PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT01483560: REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
Official title: Phase 3 Study of Metformin in Adults With Type 1 Diabetes
Conditions: Diabetes Mellitus, Type 1
Summary: The trial is conducted in the United Kingdom (UK), Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c 7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid intima-media thickness (cIMT), in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease.
Interventions:
description: 3 years treatment duration
name: Metformin
other_name: Glucophage
type: Drug
description: 3 years duration
name: Placebo
type: Drug
Study arms:
design_group_description: Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
design_group_title: Metformin
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Glasgow
Collaborators: University Of Dundee
Merck Serono SA
NHS Greater Glasgow & Clyde
Maastricht UMC+
University of Western Ontario
Juvenile Diabetes Research Foundation
University of Wisconsin-Madison
Steno Diabetes Center A/S
University of Melbourne
Imperial College London
Itamar Medical Ltd.
Drug name mappings:
name: 盐酸二甲双胍
lang: CN
name: Metformin Hydrochloride
lang: EN
name: メトホルミン塩酸塩
lang: JP
Clinical trial NCT03283059: Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease
Official title: Phase III Trial of Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease: a 26 Weeks, Randomized, Double-blind, Double-dummy, Placebo- and Positive- Parallel Controlled and Extended Single Arm to 54 Weeks Multicentre Study
Conditions: Alzheimer Disease
Summary: Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind, double-dummy, placebo- and positive- parallel controlled and extended single arm to 54 weeks multicentre phase III clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate Alzheimer's disease. Patients were randomized to receive placebo thrice daily, or octohydroaminoacridine 4 mg/TID or ARICEPT 5mg/QD.
Interventions:
description: Octohydroaminoacridine Succinate Tablet:4mg P.O. tid
name: Octohydroaminoacridine Succinate
type: Drug
description: Aricept 5mg/day, P.O.
name: Aricept
type: Drug
description: Placebo Tablet: P.O. tid
name: Placebos
type: Drug
Study arms:
design_group_description: Octohydroaminoacridine Succinate Tablet 4mg P.O. tid
design_group_title: Octohydroaminoacridine Succinate Tablet
design_group_type: Experimental
design_group_description: Aricept 5mg/day P.O.
design_group_title: Aricept
design_group_type: Active Comparator
design_group_description: Placebo P.O. tid
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Shanghai Mental Health Center
Collaborators: Hygk
Jiangsu Sheneryang High-Tech Co., Ltd.
Drug name mappings:
name: 琥珀八氢氨吖啶
lang: CN
name: Octahydroaminoacridine succinate
lang: EN
Clinical trial NCT03888066: Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
Conditions: Hyperkalemia
Summary: The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
Interventions:
description: The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
name: Patiromer
other_name: Veltassa
type: Drug
description: The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
name: Placebos
type: Drug
Study arms:
design_group_description: Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.
design_group_title: Group 1: Patiromer
design_group_type: Experimental
design_group_description: Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.
design_group_title: Group 2: Placebo
design_group_type: Placebo Comparator
Sponsor: Corden Pharma Fribourg SA
Collaborators: Syneos Health, Inc.
Drug name mappings:
name: 帕替罗姆
lang: CN
name: Patiromer sorbitex calcium
lang: EN
name: パチロマーソルビテクスカルシウム
lang: JP
Clinical trial NCT06628778: Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)
Official title: Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)
Conditions: Venous Thromboembolism (VTE)
Summary: Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. The investigators will perform a United States definitive multicenter phase 3 randomized controlled trial of the low molecular weight heparin dalteparin as primary venous thromboembolism prophylaxis among critically ill adolescents who are classified a priori as high risk based upon the investigators validated risk prediction models.
Interventions:
description: Dalteparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge
name: Dalteparin
type: Drug
Study arms:
design_group_description: This arm will receive the study intervention, dalteparin thromboprophylaxis during pediatric intensive care unit hospitalization
design_group_title: Dalteparin Thromboprophylaxis
design_group_type: Experimental
design_group_description: This arm will receive standard of care (i.e., no pharmacological thromboprophylaxis)
design_group_title: Standard-of-Care Arm
design_group_type: No Intervention
Sponsor: Johns Hopkins All Children's Hospital
Collaborators: University of California San Diego
Drug name mappings:
name: 达肝素钠
lang: CN
name: Dalteparin Sodium
lang: EN
name: ダルテパリンナトリウム
lang: JP
Clinical trial NCT02304523: Safety and Efficacy of CDFR0612 and CDFR0613 for Bowel Cleansing Before Colonoscopy
Official title: A Prospective, Randomized, Single-blinded (Evaluator), 3-treatment Arm, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of CDFR0612 and CDFR0613
Conditions: Colonoscopy Preparation
Colon Disease
Summary: The purpose of this study is to evaluate the safety and efficacy of CDFR0612 and CDFR0613 compared to PEG+picosulfate (Coolprep Powder) preparation. The effectiveness for bowel cleansing will be assessed with Harefield Cleansing Scale (HCS) by blinded assessor.
Interventions:
description: Preparation 500mL is a mixture of CDFR0612 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
name: CDFR0612
type: Drug
description: Preparation 500mL is a mixture of CDFR0613 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
name: CDFR0613
type: Drug
description: Preparation 500mL is a water solution of Coolprep Powder A and B. A total of 3L (Preparation 2L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
name: Coolprep Powder
other_name: Moviprep
type: Drug
Study arms:
design_group_description: CDFR0612 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min.<br/>These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.
design_group_title: Test 1
design_group_type: Experimental
design_group_description: CDFR0613 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min.<br/>These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.
design_group_title: Test 2
design_group_type: Experimental
design_group_description: Coolprep Powder A and B will be mixed with water to prepare a mixture of a bowel cleansing preparation solution 500mL. Repeat it twice. Take these of IL (2 * 500mL) within 1 hour. After then, take additional 500ml water.<br/>These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.
design_group_title: Comparator
design_group_type: Active Comparator
Sponsor: CTC Bio, Inc.
Collaborators: Symyoo
Drug name mappings:
name: CDFR0612
lang: EN
name: CDFR0613
lang: EN
Clinical trial NCT01905592: A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Official title: A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Conditions: Neoplasms, Breast
Carcinoma of Breast
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Ovarian Neoplasms
Summary: The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
Interventions:
description: 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
name: niraparib
other_name: formerly MK-4827
type: Drug
description: Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops
name: Physician's choice
type: Drug
Study arms:
design_group_description: Physician may select from 4 active comparators
design_group_title: Physician's choice
design_group_type: Active Comparator
design_group_description: Patients will be randomized 2:1 to receive niraparib 300 mg (3x100 mg capsules) once daily for 21 continuous days
design_group_title: niraparib
design_group_type: Experimental
Sponsor: Tesaro, Inc.
Collaborators: Myriad Genetic Laboratories, Inc.
Breast International Group
European Organisation for Research & Treatment of Cancer
US Oncology Research LLC
Sarah Cannon Research Institute LLC
Drug name mappings:
name: 甲苯磺酸尼拉帕利
lang: CN
name: Niraparib Tosylate
lang: EN
name: ニラパリブトシル酸塩水和物
lang: JP
Clinical trial NCT00910780: Metabolic Effects of Antipsychotic Substitution in Children
Official title: Metabolic Effects of Antipsychotic Substitution in Children
Conditions: Diabetes
Summary: This project aims to identify whether therapeutic substitution of aripiprazole for risperidone or olanzapine, combined with standard nutrition intervention, will impact the metabolic changes associated with antipsychotic treatment in children and adolescents.
Interventions:
description: via oral tablets, everyday
name: Aripiprazole
type: Drug
description: via oral tablets, taken once daily
name: Zyprexa
type: Drug
description: via oral tablets, taken once daily
name: Risperdal
type: Drug
Study arms:
design_group_title: Staying on Risperdal
design_group_type: Active Comparator
design_group_title: Risperdal switched to Abilify
design_group_type: Active Comparator
design_group_title: Staying on Zyprexa
design_group_type: Active Comparator
design_group_title: Zyprexa switched to Abilify
design_group_type: Active Comparator
Sponsor: Washington University School of Medicine
Collaborators: Pfizer Inc.
Drug name mappings:
name: 阿立哌唑
lang: CN
name: Aripiprazole
lang: EN
name: アリピプラゾール水和物
lang: JP
name: 利培酮
lang: CN
name: Risperidone
lang: EN
name: リスペリドン
lang: JP
name: 奥氮平
lang: CN
name: Olanzapine
lang: EN
name: オランザピン
lang: JP
Clinical trial NCT01848873: Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
Official title: Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine in Patients With Mild to Moderate Hypertension and Hyperhomocysteinemia ：a Double-blind Randomized Controlled Trial
Conditions: Essential Hypertension
Summary: To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.
Interventions:
description: amlodipine 5mg daily
name: Amlodipine
other_name: control
type: Drug
description: 5mg amlodipine combined with 0.4 mg of folic acid, daily.
name: amlodipine-FA tablet, low dose group
other_name: low dose
type: Drug
description: amlodipine 5mg and folic acid 0.8mg daily
name: amlodipine-FA tablet ,high dose group
other_name: high dose
type: Drug
Study arms:
design_group_description: 5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks.
design_group_title: amlodipine-FA tablet, low dose group
design_group_type: Experimental
design_group_description: 5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks.
design_group_title: amlodipine-FA tablet ,high dose group
design_group_type: Experimental
design_group_description: 5 mg amlodipine, once daily for 8 weeks.
design_group_title: amolodipine
design_group_type: Active Comparator
Sponsor: Shenzhen Ausa Pharmed Co. Ltd.
Collaborators: The First Hospital of Harbin Medical University
Chinese People's Liberation Army General Hospital
Ruijin Hospital
Guangdong General Hospital
Huazhong University of Science & Technology
Capital University of Medical Sciences
The Second Affiliated Hospital Zhejiang University
Xi'an Jiaotong University
Anhui Medical University
West China Hospital
Peking University First Hospital
Fudan University
Xuzhou Medical University
Nanchang University
First Affiliated Hospital Of Fujian Medical University
China Medical University
Drug name mappings:
name: 苯磺酸氨氯地平
lang: CN
name: Amlodipine Besylate
lang: EN
name: アムロジピンベシル酸塩
lang: JP
Clinical trial NCT00389168: Irbesartan and Atenolol in Hypertensive Heart Disease
Official title: Randomized, Double-blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy
Conditions: Hypertension
Summary: The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.
This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.
Interventions:
description: Titrated to 300 mg od, 48 weeks.
name: Irbesartan
other_name: Aprovel
type: Drug
description: Titrated to 100 mg od, 48 weeks.
name: Atenolol
other_name: Tenormin
type: Drug
Study arms:
design_group_description: Irbesartan per os titrated to 300 mg od, 48 weeks
design_group_title: Irbesartan
design_group_type: Experimental
design_group_description: Atenolol per os titrated to 100 mg od, 48 weeks
design_group_title: Atenolol
design_group_type: Active Comparator
Sponsor: Karolinska Institutet
Collaborators: Sanofi
Hjärt-Lungfonden Svenska Nationalföreningen mot hjärt
Bristol Myers Squibb Co.
Drug name mappings:
name: 厄贝沙坦
lang: CN
name: Irbesartan
lang: EN
name: イルベサルタン
lang: JP
Clinical trial NCT00989339: Effects of Intralipid Versus Olive Oil Infusions on Endothelial Function, Immune Function, Inflammatory Markers
Official title: Effects of Intralipid and Olive Oil Infusion on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism
Conditions: Diabetes
Hypertension
Obesity
Summary: Recent evidence suggests that increased levels of a circulation fat (free fatty acids or FFAs) can cause high blood pressure and cardiac complications. Intralipid is the only type of fat approved by the FDA for clinical use. It is usually used as nutrition support in malnourished patients. The investigators' preliminary studies indicate that Intralipid results in a significant rise in blood pressure, blood vessel stiffness, and inflammation in obese subjects. Olive oil can also be used as nutrition support. The effect of olive oil intravenous (IV) on blood pressure and inflammation is not known. In this study, the investigators will compare the effect of Intralipid and olive oil on blood pressure, blood vessel stiffness and inflammation in healthy subjects. The investigators hypothesize that Olive oil emulsions will result in less vascular changes and less inflammatory response than Intralipid solutions. Accordingly, the investigators propose a systematic evaluation of the effects of Intralipid, olive oil and normal saline on blood pressure, endothelial function (vascular stiffness), inflammation in normal subjects.
A group of obese subjects will be admitted to the Clinical Research Center on 3 occasions. Subjects will receive repeated infusions of Intralipid, ClinOleic, and normal saline at 20 ml/hour for 24 hours.
Interventions:
description: Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.
name: Twenty-four Hour TPN and Saline Infusion
type: Drug
Study arms:
design_group_description: Subjects will be admitted to the Grady research center on the evening before each study. The next morning, after an overnight fast, they will receive, in random order, Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr. The interval between admissions will be 1 month.
design_group_title: Twenty-four Hour TPN and Saline Infusion
design_group_type: Experimental
Sponsor: Emory University
Collaborators: American Diabetes Association
Drug name mappings:
name: 奥普瑞白介素
lang: CN
name: Oprelvekin
lang: EN
Clinical trial NCT03530085: Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT
Official title: Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Acute Myeloid Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Conditioning
Elderly
Summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.
Interventions:
description: Decitabine was administered at 20mg/m2/day on days -9 to -7.
name: Decitabine
type: Drug
description: Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
name: Busulfan (BU)
type: Drug
description: Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.
name: Fludarabine(Flu)
type: Drug
Study arms:
design_group_description: For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7；Fludarabine(Flu) 30mg/m2/day on days -6 to -3；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).
design_group_title: Dec+Flu+Bu Conditioning Regimen
design_group_type: Experimental
Sponsor: Nanfang Hospital
Collaborators: Guangzhou First People's Hospital
Peking University People's Hospital
Sun Yat-Sen Memorial Hospital
The Third Affiliated Hospital, Sun Yat-Sen University
Drug name mappings:
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: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 地西他滨
lang: CN
name: Decitabine
lang: EN