PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00002888: Combination Chemotherapy in Treating Patients With Advanced Head and Neck Cancer
Official title: A RANDOMIZED PHASE III EVALUATION OF PACLITAXEL + G-CSF + CISPLATIN VERSUS CISPLATIN + 5-FU IN ADVANCED HEAD AND NECK CANCER
Conditions: Head and Neck Cancer
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin plus fluorouracil are more effective than paclitaxel plus cisplatin in treating patients with advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with advanced head and neck cancer.
Interventions:
name: cisplatin
type: Drug
name: fluorouracil
type: Drug
name: paclitaxel
type: Drug
Study arms:
Sponsor: Eastern Cooperative Oncology Group
Collaborators: National Cancer Institute
Drug name mappings:
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
name: 氟尿嘧啶
lang: CN
name: Fluorouracil
lang: EN
name: フルオロウラシル
lang: JP
Clinical trial NCT05695027: Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study
Official title: Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study
Conditions: Primary Open Angle Glaucoma
Summary: The objective of this study is to determine if a combination of oral nicotinamide and pyruvate (N&P) can maintain eye health as compared to placebo while standard-of-care intraocular pressure-lowering glaucoma medications are used to treat glaucoma.
A total of up to 188 participants will be enrolled and randomized 1:1 to receive N&P or placebo for 87 weeks (20 months). Participants will be followed for a total of 91 weeks (21 months).
Interventions:
description: Nutritional supplements
name: Dietary supplements - Nicotinamide and Pyruvate
type: Drug
description: Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: The N&P group will receive nicotinamide and pyruvate for 87 weeks (20 months).
design_group_title: Nicotinamide and Pyruvate
design_group_type: Experimental
design_group_description: The placebo group will receive placebo for 87 weeks (20 months).
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Columbia University
Collaborators: Stanford University
Drug name mappings:
name: 烟酰胺
lang: CN
name: Nicotinamide
lang: EN
name: ニコチン酸アミド
lang: JP
Clinical trial NCT04394143: Effect of AD128 to Treat Obstructive Sleep Apnea
Official title: Effect of AD128 on Obstructive Sleep Apnea Severity: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
Conditions: Sleep Apnea, Obstructive
Summary: This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.
Interventions:
description: Oral administration of two capsules before sleep for 7 days.
name: AD128
type: Drug
description: Oral administration of two capsules before sleep for 7 days.
name: Mannitol
other_name: Placebo
type: Drug
Study arms:
design_group_description: The study specific intervention includes per oral administration of two capsules of AD128, once daily, just before lights out, for 7 days.
design_group_title: AD128
design_group_type: Experimental
design_group_description: Two placebo capsules (Mannitol) will be administered for the control intervention once daily, just before light outs, for one week.
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: Centre Hospitalier Universitaire Vaudois
Collaborators: Apnimed, Inc.
Drug name mappings:
name: AD-128
lang: EN
Clinical trial NCT04655586: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19
Official title: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)
Conditions: Covid19
Summary: Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2 (AB201), a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels.
Interventions:
description: two dose levels of rNAPc2
name: rNAPc2
other_name: AB201
Recombinant Nematode Anticoagulant Protein c2
type: Drug
description: standard of care heparin per institution (therapeutic or prophylactic regimen)
name: Heparin
type: Drug
Study arms:
design_group_description: loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5
design_group_title: rNAPc2 Higher Dose
design_group_type: Experimental
design_group_description: loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5
design_group_title: rNAPc2 Lower Dose
design_group_type: Experimental
design_group_description: heparin at either prophylactic or therapeutic doses per Standard of Care at Institution
design_group_title: Heparin
design_group_type: Active Comparator
Sponsor: ARCA biopharma, Inc.
Collaborators: Colorado Prevention Center
Drug name mappings:
name: rNAPc2
lang: EN
Clinical trial NCT06082167: Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official title: A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Conditions: Head and Neck Squamous Cell Carcinoma
Summary: This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with programmed death-ligand 1 (PD-L1) positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.
Interventions:
description: Specified doses on specified days
name: Zanzalintinib
other_name: XL092
type: Drug
description: Specified doses on specified days
name: Zanzalintinib-matched Placebo
other_name: XL092-matched Placebo
type: Drug
description: Specified doses on specified days
name: Pembrolizumab
other_name: KEYTRUDA®
type: Biological
Study arms:
design_group_description: Subjects with R/M HNSCC will receive zanzalintinib + pembrolizumab
design_group_title: Zanzalintinib + Pembrolizumab
design_group_type: Experimental
design_group_description: Subjects with R/M HNSCC will receive zanzalintinib-matched placebo + pembrolizumab
design_group_title: Zanzalintinib-Matched Placebo + Pembrolizumab
design_group_type: Placebo Comparator
Sponsor: Exelixis, Inc.
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
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
name: Zanzalintinib
lang: EN
Clinical trial NCT02262936: Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older
Official title: A Randomized Double-blinded Trial Comparing DEsmopressin to FEsoterodine in the Treatment of Severe Nocturia in Women Aged 65 and olDer: The DEFEND Trial
Conditions: Nocturia
Summary: Nocturia, or voiding at night, is an extremely troublesome symptom which is highly prevalent in the elderly. Desmopressin is a treatment for nocturia but it can result in hyponatremia (low blood sodium), particularly in those aged 65 and older. Fesoterodine is used for the treatment of overactive bladder (OAB). Recent trials showed Fesoterodine was effective in reducing nocturia. This study aims to answer the following: In women 65 and older with severe nocturia, is Fesoterodine more effective than Desmopressin in reducing the number of night time voids? Does Fesoterodine have a better side effect profile compared to Desmopressin?
The study design is a 12 week randomized double-blinded trial of Fesoterodine and Desmopressin in the treatment of severe nocturia in women aged 65 and older. This will be conducted at the Urogynecology Unit at Mount Sinai Hospital (MSH) and Baycrest. A 3 day voiding diary and Nocturia, Nocturnal Enuresis and Sleep-interruption Questionnaire (NNES-Q) will be completed at baseline and at week 12. The primary outcome will be the number of night time voids in the Fesoterodine group compared to the Desmopressin group, 12 weeks after starting treatment. Secondary outcomes include changes in the NNES-Q scores and the safety of each medication.
This study is expected to show that, in women 65 and older with severe nocturia, Fesoterodine will be more effective in reducing the number of night time voids, reducing the volume of voided urine, increasing the duration of sleep prior to first nocturnal void and improving quality of life relative to Desmopressin. Fesoterodine will also be better tolerated, with fewer significant adverse events, relative to Desmopressin.
Interventions:
name: Desmopressin
type: Drug
name: Fesoterodine
type: Drug
Study arms:
design_group_description: Patients randomized to receive Desmopressin will be given 0.1mg daily by mouth at bedtime. After 4 weeks, patients will have the option to increase their dose to 0.2mg daily by mouth at bedtime. Total time of drug administration will be 12 weeks.
design_group_title: Desmopressin
design_group_type: Active Comparator
design_group_description: Patients randomized to receive Fesoterodine will be given 4mg daily by mouth at bedtime. After 4 weeks, patients will have the option to increase their dose to 8mg daily by mouth at bedtime. Total time of drug administration will be 12 weeks.
design_group_title: Fesoterodine
design_group_type: Active Comparator
Sponsor: Mount Sinai Hospital (Canada)
Collaborators: Physicians' Services, Inc. Foundation
Baycrest
Drug name mappings:
name: 醋酸去氨加压素
lang: CN
name: Desmopressin Acetate
lang: EN
name: デスモプレシン酢酸塩水和物
lang: JP
name: 富马酸非索罗定
lang: CN
name: Fesoterodine Fumarate
lang: EN
name: フェソテロジンフマル酸塩
lang: JP
Clinical trial NCT00978315: Trial of Vitamin D Supplementation in Asthma
Official title: Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
Conditions: Asthma
Summary: The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.
Interventions:
description: Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
name: Cholecalciferol
type: Dietary Supplement
description: Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
name: Miglyol oil
type: Dietary Supplement
Study arms:
design_group_description: Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
design_group_title: Vigantol oil
design_group_type: Active Comparator
design_group_description: Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
design_group_title: Miglyol oil
design_group_type: Placebo Comparator
Sponsor: Barts & The London NHS Trust
Collaborators: National Health Service
Drug name mappings:
name: 维生素D3
lang: CN
name: Colecalciferol
lang: EN
Clinical trial NCT02720094: Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
Official title: A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
Conditions: HIV Infections
Summary: This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Interventions:
description: 30 mg tablet
name: Cabotegravir Oral Tablet
other_name: Oral cabotegravir
type: Drug
description: 300 mg/200 mg fixed-dose combination tablets
name: TDF/FTC tablets
other_name: Truvada
type: Drug
name: Placebo for TDF/FTC tablets
other_name: Placebo for Truvada
type: Drug
name: Placebo for cabotegravir oral tablet
other_name: Placebo for oral cabotegravir
type: Drug
description: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
name: CAB LA
other_name: Injectable cabotegravir
Long acting cabotegravir
type: Drug
description: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
name: Placebo for CAB LA
other_name: Placebo for long acting cabotegravir
type: Drug
Study arms:
design_group_description: In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.
design_group_title: Arm A
design_group_type: Experimental
design_group_description: In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.
design_group_title: Arm B
design_group_type: Experimental
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: ViiV Healthcare Ltd.
Gilead Sciences, Inc.
Drug name mappings:
name: 卡替拉韦钠
lang: CN
name: Cabotegravir sodium
lang: EN
name: カボテグラビル
lang: JP
name: 恩曲他滨替诺福韦
lang: CN
name: Emtricitabine/Tenofovir Disoproxil Fumarate
lang: EN
name: エムトリシタビン/テノホビル ジソプロキシルフマル酸塩
lang: JP
Clinical trial NCT01140893: Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes
Official title: Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.
Conditions: Type 2 Diabetes
Summary: The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.
Interventions:
description: Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal.<br/>From V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time.
name: Exenatide
other_name: Exenatide = BYETTA (R)
type: Drug
description: Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: 55 subjects
design_group_title: exenatide
design_group_type: Experimental
design_group_description: 55 subjects
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Caen University Hospital
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 艾塞那肽
lang: CN
name: Exenatide
lang: EN
name: エキセナチド
lang: JP
Clinical trial NCT03519646: Eliglustat on Gaucher Disease Type IIIB
Official title: Evaluation of the Safety in the Combination Usage of Cerdelga and Cerezyme in Type III Gaucher Disease Patients and the Efficacy on Soft Tissue Diseases.
Conditions: Gaucher Disease, Type III
Summary: Evaluation of the safety in the combination usage of Cerdelga and Cerezyme in type III Gaucher disease patients and the efficacy on soft tissue diseases.
Interventions:
description: 1. This is a 3-year study and the enrollment time of this study is 24 months.<br/>2. The participants have to receive the investigational agent, Cerdelga<br/>3. The participants have to go back to the hospital and receive the investigational agent and take the test before receving Cerdelga, and 2 weeks, 1, 3, 6, 12, 18 and 24 months after receiving Cerdelga.<br/>4. IMP Administration Method: Cerdelga have 21 mg、42 mg and 84 mg capsule.<br/>5. No need for fasting before use, but can't take with grapefruit juice.<br/>6. Five ml Blood and 10 ml urine shoud be taken before receiving Cerdelga, and 1, 3, 6, 12, 18 and 24 months after receiving Cerdelga for Gaucher related biomarkers test.
name: Eliglustat
other_name: Cerdelga
type: Drug
Study arms:
design_group_description: Besides regular ERT, patients also need to take Eiglustat for 24 months.
design_group_title: Experimental Case_Eiglustat
design_group_type: Experimental
Sponsor: National Taiwan University Hospital
Collaborators: Sanofi
Drug name mappings:
name: 依鲁司他
lang: CN
name: Eliglustat
lang: EN
name: エリグルスタット酒石酸塩
lang: JP
Clinical trial NCT00476242: Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Official title: Placebo Controlled Study of Memantine as an Adjunct to Naltrexone in the Treatment of Opioid Dependence
Conditions: Opioid Dependence
Heroin Dependence
Summary: Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.
Interventions:
description: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
name: Vivitrol
other_name: intramuscular injection of Vivitrol 380 mg
type: Drug
description: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment.
name: memantine
type: Drug
Study arms:
design_group_description: intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
design_group_title: Memantine and Vivitrol
design_group_type: Experimental
design_group_description: intramuscular injection of Vivitrol 380 mg and Placebo
design_group_title: Placebo and Vivitrol
design_group_type: Placebo Comparator
Sponsor: The New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸美金刚
lang: CN
name: Memantine hydrochloride
lang: EN
name: メマンチン塩酸塩
lang: JP
name: 纳曲酮
lang: CN
name: Naltrexone
lang: EN
Clinical trial NCT01748097: Intravenous Bicarbonate To Verify The Correct Position of IV Catheters in Oncological Patients Oncological Patients Receiving Chemotherapy
Official title: Phase III Study to Assess the Utility of a New Innovative Technique Using Intravenous Bicarbonate to Verify the Correct Position of Patients Scheduled for Intravenous Bicarbonate
Conditions: Detection of the Correct Position of Intravenous Line
Summary: The investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue
Interventions:
name: sodium bicarbonate 4.2%
type: Drug
Study arms:
design_group_description: injecting 20cc 4.2% to a newly administered IV line
design_group_title: IV bicarbonate 4.2% 20 cc
design_group_type: Experimental
design_group_description: injecting 20 cc normal saline to a newly administered IV line
design_group_title: IV normal saline
design_group_type: Placebo Comparator
Sponsor: Sheba Medical Center
Collaborators: Netherlands Ministry of Health, Welfare & Sport
Drug name mappings:
name: 碳酸氢钠
lang: CN
name: Sodium Bicarbonate
lang: EN
name: 炭酸水素ナトリウム
lang: JP
Clinical trial NCT00571727: Long-Term Treatment With rhIGF-1 in GHIS
Official title: A Study of Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)
Conditions: Growth Hormone Insensitivity Syndrome
Summary: The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).
Interventions:
description: injections BID of rhIGF-1, mecasermin
name: mecasermin
other_name: Increlex
type: Drug
Study arms:
design_group_title: mecasermin, injections BID of rhIGF-1
design_group_type: Experimental
Sponsor: Ipsen SA
Collaborators: University of Oklahoma
Drug name mappings:
name: 美卡舍明生（Ipsen SA）
lang: CN
name: Mecasermin (Ipsen SA)
lang: EN