PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT07346079: Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
Official title: A Randomized, Multicenter, Double-blind, Efficacy and Safety Study of 2 Dose Levels of Purified Cortrophin® Gel in Patients With Acute Gouty Arthritis Flares
Conditions: Gout Arthritis
Gout Flare
Gout
Summary: This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare.
The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period.
The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.
Interventions:
description: This will be the 40 U dose of the purified Cortophin Gel
name: Purified Cortophin Gel, 40 U
type: Drug
description: This will be the 80 U dose of the purified Cortophin Gel
name: Purified Cortophin Gel 80 U
type: Drug
Study arms:
design_group_description: Patients in this arm will receive the 40 U dose at Day 0
design_group_title: Purified Cortophin Gel 40 U
design_group_type: Experimental
design_group_description: Patients in this arm will receive the 80 U dose at Day 0
design_group_title: Purified Cortophin Gel 80 U
design_group_type: Experimental
Sponsor: The Massachusetts General Hospital
Collaborators: ANI Pharmaceuticals, Inc.
Drug name mappings:
name: 促皮质素
lang: CN
name: Corticotropin
lang: EN
Clinical trial NCT01390246: Bupropion for Smoking Cessation During Pregnancy
Official title: Bupropion for Smoking Cessation During Pregnancy
Conditions: Pregnancy Related
Tobacco Use Disorder
Summary: This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.
Interventions:
description: Bupropion SR 150 mg tablet
name: Bupropion SR
other_name: Zyban
buproban
type: Drug
description: 35-min counseling by trained research nurse
name: Smoking Cessation Counseling
other_name: Behavioral counseling
type: Behavioral
description: Matching Bupropion SR placebo tablet
name: Placebo
other_name: Control
type: Drug
Study arms:
design_group_description: Bupropion SR and smoking cessation counseling Subjects received Bupropion SR 150 mg tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose Bupropion SR 150 mg tablet orally BID for a total medication treatment of 12 full weeks.<br/>Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.
design_group_title: Bupropion SR + cessation counseling
design_group_type: Active Comparator
design_group_description: Placebo and smoking cessation counseling Subjects received matching Bupropion SR placebo tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose matching Bupropion SR placebo tablet orally BID for a total medication treatment of 12 full weeks of therapy.<br/>Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.
design_group_title: Placebo + cessation counseling
design_group_type: Placebo Comparator
Sponsor: University of Texas Medical Branch
Collaborators: National Institute on Drug Abuse
University of Connecticut Health Center
Drug name mappings:
name: 盐酸安非他酮
lang: CN
name: Bupropion Hydrochloride
lang: EN
Clinical trial NCT02547844: Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
Official title: Open Randomized Study to Assess the Evolution of Plasma Lipid Profile by Lipidomic in Patients Infected With Human Immunodeficiency Virus (HIV-1) With Viral Suppression That Change Atripla® to Eviplera® Compared to Continue With Atripla®
Conditions: HIV-1
Summary: To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.
Interventions:
name: efavirenz + emtricitabina + tenofovir
other_name: atripla
type: Drug
name: rilpivirina + emtricitabina + tenofovir
other_name: eviplera
type: Drug
Study arms:
design_group_description: Patients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir)
design_group_title: efavirenz + emtricitabina + tenofovir
design_group_type: Active Comparator
design_group_description: Patients assigned to the experimental group will change the medication that are taking before to enter in the study ( atripla) for eviplera (rilpivirina + emtricitabina + tenofovir)
design_group_title: rilpivirina + emtricitabina + tenofovir
design_group_type: Experimental
Sponsor: Vall DHebron University Hospital
Collaborators: Gilead Sciences, Inc.
Drug name mappings:
name: 恩曲他滨/盐酸利匹韦林/富马酸磷丙替诺福韦
lang: CN
name: Emtricitabine/Rilpivirine Hydrochloride/Tenofovir Alafenamide Fumarate
lang: EN
name: リルピビリン塩酸塩/テノホビル アラフェナミドフマル酸塩/エムトリシタビン
lang: JP
Clinical trial NCT01973283: Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults
Official title: Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults
Conditions: Major Depressive Disorder
Dysthymic Disorder
Depressive Disorder, NOS
Summary: The goal of this open-administration treatment study of citalopram (or duloxetine) is to evaluate the effect of antidepressant medication on treating the syndrome of "frailty" in older adults with depressive symptoms. Patients with significant depressive symptoms (defined as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8 weeks to test whether antidepressant medication improves both the syndrome of frailty and depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and eligible to participate in the study will be treated with an antidepressant medication and assessed on the primary outcome variables (characteristics of frailty, depressive symptoms) as well as on secondary variables which include cognition (global cognition, episodic memory, executive function), and function (physical mobility, instrumental activities of daily living, and social functioning) prior to treatment initiation and following 8-weeks of treatment. The hypotheses for this protocol predict that we will discover a significant improvement on both frailty characteristics and depressive symptoms in this clinical population when treated with antidepressant medication (citalopram or duloxetine).
Interventions:
description: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.
name: Antidepressant Medication
other_name: Duloxetine
Escitalopram
Open treatment
type: Drug
Study arms:
design_group_description: Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.
design_group_title: Medication Treatment
design_group_type: Experimental
Sponsor: The New York State Psychiatric Institute
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 草酸艾司西酞普兰
lang: CN
name: Escitalopram Oxalate
lang: EN
name: エスシタロプラムシュウ酸塩
lang: JP
Clinical trial NCT00205699: Metabolic Effects of Antipsychotics in Children
Official title: Metabolic Effects of Antipsychotics in Children
Conditions: Aggression
Attention Deficit-Hyperactivity
Oppositional Defiant Disorder
Pervasive Development Disorders
Bipolar Disorder
Summary: The project aims to describe and compare the outcome of 12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on insulin action in skeletal muscle, liver and adipose tissue, abdominal fat mass, total body and fat-free mass, efficacy for symptoms of aggression and non-metabolic adverse events. Children aged 6-18 will be studied, exploring effects of stimulant therapy and age-related differences in vulnerability to treatment-induced adverse metabolic changes. Aims are addressed by measuring glucose and lipid kinetics with stable isotope tracers, body composition with dual energy x-ray absorptiometry and magnetic resonance imaging (MRI), and standardized assessments of efficacy and adverse events. Relevant data are critically needed to target clinical therapy and basic research, identify medical risks, and guide regulatory decisions in this vulnerable population.
Interventions:
description: randomized to begin 12 week trial of risperidone
name: risperidone
other_name: Risperdal
type: Drug
description: randomized to begin 12 week trial of olanzapine
name: olanzapine
other_name: Zyprexa
type: Drug
description: randomized to 12 week trial of aripiprazole
name: aripiprazole
other_name: Abilify
type: Drug
Study arms:
design_group_description: Participants in this group will be randomized to flexibly-dosed treatment with aripiprazole.
design_group_title: aripiprazole
design_group_type: Active Comparator
design_group_description: Participants in this group will be randomized to flexibly-dosed treatment with olanzapine.
design_group_title: olanzapine
design_group_type: Active Comparator
design_group_description: Participants in this group will be randomized to flexibly-dosed treatment with risperidone.
design_group_title: risperidone
design_group_type: Active Comparator
Sponsor: Washington University School of Medicine
Collaborators: National Institute of Mental Health
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 NCT03219294: Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Official title: Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Conditions: Arthropathy of Hip
Summary: During many surgeries, increased muscle tension makes it harder for the surgeon to expose the site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction, blocking their action and producing muscle relaxation. This muscle relaxation allows easier retraction of muscle tissues and manipulation of structures in the wound. Improved surgical conditions are likely to result in improved patient outcomes. While increased depths of NMB have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To address this, we propose to study the effect of NMB depth on surgical conditions during total hip replacement (THR).
Interventions:
description: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.
name: Vecuronium 0.1 mg/kg
other_name: vecuronium bromide
type: Drug
description: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
name: Vecuronium 0.2mg/kg
other_name: vecuronium bromide
type: Drug
Study arms:
design_group_description: Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 train-of-four (TOF) contractions. Redosing in this manner is a current clinical practice.
design_group_title: Moderate Neuromuscular Blockade (NMB)
design_group_type: Active Comparator
design_group_description: Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at Maine Medical Center (MMC) but is in common use since the advent of Sugammadex.
design_group_title: Deep NMB
design_group_type: Active Comparator
Sponsor: MaineHealth
Collaborators: MaineHealth
Spectrum Medical Group Ltd.
Drug name mappings:
name: 维库溴铵
lang: CN
name: Vecuronium Bromide
lang: EN
name: ベクロニウム臭化物
lang: JP
Clinical trial NCT03427892: Brexpiprazole for Bipolar Depression
Official title: Brexpiprazole for Bipolar Depression
Conditions: Bipolar Depression
Summary: The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life.
Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.
Interventions:
description: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
name: Brexpiprazole
other_name: Rexulti
type: Drug
Study arms:
design_group_description: Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
design_group_title: Brexpiprazole
design_group_type: Experimental
Sponsor: The University of Texas Southwestern Medical Center
Collaborators: Otsuka America Pharmaceutical, Inc.
Drug name mappings:
name: 布瑞哌唑
lang: CN
name: Brexpiprazole
lang: EN
name: ブレクスピプラゾール
lang: JP
Clinical trial NCT03921294: HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor
Official title: Prospective, Single-arm, Open-label Use of Hemlibra (Emicizumab) to Treat Hemophilic Pseudotumor
Conditions: Haemophilic Pseudotumour
Summary: This is a single arm, phase 4, prospective, open-label, United States single-center study to assess the hemostatic efficacy and safety of Hemlibra (emicizumab) for hemostatic control of hemophilia A patients (baseline FVIII level <40%) with and without inhibitors with hemophilic pseudotumors; secondary outcomes will assess changes in quality of life and activity level in treated patients.
Interventions:
description: bispecific monoclonal antibody binding to activated Factor IX and Factor X
name: Emicizumab
other_name: HemLibra
type: Drug
Study arms:
design_group_description: Patients with hemophilic pseudotumor will be treated with prophylactic emicizumab and assessed for improvement.
design_group_title: Single Arm
design_group_type: Experimental
Sponsor: Indiana Hemophilia & Thrombosis Center, Inc.
Collaborators: Genentech, Inc.
Drug name mappings:
name: 艾美赛珠单抗
lang: CN
name: Emicizumab
lang: EN
name: エミシズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT02444507: A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product
Official title: A Randomized, Two-Way Crossover, Single-Dose Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product (Nexium Powder for Injection and Infusion 40 mg) in Healthy Adult Subjects
Conditions: Healthy Adult Subjects
Summary: To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.
Interventions:
description: Reference Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
name: Nexium powder for injection and infusion 40 mg
type: Drug
description: Test Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
name: Esomelone Powder for Solution for Injection / Infusion 40 mg
type: Drug
Study arms:
design_group_description: Name: Nexium powder for injection and infusion 40 mg, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
design_group_title: Reference Drug: Nexium
design_group_type: Active Comparator
design_group_description: Name: Esomelone Powder for Solution for Injection / Infusion 40 mg Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
design_group_title: Test Drug: Esomelone
design_group_type: Active Comparator
Sponsor: isRed Pharma & Biotech Research Co.,Ltd.
Collaborators: Yung Shin Pharmaceutical Industrial Co., Ltd.
Drug name mappings:
name: 埃索美拉唑锶
lang: CN
name: Esomeprazole Strontium
lang: EN
name: 埃索美拉唑镁
lang: CN
name: Esomeprazole Magnesium
lang: EN
name: エソメプラゾールマグネシウム水和物
lang: JP
Clinical trial NCT03370536: ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization
Official title: Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization
Conditions: Atrial Fibrillation
Persistent Atrial Fibrillation
Summary: This is a prospective, multi-center, non-randomized, un-blinded, observational trial.
Interventions:
description: The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.
name: CardioInsight ECGI Mapping System
other_name: ECGi mapping
type: Device
description: Empiric ablation (CFAE or linear ablation) is not permitted
name: AF ablation
other_name: Biosense Smart Touch SF (STSF)
Biosense Thermocool SF
type: Procedure
description: Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)
name: Ibutilide
type: Drug
Study arms:
design_group_description: Patients with AF and planned to undergo first catheter procedure
design_group_title: Patients with AF
design_group_type: Experimental
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Medtronic Plc
Drug name mappings:
name: 富马酸伊布利特
lang: CN
name: Ibutilide Fumarate
lang: EN
Clinical trial NCT00991510: Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
Official title: Comparative Bioavailability of Myfenax® (Teva) and CellCept® (Roche) in Stable Patients After Renal Transplantation
Conditions: Stable Renal Transplant Recipients
Summary: The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side effects of the two products will be compared. All information already available on these products indicates that the safety profiles of the two products will be the same.
Interventions:
description: Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.
name: mycophenolate mofetil (Myfenax)
other_name: Myfenax®
type: Drug
description: Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.
name: mycophenolate mofetil (Cellcept)
other_name: CellCept®
type: Drug
Study arms:
design_group_description: The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).<br/>Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
design_group_title: Reference/Test/Test
design_group_type: Experimental
design_group_description: The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).<br/>Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
design_group_title: Test/Reference/Reference
design_group_type: Experimental
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Collaborators: PAREXEL International Corp.
Drug name mappings:
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP