PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00794443: ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
Official title: A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.
Conditions: Osteoporosis
Bone Loss, Age-Related
Summary: This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.
Interventions:
description: Oral
name: YM529 / ONO-5920
other_name: Minodronic acid
ONO-5920
YM529
type: Drug
Study arms:
design_group_description: Monthly intermittent administration, dose 1
design_group_title: 1. Monthly - Dose 1
design_group_type: Experimental
design_group_description: Monthly intermittent administration, dose 2
design_group_title: 2. Monthly - Dose 2
design_group_type: Experimental
design_group_description: Daily administration
design_group_title: 3. Daily
design_group_type: Active Comparator
Sponsor: Astellas Pharma, Inc.
Collaborators: Ono Pharmaceutical Co., Ltd.
Drug name mappings:
name: 米诺膦酸
lang: CN
name: Minodronic Acid Hydrate
lang: EN
name: ミノドロン酸水和物
lang: JP
Clinical trial NCT06607419: Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Official title: Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Conditions: B-Cell Lymphoblastic Leukemia
Summary: The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:
• If the flow cytometric MRD negative (<0.01%) rate and the NGS- MRD negative (<0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol).
Participants will:
* Take 14 days full dose Blinatumomab;
* With bone marrow evaluated before and after Blinatumomab treatment.
Interventions:
description: Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
name: Blinatumomab
type: Drug
Study arms:
design_group_description: Patients in this group should receive Blinatumomab
design_group_title: Blinatumomab
design_group_type: Experimental
Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: Ningbo Women and Children’s Hospital
The Third Xiangya Hospital of Central South University
Fujian Medical University
Guizhou Provincial People's Hospital
Wenzhou Medical College
Hunan Provincial People's Hospital
The First Affiliated Hospital of Xiamen University
Drug name mappings:
name: 贝林妥欧单抗
lang: CN
name: Blinatumomab
lang: EN
name: ブリナツモマブ（遺伝子組換え）
lang: JP
Clinical trial NCT06316830: Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
Official title: Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder
Conditions: Opioid Use Disorder
Summary: The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).
The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).
Interventions:
description: Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.
name: Buprenorphine
type: Drug
Study arms:
design_group_description: The experimental intervention is a high daily maintenance dose of buprenorphine (24 mg) plus any usual clinical care the participant receives at the clinic. This high daily dose is the upper limit of the FDA-approved dose range and was selected based on preclinical studies, clinician anecdotes, case reports, and retrospective analyses suggesting improved effectiveness of higher buprenorphine doses among patients with a history of fentanyl use. Underlying pharmacodynamic principles support that the 24 mg daily dose of buprenorphine is likely to be well-tolerated, safe, and better control cravings among people with a history of fentanyl use.
design_group_title: High Maintenance Daily Dose (24mg)
design_group_type: Experimental
design_group_description: The control intervention is the FDA-recommended target daily maintenance dose of buprenorphine (16 mg) plus any usual clinical care the participant receives at the clinic.
design_group_title: Standard Maintenance Daily Dose (16mg)
design_group_type: Active Comparator
Sponsor: Rhode Island Hospital
Collaborators: Brown University
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 NCT04973306: Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC
Official title: Neoadjuvant Immunotherapy Combined With Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (cII-III Stage): A Multi-center Prospective Randomized Clinical Trial
Conditions: Esophageal Squamous Cell Carcinoma Stage II
Esophageal Squamous Cell Carcinoma Stage III
Summary: The purpose of this study was to evaluate the safety, feasibility and outcome of anti-PD-1 antibody (Tislelizumab, BeiGene) combined with neoadjuvant chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy for locally advanced resectable esophageal squamous cell carcinoma (cII-III Stage) patient.
Interventions:
description: Chemotherapy: carboplatin (AUC 2 mg/mL per min) and paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. For each cycle, Carboplatin and paclitaxel were administered 30 minutes apart.<br/>Radiotherapy: A total radiation dose of 41.4 Gy was given in 23 fractions of 1.8 Gy, 5 days per week (Radiotherapy was performed on the 2nd, 3rd, 4th, 5th, and 6th day in each cycle, and only 3 times in the 5th cycle)
name: Neoadjuvant Chemoradiotherapy
type: Procedure
description: Tislelizumab (200mg/time) was administered intravenously on the 1st and 22nd day.<br/>The intravenous injection lasts about 30 minutes (micropump is recommended, intravenous bolus is prohibited, duration should be not less than 20 minutes and not more than 60 minutes);
name: Tislelizumab
other_name: anti-PD-1 antibody
type: Drug
description: After neoadjuvant therapy, patients in groups receive Ivor-Lewis or Mckeown Esophagectomy (Mckeown Esophagectomy recommended)
name: Ivor-Lewis or Mckeown Esophagectomy(Mckeown Esophagectomy recommended)
type: Procedure
Study arms:
design_group_description: Neoadjuvant chemoradiotherapy (NCRT) combined with tislelizumab is performed followed by Ivor-Lewis or Mckeown esophagectomy in enrolled patients.
design_group_title: Neoadjuvant chemoradiotherapy combined with anti-PD-1 antibody
design_group_type: Experimental
design_group_description: Neoadjuvant chemoradiotherapy (NCRT) is performed followed by Ivor-Lewis or Mckeown esophagectomy in enrolled patients.
design_group_title: Neoadjuvant chemoradiotherapy
design_group_type: Active Comparator
Sponsor: Zhongshan Hospital Fudan University
Collaborators: Zhongshan Hospital Fudan University
Shanghai Xuhui District Central Hospital
Zhejiang Cancer Hospital
Sun Yat-Sen University
Sichuan Cancer Hospital
Tianjin Medical University Cancer Institute and Hospital
Cancer Hospital Chinese Academy of Medical Sciences
The First Affiliated Hospital of Wenzhou Medical College
Shanghai Chest Hospital
Shenzhen Fifth People's Hospital
Drug name mappings:
name: 替雷利珠单抗
lang: CN
name: Tislelizumab
lang: EN
name: チスレリズマブ（遺伝子組換え）（JAN）
lang: JP
Clinical trial NCT03047005: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Official title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Conditions: Binge-Eating Disorder
Obesity
Summary: This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.
Interventions:
description: NB medication
name: NB medication (Naltrexone Bupropion combination)
other_name: Contrave
type: Drug
description: Placebo
name: Placebo
type: Other
Study arms:
design_group_description: Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
design_group_title: NB medication
design_group_type: Experimental
design_group_description: Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 盐酸纳曲酮/盐酸安非他酮
lang: CN
name: Bupropion Hydrochloride/Naltrexone Hydrochloride
lang: EN
Clinical trial NCT01809132: Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
Official title: Double-blind Randomized Controlled Trial of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
Conditions: Acute Alcoholic Hepatitis
Summary: This study will compare two different treatments of acute alcoholic hepatitis. The current standard of care is treatment with corticosteroids (methylprednisolone). This will be compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will be treated and followed for 6 months and the two treatment groups will be compared for differences in death rates and laboratory tests that measure liver and gut function.
Interventions:
description: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.
name: Anakinra
other_name: Kineret
type: Drug
description: Pentoxifylline, generic
name: Pentoxifylline
other_name: Pentoxifylline, generic
type: Drug
description: Zinc Sulfate, nutritional supplement
name: Zinc Sulfate
other_name: Zinc Sulfate, generic
type: Drug
description: Methylprednisolone, corticosteroid
name: Methylprednisolone
other_name: Methylprednisolone, generic
type: Drug
Study arms:
design_group_description: anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days
design_group_title: Anakinra & Pentoxifylline & Zinc Sulfate
design_group_type: Experimental
design_group_description: methylprednisolone 32 mg orally daily for 28 days
design_group_title: Methylprednisolone
design_group_type: Active Comparator
design_group_description: Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
design_group_title: Observational
design_group_type: No Intervention
Sponsor: The University of Texas Southwestern Medical Center
Collaborators: University of Massachusetts
National Institute on Alcohol Abuse & Alcoholism
The Cleveland Clinic Foundation
University of Louisville
Drug name mappings:
name: 安纳白介素
lang: CN
name: Anakinra (Amgen)
lang: EN
name: 己酮可可碱
lang: CN
name: Pentoxifylline
lang: EN
name: ペントキシフィリン
lang: JP
name: Zinc Sulfate Hydrate
lang: EN
name: 硫酸亜鉛水和物
lang: JP
Clinical trial NCT00810030: FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR
Official title: Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease
Conditions: Inflammatory Bowel Disease
Anemia
Iron Deficiency
Iron-Deficiency Anemia
Crohn's Disease
Ulcerative Colitis
Summary: The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.
Interventions:
description: Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® (10 to 20 ml) must be diluted only in sterile 0.9% sodium chloride (max 250 ml) FERINJECT® will be administered via i.v. drip infusion. Minimum administration time 15 minutes Dosage: 500 mg, 1000 mg, 1500 mg, according to patients' Hb and body weight
name: Ferric carboxymaltose
other_name: FERINJECT®
type: Drug
description: VENOFER® will be administered via i.v. drip infusion, diluted only in sterile 0.9% sodium chloride solution as follows:<br/>• 10 mL Venofer® (200 mg iron) in maximum 200 mL sterile 0.9% sodium chloride solution in at least 30 minutes.<br/>The first 25 mL of solution should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur, use infusion rate no more than 50 mL in 15 minutes.<br/>The individual iron deficit will be calculated using the modified formula of Ganzoni.<br/>If the patient's body mass index is >25, a normalised weight will be used for the calculation of iron deficit. Normalised weight = 25 x height [m] x height [m].<br/>The calculated cumulative VENOFER® dose is to be rounded up or down to the nearest 200 mg.<br/>Patients will receive one 200 mg VENOFER® infusion, twice a week, up to 11 times (max dosage 2200 mg), depending on their calculated iron deficit.
name: Iron Sucrose
other_name: VENOFER®
type: Drug
Study arms:
design_group_title: FERINJECT® (Ferric carboxymaltose)
design_group_type: Experimental
design_group_title: VENOFER® (Iron Sucrose)
design_group_type: Active Comparator
Sponsor: Corden Pharma Fribourg SA
Collaborators: ClinStar LLC
PAREXEL International Corp.
Drug name mappings:
name: 羧基麦芽糖铁
lang: CN
name: Ferric Carboxymaltose
lang: EN
name: カルボキシマルトース第二鉄
lang: JP
Clinical trial NCT01275365: Optimizing Protein Intake in Older Americans With Mobility Limitations
Official title: Optimizing Protein Intake in Older Americans With Mobility Limitations
Conditions: Mobility Limitation
Summary: This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial in community dwelling, older men, 65 years of age or older, who have mobility limitation and low protein intake. The study will have a 2 X 2 factorial design, which will allow us to investigate the effects of dietary protein intake and testosterone separately and together.
Interventions:
description: Testosterone enanthate 100 mg intramuscularly weekly
name: Testosterone enanthate
type: Drug
description: Testosterone enanthate 100 mg intramuscularly weekly
name: Testosterone enanthate
type: Drug
Study arms:
design_group_description: Placebo injections weekly; 0.8 g/kg/day protein
design_group_title: Placebo/Low Protein
design_group_type: No Intervention
design_group_description: Placebo injections weekly; 1.3 g/kg/day protein
design_group_title: Placebo/High Protein
design_group_type: No Intervention
design_group_description: Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
design_group_title: Testosterone/Low Protein
design_group_type: Other
design_group_description: Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
design_group_title: Testosterone/High Protein
design_group_type: Other
Sponsor: The Brigham & Women's Hospital, Inc.
Collaborators: National Institute on Aging
Drug name mappings:
name: 庚酸睾酮
lang: CN
name: Testosterone Enanthate
lang: EN
name: テストステロンエナント酸エステル
lang: JP
Clinical trial NCT03957668: Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Official title: Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Conditions: Constipation - Functional
Summary: The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.
Interventions:
description: PEG 3350 17 g once daily for 14 days
name: PEG 3350
type: Drug
description: Lactulose 10 g once daily for 14 days
name: Lactulose
type: Drug
Study arms:
design_group_description: The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days.
design_group_title: PEG 3350
design_group_type: Experimental
design_group_description: 15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days
design_group_title: Lactulax
design_group_type: Active Comparator
Sponsor: Fakultas Kedokteran, Universitas Indonesia
Collaborators: PT Meiji Indonesian Pharmaceutical Industries
Drug name mappings:
name: 聚乙二醇3350
lang: CN
name: Polyethylene glycol 3350
lang: EN
Clinical trial NCT00481364: Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
Official title: Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study
Conditions: Vascular Calcification
Atherosclerosis
Dyslipidemia
Inflammation
Summary: This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation.
Interventions:
description: atorvastatin 40 mg/day
name: atorvastatin
type: Drug
description: 1 tb/day
name: placebo
type: Drug
Study arms:
design_group_description: Atorvastatin 40 mg/day
design_group_title: Statin
design_group_type: Active Comparator
design_group_description: placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Ege Universitesi
Collaborators: Pfizer Inc.
Drug name mappings:
name: 阿托伐他汀钙
lang: CN
name: Atorvastatin Calcium
lang: EN
name: アトルバスタチンカルシウム水和物
lang: JP
Clinical trial NCT01305109: A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E
Official title: A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
Conditions: Viral Gastroenteritis Due to Rotavirus
Summary: The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.
Interventions:
description: Oral Rotavirus Vaccine 116E (ORV 116E), 10^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5mL at 4 week intervals
name: ORV 116E
other_name: ROTAVAC
type: Biological
description: 3 doses of 0.5 mL at 4 week intervals
name: Placebo
type: Biological
Study arms:
design_group_description: Oral Rotavirus Vaccine 116E (ORV 116E), 10^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5 mL at 4 week intervals
design_group_title: Oral Rotavirus Vaccine 116E (ORV 116E)
design_group_type: Experimental
design_group_description: 3 doses of 0.5 mL at 4 week intervals
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Bharat Biotech International Ltd.
Collaborators: Ministry of Science and Technology
Program for Appropriate Technology in Health
Drug name mappings:
name: 轮状病毒疫苗116E(Bharat Biotech International Ltd.)
lang: CN
name: Rotavirus vaccine 116E(Bharat Biotech International Ltd.)
lang: EN
Clinical trial NCT00630812: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Official title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
Conditions: Cystic Fibrosis
Summary: The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.
Interventions:
description: 400 mg BD for 26 + 26 weeks
name: inhaled mannitol
type: Drug
description: BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
name: Placebo comparator
type: Drug
Study arms:
design_group_description: active treatment
design_group_title: A
design_group_type: Experimental
design_group_title: B
design_group_type: Placebo Comparator
Sponsor: Syntara Ltd.
Collaborators: ethica Clinical Research Inc.
ReSolution Latin America
Drug name mappings:
name: 甘露醇
lang: CN
name: Mannitol
lang: EN
name: D-マンニトール
lang: JP