PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02854800: Smoking Cessation & Opioid Dependence Treatment Integration
Official title: Smoking Cessation & Opioid Dependence Treatment Integration: Does Timing Matter?
Conditions: Smoking Cessation
Opioid Related Disorders
Summary: The primary purpose of this study was to examine the feasibility of integrating a smoking cessation intervention for cigarette smokers enrolled in an outpatient program for opioid dependence. The secondary purpose was to compare treatment effects as a function of phase in the outpatient program: 0-90 days (weekly attendance), 90 days-1 year (biweekly attendance), and more than 1 year (monthly attendance).
Interventions:
description: Participants followed the schedule of dosing that is specified on the label: 0.5 mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84).
name: varenicline
other_name: Chantix
type: Drug
Study arms:
design_group_description: Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, they received 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
design_group_title: Weekly Opioid Tx
design_group_type: Experimental
design_group_description: Participants in this group attended an outpatient opioid clinic once bi-weekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
design_group_title: Biweekly Opioid Tx
design_group_type: Experimental
design_group_description: Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
design_group_title: Monthly Opioid Tx
design_group_type: Experimental
Sponsor: West Virginia University
Collaborators: Pfizer Inc.
National Institute on Drug Abuse
Drug name mappings:
name: 酒石酸伐尼克兰
lang: CN
name: Varenicline Tartrate
lang: EN
name: バレニクリン酒石酸塩
lang: JP
Clinical trial NCT02686697: Carnosine and Cognitive Training in Schizophrenia
Official title: A Double-blind, Placebo-controlled Study on the Effects of Combined L-Carnosine and Cognitive Training on Cognition in Schizophrenia
Conditions: Schizophrenia
Summary: This is a double-blind placebo-controlled trial to evaluate the effects of the combination of a cognition enhancing drug, i.e carnosine, with cognitive training in patients with schizophrenia. All participants will receive the same cognitive training sessions and will be randomised to either carnosine or placebo for the duration of the combined treatment period (2 weeks). Before combined training and carnosine/placebo, there is a two-week carnosine/placebo only phase to examine the effects of carnosine alone on functioning without training.
Interventions:
name: L-Carnosine
other_name: Carnosine
type: Drug
name: Placebo
type: Drug
description: Cognitive Training for 2 weeks
name: Cognitive Training
type: Behavioral
Study arms:
design_group_description: oral doses of 2000mg for 4 weeks total - 2 weeks medication phase only, and then 2 weeks combined treatment with cognitive training.
design_group_title: L-Carnosine
design_group_type: Experimental
design_group_description: matching placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: The Stanley Medical Research Institute
Drug name mappings:
name: L-carnosine
lang: EN
Clinical trial NCT00111956: Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome
Official title: Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome
Conditions: Metabolic Syndrome X
Summary: Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
Interventions:
name: Etanercept
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_title: Etanercept
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: National Institute of Diabetes & Digestive & Kidney Diseases
Collaborators: The General Hospital Corp.
Drug name mappings:
name: 依那西普
lang: CN
name: Etanercept
lang: EN
name: エタネルセプト（遺伝子組換え）
lang: JP
Clinical trial NCT03624530: Effect of Prophylactic TKI Therapy Post-transplants on Ph+ ALL Undergoing Allo-HSCT With MRD Positive Pre-transplants
Official title: Effect of Prophylactic Tyrosine Kinase Inhibitor Therapy Post-transplants on Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Undergoing Allo-HSCT With Minimal Residual Disease Positive Pre-transplants
Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
Tyrosine Kinase Inhibitor
Minimal Residual Disease
Allogeneic Hematopoietic Stem Cell Transplantation
Summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) in early first complete remission improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Our previous clinical trial (ID: NCT01883219) demonstrated that pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ ALL. Moreover, our result suggested that Ph+ ALL with MRD positive pre-transplants had the higher rate of molecular biology relapse. In this study, we will evaluate the safety and efficacy of prophylactic TKI therapy post-transplants on Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants.
