| Carlo, Waldemar A |
NCT06518603: Caffeine Citrate in Preterm Infants At Risk of Apnea in Zambia |
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| Not yet recruiting | 4 | 340 | RoW | Caffeine citrate 20mg/kg/day, Placebo-Sterile water 1ml/kg/day | University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, Centre for Infectious Disease Research in Zambia | Premature Infant Disease, Apnea of Prematurity, Development, Infant | 12/25 | 11/26 | | |
| Active, not recruiting | 3 | 1824 | US | Liberal Cell Transfusion, Restricted red cell transfusion | NICHD Neonatal Research Network, National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD), Anemia | 01/20 | 08/25 | | |
| Active, not recruiting | 3 | 800 | US | Hydrocortisone, Placebo | NICHD Neonatal Research Network, National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS) | Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature, Bronchopulmonary Dysplasia | 09/20 | 01/25 | | |
| Terminated | 3 | 827 | US | Caffeine Citrate, Placebo | NICHD Neonatal Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Apnea of Prematurity | 01/23 | 03/23 | | |
NCT04214834: Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) |
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| Active, not recruiting | 3 | 190 | US | Morphine, Methadone | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Neonatal Opioid Withdrawal Syndrome | 01/24 | 06/26 | | |
| Not yet recruiting | 3 | 316 | US | Milrinone infusion, Placebo infusion | NICHD Neonatal Research Network, National Heart, Lung, and Blood Institute (NHLBI) | Post-ligation Cardiac Syndrome | 06/27 | 08/29 | | |
| Active, not recruiting | 3 | 1160 | US | budesonide (Pulmicort nebulizing suspension)., Pulmicort nebulizing suspension., surfactant (poractant alfa;Curosurf), poractant alfa;Curosurf | NICHD Neonatal Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal | 09/24 | 12/26 | | |
| Active, not recruiting | 3 | 836 | US | Active Treatment, Expectant Management | NICHD Neonatal Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth | 04/25 | 05/27 | | |
MIDAS, NCT03231735: Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome |
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| Completed | 2/3 | 60 | US | Mid frequency ventilation, Standard frequency ventilation | University of Alabama at Birmingham, University of South Alabama | Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Preterm Infant | 11/21 | 10/24 | | |
NCT03779711: Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome |
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| Active, not recruiting | 2b | 95 | US | Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair | Timothy J Nelson, MD, PhD, University of Oklahoma, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, Children's Hospital Colorado, Children's Hospitals and Clinics of Minnesota, Ochsner Health System, Children's of Alabama, Children's Hospital Medical Center, Cincinnati | Hypoplastic Left Heart Syndrome | 05/22 | 02/26 | | |
| Active, not recruiting | 2 | 66 | US | Milrinone, Milrinone Lactate Injection, Primacor, Placebo (5% Dextrose), D5W | NICHD Neonatal Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Congenital Diaphragmatic Hernia, Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure, Pulmonary Hypoplasia | 09/24 | 03/25 | | |
| Not yet recruiting | 2 | 1000 | RoW | Sildenafil 50 mg Oral Tablet, Revatio, Sildenafil, Placebo Oral Tablet | University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, Egerton University, Cameroon Baptist Convention Health | Neonatal Asphyxia, Intrapartum Fetal Distress, Development, Infant, Intrapartum Asphyxia | 08/26 | 09/28 | | |
NCT06522854: Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings |
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| Not yet recruiting | 2 | 2000 | RoW | Sildenafil 50 mg Oral Tablet, Revatio, Placebo Oral Tablet | University of Alabama at Birmingham, University of Lagos, Nigeria, Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso, Lagos State University, National Health and Medical Research Council, Australia, Mater Medical Research Institute, The University of Queensland | Intrapartum Fetal Distress, Neonatal Asphyxia, Intrapartum Asphyxia, Instrumental Delivery; Affecting Fetus | 05/26 | 11/26 | | |
NCT04907526: Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD |
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| Active, not recruiting | 1 | 30 | US | Autologous mononuclear cells | Timothy J Nelson, MD, PhD, Mayo Clinic, University of Oklahoma, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, Children's Hospitals and Clinics of Minnesota, Children's Hospital Colorado, Ochsner Health System, Children's of Alabama, Children's Hospital Medical Center, Cincinnati, The Hospital for Sick Children | Congenital Heart Disease, SRV Dependent | 05/23 | 06/25 | | |
NCT05403684: Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia |
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| Completed | N/A | 214 | RoW | High-volume breastmilk | University of Alabama at Birmingham, Centre for Infectious Disease Research in Zambia, Chiesi Foundation | Postnatal Growth Restriction | 12/22 | 02/23 | | |
COCO, NCT04792099: CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial |
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| Completed | N/A | 38 | US | Continuous positive airway pressure, CPAP, Nasal Cannula, NC | University of Alabama at Birmingham | Infant, Newborn, Disease, Hypoxia, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia | 03/23 | 03/23 | | |
| Recruiting | N/A | 950000 | US, RoW | There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery. | NICHD Global Network for Women's and Children's Health | Pregnancy Outcome Trends in Low-resource Geographic Areas | 01/25 | 01/25 | | |
NCT01604317: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I |
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| Active, not recruiting | N/A | 182 | RoW | Resuscitation-torso plastic bag, Resuscitation-partial-head plastic bag | University of Alabama at Birmingham, Children's Health System, Alabama | Hypothermia, Immature Newborn | 08/25 | 08/25 | | |
| Recruiting | N/A | 188 | US | Finger puppet, Bookworm reading intervention training and routine EDI care. | University of Alabama at Birmingham | Child Development, Infant Development, Infant, Premature, Diseases | 08/26 | 08/28 | | |
| Recruiting | N/A | 1700 | US | Phototherapy lights | NICHD Neonatal Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Hyper Bilirubinemia, Premature Infant | 07/25 | 07/25 | | |
NPC-QIC, NCT02852031: National Collaborative to Improve Care of Children With Complex Congenital Heart Disease |
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| Recruiting | N/A | 1000 | Europe, Canada, US | Collaborative Learning Network | Children's Hospital Medical Center, Cincinnati | Hypoplastic Left Heart Syndrome (HLHS) | 05/26 | 05/28 | | |
NCT00063063: Generic Database of Very Low Birth Weight Infants |
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| Recruiting | N/A | 80000 | US | | NICHD Neonatal Research Network, National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature | 03/30 | 03/30 | | |
| Recruiting | N/A | 68000 | US | | NICHD Neonatal Research Network, National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature | 03/30 | 03/30 | | |
| Chomba, Elwyn |
ABLE, NCT06723392: Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries |
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| Not yet recruiting | 3 | 1134 | RoW | Oral nitrofurantoin monohydrate/macrocrystals, Placebo | NICHD Global Network for Women's and Children's Health, RTI International, University of Virginia, University of Alabama at Birmingham, Thomas Jefferson University, Columbia University, Boston University, University of Colorado, Denver, University of North Carolina, Chapel Hill, International Centre for Diarrhoeal Disease Research, Bangladesh, Kinshasa School of Public Health, Institute of Nutrition of Central America and Panama, Lata Medical Research Foundation, Nagpur, Aga Khan University, University Teaching Hospital, Lusaka, Zambia, KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India | Preterm Birth, Small for Gestational Age (SGA), Stillbirth, Bacteriuria (asymptomatic) in Pregnancy | 06/28 | 08/28 | | |
| Recruiting | 3 | 4800 | RoW | IV iron infusion, Oral iron tablets | NICHD Global Network for Women's and Children's Health, Thomas Jefferson University, University of North Carolina, Chapel Hill, Kinshasa School of Public Health, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of Colorado, Denver, Institute of Nutrition of Central America and Panama, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Columbia University, Aga Khan University, Boston University, Lata Medical Research Foundation, Nagpur, Indiana University, Moi University, RTI International, Bill and Melinda Gates Foundation, KLE University Jawaharlal Nehru Medical College | Postpartum Anemia | 10/25 | 12/25 | | |
| Not yet recruiting | 2 | 1000 | RoW | Sildenafil 50 mg Oral Tablet, Revatio, Sildenafil, Placebo Oral Tablet | University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, Egerton University, Cameroon Baptist Convention Health | Neonatal Asphyxia, Intrapartum Fetal Distress, Development, Infant, Intrapartum Asphyxia | 08/26 | 09/28 | | |
| Recruiting | N/A | 950000 | US, RoW | There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery. | NICHD Global Network for Women's and Children's Health | Pregnancy Outcome Trends in Low-resource Geographic Areas | 01/25 | 01/25 | | |
PRISM, NCT05946681: Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings |
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| Completed | N/A | 1017 | RoW | | NICHD Global Network for Women's and Children's Health, Global Network for Women's and Children's Health Research, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, RTI International | Fetal Distress, Perinatal Asphyxia, Birth Asphyxia, Stillbirth | 10/23 | 12/23 | | |
| Kelly, Paul M |
| Active, not recruiting | 3 | 1100 | Europe, Canada, US, RoW | Darolutamide, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy | University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, Cancer Trials Ireland, Canadian Cancer Trials Group, Memorial Sloan Kettering Cancer Center, Prostate Cancer Clinical Trials Consortium | Prostate Cancer | 01/28 | 07/28 | | |
| Recruiting | 3 | 1128 | Europe, RoW | SBRT, SABR | Institute of Cancer Research, United Kingdom, Prostate Cancer UK | Prostate Cancer | 06/28 | 06/30 | | |
EMP, NCT05608928: Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia |
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| Not yet recruiting | 2 | 76 | RoW | VSL#3, Vivomixx, Capscan device, capstan, Placebo | Tropical Gastroenterology & Nutrition Group (TROPGAN), Bill and Melinda Gates Foundation | Environmental Enteropathy | 05/23 | 06/23 | | |
Spine-SABR, NCT06078813: Spine SABR - Dose-escalated Stereotactic Ablative Body Radiotherapy (SABR) for Solid Tumour Spine Metastases |
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| Recruiting | 1/2 | 126 | Europe | Radiation: image guided dose escalated SABR using a simultaneous integrated boost (SIB) | Cancer Trials Ireland | Solid Tumor Spine Metastases | 08/28 | 04/34 | | |
SBT4EE, NCT04109352: Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy |
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| Recruiting | N/A | 600 | Europe, RoW | | University of Virginia, International Atomic Energy Agency, Flinders University, International Centre for Diarrhoeal Disease Research, Bangladesh, St. John's Research Institute, The University of The West Indies, Mmust Masinde Muliro University of Science and Technology, Asociacion Benefica Prisma, Scottish Universities Environmental Research Centre, University of Michigan, Tropical Diseases Research Centre, Zambia, Gastroenterology Services, Ltd. | Glucose-Galactose Malabsorption, Enteropathy, Malnutrition, Child, Intestinal Permeability, Linear Growth Failure | 07/22 | 12/22 | | |
SABRE, NCT04905069: Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy |
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| Recruiting | N/A | 500 | Europe, US, RoW | SpaceOAR Vue System | Boston Scientific Corporation | Prostate Cancer | 04/27 | 04/30 | | |
SABR-COMET-3, NCT03862911: Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer |
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| Recruiting | N/A | 330 | Europe, Canada, RoW | palliative radiotherapy, Stereotactic ablative radiotherapy | British Columbia Cancer Agency, London Regional Cancer Program, Canada, The Alfred, Beacon Hospital, Ireland, Cancer Trials Ireland, Cancer Research UK Edinburgh Centre, Bon Secours Cork Cancer Centre, UPMC Hillman Cancer Centre, Beatson West of Scotland Cancer Centre, Tom Baker Cancer Centre, Walker Family Cancer Centre, Riverina Cancer Care Centre | Metastatic Tumors | 09/30 | 09/30 | | |
SAMPA, NCT05361148: Long-term Health After Severe Acute Malnutrition in Children and Adults: the Role of the Pancreas |
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| Recruiting | N/A | 3700 | RoW | no interventions will be used | London School of Hygiene and Tropical Medicine, Newcastle University, UK, University of Copenhagen, National Institute for Medical Research, Tanzania, Nutrition Centre of the Philippines, University Teaching Hospital, Lusaka, Zambia, Delhi University | Pancreas Atrophy, Diabetes, Malnutrition | 04/24 | 10/24 | | |
| Carlo, Wally A |
| Recruiting | 3 | 4800 | RoW | IV iron infusion, Oral iron tablets | NICHD Global Network for Women's and Children's Health, Thomas Jefferson University, University of North Carolina, Chapel Hill, Kinshasa School of Public Health, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of Colorado, Denver, Institute of Nutrition of Central America and Panama, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Columbia University, Aga Khan University, Boston University, Lata Medical Research Foundation, Nagpur, Indiana University, Moi University, RTI International, Bill and Melinda Gates Foundation, KLE University Jawaharlal Nehru Medical College | Postpartum Anemia | 10/25 | 12/25 | | |
NCT02742454: VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants |
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| Active, not recruiting | N/A | 570 | Canada, US | Standard 30-60 Seconds Cord Clamping, VentFirst 120 Seconds Cord Clamping | University of Virginia, Brigham and Women's Hospital, Mayo Clinic, St. Louis University, University of Colorado, Denver, Oregon Health and Science University, University of Calgary, Columbia University, Indiana University, University of California, Davis, University of Alberta, University of Alabama at Birmingham | Intraventricular Hemorrhage | 03/23 | 12/23 | | |
P3OPPY, NCT06510075: Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial |
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| Recruiting | N/A | 400 | US | Digital Health intervention, DHI, Community Health Worker, CHW, Digital Health Intervention plus Community Health Worker, DHI plus CHW | University of Alabama at Birmingham, American Heart Association, ConnectionHealth, Memora Health | Pregnancy Complications, Maternal Distress, Adverse Birth Outcomes, Infant Conditions | 07/26 | 01/27 | | |
PREMOD2FU, NCT03476980: Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping) |
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| Recruiting | N/A | 1200 | Europe, Canada, US | Randomized to Umbilical Cord Milking at birth, UCM, Randomized to Delayed Cord Clamping at birth, DCC | Sharp HealthCare, Sharp Mary Birch Hospital for Women & Newborns, Loma Linda University, University of Pittsburgh, Providence Hospital, University of Alabama at Birmingham, University of Alberta, University College Cork, University of Ulm, Christiana Care Health Services, Thrasher Research Fund, Sharp Grossmont Hospital, University of Utah, University of Mississippi Medical Center, PIH Health Good Samaritan Hospital, University of California, Irvine, Children's Hospital Medical Center, Cincinnati, John H. Stroger Hospital, St. Louis University, LAC+USC Medical Center | Neurodevelopmental Abnormality | 12/24 | 12/24 | | |
| Ambalavanan, Namasivayam |
NCT04214834: Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) |
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| Active, not recruiting | 3 | 190 | US | Morphine, Methadone | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Neonatal Opioid Withdrawal Syndrome | 01/24 | 06/26 | | |
OPTimize NOW, NCT05980260: Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (): A Symptom-Based Dosing Approach |
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| Recruiting | 3 | 480 | US | Symptom-based Dosing Approach, Scheduled Opioid Taper Approach | HELP for NOWS Consortium, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Neonatal Opiate Withdrawal Syndrome | 04/25 | 06/25 | | |
| Active, not recruiting | 3 | 1160 | US | budesonide (Pulmicort nebulizing suspension)., Pulmicort nebulizing suspension., surfactant (poractant alfa;Curosurf), poractant alfa;Curosurf | NICHD Neonatal Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal | 09/24 | 12/26 | | |
OBOE, NCT04149509: ACT NOW Longitudinal Study: Outcomes of Babies with Opioid Exposure Study |
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| Active, not recruiting | N/A | 300 | US | | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Neonatal Opioid Withdrawal Syndrome | 12/26 | 12/26 | | |
| Recruiting | N/A | 1098 | US | Non-invasive forced airway oscillometry | University of Alabama at Birmingham | Infant, Premature, Diseases, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Newborn, Meconium Aspiration Syndrome, Transient Tachypnea of the Newborn | 05/25 | 05/27 | | |
| Krebs, Nancy F |
| Recruiting | 3 | 4800 | RoW | IV iron infusion, Oral iron tablets | NICHD Global Network for Women's and Children's Health, Thomas Jefferson University, University of North Carolina, Chapel Hill, Kinshasa School of Public Health, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of Colorado, Denver, Institute of Nutrition of Central America and Panama, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Columbia University, Aga Khan University, Boston University, Lata Medical Research Foundation, Nagpur, Indiana University, Moi University, RTI International, Bill and Melinda Gates Foundation, KLE University Jawaharlal Nehru Medical College | Postpartum Anemia | 10/25 | 12/25 | | |
| Recruiting | N/A | 950000 | US, RoW | There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery. | NICHD Global Network for Women's and Children's Health | Pregnancy Outcome Trends in Low-resource Geographic Areas | 01/25 | 01/25 | | |
Mini-MED, NCT05500976: Metabolomics Initiative: Mediterranean-amplified vs Habitual Western Diet on Food Signatures, Health, and Microbiome |
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| Active, not recruiting | N/A | 22 | US | Semi-controlled dietary intervention - Western, Semi-controlled dietary intervention - MiniMed | University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cattlemen's Beef Association, Purdue University | Dietary Habits | 03/25 | 03/25 | | |
| Recruiting | N/A | 56 | RoW | Biofortified maize, Placebo | University of Colorado, Denver, Institute of Nutrition of Central America and Panama, Semilla Nueva | Zinc Absorption, Iron Absorption | 06/25 | 09/26 | | |
| Investigator, Principal |
| Completed | 4 | 144 | Europe | Opicapone 50 mg, BIA 9-1067, Placebo | Bial - Portela C S.A., Bial - Portela & Ca, S.A. | Parkinson Disease | 02/24 | 02/24 | | |
NCT04248205: Ketamine for Post-operative Analgesia in Hemorrhoidectomy |
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| Recruiting | 4 | 100 | US | Ketamine | University of Oklahoma | Hemorrhoids | 01/25 | 07/25 | | |
NCT05400369: A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease |
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| Completed | 4 | 140 | RoW | Sitafloxacin, Gracevit, Moxifloxacin Hydrochloride, Avelox | Daiichi Sankyo | COPD Exacerbation Acute | 09/24 | 09/24 | | |
TrEAT_TD2, NCT05677282: Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, with Loperamide Adjunct |
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| Recruiting | 4 | 150 | RoW | Rifaximin 550 MG, Azithromycin 500 MG, Loperamide | Henry M. Jackson Foundation for the Advancement of Military Medicine, Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences | Diarrhoea;Acute, Diarrhea Travelers | 09/25 | 12/25 | | |
NCT06397781: Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients |
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| Not yet recruiting | 4 | 100 | US | Skin Cleanser Combination No.1 | Boston Children's Hospital | Atopic Dermatitis | 12/28 | 12/28 | | |
NCT06793358: Use of Remimazolam and Fentanyl for Procedural Sedation in Patients Undergoing Dental Extraction |
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| Not yet recruiting | 4 | 40 | US | fentanyl and Remimazolam | Indiana University, Indiana University Health | Dental Extraction | 01/26 | 03/26 | | |
POUR, NCT04994431: Post-Operative Urinary Retention () in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin |
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| Terminated | 4 | 109 | US | Tamsulosin Hydrochloride | University of Massachusetts, Worcester, UMass Memorial Health Care | Thoracic Diseases, Urinary Retention | 10/23 | 10/23 | | |
NCT02932410 / 2016-001062-28: A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) |
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| Active, not recruiting | 3 | 165 | Europe, Canada, US, RoW | Macitentan, ACT-064992, Standard-of-care | Actelion | Pulmonary Arterial Hypertension | 08/24 | 07/25 | | |
| Active, not recruiting | 3 | 590 | Europe, Canada, Japan, US, RoW | DS-1062a, Datopotamab deruxtecan (Dato-DXd), Docetaxel | Daiichi Sankyo, AstraZeneca | Non-small Cell Lung Cancer | 05/24 | 06/25 | | |
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IDeate-Lung02, NCT06203210: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer |
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| Recruiting | 3 | 540 | Europe, Canada, Japan, US, RoW | Ifinatamab deruxtecan, I-DXd, Topotecan, Amrubicin, Lurbinectedin | Daiichi Sankyo, Merck Sharp & Dohme LLC | Small Cell Lung Cancer | 04/27 | 02/29 | | |
TNX-N, NCT03503136: Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC |
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| Not yet recruiting | 3 | 632 | RoW | docetaxel, nedaplatin, and capecitabine, TNX induction chemotherapy, nedaplatin, N, docetaxel, cisplatin, and fluorouracil, TPF induction chemotherapy, cisplatin, P, docetaxel, cisplatin, and capecitabine, TPX induction chemotherapy, docetaxel, nedaplatin, and fluorouracil, TNF induction chemotherapy | Sun Yat-sen University, Tongji Hospital, Wuhan Union Hospital, China, Peking University, Air Force Military Medical University, China, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital of Guangdong Pharmaceutical University, First People's Hospital of Foshan, Fifth Affiliated Hospital, Sun Yat-Sen University, Cancer Hospital of Guizhou Province, Xiangya Hospital of Central South University, Jilin Provincial Tumor Hospital, Henan Cancer Hospital, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhejiang Cancer Hospital | Nasopharyngeal Carcinoma | 06/24 | 06/26 | | |
NCT05839899: Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location |
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| Recruiting | 3 | 50 | US | Mifepristone plus one dose Misoprostol, Mifepristone plus two doses Misoprostol | Planned Parenthood League of Massachusetts | Abortion | 07/24 | 09/24 | | |
| Active, not recruiting | 3 | 586 | Europe, Canada, Japan, US, RoW | Patritumab Deruxtecan, HER3-DXd, U3-1402, Platinum-based chemotherapy | Daiichi Sankyo, Merck Sharp & Dohme LLC | Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion | 05/24 | 06/26 | | |
CYPRESS, NCT05696717: Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic NOH in Participants with Multiple System Atrophy |
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| Recruiting | 3 | 102 | Europe, Canada, US, RoW | Ampreloxetine, TD-9855, Placebo | Theravance Biopharma | Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy | 12/24 | 01/27 | | |
NCT06672016: Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential |
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| Not yet recruiting | 3 | 1500 | US | Transdermal system containing progestin | Mylan Pharmaceuticals Inc | Female Contraception | 03/27 | 04/27 | | |
| Not yet recruiting | 3 | 615 | RoW | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection | Beijing VDJBio Co., LTD. | Rheumatoid Arthritis (RA) | 12/25 | 12/26 | | |
LIBERTY, NCT06716814: Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa |
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| Not yet recruiting | 3 | 78 | Europe | Efanesoctocog alfa, BIVV001, Altuvoct, Altuviiio, Recombinant coagulation factor VIII Fc-von-Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN) | Swedish Orphan Biovitrum, PSI CRO | Severe Haemophilia A | 08/26 | 08/26 | | |
| Active, not recruiting | 3 | 899 | Europe, Canada, Japan, US, RoW | Tafasitamab, Monjuvi, Lenalidomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Tafasitamab placebo, Lenalidomide placebo | Incyte Corporation | Diffuse Large B-cell Lymphoma | 06/25 | 05/26 | | |
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| Completed | 3 | 1 | US | StrataGraft | Stratatech, a Mallinckrodt Company, Biomedical Advanced Research and Development Authority | Skin Wound, Burns, Trauma-related Wound | 05/24 | 05/24 | | |
| Active, not recruiting | 3 | 490 | Europe, Japan, RoW | Trastuzumab deruxtecan, T-DXd, DS-8201a, ENHERTU®, Ramucirumab, CYRAMZA®, Paclitaxel | Daiichi Sankyo, AstraZeneca | Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma | 10/25 | 02/26 | | |
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NCT05847348: 68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients |
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| Recruiting | 3 | 110 | RoW | 68Ga-PSMA-11, Illucix, gallium Ga 68 Gozetotide, PET/CT or PET/MRI, Imaging by PET | Telix Pharmaceuticals (Innovations) Pty Limited, Grand Pharmaceutical (China) Co., Ltd. | Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer, BCR Prostate Carcinoma | 12/25 | 07/26 | | |
| Active, not recruiting | 3 | 1600 | Europe, Canada, Japan, US, RoW | DS-8201a, Trastuzumab deruxtecan (T-DXd), T-DM1, Trastuzumab emtansine (T-DM1) | Daiichi Sankyo, AstraZeneca, NSABP Foundation Inc, German Breast Group, Spanish Breast Cancer Research Group (SOLTI) | HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer | 12/25 | 12/30 | | |
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FREEDOM, NCT05817812: A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa |
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| Active, not recruiting | 3 | 93 | Europe, RoW | Efanesoctocog alfa, BIVV001 | Swedish Orphan Biovitrum, Syneos Health | Hemophilia A, Severe | 05/26 | 05/26 | | |
TROPION-Lung07, NCT05555732: Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer |
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| Recruiting | 3 | 1170 | Europe, Canada, Japan, US, RoW | Datopotamab Deruxtecan, Dato-DXd, Pembrolizumab, KEYTRUDA®, Pemetrexed, Alimta, Pemfexy, Carboplatin, Cisplatin | Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme LLC | Metastatic Non Small Cell Lung Cancer | 08/27 | 08/27 | | |
DESTINY-Breast15, NCT05950945: Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer |
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| Recruiting | 3 | 250 | Europe, US, RoW | Trastuzumab Deruxtecan, T-DXd, DS-8201a (trastuzumab derextecan), Enhertu® | Daiichi Sankyo, AstraZeneca | Breast Cancer | 10/27 | 10/27 | | |
| Recruiting | 3 | 740 | Europe, Canada, Japan, US, RoW | Datopotamab Deruxtecan, Dato-DXd, Pembrolizumab, KEYTRUDA® | Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme LLC | Metastatic Non Small Cell Lung Cancer | 02/28 | 04/28 | | |
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ARTEMIS, NCT04797884: Electromagnetic Fields Versus Placebo For Child-Pugh A and B Patients With Advanced Hepatocellular Carcinoma |
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| Recruiting | 2/3 | 166 | US | TheraBionic Device, Placebo Device, Quality of Life Assessment | THERABIONIC INC., National Cancer Institute (NCI) | Hepatocellular Carcinoma | 10/24 | 10/24 | | |
FORTIFI-HN01, NCT06788990: a Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC |
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| Recruiting | 2/3 | 650 | US | Ficerafusp alfa, Pembrolizumab (KEYTRUDA®), Placebo | Bicara Therapeutics | Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma | 04/28 | 07/29 | | |
TRIPHASE, NCT06101745: Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery |
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| Recruiting | 2/3 | 336 | Europe | Nizaracianine Triflutate, ZW800-1, Placebo Comparator, Sugar | Curadel Surgical Innovations, Inc., Leiden University Medical Center, Erasmus Medical Center | Injury of Ureter During Surgery (Disorder) | 10/25 | 11/25 | | |
| Terminated | 2 | 16 | Europe, Canada, US, RoW | Belcesiran, Placebo | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | Alpha 1-Antitrypsin Deficiency | 12/23 | 05/24 | | |
AAVIATE, NCT04514653: RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) |
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| Recruiting | 2 | 115 | US | Ranibizumab, RGX-314 Dose 1, Combination Product, RGX-314 Dose 2, RGX-314 Dose 3, Local Steroid, Topical Steroid | AbbVie, AbbVie | Neovascular Age-Related Macular Degeneration (nAMD) | 10/25 | 08/26 | | |
| Completed | 2 | 60 | US | RGX-314 | AbbVie | Neovascular Age-related Macular Degeneration, Wet Macular Degeneration, Wet Age-related Macular Degeneration | 10/23 | 03/24 | | |
Orchid 1, NCT06132919: Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS) |
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| Recruiting | 2 | 40 | Europe | MC2-25 cream, MC2-25 vehicle | MC2 Therapeutics | Vulvar Lichen Sclerosus | 11/24 | 11/24 | | |
| Completed | 2 | 13 | US | AG Tx, Meshed Autograft, SOMA Tx, StrataGraft skin tissue Overlay of Meshed Autograft (SOMA) | Stratatech, a Mallinckrodt Company | Full Thickness Thermal Burn | 03/24 | 03/24 | | |
| Recruiting | 2 | 400 | Europe, Japan, US, RoW | HER3-DXd, Patritumab Deruxtecan, U3-1402 | Daiichi Sankyo, Merck Sharp & Dohme LLC | Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer, Esophageal Cancer, Pancreatic Carcinoma, Prostate Cancer | 06/25 | 04/26 | | |
NCT05198310 / 2022-000169-42: Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor |
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| Completed | 2 | 145 | Europe, US, RoW | KPL-404, abiprubart, Placebo | Kiniksa Pharmaceuticals, Ltd., Kiniksa Pharmaceuticals, Ltd. | Arthritis, Rheumatoid | 02/24 | 05/24 | | |
| Recruiting | 2 | 90 | US | Hydroxypropyl Beta Cyclodextrin, Trappsol Cyclo, Placebo, 0.5N saline | Cyclo Therapeutics, Inc., Cyclo Therapeutics Inc. | Alzheimer's Disease | 03/24 | 03/24 | | |
| Completed | 2 | 65 | Europe, US | DS-1211b, Placebo | Daiichi Sankyo, PXE International | Pseudoxanthoma Elasticum | 11/23 | 11/23 | | |
IDeate-PanTumor02, NCT06330064: A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors |
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| Recruiting | 2 | 520 | Europe, Japan, US, RoW | Ifinatamab deruxtecan, I-DXd | Daiichi Sankyo, Merck Sharp & Dohme LLC | Recurrent or Metastatic Solid Tumors | 07/28 | 07/28 | | |
MAST, NCT06355583: Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant () Trial |
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| Not yet recruiting | 2 | 50 | Europe | EBX-102, IMT capsules, Placebo | Imperial College London | Acute Lymphoblastic Leukaemia, Acute Leukemia of Ambiguous Lineage, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia | 02/26 | 05/27 | | |
NCT04870905: Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma |
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| Not yet recruiting | 2 | 100 | RoW | Tis-U-Sol | Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Union hospital of Fujian Medical University, Zhujiang Hospital, Guangdong Provincial People's Hospital | Nasopharyngeal Neoplasms | 05/24 | 05/26 | | |
| Active, not recruiting | 2 | 187 | Europe, Japan, US, RoW | Ifinatamab Deruxtecan (I-DXd), DS-7300a | Daiichi Sankyo, Merck Sharp & Dohme LLC | Extensive-stage Small-cell Lung Cancer | 01/25 | 04/25 | | |
| Recruiting | 2 | 32 | RoW | SPG302, Placebo | Spinogenix | Schizophrenia | 06/25 | 10/25 | | |
CBeyond, NCT06577090: Study to Evaluate the Effect on Obesity of Once Weekly Nimacimab Injection and Once Weekly Nimacimab Injection Co-administered With Semaglutide Injection Versus Placebo |
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| Recruiting | 2 | 120 | US | Nimacimab injection, Nimacimab placebo injection, semaglutide injection | Skye Bioscience, Inc., Bird Rock Bio Sub, Inc. | Obesity | 08/25 | 01/26 | | |
NCT05029336: Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases |
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| Recruiting | 2 | 20 | US | Depletion of CD3/CD19 in an autologous stem cell transplant, CD3/CD19 depletion using cliniMACs device | Stephan Grupp MD PhD | Systemic Lupus Erythematosus, Systemic Sclerosis | 12/26 | 05/31 | | |
| Recruiting | 2 | 64 | US | Bevonescein, ALM-488 | Alume Biosciences, Inc. | Surgery, Nerve Injury, Imaging | 06/25 | 09/25 | | |
NCT04935762: A Study of CST-103 Co-administered With CST-107 in Subjects With Parkinson's Disease Having Freezing of Gait (CLIN-012) |
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| Withdrawn | 2 | 25 | RoW | CST-103, CST-107, matching placebo | CuraSen Therapeutics, Inc. | Freezing of Gait Symptoms in Parkinson's Disease | 12/24 | 03/25 | | |
| Not yet recruiting | 2 | 200 | Japan, US | Raludotatug deruxtecan, R-DXd | Daiichi Sankyo, Merck Sharp & Dohme LLC | Advanced Solid Tumor, Metastatic Solid Tumors | 09/27 | 09/27 | | |
NCT04977024: SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer |
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| Recruiting | 2 | 240 | US | COVID-19 Vaccine, Diagnostic Laboratory Biomarker Analysis, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1, COH04S1, SARS-CoV-2 Vaccine COH04S1, sMVA-based SARS-CoV-2 Vaccine COH04S1, GEO-CM04S1 | GeoVax, Inc., National Cancer Institute (NCI) | COVID-19 Infection, Hematopoietic and Lymphoid System Neoplasm, Leukemia, Lymphoma, Plasma Cell Myeloma | 12/26 | 12/27 | | |
STEP, NCT06594393: A Phase 2 Study of TCP-25 Gel in Patients with Epidermolysis Bullosa, -study |
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| Not yet recruiting | 2 | 26 | Europe | TCP-25 gel, Vehicle (placebo) | Xinnate AB | Epidermolysis Bullosa (EB) | 06/26 | 06/26 | | |
NCT06038578: A Study of TRK-950 When Used in Combination with Ramucirumab and Paclitaxel in Patients with Gastric Cancer |
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| Recruiting | 2 | 146 | Japan, US, RoW | TRK-950, Ramucirumab, CYRAMZA®, Paclitaxel | Toray Industries, Inc | Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma | 06/26 | 06/26 | | |
