PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03442972: Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids
Official title: Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans
Conditions: Hyperlipidemias
Summary: Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known. The research team in this study is interested in finding out how teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut by studying samples from patients undergoing endoscopy and small bowel biopsy.
Interventions:
description: Teduglutide
name: Teduglutide
type: Drug
description: Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: Teduglutide, up to 0.05mg/kg, subcutaneous, single dose
design_group_title: Teduglutide
design_group_type: Experimental
design_group_description: Placebo, subcutaneous, single dose
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University Health Network
Collaborators: Kensington Screening Clinic
Drug name mappings:
name: 替度格鲁肽
lang: CN
name: Teduglutide Recombinant
lang: EN
name: テデュグルチド（遺伝子組換え）
lang: JP
Clinical trial NCT01813773: Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study
Official title: Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study
Conditions: Proliferative Diabetic Retinopathy
Summary: To assess the safety of intravitreal aflibercept injection in the treatment of proliferative diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.
Interventions:
description: EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.
name: Intravitreal Aflibercept Injection (IAI)
other_name: Eylea
type: Drug
Study arms:
design_group_description: Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will continue to receive IAI every 4 weeks, beginning week 20, through week 48.
design_group_title: Group A - IAI every 4 weeks
design_group_type: Experimental
design_group_description: Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will receive IAI every 8 weeks, beginning week 24, through week 48.
design_group_title: Group B - IAI every 8 weeks
design_group_type: Experimental
Sponsor: Ophthalmic Consultants of Long Island
Collaborators: Regeneron Pharmaceuticals, Inc.
Drug name mappings:
name: 阿柏西普
lang: CN
name: Aflibercept
lang: EN
name: アフリベルセプト（遺伝子組換え）
lang: JP
Clinical trial NCT00128466: Treatment and Diagnosis of Plague
Official title: Safety and Efficacy of Gentamicin Versus Streptomycin for the Treatment of Naturally Occurring Human Plague and Evaluation of Rapid Diagnostic Test Kits for Yersinia Pestis
Conditions: Plague
Summary: This clinical trial will compare the effectiveness of streptomycin, which historically is the standard drug for treatment of plague, with gentamicin. The hypothesis is that gentamicin is not inferior to streptomycin but that it will have less severe side effects. The study is being done in Madagascar because that country reports the most plague cases in the world. Patients coming into a participating clinic with suspected plague (bubonic, pneumonic, or septicemic) will be randomized into one of two treatment arms after giving informed consent. Patients will be monitored for side effects and for improvement of symptoms.
In addition, rapid diagnostic test strips have been developed but not fully evaluated for use on humans. The investigators will evaluate these new tests on specimens from the same patients, comparing their performance with that of classical diagnostic methods such as culture and serology.
Interventions:
name: gentamicin
type: Drug
name: streptomycin
type: Drug
Study arms:
Sponsor: Centers for Disease Control & Prevention
Collaborators: Uganda Ministry of Health
US Food & Drug Administration
Drug name mappings:
name: 硫酸链霉素
lang: CN
name: Streptomycin Sulfate
lang: EN
name: ストレプトマイシン硫酸塩
lang: JP
name: 硫酸庆大霉素
lang: CN
name: Gentamicin Sulfate
lang: EN
name: ゲンタマイシン硫酸塩
lang: JP
Clinical trial NCT00517712: Single Agent Arsenic Trioxide in the Treatment of Newly Diagnosed Acute Promyelocytic Leukemia
Official title: Molecular Remission With Arsenic Trioxide in Acute Promyelocytic Leukemia: Indian APL Study Group - IAPLSG
Conditions: Acute Promyelocytic Leukemia
Summary: There is very limited data on the use of arsenic trioxide in newly diagnosed patients with acute promyelocytic leukemia. The use of arsenic trioxide was limited to relapsed patients mainly because of the superior efficacy of ATRA as primary therapy for newly diagnosed APML. Though the early study by Niu et al showed 72% remission rates in 11 newly diagnosed patients, the role of arsenic trioxide as primary therapy was limited by the hepatic toxicity seen in this study. Studies from our centre have shown remission rates of 70-75% in newly diagnosed patients with acute promyelocytic leukemia. There was no major toxicity seen related to the administration of arsenic trioxide. Follow up data on these patients continue to show long term remission rates above 70%. These remission rates are similar to the data available in patients with acute promyelocytic leukemia treated with ATRA. Lu et al studied 19 patients treated with oral arsenic (Tetra-arsenic tetra-sulfide) wherein 84% achieved hematological remission with disease free survival of 76% at 3 years. Studies from other groups using arsenic trioxide alone or in combination with ATRA have shown similar remission rates. Arsenic trioxide as primary therapy for patients with newly diagnosed acute promyelocytic leukemia is a very attractive treatment option for developing countries mainly because of the low cost involved along with the favorable toxicity profile. However long term remission data is still not available and the ideal course and duration of treatment still needs to be defined. This multi-center study aims to further clarify the efficacy of this agent in the treatment of newly diagnosed cases of acute promyelocytic leukemia and to study the optimal maintenance regimen.
Interventions:
description: duration of maintenance therapy, 6 months versus 12 months
name: Single agent arsenic trioxide
type: Drug
Study arms:
design_group_description: Duration of maintenance therapy with single agent ATO of 12 months
design_group_title: A
design_group_type: Active Comparator
design_group_description: Duration of maintenance therapy with single agent ATO for 6 months
design_group_title: B
design_group_type: Active Comparator
Sponsor: Christian Medical College & Hospital
Collaborators: Ministry of Science and Technology
Drug name mappings:
name: 三氧化二砷
lang: CN
name: Arsenic Trioxide
lang: EN
name: 三酸化二ヒ素
lang: JP
Clinical trial NCT04345718: EXHIT ENTRE Comparative Effectiveness Trial
Official title: Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Comparative Effectiveness Trial of Extended Release Buprenorphine Versus Treatment as Usual for Hospitalized Patients With Opioid Use Disorder
Conditions: Substance Use Disorder
Opioid Use Disorder, Moderate
Opioid Use Disorder, Severe
Summary: This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.
Interventions:
description: XR-BUP administration prior to hospital discharge will increase engagement in OUD care on the 34th day following hospital discharge more than is currently afforded by ACS TAU approaches (e.g., methadone, SL-BUP, and naltrexone).
name: Extended Release Buprenorphine
other_name: Medication for Opioid Use Disorder
type: Drug
description: Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.
name: Treatment as Usual
other_name: Standard Medication for Opioid Use Disorder
type: Drug
Study arms:
design_group_description: Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.
design_group_title: Interventional
design_group_type: Experimental
design_group_description: Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.
design_group_title: Treatment as Usual
design_group_type: Active Comparator
Sponsor: Hennepin Healthcare Research Institute
Collaborators: The Emmes Co. LLC
National Institute on Drug Abuse
Hennepin Healthcare Research Institute
Drug name mappings:
name: 盐酸丁丙诺啡
lang: CN
name: Buprenorphine Hydrochloride
lang: EN
name: ブプレノルフィン塩酸塩
lang: JP
Clinical trial NCT03217734: MAP Study: Methotrexate and Adalimumab in Psoriasis
Official title: MAP Study (Methotrexate and Adalimumab in Psoriasis): Adalimumab vs. Combination Adalimumab and Methotrexate in Psoriasis: Efficacy and Anti-Adalimumab Antibody Formation
Conditions: Psoriasis
Summary: Assess the efficacy and safety of ADA compared to ADA/MTX in patient with Psoriasis. Compare Anti-ADA antibody formation and serum ADA levels in patients on ADA compared with those on combination ADA and MTX.
Interventions:
description: Subcutaneous Injection
name: Adalimumab
other_name: Humira
type: Biological
description: Oral Tablet
name: Methotrexate
other_name: MTX
type: Drug
description: Oral Tablet
name: Placebo
type: Drug
Study arms:
design_group_description: Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Placebo, Tablet, Oral, Weekly, 16 Weeks
design_group_title: ADA and Placebo
design_group_type: Placebo Comparator
design_group_description: Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Methotrexate, 2.5 mg Tablet, 10 mg Weekly, Oral, 16 Weeks
design_group_title: ADA and MTX
design_group_type: Active Comparator
Sponsor: Bakersfield Dermatology & Skin Cancer Medical Group
Collaborators: AbbVie, Inc.
Drug name mappings:
name: 阿达木单抗
lang: CN
name: Adalimumab
lang: EN
name: アダリムマブ（遺伝子組換え）
lang: JP
name: 甲氨蝶呤钠
lang: CN
name: Methotrexate Sodium
lang: EN
Clinical trial NCT00272324: Aspirin/Folate Prevention of Large Bowel Polyps
Official title: Aspirin/Folate Prevention of Large Bowel Polyps
Conditions: Colorectal Cancer
Polyps
Adenomas
Summary: This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.
Interventions:
name: Aspirin
type: Drug
name: Folate
type: Drug
Study arms:
Sponsor: Dartmouth-Hitchcock Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 叶酸
lang: CN
name: Folic Acid
lang: EN
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
Clinical trial NCT03094429: An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
Official title: An Adaptive Phase II/III, Double-Blind, Randomized, Placebo-controlled, Two-Part, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®,a D-Amino Acid Oxidase Inhibitor, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
Conditions: Refractory Schizophrenia
Summary: This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia.
Part 1 Objectives: There are two primary objectives for Part 1 of this study:
1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study.
2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine.
Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.
Interventions:
description: 2000 mg/day or 1000 mg/day, twice daily
name: NaBen®
type: Drug
description: 0 mg total, twice daily
name: Placebo
type: Other
Study arms:
design_group_description: Two NaBen® ( 500 mg) will be taken twice daily at a total dose of 2000 mg/day during this study.
design_group_title: NaBen® - 2000 mg/day
design_group_type: Active Comparator
design_group_description: One NaBen® (500 mg) and one placebo will be taken twice daily at a total dose of 1000 mg/day during this study.
design_group_title: NaBen® - 1000 mg/day
design_group_type: Active Comparator
design_group_description: The control treatment is placebo.
design_group_title: Placebo - 0 mg/day
design_group_type: Placebo Comparator
Sponsor: SyneuRx International (Taiwan) Corp.
Collaborators: Amarex Clinical Research LLC
Drug name mappings:
name: 苯甲酸钠
lang: CN
name: Sodium Benzoate
lang: EN
name: 安息香酸ナトリウム
lang: JP
Clinical trial NCT01691768: Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
Official title: Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision Through Family Planning Services in KwaZulu-Natal, South Africa
Conditions: HIV
Summary: The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.
Interventions:
description: Participants will be randomized to receive 1% tenofovir gel through either:<br/>* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or<br/>* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).
name: 1% tenofovir gel
type: Drug
Study arms:
design_group_description: 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery
design_group_title: Intervention
design_group_type: Experimental
design_group_description: monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics
design_group_title: Control
design_group_type: Active Comparator
Sponsor: Centre for the AIDS Programme of Research in South Africa
Collaborators: FHI 360, Inc.
Contraception Research and Development
The Institute for Healthcare Improvement
Gilead Sciences, Inc.
Drug name mappings:
name: 替诺福韦
lang: CN
name: Tenofovir
lang: EN
Clinical trial NCT00063076: Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1% in Alopecia Areata
Official title: A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata
Conditions: Alopecia Areata
Summary: The goal of this clinical research study is to find the most effective dose of Targretin® (bexarotene) Gel 1% that can be given to patients as a treatment for alopecia areata. The safety and tolerability of this drug will also be studied.
Objectives:
1. Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients with alopecia areata.
2. Determine the efficacy of Targretin® Gel 1% in the treatment of patients with alopecia areata.
Interventions:
description: Alopecia lesions on one-half of the head including facial hair treated, and other half on head serves as control (untreated). Starting dose once every day till Week 3 then escalate to twice a day.
name: Targretin Gel 1%
other_name: Targretin
type: Drug
Study arms:
design_group_description: Targretin® (bexarotene) Gel 1%, treat half head
design_group_title: Targretin®
design_group_type: Experimental
design_group_description: Half head untreated as control
design_group_title: Control
design_group_type: No Intervention
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Ligand Pharmaceuticals, Inc.
