bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Different Stimuli in Patients With Disorders of Consciousness
Condition: Disorder of Consciousness
MeSH terms: Consciousness Disorders
Study type: Interventional

Summary: 
      In recent years, promoting wakening attempts in patients with disorders of consciousness are
      increasing, but there are a lack of objective indicators to evaluate the efficacy and further
      researches on the brain mechanism during the wakening processing. So, the study first
      assessed the cerebral response during emotional acoustic stimuli with quantitative EEG and
      ERP(Event-related potential), and next, the investigators explored the relationship between
      brain activation and patients' recovery.
    

Detailed description: 
      Auditory stimuli have potential beneficial effects on cognitive functions and consciousness
      in patients with disorders of consciousness (DOC)，especially the emotional sound; however,
      precise and accurate quantitative indices to estimate cerebral activation to different
      auditory stimuli remain scarce. In this study, investigators assessed the response of
      different brain regions to three acoustic stimuli using quantitative electroencephalography
      (QEEG) and ERP(Event-related potential),and further investigated the predictive value of QEEG
      in the prognosis of DOC.
    

Intervention name(s): music,name,and noise sound
Intervention type(s): Device
Intervention description(s): A 5-minute baseline silence was followed by the presentation of three contrasting auditory stimuli(music,name,and noise), with a 2-minute washout silence separating each stimulus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EEG;DOC;auditory
A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects
Condition: Infectious Disease
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of
      CMX157 at increasing dose levels.
    

Detailed description: 
      This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of
      CMX157 at increasing dose levels, in a fasted state and a fed state.
    

Intervention name(s): CMX157; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Other intervention name(s): Lipid Conjugate TFV
Intervention MeSH terms: Hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy
      men.
    


Intervention name(s): Placebo; ldalopirdine 120 mg; Idalopirdine 360 mg; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules, orally, single dose; Two 60 mg encapsulated film-coated tablets, orally, single dose; Four 90 mg encapsulated film-coated tablets, orally, single dose; Encapsulated tablets, orally, single dose
Intervention MeSH terms: Moxifloxacin; (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and
      tolerability of single/multiple-dose administration of different doses of Alprostadil
      Liposome for Injection as well as to confirm the safety dose range.
    

Detailed description: 
      Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and
      tolerability of single/multiple-dose administration of different doses of Alprostadil
      Liposome for Injection as well as to confirm the safety dose range.

        1. Single dosing tolerability test in humans.There are 7 dose
           (10ug,20ug,50ug,100ug,200ug,300ug,400ug) groups in the single dosing tolerance test in
           healthy adult volunteers.The beginning dose of the study is 10ug,according to the dose
           escalation method,subjects who have successfully completed previous dose group and
           passed the safety assessment will enter the test of next dose group with the same
           method.

        2. Multiple dosing tolerability test in humans.Choose the proper dosage for multiple dosing
           tolerance test based on the single-dose tolerance test result.
    

Intervention name(s): Alprostadil Liposomes for Injection
Intervention type(s): Drug
Intervention description(s): Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd
Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days.
Intervention MeSH terms: Alprostadil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and the tolerability of three fixed
      doses of Vortioxetine in order to establish the appropriate clinical effective dose range in
      the treatment of Major Depressive Disorder (MDD).
    


Intervention name(s): Placebo; Vortioxetine (Lu AA21004); Vortioxetine (Lu AA21004); Vortioxetine (Lu AA21004); Duloxetine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): capsules; daily; orally; 2.5 mg/day; encapsulated tablets; orally; 5 mg/day; encapsulated tablets; orally; 10 mg/day; encapsulated tablets; orally; 60 mg/day; encapsulated capsules; orally
Other intervention name(s): Brintellix; Brintellix; Brintellix; Cymbalta®
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major depressive disorder; Placebo-controlled; Active reference; Multicenter study; Randomised study; Acute treatment
Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Influenza remains a potentially significant and largely preventable source of morbidity and
      mortality, yet vaccine coverage is low. Young children are at particular risk for
      underimmunization because they may need to receive 2 doses in a current season. Even among
      those young children that initiate vaccination, only 40% receive the important second dose,
      yet one dose does not confer adequate protection. Low-income, urban children may be at
      particular risk of not receiving two doses. While traditional mail and phone immunization
      reminders notifying families that a vaccine is due have had limited efficacy in low-income,
      urban populations, we have demonstrated the success of using text messages. Comparing the
      effectiveness of different forms of reminders on receipt of this critical second dose of
      influenza vaccine has not been studied. Besides failure to remember to return for subsequent
      doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health
      literacy regarding influenza vaccination, particularly associated with understanding the need
      for a second dose since not all children require it. Text messaging offers the ability to
      combine health literacy promoting information and reminders in a scalable, efficient manner
      for populations at high risk for underimmunization, limited health literacy, and influenza
      spread. Therefore, the purpose of this study is to determine whether the provision of
      interactive vaccine health literacy-promoting information in text message vaccine reminders
      improves receipt and timeliness of the second dose of influenza vaccine within a season for
      underserved children in need of two doses.
    


Intervention name(s): Text Message; Written reminder
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Influenza; text message; vaccination
Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the open-label, dose-escalation study is to investigate the safety
      of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female
      subjects with advanced or recurrent breast cancer. The secondary objective is to investigate
      the pharmacokinetics and efficacy.
    


Intervention name(s): KHK2375; Exemestane
Intervention type(s): Drug; Drug
Intervention description(s): KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.
Exemestane will be orally administered once daily.; KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.
Exemestane will be orally administered once daily.
Other intervention name(s): Entinostat; MS-275; SDNX-275
Intervention MeSH terms: Exemestane; Entinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
4-PBA: Will it Increase the Level of Alpha 1-Antitrypsin(AAT) in Persons With AAT Deficiency?
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out whether 4-PBA will increase the level of AAT in
      persons with AAT deficiency whether or not they have liver disease.
    

Detailed description: 
      The purpose of this study is to determine whether 4-PBA will significantly increase serum Z
      AAT levels in AAT-deficient individuals with and without evidence of hepatocellular injury
      and to assess its effects on liver injury.
    

Intervention name(s): 4-PBA
Intervention type(s): Drug
Intervention description(s): During the first 3 days of this phase baseline serum AAT levels will be determined. The participants will be then given increased amounts of 4-PBA orally in 6 divided doses (day 4-6, 30 g/day and day 7-9, 40/day
Other intervention name(s): 4-phenyl butyric acid
Intervention MeSH terms: Butyric Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Disease; Liver Disease
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
Condition: Neuroendocrine Carcinoma (Carcinoid)
MeSH terms: Carcinoid Tumor; Carcinoma, Neuroendocrine
Study type: Interventional

Summary: 
      The goal of this study is to compare several methods for measurement of Chromogranin A in
      their ability to serve as a marker for disease activity in patients with neuroendocrine
      tumors.

      Further, in a subgroup, we will determine if taking a proton pump inhibitor affects
      Chromogranin A levels.
    

Detailed description: 
      Patient group: patients with neuroendocrine tumors (active or inactive) Healthy volunteers
    

Intervention name(s): Lansoprazole; lansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): lansoprazole 30 mg HS x 7 days; lanzoprazole 30 mg HS for 7 days
Other intervention name(s): Prevacid; pravacid
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: chromogranin A; neuroendocrine; carcinoid; Proton Pump Inhibitor
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and
      the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
    

Detailed description: 
      Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease with a histological picture of
      usual interstitial pneumonia and a deteriorating clinical course. The prognosis is poor.
      Chronic alveolar inflammation with associated parenchymal remodeling is theorized to promote
      an ongoing abnormal fibrogenic repair response. Corticosteroids and immunomodulatory agents
      have not been shown to benefit IPF patients. Recently several published clinical studies have
      indicated a strong correlation between IPF severity and/or disease progression and the levels
      of specific plasma biomarker proteins related to epithelial cell health and extracellular
      matrix turnover.

      PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce
      fibrosis.

      This study is the first intravenous multiple-dose study in humans, and will be conducted in
      patients with IPF. Patients will be randomized to receive either PRM-151 or placebo.
    

Intervention name(s): PRM-151; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Intravenous PRM-151 administered over 30 minutes on study days 1, 3, 5, 8, and 15 at doses of 1.0, 5.0, or 10.0 mg/kg.; Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary, fibrosis
Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human randomized, double-blind (Investigator and subject), placebo
      controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo
      per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).
    


Intervention name(s): PE0139 Injection; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
Condition: Aspergillosis; Candidemia
MeSH terms: Aspergillosis; Candidemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to
      determine the drug concentration in the lung.
    


Intervention name(s): anidulafungin and voriconazole
Intervention type(s): Drug
Intervention description(s): Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.
Intervention MeSH terms: Voriconazole; Anidulafungin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: PK; fungal infection
Responses to a Comfort Meal in Functional Dyspepsia
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Dyspepsia
Study type: Interventional

Summary: 
      Background. Dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is
      not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic
      components of perception. Methods. Parallel studies in patients with symptoms induced by
      meals (fulfilling Rome IV criteria of postprandial dyspepsia) and sex- and age-matched
      healthy subjects. Participants will be instructed to eat a standard dinner the day before, to
      consume a standard breakfast at home after overnight fast, and to report to the laboratory,
      where the test meal will be administered 4 h after breakfast. Studies will be conducted in a
      quiet, isolated room with participants sitting on a chair. Participants will ingest a probe
      meal up to the level of maximal satiation. The probe meal will be served stepwise (112 Kcal
      every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive
      well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20
      min after ingestion at 10 min intervals.
    


Intervention name(s): Probe meal
Intervention type(s): Other
Intervention description(s): The probe meal will be served in 112 Kcal portions (16 g white bread, 10 g cheese, 10 g jam, 3.25 g butter, and 50 mL orange juice) up to the level of maximal satiation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations; functional dyspepsia
Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty
Condition: Hemorrhage Postoperative; Total Blood Loss; Arthroplasty Complications
MeSH terms: Hemorrhage; Exsanguination; Postoperative Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      To find noninferiority relationship between oral and intravenous administration of tranexamic
      acid on peroperative and postoperative blood loss and serum concentration during primary
      total hip arthroplasty.
    

Detailed description: 
      Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce
      peroperative and postoperative hemorrhagic complications. The original character of our study
      lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective
      (blood loss) with this one. The investigators will focus on the reduction of the risks
      associated with the administration of intravenous medicines, the economic aspect and the ease
      of use.
    

Intervention name(s): Tranexamic Acid Oral Product; Tranexamic acid injection
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration; Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Obese Hypertension Study (0954-315)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 16-week study to evaluate high systolic and diastolic blood pressure following
      treatment in obese, hypertensive, adult patients.
    


Intervention name(s): Comparator: losartan +/- HCTZ; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.; Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus
Condition: Erosive Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in
      the treatment of erosive oral lichen planus and compare between the two therapeutic
      modalities.
    

Detailed description: 
      Twenty erosive lichen planus patients were recruited and randomly assigned in one of two
      groups, the test (lycopene) and control (corticosteroids) group.
    

Intervention name(s): Lycopene Softgel, 10 Mg; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Patients were given 10 mg of lycopene softgel capsules once daily for two months. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract.; Patients were given 40 mg of prednisolone tablets once daily in the morning for one month, afterwards, the dose was tapered along the following month. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study. The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone).
Other intervention name(s): Corticosteroids
Intervention MeSH terms: Prednisolone; Lycopene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment