[{"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:":656},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,87,0,25,[9,45,71,96,119,153,182,202,228,252,276,307,333,358,384,404,431,454,480,504,532,557,579,602,631],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100463298",false,"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.","ALL","10 Years","65 Years",{"count":21,"type":22},466,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","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.",[29],"Proteinuric Kidney Disease",[31],"APOL1-mediated kidney disease (AMKD)","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":36},"2022-03-30",{"date":40,"type":22},"2030-05-07",{"name":42,"class":43},"Vertex Pharmaceuticals Incorporated","INDUSTRY",318,{"id":46,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"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.","FEMALE","18 Years",{"count":54,"type":22},70,[56],"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.",[59],"Ovarian Cancer","2026-06-18",{"date":62,"type":36},"2026-06-23",{"date":64,"type":36},"2026-06-08",{"date":66,"type":22},"2031-06-08",{"name":68,"class":69},"University of Miami","OTHER",4,{"id":72,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"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)","100 Years",{"count":78,"type":22},1602,[26],"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.",[82,83,84,85],"Post-mastectomy Pain Syndrome","Breast Cancer","Pain, Postoperative","Pain, Chronic","2026-06-17",{"date":88,"type":36},"2026-06-22",{"date":90,"type":36},"2021-09-22",{"date":92,"type":22},"2026-11-01",{"name":94,"class":69},"University Health Network, Toronto",17,{"id":97,"slug":4,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100563138","NCT06612268","A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease","A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease","Hibiscus 2","Inclusion Criteria:\n\n* Male or female.\n* Age 12 years or above at the time of signing the informed consent.\n* Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.\n* Have 1-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g\u002FdL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 g\u002FL) at screening.\n\nExclusion Criteria:\n\n* More than 15 VOCs within the past 12 months prior to screening documented in the participant's medical record. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.\n* Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.\n* Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).\n* Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.\n* Receiving or use of concomitant medications that are strong inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.\n* Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.\n* Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).\n* Hepatic dysfunction characterized by:\n\n  * Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or\n  * Direct bilirubin greater than 3.0 × ULN.\n* Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.\n* Severe renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] at screening, calculated by the central laboratory greater than 30 mL\u002Fmin\u002F1.73 m\\^ 2) or on chronic dialysis.\n* Travelled distance on standardized 6MWT below 100m at screening.","12 Years",{"count":105,"type":22},408,[26],"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.",[109],"Sickle Cell Disease","2026-06-16",{"date":86,"type":36},{"date":113,"type":36},"2025-02-17",{"date":115,"type":22},"2029-03-12",{"name":117,"class":43},"Novo Nordisk A\u002FS",174,{"id":120,"slug":4,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"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.",true,"30 Years",{"count":129,"type":22},4500,"OBSERVATIONAL","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.",[133],"Parkinson Disease",[135,136,137,138,139,140,141,142],"Parkinson","Bio-markers","Neurodegenerative disorder","Imaging","Prodromal","Genetics","At Risk","Loss of Smell","2026-06-10",{"date":145,"type":36},"2026-06-12",{"date":147,"type":36},"2020-07-01",{"date":149,"type":22},"2033-12",{"name":151,"class":69},"Michael J. Fox Foundation for Parkinson's Research",50,{"id":154,"slug":4,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":70},"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":161,"type":22},300,[163],"NA","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",[166],"Acute Stroke",[168,169,170,171],"Stroke","Ischemic stroke","hemorrhagic stroke","stroke package","NOT_YET_RECRUITING","2026-06-09",{"date":175,"type":36},"2026-06-11",{"date":177,"type":22},"2027-12-30",{"date":179,"type":22},"2030-12-30",{"name":181,"class":69},"The George Institute",{"id":183,"slug":4,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":189,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":200,"locationsCount":201},"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":191,"type":22},480,[26],"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.",[109,195],"Thalassemia",{"date":143,"type":36},{"date":198,"type":36},"2025-01-10",{"date":179,"type":22},{"name":117,"class":43},105,{"id":203,"slug":4,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"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 16-24 years\n* self-reported proficiency in reading and understanding English.\n* PHQ9 score of 8-17 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","24 Years",{"count":211,"type":22},80,[163],"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.",[215,216,217],"Hiv","Depression","Psychological Distress","2026-05-26",{"date":220,"type":36},"2026-05-28",{"date":222,"type":36},"2025-06-01",{"date":224,"type":22},"2026-06-30",{"name":226,"class":69},"Massachusetts General Hospital",1,{"id":229,"slug":4,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":70},"100450594","NCT05147519","Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections","Multinational Observational Cohort of HIV and Other Infections (MOCHI)","MOCHI","Step 1 Inclusion Criteria: Female or male aged 14-55 years; Documented negative HIV test according to site-specific HIV testing procedures at entry\u002Fscreening; Able and willing to provide informed consent; Willing to provide biometric identification; Available for follow-up for the planned study duration; Understands English or the local language as approved by the IRB, including people who are illiterate; Willing to provide contact information for themselves and one personal contact who would know their whereabouts during the study period; Willing to provide information regarding HIV risk behaviors and to undergo testing for HIV and other STIs; Considered to be vulnerable to HIV and other STIs based on any one or more of the following test results and\u002For self-reported behaviors:\n\n1. Documented history of newly diagnosed syphilis, gonorrhea, chlamydia, Mycoplasma genitalium, herpes simplex virus, or acute hepatitis C virus infection in the 24 weeks prior to screening\n2. Self-reported vaginal, oral, or anal intercourse in exchange for money as a regular source of income in the 24 weeks prior to screening\n3. Self-reported condomless vaginal or anal intercourse with at least three different partners living with HIV or of unknown status in the 24 weeks prior to screening\n4. Self- reported injection drug use (IDU) in the 24 weeks prior to screening\n5. Self-reported insertive or receptive anal intercourse with one or more different male or transgender partners in the 24 weeks prior to screening Step 1 Exclusion Criteria: Any significant condition (medical, psychologic\u002Fpsychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the judgement of the study investigator, would interfere with adherence to study requirements; Current or past participation in a preventive or therapeutic HIV vaccine study, unless known placebo recipient; Positive β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) at screening for people of child-bearing potential and people who are amenorrheic for less than 12 consecutive months.\n\nStep 2 Inclusion Criteria: New diagnosis of HIV in the last 90 days during Step 1 as determined by site-specific HIV testing procedures; Able and willing to continue follow-up for the planned study duration Step 2 Exclusion Criteria: Any significant condition (medical, psychologic\u002Fpsychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements","14 Years","55 Years",{"count":238,"type":22},2500,"Multinational Observational Cohort of HIV and other Infections (MOCHI). This observational study is to gain information regarding the number of new HIV infections among people who engage in behaviors that make them vulnerable to acquiring HIV across multiple international sites.",[241],"HIV Infections",[243,244],"STI","Observational",{"date":220,"type":36},{"date":247,"type":36},"2021-11-05",{"date":249,"type":22},"2032-06-30",{"name":251,"class":69},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"id":253,"slug":4,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":258,"minAge":259,"maxAge":4,"enrollmentInfo":260,"targetDuration":262,"studyType":130,"phases":4,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"100297409","NCT03151629","International Registry for Men With Advanced Prostate Cancer (IRONMAN)","IRONMAN","• Willing and able to provide written informed consent and privacy authorization for the release of personal health information.\n\nNOTE: Privacy authorization may be either included in the informed consent or obtained separately.\n\n* Males 21 years of age and above\n* Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy, radical prostatectomy or TURP Or Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA \\>20ng\u002FmL at the time of initial prostate cancer diagnosis\n* No previous diagnosis of a second, non-prostate malignancy that requires additional systemic therapy except cancer in situ of bladder and basal cell cancer of skin","MALE","21 Years",{"count":261,"type":22},5000,"5 Years","Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0\u002FM1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices.\n\nDetailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs.\n\nPROMs questionnaires will be collected at enrollment and every three months thereafter.\n\nPhysician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and\u002For one year follow-up, at each subsequent change of treatment, and discontinuation of treatment.\n\nAs such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0\u002FM1 CRPC. By collecting blood at enrollment, time of first change in treatment and\u002For one year follow-up (plasma, cell free DNA, buffy coat \u002F RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.",[265],"Prostate Cancer","2026-05-19",{"date":268,"type":36},"2026-05-22",{"date":270,"type":36},"2017-07-21",{"date":272,"type":22},"2032-01",{"name":274,"class":69},"Prostate Cancer Clinical Trials Consortium",121,{"id":277,"slug":4,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100640756","NCT07602673","Pulmonary Rehabilitation in African Countries","Respiratory Medicine and Pulmonary Rehabilitation Feasibility Study and Randomised Controlled Trial in Nigeria, South Africa and Cameroon","Inclusion Criteria:\n\n* Male and female adults (\\>= 18 years) with specified clinical diagnosis (typically by detailed clinical history \\[persistent symptoms for ≥6 months\\] plus spirometry and\u002For other available tests, e.g., chest X-ray\\]\n* Individuals with CRDs, specifically COPD, asthma or post-tuberculosis lung disorder\n* Patients with CRDs who have an indication for PR (specifically, these are patients with moderate to severe staged disease who present with reduced exercise\u002Ffunctional capacity, poor quality of life, high disease symptoms, particularly dyspnea) and are medically fit to undergo exercise training (which is to be determined by pre-exercise screening and field tests).\n* Patients with CRDs attending regular follow-up in the respiratory clinics of the selected centres.