PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03660748: Safety and Efficacy of MET-3 in Obese Human Subjects
Official title: A Phase I, Open-Label, Single-Centre Study of the Safety and Efficacy of Microbial Ecosystem Therapeutics (MET)-3 in Obese Human Subjects
Conditions: Obesity
Summary: A pilot study to explore the metabolic effect and safety of a 3-week course of therapy with MET-3 in obese subjects
Interventions:
description: Ingestion of a novel human microbiome preparation
name: MET-2
type: Biological
Study arms:
design_group_description: Use of MET-2 in subjects with BMI of 30.0 to 34.9
design_group_title: Lower BMI
design_group_type: Experimental
design_group_description: Use of MET-2 in subjects with BMI of 35 to 39.9
design_group_title: Higher BMI
design_group_type: Experimental
Sponsor: NuBiyota LLC
Collaborators: Glycemic Index Laboratories, Inc.
Drug name mappings:
name: MET-2
lang: EN
Clinical trial NCT07433517: VGN-Ex05e in Patients With Autism Spectrum Disorder Associated With Severe Self-Injurious and Aggressive Behaviors
Official title: An Early-Phase Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-Ex05e in Patients With Autism Spectrum Disorder (ASD) Associated With Severe, Treatment-Resistant Self-Injurious and Aggressive Behaviors
Conditions: Autism Spectrum Disorder
Summary: To evaluate the safety and tolerability of intracerebral injection of VGN-Ex05e in the nucleus accumbens of patients with autism spectrum disorder.
Interventions:
description: Products derived from human embryonic stem cells for the treatment of allogeneic nerve cells
name: VGN-Ex05e
type: Biological
Study arms:
design_group_description: Stereotactic intracerebral injection of VGN-Ex05e solution into the nucleus accumbens with 2.0×10^6 cells or 6.0×10^6 cells.
design_group_title: VGN-Ex05e
design_group_type: Experimental
Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: Shanghai Vitalgen Biopharma Co., Ltd.
Drug name mappings:
name: VGN-Ex05e
lang: EN
Clinical trial NCT05294367: Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma
Official title: Pilot Feasibility Trial of Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma
Conditions: Lymphoma
Summary: This early phase I trial investigates the effect of dietary and topical magnesium replacement on magnesium blood levels in patients with lymphoma. Magnesium is an element in the body that is important to cell health. The body cannot make magnesium and it typically comes from the food we eat. In patients who are ill, magnesium is often replaced intravenously (IV) through a vein or by mouth. This study may help researchers find out if being on a magnesium rich diet and using a magnesium lotion on the skin helps to keep magnesium blood levels in an ideal range. This study also investigates side effects and quality of life when receiving different forms of magnesium.
Interventions:
description: Given topically
name: Magnesium Chloride-based Lotion
other_name: Ancient Minerals Magnesium Lotion
Magnesium Chloride Lotion
type: Drug
description: Ancillary studies
name: Quality-of-Life Assessment
other_name: Quality of Life Assessment
type: Other
description: Consume magnesium rich foods
name: Special Diet Therapy
other_name: DIET
type: Behavioral
Study arms:
design_group_description: Participants consume magnesium rich foods PO daily for 28 days.
design_group_title: Cycle 1
design_group_type: Experimental
design_group_description: Participants continue consuming magnesium rich foods PO daily and apply Ancient Minerals Magnesium Lotion topically daily for 28 days.
design_group_title: Cycle 2, Arm I
design_group_type: Experimental
design_group_description: Participants continue consuming magnesium rich foods PO daily for 28 days.
design_group_title: Cycle 2, Arm II
design_group_type: Experimental
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute
Drug name mappings:
name: 氯化镁
lang: CN
name: Magnesium chloride
lang: EN
Clinical trial NCT07210632: Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
Official title: Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
Conditions: Brain Cancer
HGG
Glioma
High Grade Glioma
High Grade Gliomas
High Grade Glioma (III or IV)
High Grade Glioma (HGG) of the Brain With BRAF Aberration
Summary: High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.
