| Sadhasivam, Senthilkumar |
NCT06626503: Evaluation of Analgesia for Spine Fusion Elective Surgery in Children |
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| Not yet recruiting | 2 | 500 | US | Methadone based ERAS, Methadone Based, SOC non-methadone based group, Standard Care | Senthil Sadhasivam, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Idiopathic Scoliosis | 09/25 | 09/25 | | |
NCT06626035: Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children |
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| Not yet recruiting | 2 | 500 | US | Methadone based ERAS, Methadone-Based, SOC non-methadone based group, Standard Care | Senthil Sadhasivam, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Pediatric Cardiac Surgery | 09/25 | 09/25 | | |
| Completed | N/A | 576 | US | Preemptive genotyping in medical record, Genotyping not included in electronic medical record | Children's Hospital Medical Center, Cincinnati | Pain | 11/20 | 12/22 | | |
NCT03495388: PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children |
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| Active, not recruiting | N/A | 500 | US | Oxycodone | Senthil Sadhasivam, Children's Hospital Medical Center, Cincinnati, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Postoperative Pain, Opioid Dependence | 08/22 | 12/24 | | |
NCT01140724: Personalizing Perioperative Analgesia in Children |
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| Active, not recruiting | N/A | 1200 | US | | Senthil Sadhasivam, Children's Hospital Medical Center, Cincinnati, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Postoperative Pain | 08/22 | 12/25 | | |
NCT04366544: Effects of an 8-day Advanced Meditation, Samyama on Physical, Psychological and Spiritual Wellbeing ,and Associated Neural Mechanisms |
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| Completed | N/A | 759 | US | Part A1: Survey, Part A2: Sample collection, Part B: | Indiana University | Mental Health Wellness 1, Happiness, Depression, Consciousness, Level Altered, Ecstasy, Dietary Habits, Stress, Inflammatory Bowel Diseases | 07/18 | 07/18 | | |
| Recruiting | N/A | 600 | US | Subutex / Buprenorphine, Fetal & Neonatal MRI, DNA/Genetic/Pharmacokenetic Blood Draws | Senthil Sadhasivam, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA) | Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence | 12/25 | 12/26 | | |
| Recruiting | N/A | 300 | US | Preoperative Genotyping | Senthil Sadhasivam, National Institute on Drug Abuse (NIDA) | PPAP, Spine Fusion | 08/25 | 09/25 | | |
NCT06042413: Prediction and Prevention of Postoperative Mortality and Morbidity |
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| Not yet recruiting | N/A | 1200 | US | Personalized CPC Prehabilitation, Cognitive Training, Meditation, Daily Exercise, Enhanced Social Support, Proactive Bundle Interventions, Pre-operative Standard of Care, Intra-operative Standard of Care | University of Pittsburgh, National Institute on Aging (NIA) | Alzheimer Disease, Alzheimer Disease Related Dementias | 09/25 | 09/25 | | |
| Recruiting | N/A | 600 | US | Preoperative Genotyping | Senthil Sadhasivam, National Center for Advancing Translational Sciences (NCATS) | Cesarean Section Complications, Opioid Use | 04/26 | 10/26 | | |
| Investigator |
NCT05106751: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds |
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| Completed | 4 | 104 | Europe | Hyaluronic acid dermal filler | LG Chem | Correction of Nasolabial Folds | 09/22 | 04/23 | | |
OPERA-T, NCT05238116 / 2021-004554-32: Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis ( Study) |
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| Recruiting | 3 | 123 | Europe, Canada, US, RoW | PC945, Placebo | Pulmocide Ltd | Refractory IPA | 03/26 | 04/26 | | |
| Active, not recruiting | 3 | 94 | Europe, US, RoW | Hydroxypropyl-beta-cyclodextrin, Trappsol Cyclo, Placebo, 0.5N saline | Cyclo Therapeutics, Inc. | Niemann-Pick Disease, Type C1 | 06/25 | 06/26 | | |
| Completed | 3 | 530 | Europe, RoW | Cefepime-zidebactam (FEP-ZID), Meropenem | Wockhardt, Medpace, Inc. | Complicated Urinary Tract Infection, Acute Pyelonephritis | 01/25 | 01/25 | | |
Integral-1, NCT05887908 / 2021-001441-12: Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis |
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| Completed | 3 | 614 | Europe | co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, imipenem/cilastatin | Meiji Seika Pharma Co., Ltd., Japan Agency for Medical Research and Development | Complicated Urinary Tract Infection, Acute Pyelonephritis | 11/24 | 11/24 | | |
Integral-2, NCT05905055 / 2021-001396-16: P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales |
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| Recruiting | 3 | 150 | Japan | co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, BAT | Meiji Seika Pharma Co., Ltd., Japan Agency for Medical Research and Development | Complicated Urinary Tract Infection, Acute Pyelonephritis, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Complicated Intra-abdominal Infection | 02/25 | 02/25 | | |
| 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 | | |
NCT06564311: A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone) |
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| Recruiting | 2 | 93 | Europe, US, RoW | Obexelimab, Placebo | Zenas BioPharma (USA), LLC | Relapsing Multiple Sclerosis | 08/25 | 02/26 | | |
NCT05113342: Descartes-25 in Relapsed/Refractory Multiple Myeloma |
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| Terminated | 1 | 9 | US, RoW | Descartes-25, DC-25 | Cartesian Therapeutics | Multiple Myeloma, Relapse Multiple Myeloma | 05/23 | 11/24 | | |
SER-155-001, NCT04995653: A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT |
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| Completed | 1 | 60 | US | Vancomycin Pre-Treatment, Vancomycin Placebo, SER-155, SER-155 Placebo | Seres Therapeutics, Inc., Memorial Sloan Kettering Cancer Center | Allogeneic Hematopoietic Stem Cell Transplantation | 07/24 | 07/24 | | |
NCT04784299: To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume |
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| Completed | N/A | 105 | Europe | YVOIRE volume plus, Restylane Lyft with Lidocaine | LG Chem | Midface Volume Deficit | 04/22 | 10/22 | | |
NCT05646641: Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms |
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| Recruiting | N/A | 30 | RoW | Strength exercise | University of Beira Interior, Universidade Federal de Pernambuco | Fibromyalgia | 12/24 | 01/25 | | |
NCT05314504: Clinical Investigation of YVOIRE Y-Solution 360 for Lip Augmentation in China |
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| Completed | N/A | 174 | RoW | YVOIRE Y-Solution 360 | LG Chem | Lip Augmentation | 02/23 | 02/24 | | |
| Active, not recruiting | N/A | 139 | Europe | Remote monitoring, patientMpower app | Imperial College Healthcare NHS Trust, patientMpower Ltd., Imperial College London, University College, London, Action for Pulmonary Fibrosis | Interstitial Lung Disease | 03/25 | 04/25 | | |
| Ortiz, Damara |
NCT05494593: A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) |
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| Recruiting | 4 | 5 | US | ELAPRASE, Idursulfase, Rituximab, Methotrexate, Intravenous Immunoglobulin (IVIG) | Takeda, Takeda Development Center Americas, Inc. | Mucopolysaccharidosis (MPS), Hunter Syndrome | 07/28 | 07/28 | | |
PERIDOT, NCT05206773 / 2021-002350-90: A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease |
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| Active, not recruiting | 3 | 122 | Europe, Canada, Japan, US, RoW | Venglustat (GZ402671), Placebo | Sanofi, Sanofi-Aventis Recherche & Développement | Fabry Disease | 12/25 | 12/26 | | |
NCT04145037: Lentiviral Vector Gene Therapy - The Guard1 Trial of AVR-RD-02 for Subjects With Type 1 Gaucher Disease |
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| Terminated | 1/2 | 8 | Canada, US | AVR-RD-02 | AVROBIO | Gaucher Disease | 08/23 | 08/23 | | |
| Active, not recruiting | 1/2 | 34 | Europe, Canada, US, RoW | ST-920 | Sangamo Therapeutics | Fabry Disease | 04/25 | 09/25 | | |
| Active, not recruiting | 1 | 18 | Europe, US, RoW | FLT201 | Freeline Therapeutics, Freeline Therapeutics Limited | Gaucher Disease, Type 1 | 12/24 | 01/25 | | |
NCT05795361: Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome |
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| Available | N/A | | Europe, US, RoW | Idursulfase-IT, HGT-2310, TAK-609 | Takeda | Hunter Syndrome | | | | |
| Available | N/A | | US | Arimoclomol | ZevraDenmark | Niemann-Pick Disease, Type C | | | | |
| Henderson, Nadene |
NCT04145037: Lentiviral Vector Gene Therapy - The Guard1 Trial of AVR-RD-02 for Subjects With Type 1 Gaucher Disease |
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| Terminated | 1/2 | 8 | Canada, US | AVR-RD-02 | AVROBIO | Gaucher Disease | 08/23 | 08/23 | | |
| Sadhasivam, Senthil |
| Recruiting | N/A | 600 | US | Subutex / Buprenorphine, Fetal & Neonatal MRI, DNA/Genetic/Pharmacokenetic Blood Draws | Senthil Sadhasivam, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA) | Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence | 12/25 | 12/26 | | |
| Nischal, Kanwal |
| Active, not recruiting | 3 | 678 | US | OT-101 Ophthalmic Solution, Investigational Product, Vehicle, Placebo | Ocumension (Hong Kong) Limited, ORA, Inc., Statistics & Data Corporation | Myopia, Progressive | 03/27 | 04/27 | | |
NCT06275308: Effect of Raised End-Tidal PCo2 on Choroidal Volume |
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| Recruiting | N/A | 20 | US | Ventilation manipulation | University of Pittsburgh | Intraocular Pressure | 04/25 | 04/25 | | |
| Lipner, Melanie |
| Active, not recruiting | 3 | 678 | US | OT-101 Ophthalmic Solution, Investigational Product, Vehicle, Placebo | Ocumension (Hong Kong) Limited, ORA, Inc., Statistics & Data Corporation | Myopia, Progressive | 03/27 | 04/27 | | |
| Packiasabhapathy, Senthil |
| Recruiting | N/A | 300 | US | Preoperative Genotyping | Senthil Sadhasivam, National Institute on Drug Abuse (NIDA) | PPAP, Spine Fusion | 08/25 | 09/25 | | |