\n* Patients who are willing and able to provide written or oral (audio recorded) informed consent\n* All levels (primary, secondary, and tertiary) of healthcare professionals, including doctors, nurses, physiotherapists, respiratory therapists, medical assistants, healthcare administrators, pulmonologists, and other formal practitioners working in primary, secondary, and tertiary care settings, who provide services to patients who may potentially require PR.\n* Relevant stakeholders, including policymakers, religious leaders, sports leaders, the pharmaceutical industry, social workers, managers, and hospital\u002Fpractice owners.\n* Willing and able to provide written or oral (audio recorded) informed consent.\n\nExclusion Criteria:\n\n* Patients with other significant chronic co-morbidities such as heart failure, ischemic heart disease, DM, and confusion\u002Fdementia\n* Pregnant women\n* Co-morbidity that is a contraindication to PR (e.g., unstable angina, aortic aneurysm, recent myocardial infarction, acute infection, etc.)\n* Significant cognitive or physical impairment preventing participation in PR\n* Active pulmonary tuberculosis vi. Patient with current or recent disease exacerbations\n* Non-respiratory cause for symptoms (e.g., breathlessness due to heart failure, anaemia)\n* Unable to participate in exercise (e.g., due to severe arthritis or paralysis)\n* Undertaken PR within one year.\n* Unwilling to participate in the study.\n* Unable to give written or oral (audio recorded) informed consent\n* Healthcare professionals who are not involved in the care of patients who require PR, e.g., midwives\n* Having a conflict of interest that may influence the outcome\n* Unable and unwilling to give written or oral (audio recorded) informed consent",{"count":283,"type":22},150,[163],"Chronic Respiratory Diseases (CRDs) are common disabling conditions worldwide with high prevalence, morbidity and mortality. More than half of the CRD patients live in low- and middle-income countries (LMICs) where resources for identifying the condition, understanding the disease status of individual patients, and overall management are often poor. CRDs in high-income countries (HICs) are dominated by chronic obstructive pulmonary disease (COPD) and asthma, whereas in LMICs, post-tuberculosis (TB) lung disorders, bronchiectasis, and other (often unidentified) respiratory conditions contribute to a significant proportion of CRDs. Pulmonary rehabilitation (PR) is an essential component of evidence-based clinical management guidelines for CRDs, though most of the evidence on PR is disease-specific and generated from HICs. A recent systematic review by the RESPIRE group, with whom we collaborate, revealed that 12 out of 13 studies suggested that PR for patients with CRDs in LMICs was an effective intervention, though the studies were typically at high risk of bias. This highlighted the need for further high-quality large-scale studies in LMICs to assess the enablers and barriers, effectiveness, components, and mode of delivery of PR for CRDs.\n\nIn this feasibility study, the investigators will assess the resource infrastructure, optimal components of the PR programme, relevant CRDs eligibility, and model of service delivery for providing PR in Nigeria, South Africa and Cameroon, and then conduct a pilot randomised controlled trial (RCT). The investigators will also assess potential outcomes, including before and after intervention measurement of functional exercise capacity and relevant patient-reported outcomes. In qualitative interviews, the investigators will explore the barriers and enablers and stakeholders' opinions on implementing PR in each country.\n\nThe investigators will recruit (Nigeria - 30, South Africa - 30 and Cameroon - 30) clinically eligible patients and provide them with 8 weeks of either a centre- or community-based PR incorporating components derived from global PR guidelines and informed by the prior RESPIRE's systematic review and adapted to be deliverable in a low-resource setting. The investigators will assess the patients at baseline, end of the program (8 weeks) and then at 6 months follow-up to assess sustainability. Moreover, along with the quantitative assessment of outcomes (functional exercise capacity, health-related quality of life, dyspnoea severity and other secondary parameters), the investigators will conduct a qualitative interview with a purposive sample of patients, providers, and other health care professionals, e.g., GPs, pulmonologists, physiotherapists. The investigators will synthesise the findings for conference presentations, peer review publications, and advocate for PR with stakeholders.",[287],"Chronic Respiratory Conditions",[289,290,291,292,293,294,295,296,297],"COPD","Asthma","Tuberculosis","Chronic Respiratory Diseases","Africa","Nigeria","South Africa","Cameroon","Pulmonary Rehabilitation","2026-05-18",{"date":268,"type":36},{"date":301,"type":22},"2026-09-01",{"date":303,"type":22},"2027-12-01",{"name":305,"class":69},"University of Edinburgh",3,{"id":308,"slug":4,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":258,"minAge":52,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":320,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":227},"100638317","NCT07598032","Comparative Analysis of Immunological Responses to Vitamin D Replacement Therapy in Black and West African Men Diagnosed With Prostate Cancer: Elucidating Differential Effects on Immune Function Between Patients With Localized Disease and Those With Metastatic Progression","iCCaRE","Inclusion Criteria:\n\n* Self-identified Black\u002FWest African Males, Age ≥18 years\n* Patients with a previous history of localized or metastatic or locally recurrent prostate cancer\n* Willing to travel to the University of Ilorin Surgery Outpatient Department (SOPD UITH)for baseline and 8 weeks visit for blood collection, if eligible.\n\nExclusion Criteria:\n\n* Known hypersensitivity to vitamin D.\n* End-stage renal failure on dialysis\n* Liver cirrhosis\n* Currently taking a vitamin D or multivitamin supplement, which has more than 400 IU\u002F10mcg of vitamin D daily for the past month.\n* Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature.\n* History of hypercalcemia",{"count":314,"type":22},200,[26],"This study is testing whether fixing vitamin D deficiency in Black\u002FWest African men with prostate cancer can strengthen their immune system, improve quality of life, and even slow cancer progression compared to those who remain deficient.\n\nKey ideas being tested:\n\n1. More than half of Black\u002FWest African prostate cancer patients don't have enough vitamin D.\n2. Low vitamin D weakens immune cell function and affects quality of life, but these problems improve after 8 weeks of vitamin D supplements.\n3. Immune cell function differs between patients with advanced\u002Frecurrent prostate cancer and those with localized disease.\n4. Patients with advanced disease who show stronger immune responses after vitamin D correction may live longer without their PSA levels rising (a marker of cancer progression).\n5. Immune cell function in Black\u002FWest African patients is different from that in Black\u002FAfrican American patients, and this will be checked by comparing data with a parallel Mayo Clinic study.\n\nOverall goals:\n\n1 . Measure how widespread vitamin D deficiency is in Black\u002FWest African prostate cancer patients.\n\n2\\. Understand how vitamin D levels affect immunity and quality of life. 3. Compare immune function between different groups (localized vs. advanced disease, West African vs. African American patients).\n\n4 . See if vitamin D replacement improves both patient well-being and cancer outcomes.\n\nStudy Flow\n\n1\\. Recruitment \\& Consent: Patients with prostate cancer (localized or advanced) are invited and give written consent.\n\n2 . Initial Blood Test (10 mL): Check vitamin D and calcium levels. 3. Eligibility: If vitamin D is low (\\\u003C30 ng\u002FmL), patients join the treatment phase.\n\n4\\. Baseline Testing (50 mL blood + QOL survey): Immune function measured; quality of life survey completed; virtual doctor consult.\n\n5\\. Treatment (8 weeks): Daily vitamin D3 pills (2000 IU, free); patients keep a medication diary.\n\n6\\. Midpoint Check (Week 4): Phone call to check side effects and compliance. 7 .End of Treatment (Week 8): Repeat blood tests (60 mL), second QOL survey, virtual consult.\n\n8\\. Follow up (up to 3 years). Annual phone calls and medical record review to track progression-free survival.\n\nIn short, the study is trying to show that vitamin D deficiency is common in Black\u002FWest African prostate cancer patients, that it harms immune function and quality of life, and that correcting it could improve both health and cancer survival.",[318,319],"Prostate Cancer (Adenocarcinoma)","Vitamin D on Tumor Response and Inflammatory Markers",[321,322,323],"Advanced Prostate Cancer","Vitamin D deficency","immunity","2026-05-17",{"date":326,"type":36},"2026-05-20",{"date":328,"type":22},"2026-06-01",{"date":330,"type":22},"2028-09-01",{"name":332,"class":69},"University of Ilorin Teaching Hospital",{"id":334,"slug":4,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":126,"sex":17,"minAge":339,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":348,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100637193","NCT07601503","Evaluating In-line Chlorination in Nigeria","In-line Chlorination for Drinking Water Treatment in Nigeria","Inclusion Criteria:\n\n* Adult (18+) or emancipated minor (15+) pregnant women and women with children under 5 years old who do not plan to permanently move in the next 12 months.\n* Must be knowledgeable about the household's water collection and management practices\n\nExclusion Criteria:\n\n* Non-age-eligible women. Men and non-emancipated minors. Women who do not consent.","15 Years",{"count":341,"type":22},2655,[163],"This study evaluates the implementation and effectiveness of in-line chlorination (ILC) for improving drinking water quality in rural Nigeria. Unsafe drinking water remains a major contributor to diarrheal disease, particularly among children under five. Inline chlorination is a passive water treatment approach that automatically doses chlorine at community water systems without requiring electricity or daily user action. Two cluster randomized controlled trials will be conducted in Kano State (North-West Nigeria) and Cross River State (South-South Nigeria). Communities will be randomized to either receive in-line chlorination installed at eligible communal water systems or serve as controls with no chlorination. The unit of randomization is a community or a cluster of communities that share water system for drinking water. The primary objective is to estimate the causal impact of in-line chlorination on household drinking water quality. Outcomes include the prevalence of Escherichia coli contamination in tap water and stored household water as well as the presence of free chlorine residual. Secondary objectives assess water source usage and adoption of chlorinated sources, as well as reduction in diarrheal disease. Implementation fidelity and operational performance of chlorination devices will also be monitored.",[345,346,347],"Diarrhea","Water Quality","Adoption",[349],"Inline Chlorination, Safe Water, Water Practices, Behavior, Diarrhea, Children","2026-05-14",{"date":268,"type":36},{"date":218,"type":22},{"date":354,"type":22},"2027-12-31",{"name":356,"class":69},"University of California, Berkeley",2,{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":126,"sex":258,"minAge":52,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":227},"100592982","NCT07000513","HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs) in Nigeria","Innovative Tools to Expand HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs)","ITEST-LAI","Inclusion Criteria:\n\n1. Male commercial minibus drivers who have worked as a driver for at least 6 months\n2. 18 years old or older\n3. Currently and planning on residing in one of the LGAs during the next 12 months\n4. Owning a mobile phone\n\nExclusion Criteria:\n\n1. Known HIV positivity\n2. Not ability to provide informed consent3\n3. No access to a cell phone",{"count":366,"type":22},400,[56],"Long-acting injectable antiretroviral therapy (LAI ART) and Pre-Exposure Prophylaxis (LAI PrEP) have the potential to transform HIV treatment and prevention, especially in reaching individuals such as commercial minibus drivers who have minimal or no contact with traditional health facilities. The project proposes to use a culturally appropriate and community-engaged approach to promote the uptake of HIV self-testing, LAI-ART, and LAI-PrEP among commercial minibus drivers in Nigeria by engaging commercial minibus drivers as peer educators\u002Fresearch facilitators.",[370],"HIV",[370,372,373,294,374],"PrEP","Long-acting Injectables","Minibus drivers","2026-05-13",{"date":377,"type":36},"2026-05-15",{"date":379,"type":22},"2027-02-01",{"date":381,"type":22},"2029-08-01",{"name":383,"class":69},"George Washington University",{"id":385,"slug":4,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":126,"sex":17,"minAge":390,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":227},"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":392,"type":22},900,[163],"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.",[109],"2026-05-11",{"date":375,"type":36},{"date":399,"type":36},"2024-07-01",{"date":401,"type":22},"2028-05-31",{"name":403,"class":69},"New York University",{"id":405,"slug":4,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":19,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":417,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":227},"100613658","NCT07269457","Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)","VIMOT","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Diagnosed with mild-to-moderate TBI defined by GCS 9-15\n* Presenting within 24 hours of head injury\n* Willing and able to provide informed consent or have a legal representative provide consent\n* Confirmed vitamin D-deficient status (\\\u003C30 ng\u002FmL) for randomization into treatment arms OR Vitamin D-sufficient (≥30 ng\u002FmL) to be eligible for inclusion in the observational control arm.\n\nExclusion Criteria:\n\n* Severe TBI (GCS ≤8)\n* Prior use of vitamin D supplements within the past month\n* History of hypercalcemia or hyperparathyroidism\n* Pregnancy or lactation\n* Use of immunosuppressive agents (e.g., corticosteroids, cytotoxic drugs)\n* Chronic liver disease\n* End-stage renal disease\n* Any terminal illness or comorbidity with expected survival \\\u003C3 months",{"count":411,"type":22},240,[25],"This study is a Phase II, randomized, quadruple-blinded, placebo-controlled clinical trial designed to test whether vitamin D₃ supplementation can improve recovery after mild-to-moderate traumatic brain injury (TBI) in adults.\n\nTraumatic brain injury often leads to inflammation and poor neurological outcomes, and many patients are vitamin D-deficient. Vitamin D₃ is a safe, widely available supplement that may reduce inflammation and support brain recovery.\n\nA total of 240 adults (18-65 years) with mild-to-moderate TBI will be enrolled at Lagos State University Teaching Hospital, Nigeria. Participants will be assigned to one of four groups:\n\nGroup A (Deficient + High-Dose D₃): 40,000 IU loading dose, then 4,000 IU daily for 3 weeks Group B (Deficient + Standard-Dose D₃): 2,000 IU daily for 3 weeks Group C (Sufficient + Standard-Dose D₃): 2,000 IU daily for 3 weeks Group D (Sufficient + Placebo): placebo daily for 3 weeks All groups will be followed for 24 weeks. Blood tests at baseline, week 1, week 2, and week 4 will measure inflammation. Neurological recovery will be assessed at weeks 4, 12, and 24 using the Glasgow Outcome Scale-Extended (GOS-E) and Modified Rankin Scale (mRS).\n\nThe main outcomes are changes in inflammatory markers. Secondary outcomes include mortality, functional recovery, hospital stay, safety, and cost-effectiveness.\n\nThe results may identify a low-cost, scalable treatment to improve outcomes after TBI, especially in low-resource settings.",[415,416],"Traumatic Brain Injury (TBI) Patients","Neuroinflammation",[418,416,419,420,421,422],"Traumatic Brain Injury (TBI)","Vitamin D3","Glasgow Outcome Scale - Extended (GOS-E)","Modified Rankin Scale (mRS)","Sub-Saharan Africa","2026-05-08",{"date":375,"type":36},{"date":426,"type":36},"2026-03-02",{"date":428,"type":22},"2028-12-30",{"name":430,"class":69},"Lagos State University",{"id":432,"slug":4,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":126,"sex":17,"minAge":339,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":227},"100550250","NCT06444633","The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea","The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea: a Cluster Randomized Controlled Trial in Bauchi, Nigeria","Inclusion Criteria:\n\n* At least 15 years old\n* Has at least one child under 5 at baseline\n* Proficiency in English or Hausa\n\nExclusion Criteria:\n\n* Living in a temporary home (nomadic population)\n* Does not speak English or Hausa\n* Unable to give informed consent",{"count":438,"type":22},103920,[163],"The aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. The primary research questions for the study are:\n\n* RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as \"the intervention\") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?\n* RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?\n* RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?\n\nAll wards in Bauchi state will be randomly assigned to one of two groups:\n\n* treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment\n* delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.