Interventions:
description: TKI was selected according to the mutation results of ABL kinase region. Imatinib was initiated at a dose of 200mg/d, dasatinib at a dose of 50mg/d, and ponatinib at a dose of 30mg/d. Then increase the dosage of TKI gradually and increase to therapeutic dose within one month. The duration of TKI was 180 days.
name: Tyrosine kinase inhibitor (TKIs)
type: Drug
Study arms:
design_group_description: Treatment with prophylactic TKI will be initiated from day +30 to +60 post-transplants. TKI was selected according to the mutation results of ABL kinase region.
design_group_title: Prophylactic TKI Therapy
design_group_type: Experimental
design_group_description: Prophylactic TKI will not be given.
design_group_title: No TKI therapy
design_group_type: No Intervention
Sponsor: Nanfang Hospital
Collaborators: Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital
The Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Drug name mappings:
name: 达沙替尼
lang: CN
name: Dasatinib
lang: EN
name: ダサチニブ水和物
lang: JP
name: 甲磺酸伊马替尼
lang: CN
name: Imatinib mesylate
lang: EN
name: イマチニブメシル酸塩
lang: JP
name: 盐酸普纳替尼
lang: CN
name: Ponatinib Hydrochloride
lang: EN
name: ポナチニブ塩酸塩
lang: JP
Clinical trial NCT02684812: Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage.
Official title: Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage. A Prospective, Randomized, Multicenter Study.
Conditions: Subarachnoid Hemorrhage
Summary: This is a multicenter, prospective, randomized, open-label trial with blinded endpoint (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by computed tomography (CT) within 24 hours after the onset of headache, will be randomly assigned to the treatment group or the control group. Patients in the treatment group will receive standard treatment with the addition of a bolus of TXA (1 g intravenously) immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients in the control group will receive standard treatment without TXA. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for treatment allocation.
Interventions:
description: Treatment until aneurysm treatment or maximum dosage of 4 gram
name: Tranexamic Acid
other_name: Cyklokapron
type: Drug
Study arms:
design_group_description: Eligible subjects are randomly assigned to immediate administration of TXA (1 g i.v.) after a diagnosis of SAH, as confirmed by CT-scan of the brain, continued by continuous infusion of 1 g per 8 hours to a maximum of 24 hours after start of medication. A maximum of 4 g TXA (1 g bolus + 3x 1 g continuous infusion) can be administered to one patient.
design_group_title: Tranexamic Acid
design_group_type: Active Comparator
design_group_description: Standard care
design_group_title: Control
design_group_type: No Intervention
Sponsor: Academic Medical Center University of Amsterdam
Collaborators: Fonds NutsOhra
Drug name mappings:
name: 氨甲环酸
lang: CN
name: Tranexamic Acid
lang: EN
name: トラネキサム酸
lang: JP
Clinical trial NCT03457324: Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome
Official title: Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome: a Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial
Conditions: Irritable Bowel Syndrome
Summary: This is a multicenter, randomized, double-blind, placebo controlled clinical trial, in order to evaluate the efficacy and safety of Chinese Medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome. All patients will be evaluated for study eligibility at Visits 1 (baseline) and 2 (2 weeks). On visit 2, patients who meet the criteria will be randomly assigned to receive 8-week treatment of either JCM-16021 Granules or JCM-16021 placebo Granules. The investigators, research assistants and participants are not aware of the treatment assignments throughout the study. Treatment codes will only be broken after the completion of study. The assessments at Visit 3 (4-week post treatment) and at visit 4 (end of 8-week treatment) are used to measure treatment response (i.e. changes from baseline). Assessment at visit 5 (end of 8-week follow up) is to determine any sustained response to treatment. All the visits will be carried out in HKBU and CUHK clinics.
Interventions:
description: This prescription with seven ingredients.
name: JCM-16021
type: Drug
description: Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: JCM-16021 granules 8g/sachet, three times daily for 8 weeks.
design_group_title: JCM-16021 Group
design_group_type: Experimental
design_group_description: Placebo granules 8g/sachet, three times daily for 8 weeks
design_group_title: Placebo Group
design_group_type: Placebo Comparator
Sponsor: Hong Kong Baptist University
Collaborators: The Chinese University of Hong Kong
Drug name mappings:
name: JCM-16021
lang: EN
Clinical trial NCT01720030: Levosimendan in Acute Kidney Injury Study
Official title: Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury
Conditions: Acute Kidney Injury
Summary: We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.
Interventions:
description: Verum therapy
name: Levosimendan
other_name: Simdax (R)
type: Drug
description: Placebo therapy to safeguard blinding
name: Conventional therapy
other_name: Standard care plus placebo comparator
type: Drug
Study arms:
design_group_description: Standard of care as protocolized locally
design_group_title: Conventional therapy
design_group_type: Placebo Comparator
design_group_description: The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.
design_group_title: Levosimendan
design_group_type: Experimental
Sponsor: Viecuri Medisch Centrum
Collaborators: Orion Oyj
Drug name mappings:
name: 左西孟旦
lang: CN
name: Levosimendan
lang: EN
Clinical trial NCT05277896: Randomized Trial of Sedative Choice for Intubation
Official title: The Randomized Trial of Sedative Choice for Intubation
Conditions: Acute Respiratory Failure
Summary: Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation.
Interventions:
description: Intravenous ketamine as the sedative for induction of anesthesia during emergency tracheal intubation
name: Ketamine
type: Drug
description: Intravenous etomidate as the sedative for induction of anesthesia during emergency tracheal intubation
name: Etomidate
type: Drug
Study arms:
design_group_description: Patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care.
design_group_title: Ketamine Group
design_group_type: Active Comparator
design_group_description: Patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care.
design_group_title: Etomidate Group
design_group_type: Active Comparator
Sponsor: Vanderbilt University Medical Center
Collaborators: National Heart, Lung & Blood Institute
Patient-Centered Outcomes Research Institute
Drug name mappings:
name: 依托咪酯
lang: CN
name: Etomidate
lang: EN
name: 盐酸氯胺酮
lang: CN
name: Ketamine Hydrochloride
lang: EN
name: ケタミン塩酸塩
lang: JP
Clinical trial NCT00374205: Randomized Trial on Effectiveness of ACTs in Ghana
Official title: A Comparative Assessment of the Effectiveness of Artemether Plus Lumefantrine Versus Artesunate Plus Amodiaquine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
Conditions: Malaria, Falciparum
Summary: The purpose of this study is to compare the effectiveness and safety of two Artemisinin Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium falciparum malaria
Interventions:
description: Artesunate 50 mg and Amodiaquine 153 mg co-blister tablets: 3 days once daily weight-adjusted dosing according to manufacturer
name: Artesunate plus Amodiaquine
other_name: Arsucam®
type: Drug
description: Artemether 20 mg/Lumefantrine 120mg fixe-dose-combination tablets: 3 days twice daily weight-adjusted dosing according to manufacturer
name: Artemether-Lumefantrine
other_name: Coartem®
type: Drug
Study arms:
design_group_description: Artemether plus Lumefantrine 6 dose 3 days treatment
design_group_title: AL
design_group_type: Experimental
design_group_description: Artesunate plus Amodiaquine
design_group_title: ASAQ
design_group_type: Active Comparator
Sponsor: Bernhard-Nocht-Institut für Tropenmedizin
Collaborators: Presbyterian Health Services
School of Medical Sciences Kumasi (SMS/KNUST)
Drug name mappings:
name: 复方蒿甲醚
lang: CN
name: Artemether/Lumefantrine
lang: EN
name: アルテメテル/ルメファントリン
lang: JP
Clinical trial NCT01938781: Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Official title: Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Conditions: Liver Fibrosis
Summary: Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus pegylated interferon (peg-IFN) for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, thyroid function, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
Interventions:
description: antiviral therapy
name: entecavir
other_name: entecavir dispersible tablets
type: Drug
description: antiviral and antifibrosis therapy
name: Peg-IFN
other_name: Pegasys
type: Drug
Study arms:
design_group_description: entecavir, 0.5mg, qd, oral, for 2 years.
design_group_title: Entecavir monotherapy
design_group_type: Active Comparator
design_group_description: entecavir combined peg-IFN in the middle 1 year.
design_group_title: Entecavir plus peg-IFN Therapy
design_group_type: Experimental
Sponsor: Beijing Friendship Hospital
Collaborators: Shanghai Public Health Clinical Center
Zhongshan Hospital Fudan University
Beijing Tiantan Hospital
Peking University
Nanfang Hospital
Shanghai Renji Hospital Management Co., Ltd.
Peking Union Medical College Hospital
Sir Run Run Shaw Hospital
Tangdu Hospital
Shanxi Medical University
Beijing YouAn Hospital
Shanghai Huashan Hospital
Shanghai First People's Hospital
Beijing Ditan Hospital
Peking University First Hospital
Peking University People's Hospital
Drug name mappings:
name: 恩替卡韦
lang: CN
name: Entecavir
lang: EN
name: エンテカビル水和物
lang: JP
Clinical trial NCT03581409: Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm
Official title: Comparison of Dual-Antiplatelet and Triple-Antiplatelet Preparation Using P2Y12 Assay in Patients With High On-Treatment Platelet Reactivity Undergoing Stent-Assisted Coil Embolization for An Unruptured Intracranial Aneurysm
Conditions: Aneurysm, Cerebral
Endovascular Procedures
Summary: Perform a randomized comparison study of dual-antiplatelet (aspirin, prasugrel) and triple-antiplatelet (aspirin, clopidogrel, and cilostazol) preparation using P2Y12 assay in patients with high on-treatment platelet reactivity undergoing stent-assisted coil embolization for an unruptured intracranial aneurysm
Interventions:
description: Aspirin protect tablet
name: Aspirin
other_name: Aspirin protect
type: Drug
description: Prasugrel tablet
name: Prasugrel
other_name: Effient
type: Drug
description: Clopidogrel 75mg tablet
name: Clopidogrel
other_name: Plavitor
Plavix
type: Drug
description: Cilostazol tablet
name: Cilostazol
other_name: Cilostan CR
Pletaal
type: Drug
Study arms:
design_group_description: Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received prasugrel 20mg. After that, dual-antiplatelet (aspirin 100mg & prasugrel 5mg) treatment continued for 3 months through study completion.
design_group_title: dual-antiplatelet
design_group_type: Experimental
design_group_description: Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.
design_group_title: triple-antiplatelet
design_group_type: Experimental
Sponsor: Seoul National University Hospital
Collaborators: Seoul National University Bundang Hospital
Drug name mappings:
name: 硫酸氢氯吡格雷
lang: CN
name: Clopidogrel Bisulfate
lang: EN
name: クロピドグレル硫酸塩
lang: JP
name: 盐酸普拉格雷
lang: CN
name: Prasugrel Hydrochloride
lang: EN
name: プラスグレル塩酸塩
lang: JP
name: 西洛他唑
lang: CN
name: Cilostazol
lang: EN
name: シロスタゾール
lang: JP
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
Clinical trial NCT02765399: The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis
Official title: The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis - a Single-center Randomized Controlled Study
Conditions: Type 2 Diabetes
Summary: This study aims to evaluate the mechanisms underlying the effect of incretin therapy on lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of liraglutide on hepatic de novo lipogenesis.
Interventions:
name: Liraglutide
other_name: Victoza
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: Liraglutide subcutaneous injection once daily with following dose escalation:<br/>liraglutide 0.6 mg once daily for one week; liraglutide 1.2 mg once daily for one week and thereafter liraglutide 1.8 mg once daily for 3.5 months.
design_group_title: Liraglutide
design_group_type: Experimental
design_group_description: Placebo subcutaneous injection once daily with following dose escalation:<br/>placebo 0.1 ml once daily for one week; placebo 0.2 ml once daily for one week and thereafter placebo 0.3 ml once daily for 3.5 months.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Helsinki University Central Hospital
Collaborators: University of Gothenburg
Drug name mappings:
name: 利拉鲁肽
lang: CN
name: Liraglutide
lang: EN
name: リラグルチド（遺伝子組換え）
lang: JP