Interventions:
description: Participants will receive a single infusion of nivolumab following an infusion of nivolumab-IRDye800 (nivo800), for a combined total dose of 240 mg. This dosing applies to all cohorts except Cohort 1, which is designated as the safety group. Each cohort, other than Cohort 1, will receive no more than 240 mg in total of nivolumab and nivo800 combined. Participants will then undergo planned Standard of Care (SOC) surgical resection 1 to 4 days after the infusion.
name: Nivolumab
type: Drug
description: Participants will receive an infusion of nivolumab-IRDye800 (nivo800). Nivo800 has never been assessed in patients before and therefore Cohort 1 will receive only a test dose to determine the safety (3 participants). Cohorts 2-4 will receive escalating doses of nivo800, keeping the overall dose nivolumab + nivo800 no more than 240 mg. Participants will undergo planned Standard of Care surgical resection at 1-4 days after infusion.
name: Nivolumab-IRDye800
type: Drug
Study arms:
design_group_description: 5mg nivo800
design_group_title: Nivo800 (5mg)
design_group_type: Experimental
design_group_description: 50 mg nivo800 +190 mg nivolumab
design_group_title: Nivo800 + Nivo (50mg +190)
design_group_type: Experimental
design_group_description: 100 mg nivo800 +140 mg nivolumab
design_group_title: Nivo800 + Nivo (100mg + 140mg)
design_group_type: Experimental
design_group_description: 150 mg nivo800 +90 mg nivolumab
design_group_title: Nivo800 + Nivo (150mg + 90mg)
design_group_type: Experimental
design_group_description: Expansion at optimal dose
design_group_title: Nivo800 + Nivo (expansion at optimal dose cohort)
design_group_type: Experimental
Sponsor: The Vanderbilt-Ingram Cancer Center
Collaborators: The Vanderbilt-Ingram Cancer Center
Drug name mappings:
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03159936: Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Official title: Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Conditions: Discoid Lupus Erythematosus
Systemic Lupus Erythematosus
Summary: Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent SLE.
Interventions:
description: 10 mg daily by mouth
name: Tofacitinib citrate
other_name: Xeljanz
type: Biological
Study arms:
design_group_description: All participants will take one 5 mg tablet by mouth in the morning and one tablet by mouth in the evening for the 6-month study duration.
design_group_title: Tofacitinib citrate
design_group_type: Experimental
Sponsor: Tufts Medical Center, Inc.
Collaborators: Pfizer Inc.
Drug name mappings:
name: 枸橼酸托法替布
lang: CN
name: Tofacitinib Citrate
lang: EN
name: トファシチニブクエン酸塩
lang: JP
Clinical trial NCT07457736: Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
Official title: Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
Conditions: Healthy Adult Participants
Summary: Evaluate [18F]GATT-44 (aka [18F]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of [18F]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of [18F]GATT-44 by performing whole-body imaging studies.
Interventions:
description: First in human radiotracer being evaluated in this study.
name: [ 18F]GATT-44
other_name: [18F]GAT44
type: Drug
Study arms:
design_group_description: In Part 1 we will conduct a test/retest study of the novel GABA Transporter (GAT-1) imaging tracer [18F]GATT44 in humans, to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements
design_group_title: Healthy Control - Test/Retest
design_group_type: Experimental
design_group_description: In Part 2, we will conduct a test-blocking study to assess specific binding levels of [18F]GATT44 in humans.
design_group_title: Healthy Control - Test-Blocking
design_group_type: Experimental
design_group_description: In Part 3, human dosimetry of [18F]GATT44 will be estimated by performing whole-body imaging studies
design_group_title: Healthy Control - Whole Body
design_group_type: Experimental
Sponsor: Yale University
Collaborators: National Institute of Mental Health
Drug name mappings:
name: [18F]GAT-44
lang: EN
Clinical trial NCT03468140: Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation
Official title: A Matched Intervention Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation
Conditions: End Stage Liver Disease
Summary: The number of liver transplants that can be performed is limited by the availability of organs. Livers that are steatotic (i.e., infiltrated by triglycerides and other fatty substances) are usually not used for transplants, due to increased risk of adverse events and deaths post-transplant. The investigators propose administering eculizumab to patients receiving macrosteatotic liver transplants and hypothesize that doing so will mitigate post-surgical adverse outcomes.
Interventions:
description: Eculizumab will be given at a dose of 1200mg diluted in 0.9% sodium chloride (NaCl) to 5mg/mL for a total volume of 240 mL administered by IV infusion over 25-45 minutes in the anhepatic-phase during the transplant procedure, and a second dose of 900mg diluted in 0.9% NaCl to 5mg/mL for a total volume of 180 mL administered by IV infusion over 25-45 minutes will be given 24 hours following the first dose.
name: Eculizumab
type: Drug
description: Historical control arm
name: No intervention
type: Other
Study arms:
design_group_description: Eculizumab
design_group_title: Current end stage liver disease patients
design_group_type: Experimental
design_group_description: The Ochsner database will be used to obtain 5 historical matches for each study participant. Matching criteria for each patient will include: 1) gender; 2) (MELD) Score ± 5; 3) age ± 5 years; 4) body mass index (BMI) ± 5 kg/m2; 5) donor macrosteatosis ± 5%; and 6) CIT± 3 hours.
design_group_title: Historical controls
design_group_type: Other
Sponsor: Yale University
Collaborators: Alexion Pharmaceuticals, Inc.
Drug name mappings:
name: 依库珠单抗生物类似药(Samsung Bioepis)
lang: CN
name: Eculizumab-AAGH
lang: EN
Clinical trial NCT06494488: Differential Thrombogenesis by EPA and DHA Mediated by HDL
Official title: Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)
Conditions: Lipid Metabolism Disorders
Hypertriglyceridemia
Summary: The goal of this study is to learn more about omega-3 polyunsaturated fatty acids supplementation on blood lipid profile and platelets in patients with high cholesterol levels.
The purpose of this research is to gather information on the safety and effect of two different fish oils, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Participants will:
Visit the clinic 3 times during study checkups, tests and blood collection. Randomized to either the EPA or the DHA supplementation group. Be given a 28-day food and activity log.
Interventions:
description: Fish oil
name: EPA
other_name: eicosapentaenoic acid
type: Drug
description: Fish oil
name: DHA
other_name: docosahexaenoic Acid
type: Drug
Study arms:
design_group_description: Participants will receive DHA supplement. 3 gelcaps, three times per day with meals (breakfast, lunch, and dinner). DHA supplement regimen contains 450 mg DHA and minimal EPA (60 mg) per pill.<br/>Participants will be given 28-day food and activity log.
design_group_title: DHA group
design_group_type: Experimental
design_group_description: Participants will receive EPA supplement. 2 gelcaps, two times per day with meals (breakfast and dinner). 1 gelcap consists of 1 gram of EPA.<br/>Participants will be given 28-day food and activity log.
design_group_title: EPA group
design_group_type: Experimental
Sponsor: The Miriam Hospital
Collaborators: National Heart, Lung & Blood Institute
National Institutes of Health
Drug name mappings:
name: 二十二碳六烯酸
lang: CN
name: Docosahexaenoic acid
lang: EN
name: 二十碳五烯酸
lang: CN
name: Eicosapentaenoic acid
lang: EN
Clinical trial NCT03566147: Treatment of RP and LCA by Primary RPE Transplantation
Official title: Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation
Conditions: Leber Congenital Amaurosis, Retinitis Pigmentosa
Summary: Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients
Interventions:
description: HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
name: Human primary Retinal Pigment Epithelial (HuRPE) cells
type: Biological
Study arms:
design_group_description: 300,000 HuRPE cells
design_group_title: low dose group
design_group_type: Experimental
design_group_description: 500,000 HuRPE cells
design_group_title: middle dose group
design_group_type: Experimental
design_group_description: 1,000,000 HuRPE cells
design_group_title: high dose group
design_group_type: Experimental
Sponsor: Jiangsu Aierkang Biomedical Technology Co., Ltd
Drug name mappings:
name: Human primary Retinal Pigment Epithelial (HuRPE) cells(Eyecure Therapeutics)
lang: EN
Clinical trial NCT00895466: Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
Official title: A Phase I-II Open Label Clinical Trial, Evaluating the Efficacy and Safety of Administration of the Therapeutic Vaccine PEP-223/CoVaccine HT, to Hormone Treatment naïve, Immunocompetent Subjects With T1-3, N0-1/x, M0 Prostate Cancer, Eligible for Hormone Therapy.
Conditions: Prostate Cancer
Summary: The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones.
Interventions:
name: PEP-223/CoVaccine HT
type: Biological
Study arms:
Sponsor: Pepscan Therapeutics BV
Collaborators: TFS Trial Form Support AB
Drug name mappings:
name: PEP-223/CoVaccine HT(Pepscan Therapeutics)
lang: EN
Clinical trial NCT00068718: Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant
Official title: Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-center Trial
Conditions: Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Hodgkin Lymphoma
Recurrent Non-Hodgkin Lymphoma
Recurrent Plasma Cell Myeloma
Summary: This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed (disease that has returned), or progressing cancer after donor hematopoietic cell transplantation. White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back (recurrent) after a donor hematopoietic cell transplant.
Interventions:
description: Given IV
name: Therapeutic Allogeneic Lymphocytes
other_name: Allogeneic Lymphocytes
type: Biological
Study arms:
design_group_description: Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
design_group_title: Treatment (DLI)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Cancer Institute
Drug name mappings:
name: Allogeneic lymphocytes(Sidney Kimmel Cancer Center at Thomas Jefferson University)
lang: EN
Clinical trial NCT00276406: Use of Pyridostigmine for Constipation in Diabetics
Official title: Pyridostigmine in Diabetics With Constipation: Randomized, Placebo-controlled, Double-blind Trial
Conditions: Constipation
Diabetes Mellitus
Colonic Transit
Gastric Emptying
Summary: Doctors at Mayo Clinic are doing this study to learn if pyridostigmine, a drug, affects the speed at which food travels through the stomach, intestines and colon, and if pyridostigmine improves constipation symptoms in patients with diabetes. Pyridostigmine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.
Interventions:
description: Pyridostigmine will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.
name: Pyridostigmine
other_name: Mestinon
type: Drug
description: If subject is randomized to placebo, placebo pills will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.
name: Placebo
type: Drug
Study arms:
design_group_description: Oral pyridostigmine, starting with 60 mg capsules three times per day (TID), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg TID (a total of 360 mg per day). This dose was maintained for 7 days.
design_group_title: Pyridostigmine
design_group_type: Experimental
design_group_description: Placebo (sham) capsules, matching the appearance of the active drug comparator and taken TID.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Mayo Clinic
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
National Center for Research Resources
Drug name mappings:
name: 溴吡斯的明
lang: CN
name: Pyridostigmine Bromide
lang: EN
name: ピリドスチグミン臭化物
lang: JP
Clinical trial NCT04407247: Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma
Official title: Treatment of Immune Checkpoint Inhibitor-Related Colitis With Infliximab or Vedolizumab: A Randomized Trial
Conditions: Colitis
Lung Non-Small Cell Carcinoma
Malignant Genitourinary System Neoplasm
Malignant Solid Neoplasm
Melanoma
Summary: This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrhea. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.
Interventions:
description: Given IV
name: Infliximab
other_name: Avakine
Remicade
Remsima
cA2
type: Biological
description: Given IV
name: Vedolizumab
other_name: Entyvio
Immunoglobulin G1, anti-(human integrin LPAM-1 (lymphocyte Peyer''s patch adhesion molecule 1)) (human-Mus musculus heavy chain), disulfide with human-Mus musculus kappa-chain, dimer
LDP 02
LDP-02
LDP02
MLN0002
MLN02
type: Biological
Study arms:
design_group_description: Patients receive infliximab IV over 1 hour once at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm I (infliximab)
design_group_type: Active Comparator
design_group_description: Patients receive vedolizumab IV over 1 hour at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm II (vedolizumab)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 维得利珠单抗
lang: CN
name: Vedolizumab
lang: EN
name: ベドリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00042224: Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
Official title: ECT in Clozapine Refractory Schizophrenia
Conditions: Schizophrenia
Summary: This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.
Interventions:
description: ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
name: Electroconvulsive Therapy (ECT)
type: Procedure
description: Patients with psychotic symptoms will receive clozapine
name: Clozapine
other_name: Clozaril
type: Drug
Study arms:
design_group_description: Electroconvulsive therapy ECT plus clozapine for 8 weeks
design_group_title: 1 ECT plus clozapine
design_group_type: Experimental
design_group_description: Clozapine for 8 weeks
design_group_title: 2 Clozapine
design_group_type: Active Comparator
Sponsor: Northwell Health, Inc.
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 氯氮平
lang: CN
name: Clozapine
lang: EN
name: クロザピン
lang: JP