PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00138294: Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Official title: Phase 4, School-based, Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas.
Conditions: Influenza
Summary: The main purpose of this study is to learn if influenza vaccines (live attenuated and inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can stop or lessen the influenza (flu) outbreak in the community. Another purpose is to show that vaccination of these children will significantly reduce breathing problems (in the vaccinated children and unvaccinated people they come in contact with in the community) that require a visit to the doctor for treatment. Another purpose is to continue to collect safety and flu protection information on live attenuated influenza vaccine (LAIV or FluMist) given to children. The study investigators believe that vaccination of healthy school-aged children is an effective plan for preventing many people in the community from catching the flu. Children will take part in the study for 5 to 10 months.
Interventions:
description: Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) were administered to eligible children through a research program to improve vaccination coverage in school-aged children. Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) will be offered LAIV or IIV through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received LAIV or IIV from the local healthcare providers
name: live attenuated and inactivated influenza vaccines
other_name: FluMist
Fluzone
type: Biological
Study arms:
design_group_description: Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
design_group_title: Intervention Cities
design_group_type: Experimental
design_group_description: Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers.
design_group_title: Comparison Cities
design_group_type: Active Comparator
Sponsor: Baylor College of Medicine
Collaborators: Sanofi Pasteur SA
National Institute of Allergy & Infectious Diseases
Novartis AG
Drug name mappings:
name: 四价流感病毒裂解疫苗(Sanofi)
lang: CN
name: Tetravalent influenza vaccine(Split, inactivated)(Sanofi)
lang: EN
name: Influenza vaccine live(MedImmune LLC)
lang: EN
Clinical trial NCT02592486: The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Official title: A Randomized, Open-label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Conditions: Pneumococcal Pneumonia
Influenza
Summary: The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.
Interventions:
description: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
name: Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®
other_name: Pneumovax NP® and Fluvic HA syringe®
type: Biological
description: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
name: Sequential administration of Pneumovax NP® and Fluvic HA syringe®
other_name: Pneumovax NP® and Fluvic HA syringe®
type: Biological
Study arms:
design_group_description: The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
design_group_title: Simultaneous administration group
design_group_type: Active Comparator
design_group_description: The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
design_group_title: Sequential administration group
design_group_type: Active Comparator
Sponsor: Kameda Medical Center
Collaborators: Merck Sharp & Dohme Corp.
Pharmaceutical Product Development LLC
Osaka University
Drug name mappings:
name: 23价肺炎球菌多糖疫苗 (沃森生物)
lang: CN
name: Pneumococcal polysaccharide vaccine 23-valent (Walvax Biotechnology)
lang: EN
Clinical trial NCT02531971: Fentanyl Patch Pharmacokinetics in Healthy Adults
Official title: Absolute Bioavailability/ Pharmacokinetic and Residual Drug Analysis of Duragesic ® Transdermal System and Generic Fentanyl Transdermal System in Healthy Adults
Conditions: Peer Review, Research
Summary: The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these types of products.
Interventions:
description: 100 micrograms (2 millilitres) via intravenous injection
name: Intravenous fentanyl citrate
type: Drug
description: TDDS dosage is 25 micrograms/hour (worn for 72 h)
name: Duragesic®
other_name: Duragesic® fentanyl skin patch
type: Drug
description: TDDS dosage is 25 micrograms/hour (worn for 72 h)
name: Mylan generic fentanyl
other_name: Mylan generic fentanyl skin patch
type: Drug
Study arms:
design_group_description: Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I) and blood samples obtained 0-36 h, washout at least one week, then wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (Study Session II) and blood samples obtained 0-192 h, washout at least one week, then wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (Study Session III) and blood samples obtained 0-192 h
design_group_title: Fentanyl citrate (36 h), Duragesic (192 h), Mylan (192 h)
design_group_type: Active Comparator
design_group_description: Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I) and blood samples obtained 0-36 h, washout at least one week, then wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (Study Session II) and blood samples obtained 0-192 h, washout at least one week, then wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (Study Session III) and blood samples obtained for 0-192 h
design_group_title: Fentanyl citrate (36 h), Mylan (192 h), Duragesic (192 h)
design_group_type: Active Comparator
Sponsor: University of Maryland Baltimore
Collaborators: US Food & Drug Administration
Drug name mappings:
name: 枸橼酸芬太尼
lang: CN
name: Fentanyl Citrate
lang: EN
name: フェンタニルクエン酸塩
lang: JP
name: 芬太尼
lang: CN
name: Fentanyl
lang: EN
name: フェンタニル
lang: JP
Clinical trial NCT00283504: A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
Official title: A Description of Inflammatory Cell Types in Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy (Xolair)
Conditions: ALLERGIC ASTHMA
Summary: The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).
Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures:
1. pulmonary function test (PFT)
2. asthma symptoms based on the Asthma Control Test (ACT)
Interventions:
description: Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
name: ANTI-IGE THERAPY (XOLAIR)
type: Drug
Study arms:
design_group_description: One arm:active drug
design_group_title: all patients received Xolair/active drug
design_group_type: Experimental
Sponsor: Children's Hospital of the King's Daughters
Collaborators: Genentech, Inc.
Novartis AG
Drug name mappings:
name: 奥马珠单抗
lang: CN
name: Omalizumab
lang: EN
name: オマリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04074421: Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
Official title: Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study
Conditions: IBS - Irritable Bowel Syndrome
Gut Microbiota
Summary: We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.
Interventions:
description: A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
name: Rifaximin
type: Drug
description: A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
name: Probiotic Formula
other_name: probiotic formula Bacillus subtilis and Enterococcus faecium
type: Drug
description: Placebo oral tablet that has no therapeutic effect
name: Placebo oral tablet
other_name: Placebo
type: Drug
Study arms:
design_group_description: Repeating treatment of Rifaximin
design_group_title: Rifaximin group
design_group_type: Active Comparator
design_group_description: Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium
design_group_title: Probiotics group
design_group_type: Sham Comparator
design_group_description: Placebo control group
design_group_title: Placebo group
design_group_type: Placebo Comparator
Sponsor: The Second Affiliated Hospital Zhejiang University
Collaborators: Lishui Central Hospital
Zhejiang Chinese Medical University
Shanghai Renji Hospital Management Co., Ltd.
Peking Union Medical College Hospital
Sir Run Run Shaw Hospital
The First Affiliated Hospital of Wenzhou Medical College
Drug name mappings:
name: 利福昔明
lang: CN
name: Rifaximin
lang: EN
name: リファキシミン
lang: JP
Clinical trial NCT07357597: An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Official title: A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)
Conditions: Stomatitis
Summary: This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer.
Interventions:
description: Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.
name: Dexamethasone mouthwash
type: Drug
description: Commercially available Dato-DXd is prescribed and administered to participants according to standard of care
name: Datopotamab Deruxtecan (Dato-DXd)
other_name: Datroway
type: Drug
Study arms:
design_group_description: Participants will use dexamethasone 0.5 mg/5 mL alcohol-free mouthwash (10 mL, 4 times daily, swish for approximately 2 minutes, then spit out without swallowing).<br/>Participants will remain without food or drink for at least 30 minutes after use of dexamethasone
design_group_title: Dexamethasone 0.5 mg/5 mL Mouthwash
design_group_type: Experimental
Sponsor: AstraZeneca PLC
Collaborators: Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: 德达博妥单抗
lang: CN
name: Datopotamab Deruxtecan
lang: EN
name: ダトポタマブ デルクステカン（遺伝子組換え）（JAN）
lang: JP
name: 地塞米松
lang: CN
name: Dexamethasone
lang: EN
name: デキサメタゾン
lang: JP
Clinical trial NCT01939093: Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
Official title: Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis
Conditions: Methamphetamine-induced Psychosis
Summary: The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.
Interventions:
description: If subjects had aggressive or violent symptoms and immediate symptom control was needed, 10 mg of diazepam (intravenous injection) every 4 hours is allowed for symptom control.
name: Diazepam
type: Drug
description: All subjects will be given the Institute's medication regimen, including vitamin B1-6-12 1 tablet three times a day after meals during the whole study period.
name: Vitamin B1-6-12
type: Dietary Supplement
description: All subjects will be given the Institute's medication regimen, including stugeron 1 tablet three times a day after meals during the whole study period.
name: Stugeron
type: Drug
Study arms:
design_group_description: Quetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.
design_group_title: Quetiapine
design_group_type: Experimental
design_group_description: Haloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.
design_group_title: Haloperidol
design_group_type: Active Comparator
Sponsor: University of Chulalongkorn
Collaborators: National Research Council of Thailand
Drug name mappings:
name: 地西泮
lang: CN
name: Diazepam
lang: EN
name: ジアゼパム
lang: JP
name: 桂利嗪
lang: CN
name: Cinnarizine
lang: EN
Clinical trial NCT04957927: Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Official title: Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Conditions: Allergic Rhinitis
Summary: To determine the Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age.
Interventions:
description: Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
name: Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
type: Drug
Study arms:
design_group_description: Intranasal Fluticasone Propionate 50mcg/actuation in each nostril 24 hourly
design_group_title: Intranasal Fluticasone Propionate Group
design_group_type: Experimental
design_group_description: Montelukast 4mg oral granule formulation 24 hourly
design_group_title: Montelukast Group
design_group_type: Experimental
Sponsor: King Edward Medical University
Collaborators: King Edward Medical University
Drug name mappings:
name: 孟鲁司特钠
lang: CN
name: Montelukast sodium
lang: EN
name: モンテルカストナトリウム
lang: JP
name: 丙酸氟替卡松
lang: CN
name: Fluticasone Propionate
lang: EN
name: フルチカゾンプロピオン酸エステル
lang: JP
Clinical trial NCT00543296: Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Official title: Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Conditions: Uveitis
Summary: The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
Interventions:
description: 0.59 mg Fluocinolone Acetonide implant
name: 0.59 mg Fluocinolone Acetonide implant
other_name: Retisert
type: Drug
Study arms:
design_group_description: 0.59 mg Fluocinolone Acetonide implant
design_group_title: 0.59 mg Fluocinolone Acetonide implant
design_group_type: Experimental
Sponsor: Duke University
Collaborators: Bausch & Lomb, Inc.
Drug name mappings:
name: 氟轻松丙酮酯
lang: CN
name: Fluocinolone Acetonide
lang: EN
name: フルオシノロンアセトニド
lang: JP
Clinical trial NCT01970241: Inpatient Diabetes on Corticosteroids
Official title: Inpatient Diabetes on Corticosteroids
Conditions: Diabetes Mellitus
Summary: Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
Interventions:
description: NPH given per study table based on steroid dose and patient weight in kg.
name: NPH
other_name: NPH Lilly Insulin
type: Drug
description: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
name: Correction Factor
other_name: Rapid acting regular insulin
type: Drug
Study arms:
design_group_description: Receive NPH with each corticosteroid dose during the study duration (2-5 days).<br/>Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg
design_group_title: NPH with steroid dose
design_group_type: Experimental
design_group_description: Receive usual care with background insulin and correction factor for duration of study (2-5 days)
design_group_title: Control - Background and correction insulin
design_group_type: Active Comparator
Sponsor: Hennepin Healthcare Research Institute
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 精蛋白人胰岛素（诺和诺德）
lang: CN
name: Isophane Protamine Human Insulin(Novo Nordisk A/S)
lang: EN
Clinical trial NCT02375724: BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
Official title: A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD
Conditions: Pulmonary Disease, Chronic Obstructive
Summary: The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.
Interventions:
description: Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler
name: Aclidinium Bromide
type: Drug
description: Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
name: Placebo
type: Drug
Study arms:
design_group_description: Aclidinium Bromide 400 μg twice daily by inhalation
design_group_title: Aclidinium Bromide 400 μg
design_group_type: Experimental
design_group_description: placebo twice daily by inhalation
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: AstraZeneca PLC
Collaborators: A.Menarini Industrie Farmaceutiche Riunite Srl
Drug name mappings:
name: 阿地溴铵
lang: CN
name: Aclidinium Bromide
lang: EN
name: アクリジニウム臭化物
lang: JP