation","Realist evaluation",{"date":596,"type":38},"2026-07-08",{"date":598,"type":38},"2023-11-27",{"date":600,"type":23},"2027-12",{"name":602,"class":45},"Murdoch Childrens Research Institute",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":19,"minAge":610,"maxAge":208,"enrollmentInfo":611,"targetDuration":4,"studyType":57,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":224},"100546025","change-my-story-task-shifted-mental-health-intervention-100546025","NCT06389565","Change My Story Task Shifted Mental Health Intervention","Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression","Inclusion Criteria:\n\n* HIV-positive\n* age 16-29 years\n* self-reported proficiency in reading and understanding English.\n* PHQ9 score of 9-17 and impairment in functioning (consistent with clinical depression)\n\nExclusion Criteria:\n\n* pregnant or nursing\n* in care and on ART for \\\u003C6 months\n* history of- or positive assessment for- bipolar or psychotic disorder.","16 Years",{"count":74,"type":23},[212],"Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.",[615,616,617],"Hiv","Depression","Psychological Distress",{"date":561,"type":38},{"date":620,"type":38},"2026-01-09",{"date":622,"type":23},"2026-08-30",{"name":624,"class":45},"Massachusetts General Hospital",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":631,"enrollmentInfo":632,"targetDuration":4,"studyType":57,"phases":634,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":641,"leadSponsor":643,"locationsCount":248},"100513292","phase-3-stroke-minimization-through-additive-anti-atherosclerotic-agents-in-routine-treatment-ii-study-smaart-ii-100513292","NCT05963568","Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)","Inclusion Criteria:\n\n* Above the age of 18 years; male or female\n* Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible\n* Subjects with stroke may present with at least one of the following additional conditions:\n\nDocumented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \\>140\u002F90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml\u002Fmin\u002F1.73m2); Prior myocardial infarction\n\n* Legally competent to sign informed consent.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindications to any of the components of the polypill\n* Hemorrhagic stroke\n* Severe cognitive impairment\u002Fdementia or severe global disability limiting the capacity of self-care\n* Severe congestive cardiac failure (NYHA III-IV)\n* Severe renal disease, eGFR \\\u003C30ml\u002Fmin\u002F1.73m2), renal dialysis; awaiting renal transplant or transplant recipient\n* Cancer diagnosis or treatment in past 2 years\n* Need for oral anticoagulation at the time of randomization or planned in the future months;\n* Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)\n* Nursing\u002Fpregnant mothers\n* Do not agree to the filing, forwarding and use of his\u002Fher pseudonymized data.","100 Years",{"count":633,"type":23},1000,[60],"The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.",[637,638],"Stroke","Medication Adherence",{"date":561,"type":38},{"date":40,"type":38},{"date":642,"type":23},"2029-02-01",{"name":644,"class":45},"Northern California Institute of Research and Education",{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":631,"enrollmentInfo":651,"targetDuration":4,"studyType":57,"phases":653,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":669},"100429589","phase-3-prevention-of-persistent-pain-with-lidocaine-infusions-in-breast-cancer-surgery-plan-100429589","NCT04874038","Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)\n\nExclusion Criteria:\n\n1. Previous breast surgery within 6 months of index surgery\n2. Undergoing any autologous flap procedure during index surgery\n3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery\n4. Documented hypersensitivity or allergy to lidocaine\n5. Surgery not planned to be performed under general anesthesia and\u002For planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)\n6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker\n7. Known cirrhotic liver disease\n8. Pregnant\n9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)",{"count":652,"type":23},1602,[60],"Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.",[656,657,658,659],"Post-mastectomy Pain Syndrome","Breast Cancer","Pain, Postoperative","Pain, Chronic","2026-06-17",{"date":662,"type":38},"2026-06-22",{"date":664,"type":38},"2021-09-22",{"date":666,"type":23},"2026-11-01",{"name":668,"class":45},"University Health Network, Toronto",17,{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":57,"phases":680,"briefSummary":681,"conditions":682,"keywords":684,"overallStatus":391,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":694,"locationsCount":248},"100374574","essential-acute-stroke-care-in-low-resource-settings-a-pilot-study-100374574","NCT04157231","Essential Acute Stroke Care in Low Resource Settings: a Pilot studY","Essential Acute Stroke Care in Low Resource Settings: a Pilot Study","EASY","Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* A clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset\n* Provision of written informed consent\n* Subjects in observational, natural history and\u002For epidemiological studies not involving an intervention are eligible.\n\nExclusion Criteria:\n\n* Patients who have undergone intravenous thrombolysis or mechanical thrombectomy\n* Patients who are planned for transfer to the intensive care unit\n* Subarachnoid haemorrhage\n* Participation in an interventional medical investigation or clinical trial currently or within the past 3 months.",{"count":679,"type":23},300,[212],"An investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting",[683],"Acute Stroke",[637,685,686,687],"Ischemic stroke","hemorrhagic stroke","stroke package","2026-06-09",{"date":690,"type":38},"2026-06-11",{"date":692,"type":23},"2027-12-30",{"date":148,"type":23},{"name":695,"class":45},"The George Institute",""]