PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00205842: Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Official title: A Phase IIIb, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus
Conditions: Ileus
Summary: Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.
Interventions:
name: alvimopan
type: Drug
Study arms:
Sponsor: Cubist Pharmaceuticals LLC
Collaborators: GSK Plc
Drug name mappings:
name: 爱维莫潘
lang: CN
name: Alvimopan Dihydrate
lang: EN
Clinical trial NCT01633099: Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients
Official title: The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients
Conditions: Untreated Adult Acute Myeloid Leukemia
Effect of Drugs
Drug Safety
Summary: The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.
Interventions:
description: 1. Number of Cycles: 4 cycles.<br/>2. Dose and drug delivery(decitabine):<br/>The 1st cycle: 20 mg/m2, (iv,>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle.<br/>If bone marrow blast cells<5%, the following cycle:decitabine 20 mg/m2, (iv,>1h) on d1-5 of each 28 day cycle.<br/>If Grade 4 neutropenia（<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,>1h, on d1-3 of each 28day cycle).
name: Decitabine
other_name: Dacogen
type: Drug
Study arms:
design_group_description: Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.
design_group_title: Decitabine, CR rate,OS,EFS,RFS
design_group_type: Other
Collaborators: Xian-Janssen Pharmaceutical Ltd.
Drug name mappings:
name: 地西他滨
lang: CN
name: Decitabine
lang: EN
Clinical trial NCT03515629: REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer
Official title: A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 ≥50%
Conditions: Non-small Cell Lung Cancer
Summary: The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.
Interventions:
description: REGN2810 plus ipilimumab
name: REGN2810/ipi
other_name: cemiplimab
type: Drug
description: REGN2810 plus chemotherapy plus Ipilimumab
name: REGN2810/chemo/ipi
other_name: cemiplimab
type: Drug
description: Reference drug administered IV infusion
name: Pembrolizumab
type: Drug
Study arms:
design_group_description: Pembrolizumab
design_group_title: Pembrolizumab
design_group_type: Active Comparator
design_group_description: REGN2810/ipi
design_group_title: REGN2810/ipi
design_group_type: Experimental
design_group_description: REGN2810/chemo/ipi
design_group_title: REGN2810/chemo/ipi
design_group_type: Experimental
Sponsor: Regeneron Pharmaceuticals, Inc.
Collaborators: Sanofi
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 塞普利单抗
lang: CN
name: Cemiplimab-RWLC
lang: EN
name: セミプリマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03073967: Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
Official title: A Randomized, Open Label, Multi-center, Comparative Trial, to Assess the Efficacy and Safety of Pritelivir for the Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)
Conditions: HSV Infection
Summary: Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).
Interventions:
description: 100 mg oral tablets
name: Pritelivir
type: Drug
description: Foscarnet iv, 40 mg/kg BW tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg BW given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, Solution for iv infusion or topical application
name: Investigator's choice
other_name: Foscarnet or Cidofovir or Imiquimod
type: Drug
Study arms:
design_group_description: Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
design_group_title: Part C, Pritelivir
design_group_type: Experimental
design_group_description: Investigator's Choice:<br/>Foscarnet iv, 40 mg/kg tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg body weight given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, topically applied 3 times per week, for up to 28 days and potential prolongation for up to additional 14 days.
design_group_title: Part C,
design_group_type: Active Comparator
design_group_description: Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
design_group_title: Part D, Pritelivir
design_group_type: Experimental
design_group_description: Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
design_group_title: Part E, Pritelivir
design_group_type: Experimental
design_group_description: Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
design_group_title: Part F, Pritelivir
design_group_type: Experimental
Sponsor: Aicuris Anti-Infective Cures AG
Collaborators: Medpace, Inc.
Drug name mappings:
name: 普利特利韦
lang: CN
name: Pritelivir
lang: EN
Clinical trial NCT02210325: Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
Official title: An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia
Conditions: Uncomplicated Urogenital Gonorrhea
Summary: This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.
Interventions:
name: solithromycin
type: Drug
name: ceftriaxone
type: Drug
name: azithromycin
type: Drug
Study arms:
design_group_description: A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin
design_group_title: Ceftriaxone plus Azithromycin
design_group_type: Active Comparator
design_group_description: A single oral dose of 1000 mg solithromycin
design_group_title: Solithromycin
design_group_type: Experimental
Sponsor: Melinta Therapeutics, Inc.
