PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT01066364: Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Official title: Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Conditions: Nonalcoholic Steatohepatitis
Summary: The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
Interventions:
description: 3.75 gm/day (six 675 mg tablets)
name: Colesevelam Hcl
other_name: Welchol
type: Drug
Study arms:
design_group_description: Six tablets per day (identical to colesevelam)
design_group_title: Placebo (sugar) pill
design_group_type: Placebo Comparator
design_group_description: 3.75 grams per day
design_group_title: Colesevelam arm
design_group_type: Experimental
Sponsor: University of California San Diego
Collaborators: Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: 盐酸考来维仑
lang: CN
name: Colesevelam Hydrochloride
lang: EN
Clinical trial NCT02092142: Safety and Immunogenicity of Q Fever Vaccine
Official title: Evaluation of the Safety and Immunogenicity of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105, in Subjects at Risk of Exposure to Coxiella Burnetii
Conditions: Q Fever
Summary: The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel.
Interventions:
description: Subcutaneous 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105
name: Q fever Vaccine
other_name: Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105
type: Biological
Study arms:
design_group_description: The vaccine will be administered subcutaneously in the upper outer aspect of the arm (triceps area) with 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 (which equals 30 μg)
design_group_title: Vaccinated
design_group_type: Experimental
Sponsor: U S Army Medical Research & Development Command
Collaborators: U.S. Army Medical Research Institute for Infectious Diseases
Drug name mappings:
name: Q Fever Vaccine(U.S. Army Medical Research and Development Command)
lang: EN
Clinical trial NCT02794428: Chemoprevention of Gastric Carcinogenesis
Official title: Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations
Conditions: Gastric Cancer
Gastric Intestinal Metaplasia
Summary: A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.
Interventions:
description: Eflornithine*, 2 tablets, Oral, Daily for 18 months
name: Eflornithine
type: Drug
description: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
name: Eflornithine placebo
type: Other
Study arms:
design_group_title: Eflornithine
design_group_type: Active Comparator
design_group_title: Eflornithine Placebo
design_group_type: Placebo Comparator
Sponsor: The Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute
Cancer Prevention Pharmaceuticals, Inc.
Drug name mappings:
name: 依氟鸟氨酸
lang: CN
name: Eflornithine Hydrochloride
lang: EN
Clinical trial NCT04133233: Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Official title: Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Conditions: Bipolar Depression
Summary: The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse
Interventions:
description: Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6)
name: ILT101
other_name: IL2
type: Drug
description: Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6)
name: Placebos
other_name: placebo
type: Drug
Study arms:
design_group_description: IL-2 (ILT-101) Sub-cutaneous<br/>1 million UI/j
design_group_title: active treatment
design_group_type: Experimental
design_group_description: placebo Sub-cutaneous The Placebo used is a sterile powder that will be produced by the CMO (AMATSI, France).
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: Assistance Publique des Hôpitaux de Paris SA
Collaborators: ILTOO Pharma SAS
Drug name mappings:
name: Aldesleukin(Assistance Publique Hopitaux De Paris)
lang: EN
Clinical trial NCT00693160: Effect of Spinal Ketorolac After Acute Opioid Exposure
Official title: Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure
Conditions: Healthy
Summary: This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller):
1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream?
2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
Interventions:
description: single intrathecal injection of ketorolac 2 mg
name: ketorolac
other_name: acular pf
toradol
type: Drug
description: subject will receive a placebo (preservative free normal saline) spinal injection
name: placebo
type: Drug
description: All subjects will receive a remifentanil infusion
name: remifentanil
other_name: ultiva
type: Drug
description: Topical capsaicin pain model utilized for each subject
name: Capsaicin
type: Drug
Study arms:
design_group_description: In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment.
design_group_title: Intrathecal Ketorolac
design_group_type: Experimental
design_group_description: In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment.
design_group_title: Placebo intrathecal injection
design_group_type: Placebo Comparator
Sponsor: Wake Forest University
Collaborators: National Institute of General Medical Sciences
Drug name mappings:
name: 辣椒碱
lang: CN
name: Capsaicin
lang: EN
name: 酮咯酸氨丁三醇
lang: CN
name: Ketorolac Tromethamine
lang: EN
name: 盐酸瑞芬太尼
lang: CN
name: Remifentanil Hydrochloride
lang: EN
name: レミフェンタニル塩酸塩
lang: JP
Clinical trial NCT05411146: A Study Investigating the Safety, Absorption, and Elimination of Radioactively Labeled Etrumadenant, a New Compound in the Treatment of Cancer
Official title: A Phase 1, Open-label Study to Assess the Absorption, Metabolism, and Excretion, Including the Mass Balance, of a Single Oral Dose of [14C]-Etrumadenant in Healthy Male Subjects
Conditions: Healthy Participants
Summary: This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers.
Interventions:
description: Administered as specified in the treatment arm.
name: [14C]-etrumadenant
other_name: [14C]-AB928
type: Drug
Study arms:
design_group_description: Participants will receive a single dose of [14C]-etrumadenant.
design_group_title: [14C]-etrumadenant
design_group_type: Experimental
Sponsor: Arcus Biosciences, Inc.
Collaborators: Gilead Sciences, Inc.
Drug name mappings:
name: Etrumadenant
lang: EN
Clinical trial NCT06707896: TCR1020-CD8 T Cells in KRAS-mutated Cancers
Official title: Phase I, Open-Label Study of Autologous Mutant KRAS-redirected T-cell Receptor Cells (TCR1020-CD8)
Conditions: Metastatic Pancreatic Adenocarcinoma
Colorectal Cancer
Summary: This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1020-CD8 T cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma or colorectal cancer will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.
Interventions:
description: TCR1020-CD8 T cells are autologous mKRAS-redirected CD8+ T cells engineered using a lentiviral vector to express a TCR with specificity for HLA-restricted mKRAS G12V epitopes restricted to the HLA-A*11:01 molecule.
name: TCR1020-CD8 T cells
type: Drug
Study arms:
design_group_description: After lymphodepleting chemotheerapy subjects will recieve a dose of 3 x 10(8) TCR1020-CD8 T cells
design_group_title: Dose Level 1
design_group_type: Experimental
design_group_description: After lymphodepleting chemotheerapy subjects will recieve a dose 1 x 10(8) TCR1020-CD8 T cells
design_group_title: Dose Level -1
design_group_type: Experimental
design_group_description: After lymphodepleting chemotheerapy subjects will recieve a dose 1 x 10(9) TCR1020-CD8 T cells
design_group_title: Dose Level 2
design_group_type: Experimental
design_group_description: After lymphodepleting chemotheerapy subjects will recieve a dose 3 x 10(9) TCR1020-CD8 T cells
design_group_title: Dose Level 3
design_group_type: Experimental
Sponsor: University of Pennsylvania
Collaborators: Lustgarten Foundation
Stand Up To Cancer
Drug name mappings:
name: KRAS Mutations targeting TCR-T (University of Pennsylvania)
lang: EN
Clinical trial NCT05824091: Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Trial in Healthy Adults to Evaluate the Safety, Tolerability, and PK of MK-7762
Conditions: Tuberculosis
Summary: The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study. The effect of food on the rate and extent of absorption of a single oral dose of MK-7762 (TBD09) will also be evaluated.
Interventions:
description: Cohort 1: 50 mg Cohort 2: 150 mg Cohort 3: 300 mg Cohort 4: 600 mg Cohort 5: TBD Cohort 6: TBD
name: MK-7762 (TBD09)
type: Drug
description: A subset of participants from each of the 6 dosing cohorts will receive placebo.
name: Placebo
type: Other
Study arms:
design_group_description: In Part 1 of the trial (SAD/FE), up to five sequential cohorts will be enrolled to evaluate up to five escalating single doses of MK-7762; 8 participants in each cohort will be randomized (3:1) to receive MK-7762 or placebo. A sixth cohort will evaluate the effect of food on PK of single doses of MK-7762 utilizing an open-label, two-period design in 8 participants.
design_group_title: MK-7762 (TBD09)
design_group_type: Experimental
design_group_description: Participants will receive placebos matched to MK-7762 (TBD09).
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Bill & Melinda Gates Medical Research Institute
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: MK-7762
lang: EN
Clinical trial NCT07040072: Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC
Official title: The Safety and Efficacy of Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, a Phase Ib Study
Conditions: HNSCC
Summary: This is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of recurrent/metastatic HNSCC patients.