\n\nA total of 1,732 enumeration areas (EAs) will be sampled across all wards for the study period. Within each EA, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.",[442],"Diarrhea Toddler",[444,445,446],"Oral Rehydration Salts","Child Diarrhea","Zinc",{"date":375,"type":36},{"date":449,"type":36},"2024-09-04",{"date":451,"type":22},"2027-04",{"name":453,"class":69},"RAND",{"id":455,"slug":4,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":51,"minAge":339,"maxAge":459,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":466,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":306},"100633490","NCT07527364","Evaluation of Changing the Scripts Intervention in Nigeria","Inclusion Criteria:\n\nAll eligibility criteria based on self-report:\n\n* Aged 15-44 years old at baseline\n* Female\n* Sexually active (based on self-report; i.e., in union)\n* Able to provide informed consent\n* Current residence in the selected intervention or comparison area\n\nExclusion Criteria:\n\n* Are not considered sexually active (i.e. not in union)\n* Are unable to provide consent\n* Are younger than 15 years and older than 44 years at baseline","44 Years",{"count":461,"type":22},4000,[163],"The Center on Gender Equity and Health is evaluating a multimedia social and behavior change (SBC) intervention in Kano and Kaduna states in Nigeria to assess its impact, cost-efficiency and how it works. The intervention, led by BBC Media Action, uses radio, TV, other media, community outreach and SBC approaches to increase women's and couples' ability to make and act on reproductive and family planning decisions. Over a three-year period (2025- 2028), we will use a mixed-methods prospective longitudinal cohort study design to meet the research objectives. This includes estimating the impact of the intervention on use and intent to use modern contraception (alone, when combined with other family planning programs, and among non-users), exploring the pathways through which the intervention increases contraceptive use, estimating the cost-efficiency of the intervention and, evaluating the sustainability of the intervention. Data will be collected from three states - Kano and Kaduna (intervention states) and Nasarawa (comparison state). Through this evaluation, we aim to contribute to the family planning and mass media SBC fields by strengthening the evidence on the impact of a multimedia SBC intervention as well as the additional impact of combining the intervention with family planning service delivery interventions.",[465],"Unintended Pregnancy Prevention",[467,468,469,470,471],"Contraceptive Use","Family Planning","Child Spacing","Multimedia Evaluation","Social and Behavior Change","2026-05-06",{"date":396,"type":36},{"date":475,"type":36},"2026-04-13",{"date":477,"type":22},"2028-10-31",{"name":479,"class":69},"University of California, San Diego",{"id":481,"slug":4,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":17,"minAge":103,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100433425","NCT04923958","Rapid Research in Diagnostics Development for TB Network","Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study","R2D2TB Network","Novel TB triage and diagnostic tests:\n\nWe will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:\n\nPositive TB screening definitions by risk factor:\n\n1. PLHIV (Risk Factor), CRP \\>5 mg\u002FdL OR abnormal CXR (Positive TB screening definition)\n2. Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)\n3. History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)\n\nWe will exclude people who:\n\n1. completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);\n2. have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);\n3. reside \\>20km from the study site or are unwilling to return for follow-up visits; or\n4. are unwilling to provide informed consent\n\nNovel TB rDST assays:\n\nWe will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB\u002FRIF, Xpert MTB\u002FRIF Ultra, or Hain MTBDRplus). We will exclude people who:\n\n1. have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures\n2. are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment\n3. are unable or unwilling to provide informed consent\n\nAssessment of the usability of novel TB tests:\n\nWe will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.",{"count":488,"type":22},26436,[163],"To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.",[291],[291,493,494],"Diagnostics","Global Health","2026-05-04",{"date":472,"type":36},{"date":498,"type":36},"2021-04-14",{"date":500,"type":22},"2031-05-31",{"name":502,"class":69},"University of California, San Francisco",16,{"id":505,"slug":4,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":70},"100421751","NCT04771871","MicroRNA Profiles in Triple Negative Breast Cancer","Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy","TARMAC","Inclusion Criteria:\n\n1. Women ages of 18 to 70 years old\n2. Women who give informed consent for the study\n3. Biopsy-accessible breast tumor of significant size for core needle biopsy\u002Fultrasound measurable (≥ 2cm)\n4. Patients with histologically confirmed carcinoma of the female breast with triple negative status by immuno-histochemistry (IHC)\n5. Clinical stages IIA -IIIC (AJCC 2009)\n6. Chemotherapy-naïve patients (for this malignancy)\n7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n8. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive Leuteinizing Hormone Realising Hormone (LHRH) agonist Zoladex (goserelin) for two years starting from the commencement of the study medications\n9. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:\n\n1\\. Granulocyte ≥ 1,500\u002FμL 2. Platelet count ≥ 100,000\u002FμL 3. Absolute neutrophil count (ANC) ≥ l500\u002FμL 4. Hemoglobin ≥ 10g\u002FdL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT \\\u003C 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL\u002Fmin\u002F1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (CKD EPI) equation (see http:\u002F\u002Fmdrd.com\u002F for calculator) 10. Echocardiogram (ECHO): Baseline left ventricular ejection fraction of ≥ 55%\n\nExclusion Criteria:\n\n1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.\n2. Patients with distant metastasis (brain and\u002For visceral metastasis)\n3. Serious, uncontrolled, concurrent infection(s).\n4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)\n5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment\n6. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","70 Years",{"count":513,"type":22},42,[25],"Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of Blacks affected and in younger age groups. There is no targeted therapy unlike other types of breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive subtypes. Chemotherapy is therefore the main choice of systemic treatment with rapid development of resistance in most cases. At present, there is no blood test to monitor treatment response and disease relapse. This one-stage phase II study with a single arm design will determine the response rate of standard chemotherapy using Epirubicin (60mg\u002Fm2), Cyclophosphamide (600mg\u002Fm2) , Paclitaxel (120mg\u002Fm2) and Carboplatin (6AUC) in TNBC patients. We will measure the blood level of microRNA molecules and circulating tumor DNA during and after treatment to test if changes can be used to indicate drug failure in these patients. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines while toxicity will be assessed using CTCAE v5). The trial will be conducted as per the International Council on Harmonisation Good Clinical Practice (ICH GCP) Guidelines E6 (R1) and other applicable guidelines",[517],"Triple Negative Breast Cancer",[519,520,521,522],"Breast cancer","neoadjuvant treatment","microRNA","circulating tumor cells","2026-04-30",{"date":525,"type":36},"2026-05-07",{"date":527,"type":36},"2021-11-29",{"date":529,"type":22},"2030-08",{"name":531,"class":69},"University College Hospital, Ibadan",{"id":533,"slug":4,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":553,"leadSponsor":555,"locationsCount":227},"100634715","NCT07543289","Hydroxyurea Optimisation in Sickle Cell Disease","Pharmacogenetics and Model-Informed Optimisation of Hydroxyurea Therapy in Sickle Cell Disease Patients of Nigerian Descent","PHOENIX-NG","Inclusion Criteria:\n\n* Patients with confirmed diagnosis of sickle cell disease (SCD) (e.g., HbSS, HbSC) and of Nigerian descent.\n* Patients currently on hydroxyurea therapy or hydroxyurea-naive patients who are willing to commence hydroxyurea therapy.\n* Patients whose genotypic profile for the major metabolising enzymes has been previously done e.g. CYP2D6.\n* Patients who consent to be part of the study\n\nExclusion Criteria:\n\n* Patients with severe comorbidities that may significantly alter pharmacokinetics (e.g., advanced renal or hepatic failure)\n* Patients in acute crisis at the time of sampling.\n* Patients with documented poor adherence to other medications previously on.\n* Pregnant females and lactating mothers.",{"count":540,"type":22},100,"The wide interindividual variability in clinical response to hydroxyurea therapy in the management of sickle cell disease has limited its use. These variabilities have been linked to differences in pharmacodynamics, pharmacokinetics, and pharmacogenetics. This study, therefore, aims to enhance understanding of these factors as they relate to hydroxyurea therapy, with the overall goal of developing a precision medicine algorithm.\n\nThe study will be a prospective cohort pharmacokinetic study of 100 Nigerian patients with sickle cell disease, including current hydroxyurea users and naive patients. Pharmacodynamic markers will be collected to evaluate response. PopPK and PK-PD models will be developed in Monolix, exposure-response relationships will be analysed in R, and pregnancy, lactation, and paediatrics PBPK models will be developed in Simcyp or PK-SIM to inform dose optimisation.\n\nThis study aims to build a pharmacometric model by integrating differences in pharmacokinetics, pharmacodynamics, and pharmacogenetics of hydroxyurea, which could aid the optimisation of hydroxyurea for sickle cell patients in Nigeria.\n\nThe objectives of the study are i. To determine the prevalence of genetic polymorphisms in metabolic enzymes and transporters relevant to the disposition of hydroxyurea in the Nigerian sickle cell disease population, ii. To develop and validate an analytical method for the quantification of hydroxyurea using high-performance liquid chromatography.\n\niii. To evaluate the influence of genetic and other covariates on hydroxyurea disposition in the Nigerian sickle cell disease population using population pharmacokinetic modelling, iv. To investigate the relationship between hydroxyurea exposure and clinical outcomes (foetal haemoglobin, mean corpuscular volume, reduction in vaso-occlusive crises (VOC), and improved blood count) using pharmacokinetic-pharmacodynamic modelling, v. To develop physiologically-based pharmacokinetic (PBPK) models that could predict hydroxyurea concentrations in special populations of sickle cell disease patients in Nigeria i.e. pregnant women, lactating mothers, breastfed infants, and paediatrics.\n\nvi. To develop a dosing guideline for hydroxyurea therapy in Nigerian sickle cell patients.\n\nOverall, this study will provide scientific knowledge that can enhance clinical decision-making in sickle cell management within the Nigerian population, and the models could serve as a template to optimize hydroxyurea use in this population.",[109],[544,545,546,547,548,549],"Modelling","Genetic Polymorphism","Pharmacokinetics","Clinical Outcomes","Hydroxyurea","Pharmacogenetics","2026-04-24",{"date":523,"type":36},{"date":423,"type":22},{"date":554,"type":22},"2027-03",{"name":556,"class":69},"Ochuko Orherhe",{"id":558,"slug":4,"hasResults":11,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":11,"sex":17,"minAge":564,"maxAge":52,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":578},"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":566,"type":22},95,[25],"This study is being done to learn about etavopivat, a once a day medicine taken by mouth in adolescents with sickle cell disease. The main goals are to study safety and how long etavopivat stays in the bloodstream, while also studying if there are benefits from taking etavopivat. Eligible participants who enter the study will start a 96-week treatment period. At the end of the 96 weeks, participants will have an end of study visit that occurs 4 weeks later. The participants will receive etavopivat every day throughout the treatment period.",[109],"2026-04-23",{"date":550,"type":36},{"date":573,"type":36},"2023-01-12",{"date":575,"type":22},"2029-08-08",{"name":577,"class":43},"Forma Therapeutics, Inc.",18,{"id":580,"slug":4,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":258,"minAge":52,"maxAge":4,"enrollmentInfo":585,"targetDuration":587,"studyType":130,"phases":4,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":601},"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",{"count":586,"type":22},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.",[590,591],"Benign Prostatic Hyperplasia","Lower Urinary Tract Symptoms",[593],"BPH, Registry, LUTS","2026-04-21",{"date":550,"type":36},{"date":597,"type":36},"2023-03-13",{"date":554,"type":22},{"name":600,"class":69},"Société Internationale d'Urologie",26,{"id":603,"slug":4,"hasResults":11,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":227},"100590520","NCT06968481","Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage","Phase 2, Open-label, Randomized, Dose Ascending Trial to Evaluate the Efficacy and Safety of Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage Caused by Uterine Atony in Term Pregnant Women With Uncomplicated Vaginal Delivery","Inclusion Criteria:\n\n1. Women willing and able to provide Informed consent.\n2. Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation \\\u003C6 cm).\n3. Healthy, primiparous or multiparous (2-4 deliveries), term-pregnant female with a gestational age of 37 to 42 weeks (inclusive). Gestational age should be confirmed with an obstetrical ultrasound if available.\n4. Aged between 18 and 40 years (both inclusive).\n5. Confirmed singleton pregnancy.\n6. Based on the Investigator assessment, maternal and fetal conditions are met to expect a vaginal delivery.\n7. For participants in the PK subgroup: women with baseline hemoglobin level ≥11 g\u002FdL.\n\nExclusion Criteria:\n\n1. Women who are unable to provide written Informed consent.\n2. Women undergoing an elective or emergency cesarean section.\n3. Conditions predisposing to uterine atony and PPH (e.g., previous PPH, placenta praevia, multiple gestation, severe pre-eclampsia, polyhydramnios, uterine fibroids, need for induction of labor, bleeding diathesis, sepsis, body mass index \\[BMI\\] ˃ 30 kg\u002Fm2 , macrosomia with estimated fetal weight \\>4500 g, if antenatal ultrasound was performed).\n4. Women with moderate or severe anemia (defined as Hb \\\u003C10 g\u002FdL).\n5. Women who have undergone female genital mutilation.\n6. Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial.\n7. Oral conditions before administration of sublingual oxytocin such as moderate erythema and edema, severe irritation\u002Finflammation, moderate or severe abrasion.\n8. Conditions predisposing to myocardial ischemia due to pre-existing cardiovascular diseases (such as hypertrophic cardiomyopathy, valvular heart disease and\u002For ischemic heart disease, including vasospasm of the coronary arteries) or known long QT syndrome or related symptoms.\n9. Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator (e.g., severe anemia, antepartum hemorrhage, mental disorder, history of cervical cancer or history of severe infection of the uterus, religious beliefs prohibiting blood transfusions).\n10. Previous surgery of the cervix or uterus or any other preexisting condition that could interfere with the measurement of uterine contractility.\n11. Current use or use within 30 days before the start of the IMP or reference product of one or more of predefined medications","40 Years",{"count":610,"type":22},330,[25],"An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery.",[614],"Post Partum Hemorrhage",[616,617,618,619,620,621,622],"sublingual oxytocin","oxytocin","post-partum hemorrhage","severe post-partum hemorrhage","SPPH","Prevention of post-partum hemorrhage","Efficacy and safety","2026-04-20",{"date":570,"type":36},{"date":626,"type":22},"2026-05-30",{"date":628,"type":22},"2026-10-30",{"name":630,"class":43},"Insud Pharma",{"id":632,"slug":4,"hasResults":11,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":126,"sex":17,"minAge":339,"maxAge":209,"enrollmentInfo":638,"targetDuration":4,"studyType":23,"phases":640,"briefSummary":641,"conditions":642,"keywords":644,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":655},"100583738","NCT06880224","Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness\u002FImplementation Hybrid Study","Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness\u002FImplementation Hybrid Study: Aim 2","iCARE Plus","Inclusion Criteria:\n\nHIV Case Finding Intervention:\n\n* Aged 15 to 24\n* Male birth sex of any current gender identity\n* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English For the PrEP component, must also be HIV-negative\n\nHIV Treatment Intervention:\n\n* Aged 15 to 24\n* HIV seropositive\n* Initiating ART for the first time at a Clinical Research Performance Site (CRPS) clinic or satellite clinic\n* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English\n* Intention to remain a CRPS patient during follow-up\n\nExclusion Criteria:\n\n* Unable to provide consent\n* No parental permission if aged 15 and not emancipated",{"count":639,"type":22},500,[163],"Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness\u002Fimplementation trials among youth aged 15-24 in Nigeria.",[643],"Adolescent HIV Infection",[645],"Adolescents, HIV Testing, HIV Treatment","2026-04-06",{"date":648,"type":36},"2026-04-08",{"date":650,"type":36},"2025-02-01",{"date":652,"type":22},"2028-08-31",{"name":654,"class":69},"Northwestern University",6,""]