PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT01839110: Targeting the Right Ventricle in Pulmonary Hypertension
Official title: A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine on Outcomes in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Accompanied by a Comparative Study of Cellular Metabolism in Subjects With Pulmonary Hypertension With and Without Right Ventricular Dysfunction
Conditions: Pulmonary Hypertension
Summary: This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) would improve their outcome. This study is accompanied by a baseline comparison of the metabolic profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.
Interventions:
description: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.
name: Ranolazine
other_name: Ranexa
type: Drug
description: Placebo by mouth twice per day for a total of 26 weeks.
name: Placebo
type: Drug
Study arms:
design_group_description: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day
design_group_title: Ranolazine
design_group_type: Active Comparator
design_group_description: Placebo by mouth twice per day
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention.
design_group_title: Observational
design_group_type: No Intervention
Sponsor: University of Pennsylvania
Collaborators: University of Maryland
Washington University School of Medicine
Yale University
The Brigham & Women's Hospital, Inc.
Drug name mappings:
name: 雷诺嗪
lang: CN
name: Ranolazine
lang: EN
Clinical trial NCT01488526: Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Official title: Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers
Conditions: Hepatitis B Infection
Chronic Infection
Viremia
Summary: Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10 copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients.
Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study:
1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL (or > 200,000 IU/mL) during late pregnancy and infants.
2. Its efficacy in the reduction of HBV vertical transmission rate.
Interventions:
description: About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.
name: TDF treatment
other_name: Viread, Tenofovir, TDF, Hepatitis B-IgG, Hepatitis B vaccine
type: Drug
Study arms:
design_group_description: Provide standard of care to mothers and standard immunoprophylaxis to their infants
design_group_title: Control arm: HBIG & vaccine for infants
design_group_type: No Intervention
design_group_description: tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum for mothers and standard immunoprophylaxis to their infants
design_group_title: TDF treatment arm
design_group_type: Experimental
Sponsor: New Discovery, Inc.
Collaborators: Gilead Sciences, Inc.
Drug name mappings:
name: 富马酸替诺福韦二吡呋酯
lang: CN
name: Tenofovir Disoproxil Fumarate
lang: EN
name: テノホビル ジソプロキシルフマル酸塩
lang: JP
Clinical trial NCT04587843: A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery
Official title: A Randomized Controlled Trial Evaluating the Effectiveness of Contrave (Naltrexone HCl and Bupropion HCl) in Patients Who Have Weight Recidivism Following Bariatric Surgery: Contrave Obesity Trials (COR) Weight Regain Study
Conditions: Obesity
Summary: Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. It is unknown how many or which medical treatments for weight loss, such as Contrave work in the subjects who have had bariatric surgery.
The purpose of this study is to explore the effectiveness of Contrave combined with usual care (dietary and behaviour counselling) compared to placebo with usual care, in patients who have inadequate weight loss or significant weight regain following bariatric surgery.
Interventions:
description: Each Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg.<br/>Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day).
name: Contrave 8Mg-90Mg Extended-Release Tablet
other_name: naltrexone HCl/bupropion HCl
type: Drug
description: Placebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day for 1 year (2 tablets, taken twice a day).
name: Placebo
other_name: Inactive
type: Drug
Study arms:
design_group_description: Group treated with Contrave Extended Release Tablets
design_group_title: Contrave 8mg/90mg Extended Release Tablet
design_group_type: Experimental
design_group_description: Group given placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: St. Joseph's Healthcare Hamilton
Collaborators: Bausch Health, Canada, Inc.
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 NCT00896389: Salt Loading and Thiazide Intervention Study
Official title: The Relationship Between Serine Threonine Kinase 39 (STK39) Genotypes, Salt Sensitivity, Thiazide Diuretics-induced Blood Pressure Response
Conditions: Hypertension
Summary: The investigators of this study propose to examine the relationships between STK39 (Serine Threonine Kinase 39) genotypes and responses to salt loading and to thiazide diuretics, hydrochlorothiazide. The investigators hypothesize that STK39 genotypes will be associated with the outcome of both interventions and can contribute to personalized care for hypertension.
Interventions:
description: Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 liters (L) of 0.9% sodium chloride (NaCl) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.
name: Salt loading
type: Procedure
description: We will perform short-term HCTZ intervention on the same 120 subjects. After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ.
name: Hydrochlorothiazide (HCTZ)
other_name: Apo-Hydro
Aquazide H
Dichlotride
Esidrex
HCTZ
HydroSaluric
Hydrochlorothiazide
Hydrodiuril
Microzide
Oretic.
type: Drug
Study arms:
design_group_description: Salt loading:2 L of 0.9% NaCl. HCTZ:12.5/ 25 mg of HCTZ for 1 week
design_group_title: Salt-loading and thiazide diuretic (HCTZ)
design_group_type: Other
Sponsor: University of Maryland Baltimore
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 氢氯噻嗪
lang: CN
name: Hydrochlorothiazide
lang: EN
Clinical trial NCT00371501: Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
Official title: Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
Conditions: Atherosclerosis
Thromboembolism
Systemic Lupus Erythematosus
Summary: The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).
Interventions:
description: 10mg/day
name: Rosuvastatin
other_name: Crestor
type: Drug
description: one tablet/day
name: placebo
type: Drug
description: 80mg/day
name: aspirin
type: Drug
description: placebo
name: placebo
type: Drug
Study arms:
design_group_title: treatment arm 1
design_group_type: Active Comparator
design_group_title: Treatment arm 2
design_group_type: Placebo Comparator
design_group_description: aspirin
design_group_title: treatment arm 3
design_group_type: Active Comparator
design_group_description: placebo
design_group_title: treatment arm 4
design_group_type: Placebo Comparator
Sponsor: Tuen Mun Hospital
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 瑞舒伐他汀钙
lang: CN
name: Rosuvastatin Calcium
lang: EN
name: ロスバスタチンカルシウム
lang: JP
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
Clinical trial NCT01870635: Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan
Official title: Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in Emergency Departments in Pakistan
Conditions: Dehydration
Gastroenteritis
Vomiting
Diarrhea
Summary: The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with vomiting and diarrhea in Pakistan.
Interventions:
description: Eligible children will receive one weight based (0.13 - 0.26 mg/kg) dose of an oral ondansetron disintegrating tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
name: Ondansetron
other_name: Zofran
type: Drug
description: Eligible children will receive one dose of an oral disintegrating Placebo (sugar pill) tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
name: Placebo
other_name: Sugar Pill
type: Drug
Study arms:
design_group_description: 4 mg oral disintegrating tablet of ondansetron<br/>Participant weight 8-15 kg = half dose (2mg) Participant weight greater than 15 kg = full dose (4mg)
design_group_title: Ondansetron
design_group_type: Experimental
design_group_title: Placebo (sugar pill)
design_group_type: Placebo Comparator
Sponsor: University of Calgary
Collaborators: Gates Foundation (United States)
Aga Khan University
Thrasher Research Fund
Drug name mappings:
name: 盐酸昂丹司琼
lang: CN
name: Ondansetron Hydrochloride
lang: EN
name: オンダンセトロン塩酸塩水和物
lang: JP
Clinical trial NCT03149887: Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair
Official title: Use of Liposomal Bupivacaine for Postoperative Pain Management After Arthroscopic Rotator Cuff Repair
Conditions: Rotator Cuff Tear
Summary: Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for postoperative pain control after total knee, total hip and total shoulder arthroplasty. We are conducting a randomized, controlled trial to evaluate pain control after arthroscopic rotator cuff repair in ambulatory patients, comparing standard care in the control group, with standard care plus the addition of injection of liposomal bupivacaine in the experimental group.
Interventions:
description: Liposomal bupivacaine solution (Exparel) for injection
name: Liposomal bupivacaine
other_name: Exparel
type: Drug
description: Inert solution created to appear as liposomal bupivacaine (Exparel) for injection
name: Placebo
other_name: Placebo solution for liposomal bupivacaine (Exparel)
type: Drug
Study arms:
design_group_description: Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
design_group_title: Experimental
design_group_type: Experimental
design_group_description: Injection of inert placebo solution in surgical field at end of arthroscopic rotator cuff repair.
design_group_title: Control
design_group_type: Active Comparator
Sponsor: University of Pittsburgh
Collaborators: Pacira Biosciences, Inc.
Drug name mappings:
name: 布比卡因脂质体
lang: CN
name: Bupivacaine liposome
lang: EN
Clinical trial NCT05563155: Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response
Official title: Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response - A Randomized Double-blind Placebo-controlled Trial
Conditions: Post Operative Pain, Acute
Summary: The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR population.
As a standard procedure, all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale (PCS). If TKA is decided, patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mg/kg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA.
The repeat-dosing group (RDG) will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day. The control-group (CG) will receive placebo tablets at 9-11 pm on the first postoperative day.
Interventions:
description: Dexamethasone 24 mg on day 1 after surgery.
name: Dexamethasone 24 mg
other_name: Dexa-ratiopharm
type: Drug
description: Placebo tablet given on day 1 after surgery.
name: Placebo
type: Drug
Study arms:
design_group_description: Control Group (CG):<br/>Intervention: Postoperative oral placebo tablet on day 1 after surgery given as one single dose.
design_group_title: Placebo tablet on day 1 after surgery given as one single dose.
design_group_type: Placebo Comparator
design_group_description: Repeat Dose Group (RDG):<br/>Intervention: Postoperative oral dexamethasone 24 mg on day 1 after surgery given as one single dose.
design_group_title: Dexamethasone 24 mg on day 1 after surgery given as one single dose.
design_group_type: Active Comparator
Sponsor: Vejle Hospital
Collaborators: Hvidovre University Hospital
Drug name mappings:
name: 地塞米松磷酸钠
lang: CN
name: Dexamethasone Sodium Phosphate
lang: EN
name: デキサメタゾンリン酸エステルナトリウム
lang: JP
Clinical trial NCT02777580: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Official title: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Conditions: Myocardial Infarction
Summary: In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Interventions:
description: Half dose Tenecteplase
name: Tenecteplase
other_name: Metalyse
TNKase
type: Drug
description: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
name: Clopidogrel
type: Drug
description: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
name: Coronary angiography
type: Procedure
description: Primary PCI accoring to local standards
name: Primary PCI
type: Procedure
Study arms:
design_group_description: Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
design_group_title: Pharmaco-invasive strategy
design_group_type: Experimental
design_group_description: Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
design_group_title: Standard primary PCI
design_group_type: Active Comparator
Sponsor: Katholieke Universiteit Leuven
Collaborators: Boehringer Ingelheim GmbH
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: 替奈普酶
lang: CN
name: Tenecteplase
lang: EN
Clinical trial NCT00384618: Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study
Official title: Effect of an Oxidative-Stress-Reducing Strategy Consisting of Pravastatin, Vitamin E and Homocysteine-Lowering on Carotid Intima-Media Thickness in Patients With Mild-to-Moderate Chronic Kidney Disease
Conditions: Chronic Kidney Disease
Summary: The ATIC study is a randomised, double- blind, placebo-controlled trial in which the effects of oxidative stress-lowering treatment on vascular function and structure are studied in patients with chronic non-diabetic renal failure who are free from manifest arterial occlusive disease. Participants in the trial were randomised to active treatment consisting of add-on therapy with pravastatin, vitamin E and homocysteine-lowering therapy, or to placebo. Subjects not using angiotensin converting enzyme inhibitors (ACE-inhibitors) or angiotensin receptor blockers (ARBs) at inclusion were put on ACE-inhibitors for at least two weeks before the baseline measurement and randomisation. Those who were on ARBs continued their ARBs. We excluded individuals with diabetes mellitus (ADA criteria), active vasculitis, nephrotic syndrome (>3gr/24hr urine protein), renal transplantation, fasting total cholesterol > 7 mmol/L, cholesterol-lowering therapy within three months prior to inclusion or known ischemic cardiac, cerebrovascular or peripheral arterial disease. Ninety-three patients (out of 118 eligible patients) took part in the study and written informed consent was obtained from all participants.
Interventions:
name: pravastatin
type: Drug
name: vitamin E
type: Drug
Study arms:
Sponsor: Stichting Onderzoek Cancer Center Amsterdam
Collaborators: Bristol Myers Squibb Co.
Medical Research Foundation
Drug name mappings:
name: 普伐他汀钠
lang: CN
name: Pravastatin Sodium
lang: EN
name: プラバスタチンナトリウム
lang: JP
name: 维生素E烟酸酯
lang: CN
name: Vitamin E Nicotinicate
lang: EN
name: トコフェロールニコチン酸エステル
lang: JP
Clinical trial NCT02976194: Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy
Official title: Intraocular Cytokine Changes in Recurrence of Polypoidal Choroidal Vasculopathy
Conditions: Exudative Age-related Macular Degeneration
Polypoidal Choroidal Vasculopathy
Summary: Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.
Interventions:
description: Ranibizumab 0.5mg is injected into the vitreous cavity through the pars plana using 30 gauge (or narrower) needle-attached syringe.
name: ranibizumab
other_name: Lucentis
type: Drug
Study arms:
design_group_description: Ranibizumab 0.5mg is injected in to the vitreous cavity. An injection is given every 4 weeks three times, and then the patient will be followed up every 4 weeks. An addition injection is given as needed. Recurrence is defined as increase of exudative changes, or increase of 10% or more in central subfield macular thickness (CSMT) measured using optical coherence tomography. Aqueous humor is sampled from the anterior chamber before injection at baseline, 8 weeks and 20 weeks.
design_group_title: pro-re-nata
design_group_type: Experimental
Sponsor: Pusan National University Hospital
Collaborators: Novartis AG
Drug name mappings:
name: 雷珠单抗
lang: CN
name: Ranibizumab (Genentech)
lang: EN
name: ラニビズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00740935: Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
Official title: Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
Conditions: Rotavirus Gastroenteritis
Summary: Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners.
Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units of Brest University Hospital with systematic testing for Rotavirus.
Evaluation of the impact of the vaccination program on rotaviral gastroenteritis hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from 2002-2007 in the absence of vaccination.
The principal judgement criterion is the number of pediatric hospitalizations for rotaviral GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the suburbs of Brest.
Interventions:
description: Vaccination against rotavirus<br/>Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose.
name: Rotateq vaccine
other_name: Rotateq
type: Biological
Study arms:
design_group_description: Cohort of vaccinated infants against rotavirus
design_group_title: 1
design_group_type: Other
Sponsor: University Hospital of Brest
Collaborators: MCM Vaccines B.V.
Drug name mappings:
name: 五价重配轮状病毒减毒活疫苗(Merck & Co., Inc.)
lang: CN
name: Rotavirus vaccine,live(Merck & Co.)
lang: EN
name: ５価経口弱毒生ロタウイルスワクチン
lang: JP