PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05530655: A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
Official title: A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
Conditions: Prostate Cancer
Radiation Toxicity
Urinary Complication
Summary: This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms.
Interventions:
description: This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
name: Lisinopril Tablets
type: Drug
Study arms:
design_group_description: Patients who receive radiation but no intervention
design_group_title: Control group
design_group_type: No Intervention
design_group_title: Intervention group
design_group_type: Experimental
Sponsor: University of Rochester
Collaborators: Medical College of Wisconsin
Drug name mappings:
name: 赖诺普利
lang: CN
name: Lisinopril
lang: EN
name: リシノプリル水和物
lang: JP
Clinical trial NCT03678012: Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model
Official title: Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model
Conditions: Dental Caries
Summary: To evaluate the effects of a clinically approved and commercially available iron oxide formulation Ferumoxytol (Feraheme®) to control cariogenic biofilms and enamel demineralization. This study will be testing topical application of Ferumoxytol extra-orally using a standard in situ biofilm demineralization model.
Interventions:
description: 1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
name: Ferumoxytol/Hydrogen peroxide
other_name: Feraheme
type: Drug
description: Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
name: Hydrogen Peroxide
type: Drug
description: Sham solution (water; negative control). Each subject will use this product during one of three treatment periods in the crossover study design.
name: Water
type: Drug
Study arms:
design_group_description: 1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio
design_group_title: Ferumoxytol/Hydrogen peroxide
design_group_type: Active Comparator
design_group_description: Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio
design_group_title: Hydrogen peroxide
design_group_type: Placebo Comparator
design_group_description: Sham solution (water; negative control)
design_group_title: Water
design_group_type: Sham Comparator
Sponsor: University of Pennsylvania
Collaborators: Indiana University
Drug name mappings:
name: 非莫妥尔
lang: CN
name: Ferumoxytol
lang: EN
name: 过氧化氢
lang: CN
name: Hydrogen Peroxide
lang: EN
name: 過酸化水素
lang: JP
Clinical trial NCT01856790: Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
Official title: Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
Conditions: Type 1 Diabetes
Summary: "Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.
Interventions:
description: Insulin pump controlled by closed loop unit and algorithm
name: ePID closed loop system
type: Device
description: Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
name: liraglutide
other_name: Victoza
type: Drug
Study arms:
design_group_description: Each participant recruited into the study will undergo two inpatient closed loop admissions.<br/>The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.<br/>Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.<br/>Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.
design_group_title: Closed Loop Insulin Delivery
design_group_type: Experimental
Sponsor: Yale University
Collaborators: Yale University
Juvenile Diabetes Research Foundation
Drug name mappings:
name: 利拉鲁肽
lang: CN
name: Liraglutide
lang: EN
name: リラグルチド（遺伝子組換え）
lang: JP
Clinical trial NCT05085431: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
Official title: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
Conditions: Sjogren's Syndrome
Autoimmune Diseases
Summary: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
Interventions:
description: Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
name: Assigned Interventions CD19/BCMA CAR T-cells
type: Biological
Study arms:
design_group_description: Experimental：Administration of CD19/BCMA CAR T-cells A dose levels of 1-4*10E6/kg are administrated for each subject.
design_group_title: Treatment of Sjogren's Syndrome
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
name: CD19/BCMA CAR Tcells therapy  (Yake Biotechnology)
lang: EN
Clinical trial NCT00278369: Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer
Official title: A Pilot Study of Denileukin Diftitox in Combination With High-Dose IL-2 for Patients With Metastatic Renal Cell Carcinoma
Conditions: Kidney Cancer
Summary: RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving denileukin diftitox together with interleukin-2 may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitox and interleukin-2 in treating patients with metastatic kidney cancer.
Interventions:
description: The IL-2 is given as a 15-minute infusion through an intravenous catheter (I.V.), a small plastic tube that is put into your vein for the time you are receiving the study treatment. IL-2 is given through the I.V. once every 8 hours for 5 days (days 1-5). A second 5 day cycle of IL-2 will begin on the 15th day (days 15-19). This is one complete cycle (days 1-19) of IL-2 treatment
name: aldesleukin
other_name: IL-2
Interleukin-2
Proleukin
type: Biological
description: Denileukin diftitox will be administered once daily as a 15 to 60 minute infusion for 3 consecutive days.
name: denileukin diftitox
other_name: DAB 389 IL-2
ONTAK (denileukin diftitox)
type: Biological
Study arms:
design_group_description: 6 mcg/kg Denileukin Diftitox administered IV/daily on days 8-10 of standard interleukin 2 dose course
design_group_title: A
design_group_type: Experimental
design_group_description: 9 mcg/kg Denileukin Diftitox administered IV/daily on days -4 to -2 of standard interleukin 2 dose course
design_group_title: B
design_group_type: Experimental
design_group_description: 9 mcg/kg Denileukin Diftitox administered IV/daily on days 8-10 of standard interleukin 2 dose course
design_group_title: C
design_group_type: Experimental
Sponsor: Northwestern University
Collaborators: National Cancer Institute
Drug name mappings:
name: 地尼白介素2
lang: CN
name: Denileukin Diftitox
lang: EN
name: デニロイキン ジフチトクス（遺伝子組換え）
lang: JP
name: 阿地白介素
lang: CN
name: Aldesleukin
lang: EN
Clinical trial NCT07021430: Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy
Official title: Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial
Conditions: Malaria Prevention
Summary: The purpose of this study is to demonstrate the feasibility, acceptability, and preliminary effectiveness of a focal mass drug administration program for household members of pregnant women to protect against malaria in pregnancy.
Interventions:
description: A single or monthly dose of Dihydroartemisinin Piperaquine based on weight will be taken orally.
name: Dihydroartemisinin Piperaquine
other_name: Focal Mass Drug Administration
type: Drug
Study arms:
design_group_description: A single administration of Dihydroartemisinin Piperaquine as a focal mass drug administration Focal Mass Drug Administration.
design_group_title: A single dose of Dihydroartemisinin Piperaquine
design_group_type: Experimental
design_group_description: Monthly doses of Dihydroartemisinin Piperaquine for household members
design_group_title: Monthly dose of Dihydroartemisinin Piperaquine
design_group_type: Experimental
design_group_description: Participants in this arm will receive current standard of care.
design_group_title: Control
design_group_type: No Intervention
Sponsor: The University of North Carolina at Chapel Hill
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 双氢青蒿素哌喹
lang: CN
name: Piperaquine tetraphosphate/Artenimol
lang: EN
Clinical trial NCT02228031: Oxytocin, Emotions and Mirror Neurons
Official title: The Influence of Oxytocin on the Mirror Neuron System: Developing Brain Imaging Paradigms for Future Therapeutic Interventions
Conditions: Social Cognition
Expressed Emotion
Summary: The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation. We will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively. In addition, before the beginning of the EEG recording session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal directed action perception and imitation/execution.
Interventions:
description: The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session
name: Oxytocin
other_name: Syntocinon nasal spray
type: Drug
description: The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
name: Placebo
type: Other
Study arms:
design_group_description: The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session.
design_group_title: Oxytocin
design_group_type: Experimental
design_group_description: The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Maryland Baltimore
Collaborators: University of Maryland
Drug name mappings:
name: 缩宫素
lang: CN
name: Oxytocin
lang: EN
name: オキシトシン
lang: JP
Clinical trial NCT04134325: Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma
Official title: A Prospective Pilot Study Assessing the Immunomodulatory Effect and Clinical Activity of Programmed Cell Death Protein 1 Inhibition Following CD30 Directed Chimeric Antigen Receptor T Cell Therapy in Relapsed/Refractory Classical Hodgkin Lymphoma
Conditions: Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Summary: LCCC1852-ATL is a prospective 2-arm study designed to determine if chimeric antigen receptor T (CAR-T) cells result in immunomodulation which can be subsequently exploited by programmed cell death protein 1 (PD-1) antibodies to achieve clinical responses in subjects with relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL).
Interventions:
description: Nivolumab administered at 240mg every two weeks or 480 mg every four weeks as per standard of care after treatment with CD30.CAR T cells
name: Nivolumab
other_name: Opdivo
type: Biological
description: Pembrolizumab administered at 200 mg every three weeks or 400 mg every six weeks as per standard of care after treatment with CD30.CAR T cells
name: Pembrolizumab
other_name: Keytruda
type: Biological
Study arms:
design_group_description: Subjects with relapsed/refractory classical Hodgkin lymphoma (r/r cHL) who have previously progressed on anti-PD-1 therapy, have received a CD30 CAR-T cell therapy and have evidence of progression. Subjects will be offered anti-PD-1 therapy (nivolumab or pembrolizumab, at the discretion of treating oncologist), as per standard of care in r/r cHL.
design_group_title: Arm 1: Relapse After Prior CD30 CAR-T Therapy
design_group_type: Experimental
design_group_description: Subjects with relapsed/refractory classical Hodgkin lymphoma (r/r cHL) who have previously progressed on anti-PD-1 therapy, have not received a CD30 CAR-T cell therapy and have evidence of progression. Subjects will be offered anti-PD-1 therapy (nivolumab or pembrolizumab, at the discretion of treating oncologist), as per standard of care in r/r cHL.
design_group_title: Arm 2: Relapse with no Prior CD30 CAR-T Therapy
design_group_type: Experimental
Sponsor: Lineberger Comprehensive Cancer Center
Collaborators: American Society of Clinical Oncology, Inc.
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
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04532268: A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
Official title: Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
Conditions: Acute Lymphoblastic Leukemia
Non-hodgkin Lymphoma,B Cell
Summary: A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.
Interventions:
description: Each subject receive humanized CD19 CAR T-cells by intravenous infusion
name: Humanized CD19 CAR-T cells
other_name: Humanized CD19 CAR-T cells injection
type: Drug
Study arms:
design_group_description: Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
design_group_title: Administration of Humanized CD19 CAR T-cells
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
name: Anti-CD19 CART cell therapy (YaKe Biotechnology)
lang: EN
Clinical trial NCT02754856: Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery
Official title: Pilot Study Assessing the Safety and Tolerability of the Neoadjuvant Use of Tremelimumab (Anti-CTLA-4) Plus Durvalumab (MEDI4736) (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver Metastases
Conditions: Metastatic Carcinoma in the Liver
Resectable Mass
Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
Stage IVB Colorectal Cancer AJCC v7
Summary: This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as tremelimumab and durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Interventions:
description: Given IV
name: Durvalumab
other_name: Imfinzi
Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
MEDI-4736
MEDI4736
type: Biological
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Undergo liver surgery
name: Therapeutic Conventional Surgery
type: Procedure
description: Given IV
name: Tremelimumab
other_name: Anti-CTLA4 Human Monoclonal Antibody CP-675,206
CP-675
CP-675,206
CP-675206
Ticilimumab
type: Biological
Study arms:
design_group_description: Patients receive tremelimumab IV over 1 hour and durvalumab IV over 4 hours during week 11. Between weeks 15 and 17, patients undergo liver surgery. Patients then receive durvalumab IV over 1 hour during weeks 21, 25, 29, and 33.
design_group_title: Treatment (tremelimumab, durvalumab)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 曲麦利尤单抗
lang: CN
name: Tremelimumab
lang: EN
name: トレメリムマブ（遺伝子組換え）
lang: JP
name: 度伐利尤单抗
lang: CN
name: Durvalumab
lang: EN
name: デュルバルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00995826: Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958
Official title: CS-8958 - A Phase I, Double-blind, Placebo-controlled, Ascending, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects.
Conditions: Influenza
Summary: The purpose of this study is to test the safety and tolerability of an investigational multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. Participants will be divided into two treatment groups (Groups A and B) with each group consisting of 8 subjects. Participants will be involved in study related procedures for a maximum of 14 weeks from initial screen to the follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two subjects will receive placebo (substance containing no medication), once a week for six weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects will receive placebo, twice a week for six weeks. Study procedures will include blood and urine samples, ECGs (measure of heart activity), blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin. Also continuous cardiac telemetry will be performed as well as physical examinations and spirometry assessments.
Interventions:
description: Inhaled CS-8958
name: CS-8958
other_name: Laninamivir
type: Drug
description: Inhaled placebo
name: Placebo
type: Other
Study arms:
design_group_title: placebo
design_group_type: Placebo Comparator
design_group_title: CS-8958 DPI
design_group_type: Experimental
Sponsor: Biota Scientific Management Pty Ltd.
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 辛酸拉尼米韦
lang: CN
name: Laninamivir Octanoate Hydrate
lang: EN
name: ラニナミビルオクタン酸エステル水和物
lang: JP
Clinical trial NCT01091077: A Pilot Study of the Grapefruit Flavonoid Naringenin for HCV Infection
Official title: A Pilot Study of the Grapefruit Flavonoid Naringenin for the Treatment of HCV Infection
Conditions: Hepatitis C Virus
HCV Infection
Chronic HCV
Hepatitis C
Summary: Hepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An component of grapefruit could block this fat and thus lower the amount of virus in the blood stream. We propose that treatment with this ingredient, called naringenin, could be used to block this fat and HCV in persons infected with hepatitis C.
Interventions:
description: 1 gram of naringenin mixed with 16 grams of hydroxypropyl-β-cyclodextrin in 250 mL of water
name: Naringenin
other_name: Grapefruit
type: Dietary Supplement
Study arms:
design_group_description: Single dose of naringenin, compared to placebo in the same individual.
design_group_title: Naringenin
design_group_type: Placebo Comparator
Sponsor: The General Hospital Corp.
Collaborators: Harvard University
Drug name mappings:
name: 柚皮素
lang: CN
name: Naringenin
lang: EN
Clinical trial NCT07323173: A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
Official title: A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
Conditions: Systemic Lupus Erythematosus
Summary: A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients with systemic lupus erythematosus.
Interventions:
description: Single subcutaneous injection
name: LBL-047 for Injection
other_name: LBL-047
type: Drug
description: Single subcutaneous injection
name: LBL-047 placebo for injection
other_name: LBL-047 placebo
type: Drug
Study arms:
design_group_description: LBL-047 for Injection,Single subcutaneous injection.
design_group_title: LBL-047 for Injection
design_group_type: Experimental
design_group_description: LBL-047 placebo for injection,Single subcutaneous injection.
design_group_title: LBL-047 placebo for injection
design_group_type: Active Comparator
Sponsor: Nanjing Leads Biolabs Co., Ltd.
Collaborators: Shanghai Public Health Clinical Center
Drug name mappings:
name: LBL-047
lang: EN
Clinical trial NCT02337270: Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
Official title: Phase 1, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine Administered by Aerosol
Conditions: Tuberculosis
Summary: This is a phase 1 study, in healthy volunteers who have previously been immunized with bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in the blood and lungs following the administration by aerosol of a new experimental adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A.
Interventions:
description: Aerosol administration of Ad5Ag85A
name: Ad5Ag85A
type: Biological
Study arms:
design_group_description: Receive 10^6 Ad5Ag85A by aerosol at day 0
design_group_title: Group 1 Aerosol
design_group_type: Experimental
design_group_description: Receive 2x10^6 Ad5Ag85A by aerosol at day 0
design_group_title: Group 2 Aerosol
design_group_type: Experimental
design_group_description: Receive 10^8 Ad5Ag85A by intramuscular injection at day 0
design_group_title: Group 3 Intramuscular
design_group_type: Experimental
Sponsor: McMaster University
Collaborators: Canadian Institutes of Health Research
Drug name mappings:
name: Ad5-Ag85A
lang: EN