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NCT05608005
VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age. The study duration for each participant will be approximately 13 months.
NCT06855264
This clinical study is designed to study the effect of a single dose of varegacestat on cardiac repolarization in healthy adult participants.
NCT05587309
The objective of the Healing Phase of the study is to evaluate the safety and efficacy of up to 8 weeks of once daily oral administration of BLI5100 versus a PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once daily oral administration of BLI5100 (low or high dose) versus a PPI control in the maintenance of healed EE.
NCT05456425
The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.
NCT03525574
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation
NCT05425056
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
NCT05485974
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
NCT05163028
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.
NCT05239468
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
NCT05737940
This study is intended to assess the ability of AZD3427 to reduce pulmonary vascular resistance (PVR) after 24 weeks of treatment in participants with heart failure (HF) and pulmonary hypertension (PH) Group 2
NCT06284954
This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
NCT06273124
The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS). Participants will be asked to: 1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods 2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour
NCT06501196
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). Phase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy. Phase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax. Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.
NCT04561206
This phase II trial investigates how well brentuximab vedotin and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back after initial treatment (relapsed) or has not responded to initial treatment (refractory). Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Nivolumab is an antibody that enhances the immune system to better fight Hodgkin lymphoma cells. Giving brentuximab vedotin and nivolumab may be able to defer stem cell transplant treatment and spare the considerable cost and toxicity on transplantation.
NCT05380401
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.
NCT06859073
This study will evaluate an investigational drug called NNC4004-0002. "Investigational" means NNC4004-0002 has not been approved for sale/ for clinical use or for the use described in this study/ by any regulatory authority. Its use in this study is experimental. This will be the first time that NNC4004-0002 will be given to human. This study will be testing the ability of the study medicine to lower serum uric acid. The main aim of this study will be to see if the new study medicine is safe and tolerated by the body after a single dose of study medicine in adults with asymptomatic hyperuricemia. Participants will either get NNC4004-0002 (the study medicine), or saline. Which treatment the participant get will be decided by chance. The participant will get the medicine as an injection under their skin. Depending on the dose they will receive, participant may need more than one injection. The study will last for about 19 months in total. The participant will take part in the study for about 7 months. Participant will have approximately 14 visits to the clinic and one of them will be a 4 night in-house stay.
NCT05142592
This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors. The study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a). Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.
NCT03739827
Background: Approximately 150 cases of cancer per one million per year are considered rare cancers. While all tumors originate from genetic changes, a small percentage of these tumors are familial. Researchers want to study these changes in biological samples from people with rare tumors in order to learn more about how these tumors develop. The information obtained from this study may lead to improved screening, preventive guidelines, and treatments. Objective: To better understand rare cancers and hereditary cancer syndromes. Eligibility: People who have a rare tumor, a family history of a rare tumor, a hereditary cancer syndrome, or a mutation that leads to rare tumors. Design: Participants will be screened with questions about their medical history and/or that of their family members. They will give a saliva sample. Participants who have a tumor will have their medical records and tests reviewed. They will answer questions about their wellbeing and needs. They may provide a tumor tissue sample. Participants may also have: * Physical exam * Clinical photography * Blood, urine, saliva, and stool samples taken * Consultation with specialists * A scan that produces a picture of the body. Either one that uses a small amount of radiation, or one that uses a magnetic field. * Genetic testing/genetic counseling. Participants will be contacted once a year. They will answer updated questions about their medical and family history. Participants will be asked to contact the study team if there are changes in their tumors. Participants may be invited to join focus groups for people with the same diagnosis of rare tumors. Participants may be invited to participate in other NIH protocols. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* RARE TUMOR LIST: 1. Acinar cell carcinoma of the pancreas 2. Adamantinoma 3. Adenosqaumous carcinoma of the pancreas 4. Adrenocortical carcinoma 5. Alveolar soft part sarcoma 6. Anaplastic Thyroid Cancer 7. Angiosarcoma 8. Atypical Teratoid Rhabdoid Tumor/MRT 9. Carcinoid 10. Carcinoma of Unknown Primary 11. Chondrosarcoma 12. Chondromyxoid fibroma 13. Chordoma 14. Clear cell renal carcinoma 15. Clear Cell Sarcoma 16. Clear cell sarcoma of kidney 17. Conventional chordoma 18. Dedifferentiated chordoma 19. Desmoid 20. Desmoplastic small round cell tumor 21. Epithelioid hemangioendothelioma 22. Esthenioneuroblastoma 23. Ewing Sarcoma 24. Fibrolamellar carcinoma 25. Fusion negative rhabdomyosarcoma 26. Fusion positive renal cell carcinoma 27. Fusion positive rhabdomyosarcoma 28. Gastro-enteropancreatic neuroendocrine tumor 29. Hepatoblastoma 30. Hereditary Diffuse Gastric Cancer 31. Inflammatory myofibroblastic tumor 32. Kaposiform hemangioendothelioma 33. Malignant ectomesenchymal tumor 34. Malignant peripheral nerve sheath tumor 35. Malignant triton tumor 36. Medullary thyroid cancer 37. Mixed acinar adenocarcinoma 38. Mixed acinar neuroendocrine carcinoma 39. Myxoid Liposarcoma 40. Neuroblastoma 41. Neuroendocrine tumors 42. NUT midline carcinoma 43. Osteosarcoma 44. Pancreas ductal adenocarcinoma with squamous features 45. Pancreatic acinar cell carcinoma 46. Papillary renal cell carcinoma 47. Paraganglioma 48. Parosteal Osteosarcoma 49. Periosteal Osteosarcoma 50. Peripheral nerve sheath tumor 51. Peripheral primitive neuroectodermal tumor 52. Pheochromocytoma 53. Pituitary cancer 54. Poorly differentiated chordoma 55. Renal medullary carcinoma 56. Rhabdomyosarcoma 57. Round cell Liposarcoma 58. Schwannoma 59. Sclerosing Epithelioid Fibrosarcoma 60. SDH deficient GIST 61. SMARCB1 deficient tumors 62. SMARCA4 deficient tumors 63. Synovial sarcoma 64. Undifferentiated Sarcoma \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*
NCT01357668
The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.
NCT04969224
This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.