Interventions:
description: Receive the combination of Stapokibart and Finotonlimab in cycles 1-3, and maintain treatment with Finotonlimab in subsequent cycles.<br/>Stapokibart, 600mg for the first cycle, 300mg for the second and third cycles, administered subcutaneously every 3 weeks, for a total of 3 doses of Stapokibart; Finotonlimab 200mg, administered intravenously every 3 weeks until confirmed disease progression occurs according to the RECIST 1.1 imaging criteria (if the researcher determines that the subject can benefit from continuing PD-1 drug treatment, and the subject can tolerate the study treatment and agree, PD-1 drug can be continued and recorded in the study records), unacceptable toxic side effects, initiation of new anti-tumor treatment, withdrawal from the study or death (whichever occurs first), or reaching a maximum treatment period of 2 years.
name: Stapokibart and Finotonlimab
type: Combination Product
Study arms:
design_group_description: Stapokibart, 600 mg for the first cycle, 300 mg for the second and third cycles, administered subcutaneously every three weeks, for a total of 3 doses.<br/>Finotonlimab 200 mg, administered intravenously once every three weeks, until disease progression or unacceptable toxicity.
design_group_title: Stapokibart and Finotonlimab
design_group_type: Experimental
Sponsor: Beijing Tongren Hospital
Collaborators: Sinocelltech Group Ltd.
Keymed Biosciences, Inc.
Drug name mappings:
name: 菲诺利单抗
lang: CN
name: Finotonlimab
lang: EN
Clinical trial NCT00620633: Dose Escalation Trial of WT1-Sensitized T Cells for Residual or Relapsed Leukemia After Allogeneic Hematopoietic Progenitor Cell Transplantation
Official title: A Phase I Dose Escalation Trial of WT1-Sensitized T Cells for Residual or Relapsed Leukemia After Allogeneic Hematopoietic Progenitor Cell Transplantation
Conditions: Leukemia
Myelodysplastic Syndrome
Summary: This study will test the safety of giving you specialized white cells from your donor. They are called WT1 sensitized T cells. They have been grown in the lab and are immunized against a protein. The protein is called the Wilms' tumor protein, or WT1. Your leukemic cells make too much of this protein. We want to learn whether the WT1 sensitized T cells will attack the protein and kill the leukemia cells.
Interventions:
description: Eligible patients who consent to enter this trial and for whom WT1 sensitized T cells have been generated in vitro, will receive a single dose of allogeneic WT1-sensitized T cells by bolus intravenous infusion. In this phase I trial, 6 dose levels of T cells will be evaluated, in sequential groups of 3 patients. Dose Escalation will be based on the incidence and severity of toxicities.
name: WT1-sensitized T cells
type: Biological
Study arms:
design_group_description: Patients with leukemia or myelodysplastic syndrome (MDS) who, following an HLA-matched allogeneic hematopoietic cell transplant, have relapsed with leukemia as demonstrated morphologically on peripheral blood smear or bone marrow aspirate
design_group_title: 1
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Atara Biotherapeutics, Inc.
Drug name mappings:
name: WT1-Sensitized Allogeneic T-Lymphocytes(Atara Biotherapeutics/Memorial Sloan Kettering Cancer Center)
lang: EN
Clinical trial NCT05933668: Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Solid Tumor
Official title: Phase I Clinical Study of YK0901 Injection for the Treatment of Advanced Solid Tumors With HLA-A * 11:01 Positive and KRAS G12V Mutation
Conditions: Advanced Solid Tumor
Summary: This study is a single center, open, single arm, dose increasing early clinical study. The purpose of this study is to evaluate the safety and efficacy of YK0901 immunotherapy in the treatment of patients with advanced solid tumor whose tumor antigen KRAS G12V expression is positive (HLA-A * 11:01).
Interventions:
description: On day 0, the TCR-T cells will be administered one time. Drug: Fludarabine + Cyclophosphamide+Oxaliplatin Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 300mg/m²/day×3 days Oxaliplatin：100mg×1day Drug: IL-2 After 18-24 hours of infusion of YK0901 cells, the patients will be given a small dose of IL-2 subcutaneously, 500,000 IU/time, twice a day (interval 10-12 hours), for 14 days.
name: YK0901 cells
type: Biological
Study arms:
design_group_description: Patients will undergo lymphocytapheresis, then treatment with TCR-T cells (at escalating doses) + IL-2.Accelerated titration and "3 + 3" dose escalation were used in this trial . Five dose levels were set up: the dose level was 1: 1× 108 ± 20%（8×107<br/>1.2×108）; the dose level was 2: 1 × 109 （±20%：8×108<br/>1.2×109）; the dose level was 3: 5 × 109 （±20%：4×109<br/>6×109）; the dose level was 4: 2 × 1010 （±20%：1.6×1010<br/>2.4×1010）; the dose level was 5: 5 × 1010 （±20%：4×1010<br/>6×1010）.
design_group_title: YK0901 cells
design_group_type: Experimental
Sponsor: Peking University
Collaborators: Yingkai Saiwei (Beijing) Biotechnology Co., Ltd
Drug name mappings:
name: YK-0901
lang: EN
Clinical trial NCT05379647: Natural Killer (NK) Cell Therapy for B-Cell Malignancies
Official title: QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies
Conditions: B-cell Lymphoma
B-cell Acute Lymphoblastic Leukemia
Summary: This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma.
This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL. Up to 22-36 patients will be enrolled.
Interventions:
description: Experimental Interventional Therapy
name: QN-019a
type: Drug
description: Monoclonal Antibody
name: Rituximab
type: Drug
description: Lympho-conditioning Agent
name: Cyclophosphamid
type: Drug
description: Lympho-conditioning Agent
name: Fludarabine
type: Drug
description: Lympho-conditioning Agent
name: VP-16
type: Drug
Study arms:
design_group_description: QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.
design_group_title: QN-019a in Combination with Monoclonal Antibodies
design_group_type: Experimental
design_group_description: QN-019a Monotherapy in adult subjects with r/r B-ALL
design_group_title: QN-019a Monotherapy
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Hangzhou Qihan Biotech Co., Ltd.
Drug name mappings:
name: 依托泊苷
lang: CN
name: Etoposide
lang: EN
name: エトポシド
lang: JP
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: QN-019a
lang: EN
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
Clinical trial NCT05001373: A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)
Official title: A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health
Conditions: Hiv
Summary: A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health
Interventions:
description: 100µg, Intramuscularly
name: Core-g28v2 60mer mRNA Vaccine
type: Biological
description: 100µg, Intramuscularly
name: eOD-GT8 60mer mRNA Vaccine
type: Biological
Study arms:
design_group_description: eOD-GT8 60mer mRNA Vaccine (100µg)
design_group_title: Study Group 1
design_group_type: Experimental
design_group_description: eOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)
design_group_title: Study Group 2
design_group_type: Experimental
design_group_description: eOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)
design_group_title: Study Group 3
design_group_type: Experimental
design_group_description: Core-g28v2 60mer mRNA Vaccine (100µg)
design_group_title: Study Group 4
design_group_type: Experimental
Sponsor: International AIDS Vaccine Initiative, Inc.
Collaborators: Fred Hutchinson Cancer Research Center
ModernaTX, Inc.
University of Texas Health Science Center At San Antonio
George Washington University
Emory University
Drug name mappings:
name: mRNA-1645-CoreG28v2
lang: EN
name: mRNA-1644
lang: EN
Clinical trial NCT06826313: A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors
Official title: An Open-labeled Phase I Clinical Trial Evaluating the Safety, Tolerability, Biodistribution Characteristics, Biological EEffects, and Initial Efficacy of VRT106 for Injection in the Treatment of Locally Advanced/Metastatic Solid Tumors by Intravenous Administration
Conditions: Solid Tumors
Summary: A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors
Interventions:
description: Intravenous drip administration
name: VRT106
type: Biological
Study arms:
design_group_description: VRT106 will be administered through IV drip
design_group_title: VRT106 for injection
design_group_type: Experimental
Sponsor: Guangzhou Virotech Pharmaceutical Co Ltd.
Collaborators: The Third Affiliated Hospital, Sun Yat-Sen University
Drug name mappings:
name: 重组溶瘤病毒M1(广州威溶特)
lang: CN
name: Recombinant oncolytic virus M1(Guangzhou Vitron)
lang: EN