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 索利霉素
lang: CN
name: Solithromycin
lang: EN
Clinical trial NCT00931528: Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated With Radiotherapy for Prostate Cancer
Conditions: Prostate Cancer
Sexual Dysfunction
Summary: RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is more effective than a placebo in preventing erectile dysfunction.
PURPOSE: This randomized phase III trial is studying tadalafil to see how well it works compared with a placebo in preventing erectile dysfunction in patients with prostate cancer treated with radiation therapy.
Interventions:
description: Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
name: Tadalafil
type: Drug
description: Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
name: Placebo
type: Other
Study arms:
design_group_description: Tadalafil
design_group_title: Tadalafil
design_group_type: Experimental
design_group_description: Placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Radiation Therapy Oncology Group
Collaborators: National Cancer Institute
NRG Oncology
Drug name mappings:
name: 他达拉非
lang: CN
name: Tadalafil
lang: EN
name: タダラフィル
lang: JP
Clinical trial NCT04661358: Fenofibrate for Prevention of DR Worsening
Official title: A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening
Conditions: Diabetic Retinopathy
Summary: This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.
Interventions:
description: Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
name: Fenofibrate
type: Drug
description: Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
name: Placebo
type: Other
Study arms:
design_group_title: Fenofibrate 160-mg
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Jaeb Center For Health Research Foundation, Inc.
Collaborators: The Leona M. & Harry B. Helmsley Charitable Trust
Juvenile Diabetes Research Foundation
Roche Pharma AG
National Institutes of Health
National Eye Institute
Drug name mappings:
name: 非诺贝特
lang: CN
name: Fenofibrate
lang: EN
name: フェノフィブラート
lang: JP
Clinical trial NCT00085826: A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients
Official title: A Phase III, Randomized, Double-Blind, Multi-Center Study of the Efficacy of Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) Versus Taxotere (Docetaxel) and Placebo in Non-Small Cell Lung Cancer (NSCLC) Patients After Failure of Prior Platinum-Based Chemotherapy
Conditions: Non-Small Cell Lung Cancer
Summary: Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone.
This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere.
This study has been completed and a publication is pending.
Interventions:
name: Exisulind
type: Drug
Study arms:
Sponsor: Astellas Pharma, Inc.
Collaborators: OSI Pharmaceuticals, Inc.
Drug name mappings:
name: 依昔舒林
lang: CN
name: Exisulind
lang: EN
Clinical trial NCT00697697: A Study of 2 Doses of MAP0010 in Asthmatic Children
Official title: A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)
Conditions: Asthma
Summary: The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.
Interventions:
description: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
name: 0.135mg MAP0010
type: Drug
description: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
name: 0.25mg MAP0010
type: Drug
Study arms:
design_group_description: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
design_group_title: 0.135mg MAP0010
design_group_type: Experimental
design_group_description: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
design_group_title: 0.25mg MAP0010
design_group_type: Experimental
Sponsor: Allergan UC
Collaborators: MAP Pharmaceuticals LLC
Drug name mappings:
name: 布地奈德
lang: CN
name: Budesonide
lang: EN
name: ブデソニド
lang: JP
Clinical trial NCT00529620: Three Alternative Drug Regimens for Malaria Seasonal Preventive Treatment in Senegal
Official title: Randomized Trial of Effectiveness and Acceptability of Three Alternative Regimens for Malaria Seasonal Intermittent Preventive Treatment in Senegal
Conditions: Malaria
Summary: The purpose of this trial is to compare the acceptability, efficacy and safety of three alternative drug regimens for use for seasonal Intermittent Preventive Treatment to prevent malaria in children. Children aged 2 months to 5 years will be randomized to receive IPT with one of three regimens during the transmission season: sulfadoxine-pyrimethamine (SP) plus amodiaquine, show to be highly effective for IPT in a recent trial; SP plus piperaquine, used for malaria prophylaxis in China for many years; or Duocotexcin (a combination of piperaquine with an artemisinin).
Interventions:
description: Monthly treatments during the malaria transmission season
name: sulfalene-pyrimethamine plus amodiaquine
other_name: Dualkin
type: Drug
description: Monthly treatments during the transmission season
name: dihydroartemisinin plus piperaquine
other_name: Duo cotexcin
type: Drug
description: Monthly treatments during the malaria transmission season
name: sulfadoxine pyrimethamine plus piperaquine
other_name: piperaquine phosphate
sulfadoxine pyrimethamine
type: Drug
Study arms:
design_group_description: sulfalene pyrimethamine plus amodiaquine
design_group_title: 1
design_group_type: Active Comparator
design_group_description: dihydroartemisinin piperaquine
design_group_title: 2
design_group_type: Active Comparator
design_group_description: sulfadoxine-pyrimethamine plus piperaquine
design_group_title: 3
design_group_type: Active Comparator
Sponsor: London School of Hygiene & Tropical Medicine
Collaborators: Cheikh Anta Diop University
Drug name mappings:
name: 磺胺林
lang: CN
name: Sulfalene
lang: EN
name: 双氢青蒿素哌喹
lang: CN
name: Piperaquine tetraphosphate/Artenimol
lang: EN
name: 磺胺多辛乙胺嘧啶
lang: CN
name: Pyrimethamine/Sulfadoxine
lang: EN
name: 磷酸哌喹
lang: CN
name: Piperaquine Phosphate
lang: EN
name: 盐酸阿莫地喹
lang: CN
name: Amodiaquine Hydrochloride
lang: EN
name: 乙胺嘧啶
lang: CN
name: Pyrimethamine
lang: EN
Clinical trial NCT07112144: Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial
Official title: Phase III Clinical Trials to Evaluate the Immunogenicity and Safety of Adsorption-free Diphtheria and Tetanus (Three-component) Combined Vaccine in 2-month-old Infants and Young Children
Conditions: Prevent Whooping Cough
Prevent Diphtheria
Prevent Tetanus
Summary: The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.
Interventions:
description: Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml；Injection；
name: DTacP
type: Biological
description: Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml.Injection
name: DTaP
type: Biological
description: Administer 1 dose at 2 months, 4 months, 6 months and 18 months of age respectively, with each injection dose being 0.5 ml.Injection
name: DTacP-IPV/Hib
type: Biological
Study arms:
design_group_title: DTacP
design_group_type: Experimental
design_group_title: DTaP
design_group_type: Active Comparator
design_group_title: DTacP-IPV/Hib
design_group_type: Active Comparator
Sponsor: Changchun BCHT Biotechnology Co.
Collaborators: Shandong Province Centers for Disease Control and Prevention
Drug name mappings:
name: 吸附无细胞百白破(三组分)联合疫苗(长春百克生物)
lang: CN
name: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed(Changchun BCHT Biotechnology Co.)
lang: EN
Clinical trial NCT00683514: Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer
Official title: Oral Vinorelbine And Cisplatin With Concomitant Radiotherapy Followed By Either Consolidation Therapy With Oral Vinorelbine And Cisplatin Plus Best Supportive Care Or Best Supportive Care Alone In Stage III Non Small Cell Lung Cancer (NSCLC), A Randomized Phase III Study
Conditions: NSCLC
Summary: This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small cell lung cancer (NSCLC).
The primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the LCSS questionnaire.
Interventions:
description: q 28 days :<br/>* 50 mg/m2 oral vinorelbine d1, d8, d15<br/>* 20 mg/m2/d cisplatin from d1 to d4
name: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
type: Drug
description: q 21 days :<br/>* 60 mg/m2 oral vinorelbine d1,d8 for cycle 1 or 80 mg/m2 oral vinorelbine d1,d8 for cycle 2<br/>* 80 mg/m2 cisplatin d1
name: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
type: Drug
Study arms:
design_group_description: * cycle 1 & 2 (q 28 days) = chemotherapy : oral vinorelbine (50 mg/m2 d1, d8, d15) and cisplatin (20 mg/m2/d from d1 to d4) combined with radiotherapy<br/>* cycle 3 & 4 (q 21 days) = chemotherapy : oral vinorelbine (60 mg/m2 d1, d8 for cycle 1, 80 mg/m2 d1 & d8 for cycle 2) and cisplatin (80 mg/m2 d1) plus Best Supportive Care
design_group_title: A
design_group_type: Other
design_group_description: * cycle 1 & 2 (q 28 days) = chemotherapy : oral vinorelbine (50 mg/m2 d1, d8, d15) and cisplatin (20 mg/m2/d from d1 to d4) combined with radiotherapy<br/>* Best Supportive Care only
design_group_title: B
design_group_type: Other
Sponsor: Pierre Fabre Medicament Information
Collaborators: Pierre Fabre Pharma GmbH
Drug name mappings:
name: 长春瑞滨双酒石酸盐
lang: CN
name: Vinorelbine Tartrate
lang: EN
name: ビノレルビン酒石酸塩
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP