PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02506140: Platelet Reactivity in Acute Non-disabling Cerebrovascular Events
Official title: A Randomized, Open-label, Active-Controlled and Blinded-Endpoint Trial Comparing the Antiplatelet Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin in Chinese Patients With High-risk Transient Ischemic Attack or Minor Stroke.
Conditions: Stroke
Ischemic Attack, Transient
Summary: Ticagrelor is a reversible and direct-acting oral antagonist of the P2Y12 (Purinergic receptor P2Y, G-protein coupled, 12) receptor for adenosine diphosphate, which provides faster, greater, and more consistent P2Y12 inhibition than Clopidogrel in patients with acute coronary syndrome, irrespective of the genetic variants affecting Clopidogrel metabolism. It is still undefined whether combination therapy of Ticagrelor and Aspirin is more effective than Clopidogrel and aspirin for minor stroke and transient ischemic attack (TIA). The primary purpose of the PRINCE trial is to evaluate the anti-platelet effects of a 3-month regimen of ticagrelor initiated with 180 mg loading dose followed by 90 mg twice/day combined with aspirin 100 mg/day during first 21 days versus a 3-month regimen of clopidogrel initiated with 300 mg loading dose of followed by 75 mg/day combined with aspirin 100 mg/day during first 21 days when initiated within 24 hours of symptom onset in high-risk transient ischemic attack or minor stroke.
Interventions:
description: This group will receive a 180 mg loading dose of ticagrelor on the day of randomization, followed by 90 mg twice/day ticagrelor from Day 2 to 3 months; combined with Aspirin given in a total dose of 100-300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 21.
name: Ticagrelor and Acetylsalicylic acid
other_name: Aspirin
BRILINTA
type: Drug
description: This group will receive a 300 mg loading dose of clopidogrel on the day of randomization, followed by 75 mg once/day clopidogrel from Day 2 to 3 months; combined with Aspirin given in a total dose of 100-300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 21.
name: Clopidogrel and Acetylsalicylic acid
other_name: Aspirin
Plavix
type: Drug
Study arms:
design_group_description: Drugs: Ticagrelor and Acetylsalicylic acid.
design_group_title: Ticagrelor/ASA
design_group_type: Experimental
design_group_description: Drugs: Clopidogrel and Acetylsalicylic acid.
design_group_title: Clopidogrel/ASA
design_group_type: Active Comparator
Sponsor: Beijing Tiantan Hospital
Collaborators: Beijing Municipal Science & Technology Commission
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: 替格瑞洛
lang: CN
name: Ticagrelor
lang: EN
name: チカグレロル
lang: JP
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
Clinical trial NCT05613608: Alcohol Use Disorder and Cannabidiol
Official title: Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies
Conditions: Alcohol Use Disorder
Summary: This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
Interventions:
description: The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.
name: Cannabidiol
type: Drug
description: Placebo arm.
name: Placebo
type: Drug
Study arms:
design_group_description: 210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
design_group_title: Full-Spectrum Cannabidiol
design_group_type: Active Comparator
design_group_description: 210mg/day of full-spectrum cannabidiol, containing 0.0% THC.
design_group_title: Broad-Spectrum Cannabidiol
design_group_type: Active Comparator
design_group_description: 210mg/day of hemp seed oil with no cannabinoids present.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Colorado Denver
Collaborators: National Institute on Alcohol Abuse & Alcoholism
Drug name mappings:
name: 大麻二酚
lang: CN
name: Cannabidiol
lang: EN
Clinical trial NCT03579602: Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery
Official title: A Randomized, Blinded Study of Fluorescence Detection of Pediatric Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System
Conditions: Pediatric Central Nervous System Tumor
Summary: Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. Tozuleristide is a drug that is thought to attach to tumor tissue and then fluoresces (glows) when a special light from the Canvas is shined on it. It is hypothesized that tozuleristide, when imaged with the Canvas, will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor or other ambiguous tissue in real-time as they operate. The purpose of this study is to evaluate how well tozuleristide imaged with Canvas work at helping to distinguish between tumor and normal tissue during surgery in pediatric primary central nervous system tumors.
Interventions:
description: Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor.
name: tozuleristide
other_name: BLZ-100
Tumor Paint
type: Drug
description: All subjects enrolled in the study will have their tissue imaged with the Canvas System.
name: Canvas System
other_name: mSIRIS
type: Device
Study arms:
design_group_description: Subjects randomized to Arm 1 (<br/>9% of subjects) will not receive tozuleristide but will undergo standard of care neurosurgery and will have imaging performed with the Canvas System.
design_group_title: Arm 1 (no tozuleristide)
design_group_type: Active Comparator
design_group_description: Subjects randomized to Arm 2 (<br/> 91% of subjects) will be administered tozuleristide at a dose of 15 mg/m^2 at least 1 hour and no more than 36 hours prior to surgery. They will undergo standard of care neurosurgery and will have imaging performed with the Canvas System.
design_group_title: Arm 2 (tozuleristide treated)
design_group_type: Experimental
Sponsor: Blaze Bioscience, Inc.
Collaborators: The Pacific Pediatric Neuro-Oncology Consortium Foundation
Drug name mappings:
name: Tozuleristide
lang: EN
Clinical trial NCT01902810: Protective Effects of Propranolol in Adults
Official title: Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial
Conditions: Burn
Summary: This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.
Interventions:
description: Propranolol by mouth given daily throughout hospitalization
name: Propranolol
other_name: inderol
metoprolol
type: Drug
description: Placebo by mouth given daily throughout hospitalization
name: Placebo
other_name: control
type: Drug
Study arms:
design_group_description: Propranolol by mouth given daily throughout hospitalization
design_group_title: Propranolol
design_group_type: Active Comparator
design_group_description: Placebo by mouth given daily throughout hospitalization
design_group_title: Sugar Pill
design_group_type: Placebo Comparator
Sponsor: University of Texas Medical Branch
Collaborators: American Burn Association
Drug name mappings:
name: 盐酸普萘洛尔
lang: CN
name: Propranolol Hydrochloride
lang: EN
name: プロプラノロール塩酸塩
lang: JP
Clinical trial NCT05170009: Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza
Official title: Randomized Double-blind, Placebo-controlled Single Center Pilot Study to Evaluate the Efficacy and Safety of Baloxavir in Combination With Oseltamivir in Adult Allogeneic Bone Marrow Transplant Recipients With Influenza
Conditions: Influenza
Summary: This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. Although there are no data about this treatment option currently available, the investigator hypothesizes that combination therapy may be more effective in clearing influenza virus infection and decreasing the rate of emergence of resistant influenza in immunocompromised human hosts.
Interventions:
description: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing <80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7.
name: Baloxavir Marboxil
other_name: Xofluza
type: Drug
description: Placebo at baseline, day 4, and day 7.
name: Placebo
type: Drug
description: Oseltamivir 75 mg twice daily for 10 days.
name: Oseltamivir
other_name: Tamiflu
type: Drug
Study arms:
design_group_description: Active Baloxavir Marboxil and standard of care Oseltamivir
design_group_title: Active and standard of care
design_group_type: Active Comparator
design_group_description: Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir
design_group_title: Placebo and standard of care
design_group_type: Placebo Comparator
Sponsor: Weill Medical College of Cornell University
Collaborators: Genentech, Inc.
Drug name mappings:
name: 磷酸奥司他韦
lang: CN
name: Oseltamivir Phosphate
lang: EN
name: オセルタミビルリン酸塩
lang: JP
name: 玛巴洛沙韦
lang: CN
name: Baloxavir Marboxil
lang: EN
name: バロキサビル マルボキシル
lang: JP
Clinical trial NCT04655625: Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)
Official title: A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
Conditions: COVID-19
Summary: This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.
Interventions:
description: 2 mg of AG0302-COVID19 twice at 2-week intervals
name: Group A (AG0302-COVID19)
type: Biological
description: Placebo twice at 2-week intervals
name: Group A (Placebo)
type: Biological
description: 2 mg of AG0302-COVID19 twice at 4-week intervals
name: Group B (AG0302-COVID19)
type: Biological
description: Placebo twice at 4-week intervals
name: Group B (Placebo)
type: Biological
Study arms:
design_group_title: Group A (AG-0302-COVID19)
design_group_type: Experimental
design_group_title: Group A (Placebo)
design_group_type: Placebo Comparator
design_group_title: Group B (AG-0302-COVID19)
design_group_type: Experimental
design_group_title: Group B (Placebo)
design_group_type: Placebo Comparator
Sponsor: AnGes, Inc.
Collaborators: Japan Agency for Medical Research & Development
Drug name mappings:
name: AG0302-COVID19
lang: EN
Clinical trial NCT00778908: Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial
Conditions: Nasopharyngeal Carcinoma
Summary: Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.
Interventions:
description: 1. IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease<br/>2. IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately.
name: Late-course accelerated hyperfractionated IMRT
type: Radiation
description: cisplatin:40mg/m2 weekly infusion for 6 weeks
name: Concomitant cisplatin chemotherapy
type: Drug
description: IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.
name: Conventionally fractionated IMRT
type: Radiation
Study arms:
design_group_description: Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
design_group_title: A
design_group_type: Experimental
design_group_description: Conventionally fractionated IMRT with concomitant cisplatin chemotherapy
design_group_title: B
design_group_type: Other
Sponsor: Guangxi Medical University
Collaborators: The People's Hospital of Guangxi Zhuang Autonomous Region
Drug name mappings:
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT00764699: Effect of Increlex® on Children With Crohn Disease
Official title: Effect of Increlex® on Children With Crohn Disease
Conditions: Crohn Disease
Summary: Patients with Crohn disease often have poor weight gain and short stature, yet the etiology of the poor growth is not well defined. Studies in chronically ill patients who do not have Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance in chronically ill children, particularly those who require treatment with corticosteroids. Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient short stature. This medication has not been studied in Crohn disease. The purpose of this study is to test the hypothesis that poor growth in Crohn disease is associated abnormal IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test our hypothesis we will recruit 20 patients with Crohn disease from our pediatric gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a minimum of one year and will be studied at baseline and six month intervals for one year while on treatment with Increlex.
Interventions:
description: rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.
name: rhIGF (Increlex)
other_name: Increlex
type: Drug
Study arms:
design_group_description: Treatment with rhIGF (Increlex)
design_group_title: rhIGF
design_group_type: Experimental
Sponsor: Nationwide Children's Hospital
Collaborators: Tercica, Inc.
Drug name mappings:
name: 美卡舍明生（Ipsen SA）
lang: CN
name: Mecasermin (Ipsen SA)
lang: EN
Clinical trial NCT01899820: Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya
Official title: Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya
Conditions: Malaria
Summary: Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most rapidly acting of all the current antimalarial drugs and recognition of their potential role as a component of combination therapy have led to several large trials aimed at assessing different combinations of existing drugs, and to the specific development of new combination drugs.
This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through molecular genetics and in this process further strengthen capacity in the proposed study sites as well as improve links between research and control ultimately to influence malaria treatment policy and practice.
Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative drug. The network will determine antimalarial drug efficacy using standardised protocols and collate clinical responses and adverse events. Molecular markers to artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles in drug failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies will be captured into a database developed by the network. The latter offers several advantages including
* Working towards the standardization of methodologies and common protocols as a way of comparing data across sites
* Pulling together datasets and conduct a multi-centre analysis
* Sharing and coordinating quality assurance mechanisms
Interventions:
description: Artemether 20mg Lumefantrine 120mg
name: Artemether lumefantrine
other_name: Coartem
type: Drug
description: Dihydroartemisinin 20mg Piperaquine 160mg
name: Dihydroartemisinin piperaquine
other_name: Duocortexin
type: Drug
Study arms:
design_group_description: Tablets, 1-4 tablets (weight calculated dose), BD, at hr 0, 8, 24, 36, 48 and 60.
design_group_title: Artemether lumefantrine
design_group_type: Active Comparator
design_group_description: Tablets, 2 paediatric tablets/1 adult tablet, OD, every 24 hours for 48 hours
design_group_title: Dihydroartemisinin piperaquine
design_group_type: Experimental
Sponsor: KEMRI-Wellcome Trust Research Programme
Collaborators: Kenya Medical Research Institute
The World Bank
Drug name mappings:
name: 双氢青蒿素哌喹
lang: CN
name: Piperaquine tetraphosphate/Artenimol
lang: EN
Clinical trial NCT05926258: Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
Official title: A Prospective, Observer-blind, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia for Clinical Practice in Pediatric Population
Conditions: Local Anesthetic
Summary: The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients.
74 Participants (male and female, aged 0-17 yrs) will be 1:1 randomized for receiving either the test drug (Chloroprocaine) or the reference drug (Oxybuprocaine) before undergoing to ocular exam who needs ocular surface anesthesia.
The successful surface anesthesia will be evaluated 5 minutes after receiving 2 drops (1 minute apart) of either test or reference drug by an eye spear sponge
Interventions:
description: ocular surface anesthesia
name: Chloroprocaine 3% eye gel
other_name: Chemical Abstracts Service (CAS) nr 3858-89-7
type: Drug
description: ocular surface anesthesia
name: Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops
other_name: Benoxinate
type: Drug
Study arms:
design_group_description: The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
design_group_title: Chloroprocaine 3% gel
design_group_type: Experimental
design_group_description: The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
design_group_title: Oxybuprocaine 0,4% solution
design_group_type: Active Comparator
Sponsor: Sintetica SA
Collaborators: Cross Research LLC
Drug name mappings:
name: 盐酸氯普鲁卡因
lang: CN
name: Chloroprocaine Hydrochloride
lang: EN
Clinical trial NCT03090880: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
Official title: Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
Conditions: Venous Thromboembolism
Lung Neoplasm
Summary: Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.
Interventions:
description: Subcutaneous tinzaparin 4,500 IU once daily for six months.
name: Tinzaparin Sodium
type: Drug
Study arms:
design_group_description: usual care,
design_group_title: Control
design_group_type: No Intervention
design_group_description: tinzaparin sodium
design_group_title: Experimental
design_group_type: Experimental
Sponsor: Assistance Publique des Hôpitaux de Paris SA
Collaborators: National Cancer Institute
Drug name mappings:
name: 亭扎肝素钠
lang: CN
name: Tinzaparin Sodium
lang: EN
Clinical trial NCT01949311: Open-label Study of Dupilumab in Patients With Atopic Dermatitis
Official title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
Conditions: Atopic Dermatitis
Summary: The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).
The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
Optional Sub-Study:
The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.
The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
Interventions:
name: Dupilumab
other_name: DUPIXENT®
REGN668
SAR231893
type: Drug
Study arms:
design_group_description: Participants will receive repeat doses of dupilumab
design_group_title: Dupilumab
design_group_type: Experimental
Sponsor: Regeneron Pharmaceuticals, Inc.
Collaborators: Sanofi
Drug name mappings:
name: 度普利尤单抗
lang: CN
name: Dupilumab
lang: EN
name: デュピルマブ（遺伝子組換え）
lang: JP