PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02685072: Progesterone Augmentation of Nicotine Replacement Therapy Study
Official title: Progesterone Augmentation of Nicotine Replacement Therapy Study
Conditions: Smoking Cessation
Summary: This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at the end of Week 8. All participants will also be provided behavioral treatment for smoking cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week period (Week 1) during the mid luteal phase, within a week before menses and the target quit date will be set for the 5 (+/-2) days after onset of menses. Participants will have post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving and nicotine withdrawal, and measures of response inhibition.
Interventions:
description: Transdermal Nicotine Patch (TNP) + Progesterone
name: Progesterone (200 mgs BID)
other_name: Prometrium
type: Drug
description: TNP + Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: Transdermal Nicotine Patch + Progesterone (200 mgs BID)
design_group_title: TNP + Progesterone
design_group_type: Experimental
design_group_description: Transdermal Nicotine Patch + Placebo (for Progesterone)
design_group_title: TNP + Placebo
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Cancer Institute
Drug name mappings:
name: 黄体酮
lang: CN
name: Progesterone
lang: EN
name: プロゲステロン
lang: JP
Clinical trial NCT00734968: Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
Official title: Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded Placebo Controlled Clinical Trial
Conditions: Stress Incontinence
Summary: This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.
Interventions:
description: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
name: Nitrofurantoin
other_name: Macrobid
type: Drug
description: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
name: Placebo
type: Other
Study arms:
design_group_description: Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
design_group_title: Treatment
design_group_type: Experimental
design_group_description: Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Missouri
Collaborators: Texas A&M University
Drug name mappings:
name: 呋喃妥因
lang: CN
name: Nitrofurantoin
lang: EN
Clinical trial NCT04576377: Dynamics of the Immune Responses to Repeat Influenza Vaccination Exposures
Official title: The Dynamics of the Immune Responses to Repeat Influenza Vaccination Exposures (DRIVE) Study - a Randomized Controlled Trial
Conditions: Influenza, Human
Summary: The aims of this vaccine trial are: (1) to measure humoral and selected cellular immune responses to repeated influenza vaccination with Flublok, including these responses' associations with age, birth year, and prior vaccination history; (2) to identify the characteristics of study participants who are vaccinated but still become infected with influenza virus ("vaccine failures") and participants who have poor immune responses to vaccination; and (3) to predict how influenza vaccinations and infections shape immunity.
Interventions:
description: Recombinant HA quadrivalent influenza vaccine (0.5mL Flublok®, Sanofi Pasteur) containing 180μg antigen, 45μg for each influenza strain included.
name: FluBlok
type: Biological
description: 0.5mL saline placebo.
name: Placebo
type: Other
Study arms:
design_group_title: Influenza vaccination
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The University of Hong Kong
Collaborators: The University of Chicago
National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 重组四价流感疫苗(Protein Sciences)
lang: CN
name: Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)
lang: EN
Clinical trial NCT01272414: Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
Conditions: Graves Ophthalmopathy
Summary: Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.
Interventions:
description: 2-12 units in weekly 2u doses to effect
name: Botulinum Toxin Type A
other_name: BoTox
type: Drug
description: Injection of 0.4cc 0.9% normal saline
name: Saline injection
other_name: Placebo
type: Drug
Study arms:
design_group_description: Subjects receive BoTox injection to levator complex
design_group_title: BoTox Treatment
design_group_type: Experimental
design_group_description: Saline injection to levator complex
design_group_title: Saline injection
design_group_type: Placebo Comparator
Sponsor: University of Toronto
Collaborators: Allergan UC
Drug name mappings:
name: A型肉毒毒素
lang: CN
name: Onabotulinumtoxin A
lang: EN
name: A 型ボツリヌス毒素
lang: JP
Clinical trial NCT01466712: Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function
Official title: Randomized Double-blind Placebo-controlled Crossover Study to Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function in COPD Patients.
Conditions: COPD
Emphysema
Small Airway Disease
Summary: Inuvair® is a novel fixed combination product used in the treatment of asthma and under clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is able to target the whole bronchial tree, including the small airways and hence, is expected to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its action on the small airways is not directly demonstrated thus far. By way of contrast, dear evidence is present that treatment with bronchodilators alone does not beneficially alter small airway function. The study hypothesis states that the effects of inhaled corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.
Interventions:
description: Tiotropium 18 µg/dose once daily (handihaler device) + formoterol, fumarate 6µg + beclometasone, dipropionate 100µg / dose (Pressurised inhaler): 2 puffs bid, for one month.
name: Tiotropium + formoterol/beclometasone
other_name: Inuvair (B10356)
type: Drug
description: Tiotropium 18 µg/dose once daily (handihaler device) + placebo (Pressurised inhaler): 2 puffs bid, for one month.
name: tiotropium + placebo
other_name: drug code number B10356
type: Drug
Study arms:
design_group_description: run-in of 4 weeks with thiotropium cross-over after first treatment period of 4 weeks
design_group_title: Tiotropium+formoterol/beclomethasone
design_group_type: Experimental
design_group_description: cross-over cfr arm1
design_group_title: tiotropium+placebo
design_group_type: Sham Comparator
Sponsor: Katholieke Universiteit Leuven
Collaborators: CHIESI Farmaceutici SpA
Drug name mappings:
name: 噻托溴铵
lang: CN
name: Tiotropium Bromide
lang: EN
name: チオトロピウム臭化物水和物
lang: JP
name: 二丙酸倍氯米松/富马酸福莫特罗
lang: CN
name: Beclometasone Dipropionate/Formoterol Fumarate
lang: EN
Clinical trial NCT00417482: Antipsychotic Discontinuation in Alzheimer's Disease
Official title: Antipsychotic Discontinuation in Alzheimer's Disease
Conditions: Alzheimer Disease
Psychotic Disorders
Agitation
Aggression
Summary: In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of psychosis/agitation.
Interventions:
description: Risperidone open label flexible dose 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for randomized trial
name: risperidone
other_name: Risperdal
type: Drug
Study arms:
design_group_description: Risperidone for 16 weeks followed by risperidone for 16 weeks
design_group_title: Risperidone-risperidone
design_group_type: Other
design_group_description: Risperidone for 16 weeks followed by placebo for 16 weeks
design_group_title: Risperidone-Placebo
design_group_type: Other
design_group_description: Placebo for 16 weeks followed by placebo for 16 weeks
design_group_title: Placebo-Placebo
design_group_type: Other
Sponsor: The New York State Psychiatric Institute
Collaborators: Columbia University
National Institute on Aging
Drug name mappings:
name: 利培酮
lang: CN
name: Risperidone
lang: EN
name: リスペリドン
lang: JP
Clinical trial NCT01541475: Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
Official title: Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
Conditions: Major Depressive Disorder
Summary: The current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (MRI), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
Interventions:
description: Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg
name: Bupropion, Escitalopram
type: Drug
description: Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg
name: Escitalopram
type: Drug
Study arms:
design_group_title: Escitalopram + Bupropion
design_group_type: Experimental
design_group_title: Escitalopram
design_group_type: Active Comparator
Sponsor: Ewha Womans University
Collaborators: GSK Plc
Drug name mappings:
name: 盐酸安非他酮
lang: CN
name: Bupropion Hydrochloride
lang: EN
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 NCT01131806: Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
Conditions: Chronic Obstructive Pulmonary Disease
Summary: Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Interventions:
description: fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
name: fluticasone/ salmeterol 125/25 mcg/puff
other_name: Seretide evohaler 125(GlaxoSmithKline)
type: Drug
description: fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
name: fluticasone/ salmeterol 250/25 mcg/puff
other_name: Seretide evohaler 250(GlaxoSmithKline)
type: Drug
Study arms:
design_group_description: fluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.
design_group_title: MD Flu/Sal
design_group_type: Active Comparator
design_group_description: fluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.
design_group_title: HD Flu/Sal
design_group_type: Experimental
Sponsor: Taipei Veterans General Hospital
Collaborators: National Taiwan University Hospital
Far-Eastern Memorial Hospital
Drug name mappings:
name: 丙酸氟替卡松/昔萘酸沙美特罗
lang: CN
name: Fluticasone propionate/Salmeterol xinafoate
lang: EN
name: サルメテロールキシナホ酸塩/フルチカゾンプロピオン酸エステル
lang: JP
Clinical trial NCT02996409: High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy
Official title: The Value of a High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Conditions: Tendinopathy
Achilles Tendon Pain
Injection Site Fibrosis
Summary: Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In most cases this gives satisfactory results, however there is a significant group of patients in which the exercise program is not sufficient. Prior to our study, three United Kingdom based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies had an adequate control group. This double-blind, placebo-controlled, randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy.
Interventions:
description: High Volume Image-Guided Injection with a saline/lidocain solution
name: HVIGI
other_name: Lidocain 1.0% 10 ml
Saline 0.9% 40 ml
type: Drug
description: Placebo control with injection of a saline/lidocain solution (low volume)
name: LVIGI
other_name: Lidocain 1.0% 0.4 ml
Saline 0.9% 1.6 ml
type: Drug
description: A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.
name: Progressive exercise program
type: Other
Study arms:
design_group_description: HVIGI: Injection of 50 cc ( 40 cc 0,9% sodium chloride solution + 10 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities.
design_group_title: High-Volume Image-Guided Injection
design_group_type: Experimental
design_group_description: LVIGI: Injection of 2 cc (1.6 cc 0.9% Sodium chloride solution + 0.4 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities.
design_group_title: Low-Volume Image-Guided Injection
design_group_type: Placebo Comparator
Sponsor: Erasmus Universitair Medisch Centrum Rotterdam
Collaborators: Dutch Arthritis Association
Drug name mappings:
name: 盐酸利多卡因
lang: CN
name: Lidocaine Hydrochloride
lang: EN
name: リドカイン塩酸塩
lang: JP
Clinical trial NCT01147510: Asthma Control in Elderly Patients With Montelukast
Official title: A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients
Conditions: Persistent Asthma
Elderly
Summary: To compare the efficacy of combination therapy of montelukast plus low dose inhaled budesonide and single therapy of medium dose inhaled budesonide on asthma control such as inflammatory markers and clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma
Interventions:
description: Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m and take orally a tablet of Singulair® 10mg one time per day.
name: Combination of low ICS and montelukast
type: Drug
description: Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m. and between 7 p.m. and 10 p.m. two times per day
name: Monotherapy of medium dose ICS
type: Drug
Study arms:
design_group_title: Monotherapy of medium dose ICS
design_group_type: Active Comparator
design_group_title: Combination of low ICS and montelukast
design_group_type: Experimental
Sponsor: Ajou University
Collaborators: Hallym University Medical Center
Korea University Guro Hospital
MCM Vaccines B.V.
Drug name mappings:
name: 布地奈德
lang: CN
name: Budesonide
lang: EN
name: ブデソニド
lang: JP
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
Clinical trial NCT05288374: Celecoxib in Postoperative Analgesia for Radius Fracture Surgery
Official title: Celecoxib for Treatment of Postoperative Pain After Osteosynthesis of Distal Radius Fracture
Conditions: Pain, Postoperative
Summary: Patients scheduled for elective osteosynthesis of the distal radius will be randomized to receive celecoxib 100 mg orally (PO) at 6 in the morning before surgery and every 12 hours for 2 days thereafter, or a placebo pill in the same regimen. After surgery under general anaesthesia, they will receive paracetamol 1 g intravenously (IV) every 6 hours and if pain intensity is greater than 4 on a numeric rating scale (NRS) of 0-10, piritramid 15 mg intramuscularly (IM) will be administered. Pain intensity, piritramid consumption and side effects of treatment will be recorded in a questionnaire for 2 days.
Interventions:
description: Administering Celecoxib 100 mg (Celebrex) regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery
name: Celecoxib 100 mg
other_name: Celebrex 100 mg
type: Drug
description: Administering placebo regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery
name: Placebo
other_name: Placebo pill
type: Drug
Study arms:
design_group_description: Celecoxib 100 mg orally will be administered in the day of surgery at 6 in the morning and will be continued regularly at 6 in the morning and 6 in the afternoon for 3 days.
design_group_title: Celecoxib
design_group_type: Experimental
design_group_description: A placebo pill provided by a hospital pharmacy will be administered in the day of surgery at 6 in the morning and 6 in the afternoon for 3 days.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Charles
Collaborators: University Hospital Královské Vinohrady
Drug name mappings:
name: 塞来昔布
lang: CN
name: Celecoxib
lang: EN
name: セレコキシブ
lang: JP
Clinical trial NCT00140465: 75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)
Official title: A Double-Blind, Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention (ISAR-CHOICE-2)
Conditions: Coronary Disease
Summary: The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation
Interventions:
description: after PCI
name: Clopidogrel
other_name: Iscover
Plavix
type: Drug
description: after PCI
name: Clopidogrel
other_name: Iscover
Plavix
type: Drug
Study arms:
design_group_description: 75 mg Clopidogrel Maintenance Doses
design_group_title: 1
design_group_type: Active Comparator
design_group_description: 150 mg Clopidogrel Maintenance Doses
design_group_title: 2
design_group_type: Active Comparator
Sponsor: Deutsches Herzzentrum Berlin
Collaborators: Technische Universität München
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
Clinical trial NCT01818661: Longitudinal Multi-Modality Imaging in Progressive Apraxia of Speech
Official title: Longitudinal Multi-Modality Imaging in Progressive Apraxia of Speech
Conditions: PPA
Non-fluent Aphasia
Apraxia of Speech
Primary Progressive Non-fluent Aphasia
Primary Progressive Aphasia
Summary: The study is designed to determine the relationship between structural and functional changes in the brain on imaging and progression of speech and language, neurological and neuropsychological features in patients with neurodegenerative apraxia of speech (AOS).
Interventions:
description: This is used to assess Tau burden in the brain.
name: AV-1451
type: Drug
Study arms:
design_group_description: All subjects will receive Tau PET scan on approximately day 1 or day 2 of study to assess Tau burden in the brain.
design_group_title: Tau positron emission tomography (PET)
design_group_type: Experimental
Sponsor: Mayo Clinic
Collaborators: National Institute on Deafness & Other Communication Disorder
Drug name mappings:
name: 氟妥西吡
lang: CN
name: Flortaucipir F-18
lang: EN
name: フロルタウシピル（１８Ｆ）
lang: JP
Clinical trial NCT01740947: Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?
Official title: Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
Conditions: Colorectal Cancer
Summary: The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as other infectious complications. By reduction of septic complications long-term oncological outcome might simultaneously improve.
Interventions:
description: SDD suspension contains per dose of 10 ml 100 mg colistin sulfate, 80 mg tobramycin and 500 mg amphotericin B
name: Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)
other_name: SDD
type: Drug
Study arms:
design_group_description: Standard treatment for colorectal cancer
design_group_title: Standard treatment
design_group_type: No Intervention
design_group_description: Standard treatment + SDD perioperatively 4 times daily 10 ml of SDD suspension, consisting of 100mg colistin sulfate, 80mg tobramycin and 500mg of amphotericin B.<br/>SDD treatment starts 3 days before surgery and is continued until at least 3 days postoperatively.
design_group_title: Selective decontamination of the digestive tract (SDD)
design_group_type: Experimental
Sponsor: Stichting Onderzoek Cancer Center Amsterdam
Collaborators: Dutch Digestive Diseases Foundation
Drug name mappings:
name: 妥布霉素
lang: CN
name: Tobramycin
lang: EN
name: トブラマイシン
lang: JP
name: 硫酸多粘菌素E
lang: CN
name: Colistin Sulfate
lang: EN
name: 两性霉素B
lang: CN
name: Amphotericin B
lang: EN
name: アムホテリシンB
lang: JP