Drug name mappings:
name: 贝沙罗汀
lang: CN
name: Bexarotene
lang: EN
name: ベキサロテン
lang: JP
Clinical trial NCT00624923: Targeting Inflammation Using Salsalate in CardioVascular Disease
Official title: Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)
Conditions: Coronary Artery Disease
Overweight
Summary: The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote a chronic, subacute inflammatory state that participates in the development and progression of atherosclerosis. We will evaluate the effects of targeting inflammation using the anti-inflammatory drug salsalate, compared to placebo, on coronary artery plaque volume assessed by multi-detector computed tomographic angiography (MDCTA). The TINSAL-CVD study is a randomized, double-masked, placebo-controlled, 2 arm, clinical trial.
The purpose of the study is to compare the effect of salsalate or placebo on sub-acute inflammation and coronary plaque, in people with cardiovascular disease. Participants are randomized to active intervention (salsalate) or placebo interventions for a period of 30 months. The primary endpoint is change in plaque volume in the coronary arteries assessed by MDCTA from baseline to 30 months.
Interventions:
description: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months
name: Salsalate
other_name: Disalcid
type: Drug
description: Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months
name: Placebo
other_name: Placebo to Salsalate
type: Drug
Study arms:
design_group_description: Salsalate
design_group_title: 1- Active Pharmacologic
design_group_type: Experimental
design_group_description: Placebo
design_group_title: 2- Placebo
design_group_type: Placebo Comparator
Sponsor: Joslin Diabetes Center, Inc.
Collaborators: Tufts Medical Center, Inc.
National Heart, Lung & Blood Institute
Beth Israel Deaconess Medical Center, Inc.
Drug name mappings:
name: 双水杨酯
lang: CN
name: Salsalate
lang: EN
Clinical trial NCT04452474: Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19).
Official title: A Multicenter, Randomized, Double-blind, Adaptive, Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe SARS-CoV-2 Infection (COVID-19)
Conditions: COVID-19
Summary: The primary objective of the study is to evaluate the efficacy of a single dose of OKZ (64 mg) vs placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 29.
Interventions:
description: solution for subcutaneous administration 160 mg/mL
name: Olokizumab 64 mg
type: Drug
description: Normal Saline (0.9% Sodium Chloride solution for Injection), in the market package
name: Placebo
type: Drug
Study arms:
design_group_description: Subject randomized to receive subcutaneous single injection of 0,4 ml solution of Olokizumab on Day 1, in addition to standard therapy
design_group_title: Olokizumab 64 mg
design_group_type: Experimental
design_group_description: Subject randomized to receive subcutaneous single injection of 0,4 ml solution of Placebo on Day 1, in addition to standard therapy
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: R-Pharm JSC
Collaborators: Cromos Pharma LLC
Labcorp Drug Development, Inc.
Drug name mappings:
name: Olokizumab
lang: EN
Clinical trial NCT04098653: Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT
Official title: Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Conditioning
Myeloid Tumors
Summary: Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.
Interventions:
description: Decitabine was administered at 20mg/m2/day on days -14 and -10.
name: Decitabine
type: Drug
description: Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
name: Busulfan (BU)
type: Drug
description: Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
name: Cyclophosphamide (CY)
type: Drug
Study arms:
design_group_description: For myeloid tumors undergoing allo-HSCT, Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10, Busulfan (BU) 3.2 mg/kg/day on days -7 and -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
design_group_title: Decitabine + BUCY
design_group_type: Experimental
design_group_description: For myeloid tumors undergoing allo-HSCT, BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
design_group_title: BUCY
design_group_type: Active Comparator
Sponsor: Nanfang Hospital
Collaborators: Sun Yat-Sen Memorial Hospital
The Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Drug name mappings:
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
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: 地西他滨
lang: CN
name: Decitabine
lang: EN