bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection
Condition: Common Cold; Acute Respiratory Infection; Influenza, Human
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Virus Diseases; Common Cold; Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with
      placebo in patients with dry non-productive cough against acute respiratory infections, and
      to determine the dosing regimen of XC8, film-coated tablets, 10 mg for treatment of dry
      non-productive cough against acute respiratory infections.
    


Intervention name(s): XC8, film-coated tablets, 20 mg/day; XC8, film-coated tablets, 40 mg/day; XC8, film-coated tablets, 80 mg/day; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20 mg/day (1 tablet twice a day); 40 mg/day (2 tablets twice a day); 80 mg/day (4 tablets twice a day); 1, 2, or 4 tablets twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more
      like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed
      by bexarotene may be an effective treatment for cutaneous T-cell lymphoma.

      PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by
      bexarotene works in treating patients with cutaneous T-cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the progression-free survival of patients with stage IB-IV cutaneous T-cell
           lymphoma treated with doxorubicin HCl liposome followed by bexarotene.

      Secondary

        -  Determine the complete and partial response rate in patients treated with this regimen.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive doxorubicin HCl liposome IV over 30-90 minutes once on day 1. Treatment
      repeats every 2 weeks for 8 courses. Beginning within 4 weeks after the last dose of
      doxorubicin HCl liposome, patients receive oral bexarotene once daily for at least 16 weeks.
      Patients who achieve a complete or partial response may continue to receive bexarotene in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 5 years.
    

Intervention name(s): Targretin® (bexarotene); pegylated liposomal doxorubicin hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Bexarotene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome
Antioxidants for Prevention of Cataracts Follow-up Study
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor
      Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from
      1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural
      villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15
      mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no
      significant difference in cataract formation between the antioxidant group and placebo. In
      this follow-up study, we will return to study villages to determine whether rates of cataract
      surgery are different in the 2 groups.

      1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts
      Study: effects of antioxidant supplements on cataract progression in South India. The British
      journal of ophthalmology 2006;90:847-51.
    


Intervention name(s): Antioxidant; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Brain-Behavior Interactions in Tic Suppression
Condition: Tourette's Syndrome; Chronic Motor Tic Disorder; Chronic Vocal Tic Disorder
MeSH terms: Tourette Syndrome; Tics; Tic Disorders
Study type: Observational

Summary: 
      The purpose of this study is to examine how the brain and environment interact to influence
      children's ability to suppress tics using a medical technology called Transcranial Magnetic
      Stimulation (TMS).
    

Detailed description: 
      Objectives: This study will recruit youth with chronic tics. Chronic tics are the most common
      movement disorder in children. The goal of the study is to learn how the brain and
      environment influence children's ability to suppress tics. Specifically, we want to learn how
      tics are influenced by a certain part of the brain called the supplementary motor area (SMA).
      This part of the brain is thought to be more active in people with tics. This will be the
      first study to look at the relationship between SMA, tic suppression, and urges to tic.

      Research Procedures: The study will take place over the course of three days within a week
      (about 5 hours total). The study will examine the relationship between the SMA and tic
      suppression using a non-invasive medical technology called Transcranial Magnetic Stimulation
      (TMS). Participants will have a diagnostic interview, MRI brain scan (used to find the
      location of the SMA), and TMS. Participants will be asked to try to suppress tics before and
      after TMS. The information that will be collected from participation includes information
      about tic symptoms, emotional and behavioral functioning, and brain activity (from MRI brain
      images and TMS results).
    

Intervention name(s): Active TMS; Sham TMS
Intervention type(s): Other; Other
Intervention description(s): There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive 1hz "active" TMS. Tics and urges will be monitored immediately before and after TMS.; There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive inactive ("sham") TMS. Tics and urges will be monitored immediately before and after TMS.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury
Study type: Interventional

Summary: 
      The purpose of this trial is to determine whether low tidal volume during intraoperative
      one-lung ventilation could decrease the incidence rate of postoperative acute lung injury
      compared to "normal" tidal volume.
    

Detailed description: 
      Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low
      tidal volume has been shown to attenuate lung injuries in critically ill
      patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal
      tidal volume of two-lung ventilation should be a large one when exerted to one lung. We
      hypothesized that low tidal volume ventilation during one-lung ventilation could decrease
      incidence rate of postoperative acute lung injury and mortality.
    

Intervention name(s): protective ventilation; conventional ventilation
Intervention type(s): Other; Other
Intervention description(s): set tidal volume of 5ml/kg during one-lung ventilation; keep tidal volume at 8ml/kg during one-lung ventilation
Other intervention name(s): low tidal volume ventilation; normal tidal volume ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: esophagectomy; acute lung injury; protective ventilation
Reliability of the Swiss Emergency Triage Scale (SETS®) Used by Emergency Medical Service (EMS) Providers
Condition: Emergency Medical Services; Triage
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in
      Switzerland, France and Belgium. No validated triage scale is actually used by Emergency
      Medical Service (EMS) providers. The objective of this project is to evaluate the reliability
      and performance of triage by EMS providers with the SETS.
    

Detailed description: 
      The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in
      Switzerland, France and Belgium. No validated triage scale is actually used by EMS providers.
      The objective of this project is to evaluate the reliability and performance of triage by EMS
      providers with the SETS.

      In order to perform this evaluation a cohort of 22 EMS providers will evaluate 28
      standardized clinical scenarios using a computer simulator.
    

Intervention name(s): Mobile triage system
Intervention type(s): Device
Intervention description(s): A mobile triage system used by EMS providers will be evaluated using standardized clinical vignettes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Observational

Summary: 
      The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select
      immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal
      fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo
      treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled
      in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.
    

Detailed description: 
      This study is complementary to a multi-center, randomized, double-blind,parallel-group,
      placebo-controlled, variable treatment duration study comparing the efficacy and safety of
      BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both
      immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the
      setting of a SPMS clinical trial.

      This study is part of a multi-center study, with the University of Michigan serving as the
      central site.
    

Intervention name(s): Blood Draw; CSF collection by lumbar puncture (Optional)
Intervention type(s): Procedure; Procedure
Intervention description(s): Blood draws (65 mLs [~4 tablespoons] per blood draw) at 4 time points: Prior to study medication initiation, and at +6, +12 and+24 months post treatment initiation.; For participants who volunteer to donate CSF samples: up to 25 mLs (<2 tablespoons): prior to study medication initiation, and at month 24 post treatment initiation.
Other intervention name(s): Phlebotomy; Venipuncture; CSF by LP; cerebrospinal fluid collected by lumbar puncture
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ambulatory participants with Secondary Progressive Multiple Sclerosis (SPMS) enrolled in
        the EXPAND trial (BAF312 treated and placebo [control] participants) may be enrolled in
        this study after the EXPAND baseline visit has occurred provided that the subject has not
        passed the Month 12 time point.

        -Refer to ClinicalTrials.gov record NCT01665144.
      
Biospecimen description: 
      Blood & Cerebrospinal Fluid Samples
    
Keywords: autoimmunity; clinical research; mechanistic studies; blood draw; cerebrospinal fluid (CSF) by lumbar puncture (optional)
Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      This study is designed to assess effectiveness, safety and cost-utility of conventional
      rehabilitation and traditional Korean medicine conjugated rehabilitation on children with
      cerebral palsy.
    

Detailed description: 
      1. Survey

             1. An interview survey on baseline

                  -  Basic characteristics

                  -  Cause of cerebral palsy

                  -  Accompanied disorders

                  -  Health problems

                  -  Operation history

                  -  Drug-taking

                  -  Rehabilitation treatment

                  -  Korean medicine treatment

                  -  Health functional food

                  -  Medical care cost

             2. An interview survey on 26th and 52nd weeks

                  -  Accompanied disorders

                  -  Health problems

             3. A weekly tracking survey

                  -  Health problems

                  -  Therapeutic change

                  -  Medical care cost

                  -  Quality of life

        2. Assessment for function development on baseline, 26th and 52nd weeks

             -  Gross Motor Function Classification System (GMFCS)

             -  Gross Motor Function Measure-66 (GMFM-66)

             -  Pediatric Evaluation of Disability Inventory (PEDI)
    

Intervention name(s): Korean medical treatment
Intervention type(s): Other
Intervention description(s): acupuncture and herbal drugs
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population will be selected from rehabilitation clinics for children
      
Keywords: Cerebral palsy; GMFM-66; PEDI
Alternate Dosing Regimens of BG00012 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and PK of different doses
      and dosing regimens of BG00012 administered with and without ASA compared to placebo
    

Detailed description: 
      Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The
      study will use a variety of clinical scales, including a flushing scale derived from a
      validated questionnaire [Norquist 2007], to better understand the safety and tolerability of
      several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology
      of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the
      impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be
      performed.
    

Intervention name(s): Dimethyl Fumarate (BG00012); Aspirin; BG00012 matching placebo; ASA matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Dimethyl Fumarate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous
      administrations of MEDI-563 on adults with uncontrolled asthma.
    

Detailed description: 
      This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to
      evaluate the efficacy and safety of multiple-dose (7 doses) subcutaneous administration of
      benralizumab (MEDI-563) in adult subjects with uncontrolled asthma.
    

Intervention name(s): Benralizumab 2 mg; Benralizumab 20 mg; Benralizumab 100 mg; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.; EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.; EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.; EOS+ and EOS- participants received two placebo injections subcutaneously.
Other intervention name(s): MEDI-563; MEDI-563; MEDI-563
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Benralizumab; MEDI-563
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone
      hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone
      hydrochloride tablets.
    


Intervention name(s): oxymorphone hydrochloride; Opana
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxymorphone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Seroquel XR in the Long Term Treatment of Schizophrenia
Condition: Relapse in Schizophrenia
MeSH terms: Recurrence; Schizophrenia
Study type: Observational

Summary: 
      The purpose of the study is to determine whether the Seroquel XR treatment for 6 months
      improves the relapse prevention in schizophrenic outpatients
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Psychiatric outpatients
      
Keywords: Seroquel XR; schizophrenia; relapse prevention
A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of
      HD201 to the European (EU) and American (US) reference products Herceptin, following a single
      i.v. infusion of 6 mg/kg in healthy volunteers.
    

Detailed description: 
      This is a double-blind, randomised, parallel group study, where a total of 105 healthy adult
      male volunteers, ≥ 18 and ≤ 55 years of age, non-smoker, will be dosed; 35 subjects per
      treatment group, randomly assigned to one of the 3 treatment arms.
    

Intervention name(s): HD201; EU-Herceptin; US-Herceptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single-dose 6mg/kg body weight by 90 minute intravenous infusion; Single-dose 6mg/kg body weight by 90 minute intravenous infusion; Single-dose 6mg/kg body weight by 90 minute intravenous infusion
Other intervention name(s): Trastuzumab; Trastuzumab; Trastuzumab
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: randomized; double-blind
Esophageal Hypersensitivity Study in Healthy Volunteers
Condition: Pain; Esophageal Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare sensitivity and sensitization of visceral pain in the
      esophagus using different pain stimuli
    


Intervention name(s): AZD1386; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, single dose; Oral solution, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GERD; healthy volunteer; esophagus; pain
A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
Condition: Diabetes Mellitus, Type 2; Healthy Males
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      26 subjects will be enrolled into 5 different dose groups. The trial will consist of a
      screening, a dosing and a follow-up visit.

      Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given
      at 5 dose levels.
    

Detailed description: 
      This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to
      determine the safety & tolerability of MKC253 (GLP1/TechnosphereÂ®)Inhalation Powder.

      The trial consists of a screening, dosing and a follow-up visit. Single dose administration
      of MKC253 occurs at the dosing visit. Five doses are being assessed: 0.05, 0.45, 0.75, 1.05 &
      1.5 mg GLP-1. Dosing of each ascending cohort will occur after the Principal Investigator has
      reviewed all safety/tolerability data
    

Intervention name(s): MKC253 Inhalation Powder
Intervention type(s): Drug
Intervention description(s): Inhalation powder
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Diabetes Mellitus: Type II