RISP Search - Regulatory Information Discovery

Type	Title & Description	Details	Country	Status
Trial	Trial of a Novel Nutritional Supplement for Pregnant Women to Prevent Low Birth Weight Biologics - European Union Humanitarian Aid - Action Contre la Faim Madagascar	Mfr: European Union Humanitarian Aid Applicant: Action Contre la Faim Madagascar Sponsor: European Union Humanitarian Aid Cat: Biologics Type: Biologics 📅 Sep 18, 2024	● Madagascar	Recruiting
Trial	A multi-country, multi-centre, two arm, parallel, double blind, placebo controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low resource countries to improve newborn out Biologics - World Health Organization - Dr Idowu Ayede	Mfr: World Health Organization Applicant: Dr Idowu Ayede Sponsor: World Health Organization Cat: Biologics Type: Biologics	—	Approved
Trial	A multi-country, multi-centre, two arm, parallel, double blind, placebo- controlled, randomized trial of antenatal corticosteriods for women at risk of imminent birth in the late preterm period in hospitals in low resource countries to improve newborn out Drug - Department of Reproductive Health & Research, World Health Organisation - Dr Adejumoke Idowu Ayede	Mfr: Department of Reproductive Health & Research, World Health Organisation Applicant: Dr Adejumoke Idowu Ayede Sponsor: Department of Reproductive Health & Research, World Health Organisation Cat: Drug Type: Drug	—	Approved
Trial	A multi-country, multi-centre, two-arm, parallel, double blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low resource countries to improve newborn out Drug - World Health Organization - Prof Oluwafemi Kuti	Mfr: World Health Organization Applicant: Prof Oluwafemi Kuti Sponsor: World Health Organization Cat: Drug Type: Drug	—	Approved
Trial	A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteriods for women at risk of imminent birth in the late preterm period in hospitals in low-resource countries to improve newborn outc Drug - World Health Organization - Prof Olufemi Kuti	Mfr: World Health Organization Applicant: Prof Olufemi Kuti Sponsor: World Health Organization Cat: Drug Type: Drug	—	Approved
Trial	A Multicentre, Double blind, Randomized, parallel group, clinical trial to compare the sexual pleasure, performance, acceptability and safety of Graphene incorporated natural rubber latex condoms and natural rubber latex compounds in healthy humans. Vaccine - The George Institute for Global Health, - Xcene Research Ltd	Mfr: The George Institute for Global Health, Applicant: Xcene Research Ltd Sponsor: The George Institute for Global Health, Cat: Vaccine Type: Vaccine	—	Approved
Trial	A Phase 2/3 Trial of a New Oral Cholera Vaccine in High-Risk Populations Vaccine - Gavi, the Vaccine Alliance, International Vaccine Institute - African Medical Research Foundation (AMREF) Somalia	Mfr: Gavi, the Vaccine Alliance, International Vaccine Institute Applicant: African Medical Research Foundation (AMREF) Somalia Sponsor: Gavi, the Vaccine Alliance, International Vaccine Institute Cat: Vaccine Type: Vaccine 📅 Aug 30, 2024	● Somalia	Active
Trial	A phase III, randomised, double-blind, active, controlled, multinational, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering v Drug - Department of Reproductive Health & Research, World Health Organization - Dr Bukola Fawole	Mfr: Department of Reproductive Health & Research, World Health Organization Applicant: Dr Bukola Fawole Sponsor: Department of Reproductive Health & Research, World Health Organization Cat: Drug Type: Drug	—	Approved
Trial	A phase III, randomized, double blind, active, controlled, multi national, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of post partum haemorrhage during the third stage of labour in women delivering Drug - Department of Reproductive Heath & Research, World Health Organization - Dr Bukola Fawole	Mfr: Department of Reproductive Heath & Research, World Health Organization Applicant: Dr Bukola Fawole Sponsor: Department of Reproductive Heath & Research, World Health Organization Cat: Drug Type: Drug	—	Approved
Trial	A Phase IIIB/IV Randomized Open-label Trial Comparing Dolutegravir with Predetermined Nucleosides Versus Recommended Standard of Care ART R regimens in Patients with HIV-1 Infection Failing First Line Therapy Drug - University of New South Wales - The Institute of Human Virology-IHVN	Mfr: University of New South Wales Applicant: The Institute of Human Virology-IHVN Sponsor: University of New South Wales Cat: Drug Type: Drug	—	Approved
Trial	A randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events Vaccine - McMaster University - Prof Kamilu M. Karaye	Mfr: McMaster University Applicant: Prof Kamilu M. Karaye Sponsor: McMaster University Cat: Vaccine Type: Vaccine	—	Approved
Trial	An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel group, randomized controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination Drug - The George Institute for Global Health - Xcene Research Ltd	Mfr: The George Institute for Global Health Applicant: Xcene Research Ltd Sponsor: The George Institute for Global Health Cat: Drug Type: Drug	—	Approved
Trial	ClustEr randomised Trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low and middle income counties (LMICs) Procedure - University of Birmingham - NIHR GSU Lagos Hub, College of Medicine, University of lagos	Mfr: University of Birmingham Applicant: NIHR GSU Lagos Hub, College of Medicine, University of lagos Sponsor: University of Birmingham Cat: Procedure Type: Procedure	—	Approved
Trial	Implementation Trial of a New Maternity Care Bundle to Reduce Postpartum Hemorrhage Procedure - UNFPA, University of Montreal - UNFPA Burundi	Mfr: UNFPA, University of Montreal Applicant: UNFPA Burundi Sponsor: UNFPA, University of Montreal Cat: Procedure Type: Procedure 📅 Feb 06, 2026	—	Active
Trial	Investigation of Rheumatic AF Treatment Using Vitamin K antagonists, Rivaroxaban or Aspirin Studies (INVICTUS Trials) Drug - Hamilton Health Science, Hamilton, Ontario, Canada - Dr. Okechwukwu S. Ogah	Mfr: Hamilton Health Science, Hamilton, Ontario, Canada Applicant: Dr. Okechwukwu S. Ogah Sponsor: Hamilton Health Science, Hamilton, Ontario, Canada Cat: Drug Type: Drug	—	Approved
Trial	Pragmatic multicentre Factorial randomized controlled trial testing measures of reducing surgical site infection in low and middle income countries Procedure - University of Birmingham - NIHR GSU Lagos Hub, College of Medicine, University of Lagos	Mfr: University of Birmingham Applicant: NIHR GSU Lagos Hub, College of Medicine, University of Lagos Sponsor: University of Birmingham Cat: Procedure Type: Procedure	—	Approved
Trial	Primary Prevention of Stroke in Nigerian Children with Sickle Cell Disease in Sub Saharan Africa II: a partial double blind randomized Phase III clinical trial Drug - Vanderbilt University School of Medicine - Aminu Kano Teaching Hospital	Mfr: Vanderbilt University School of Medicine Applicant: Aminu Kano Teaching Hospital Sponsor: Vanderbilt University School of Medicine Cat: Drug Type: Drug	—	Approved
Trial	Tranexamic acid for the treatment of gastrointestinal bleeding: an international randomised, double blind placebo control trial Drug - London School of Hygiene & Tropical Medicine - Prof. Bukonla Fawole	Mfr: London School of Hygiene & Tropical Medicine Applicant: Prof. Bukonla Fawole Sponsor: London School of Hygiene & Tropical Medicine Cat: Drug Type: Drug	—	Approved
Trial	Traxenamic acid for reducing postpartum bleeding in women with anaemia: an international, randomized, double blind, placebo controlled trial.b Drug - London School of Hygiene and Tropical Medicine - Prof Oladapo Olayemi	Mfr: London School of Hygiene and Tropical Medicine Applicant: Prof Oladapo Olayemi Sponsor: London School of Hygiene and Tropical Medicine Cat: Drug Type: Drug	—	Approved
Trial	Traxenamic acid for the treatment of postpartum haemorrhage: An international, randomised, double blind placebo controlled trial Drug - London School of Hygiene & Tropical Medicine - Prof Bukola Fawole	Mfr: London School of Hygiene & Tropical Medicine Applicant: Prof Bukola Fawole Sponsor: London School of Hygiene & Tropical Medicine Cat: Drug Type: Drug	—	Approved

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