bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy
      and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis
    

Detailed description: 
      This trial comprises a total observation period of up to 56 days (an on-treatment period of
      up to 28 days and a safety follow-up of up to 28 days).
    

Intervention name(s): Ivermectin Tablets; Matching placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.; Daily placebo tablets intake for 28 days
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prophylaxis; RT-PCR test
A Study for Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023
      given orally to patients with schizophrenia twice daily for 4 weeks will have significantly
      greater effect than placebo.
    


Intervention name(s): LY2140023; LY2140023; LY2140023; LY2140023; Olanzapine; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 80mg, PO (by mouth) BID (twice a day) for up to 4 weeks.; 40mg, PO (by mouth) BID (twice daily) for up to 4 weeks.; 20mg, PO (by mouth) BID (twice daily) for up to 4 weeks.; 5mg, PO (by mouth) BID (twice daily) for up to 4 weeks.; 10mg, PO (by mouth) QPM (every evening) for the first 3 days, then 15mg PO QPM, for up to 4 weeks.; Taken PO (by mouth) QAM (every morning) for up to 4 weeks.; Taken PO (by mouth) BID (twice daily) for up to 4 weeks.
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Non-deceptive Application of Placebos in Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether non-deceptive application of a placebo has
      an impact on subjective or objective sleep parameters in patients with primary insomnia.
    


Intervention name(s): Placebo; Film sequence; Film sequence
Intervention type(s): Drug; Other; Other
Intervention description(s): Placebo pill; The experimental group watches a film about the power of placebo effects.; The control group watches a film about sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Infant Massage on Development of Down Syndrome Babies
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of ths study is to know the effects of infant massage in the maturation of the baby
      with Down syndrome. Scale Psychomotor Development Early Childhood Brunet-Lézine-Revised will
      be used to measure the maturational development of the baby with Down syndrome .
      Investigators will analyze two groups of intervention, the experimental group, in which
      parents will participate and will apply the knowledge learned in the course of Infant Massage
      and control, which does not receive the Infant Massage course during the study. Babies in
      both groups will be evaluated twice, at the beginning of the intervention (pretest) and end
      it after five weeks (posttest). The study population consists of 32 babies with Down syndrome
      between 4 and 8 months old.
    

Detailed description: 
      In this study, the investigators will compare the maturational development of the
      experimental group Down syndrome babies (will receive infant massage in the period between
      the two measurements) with the maturational development of the control group Down syndrome
      babies (will receive infant massage after two measurements). Assess both the development
      partial motor, cognitive, language and social, and also the maturational development global.
      Finally, measure also the ratio of development, both in the pretest as on the posttest. The
      test that will use to measure the development of them babies is the scale of development
      psychomotor of her first childhood Brunet-Lezine-R. The babies of the study may hay between 4
      and 8 months old.
    

Intervention name(s): Infant Massage
Intervention type(s): Procedure
Intervention description(s): The first day, investigators will make the initial assessment of the baby through Psychomotor Development Scale of Early Childhood Brunet- Lézine. Participants will keep the sessions early attention and will participate in the course of Infant Massage, which develop for 5 weeks.
Infant Massage course will take place with families and is based on the methodology and program of the International Association of Infant Massage ( IAIM ), created by Vimala McClure. The course will consist of 5 sessions (one per week) approximately 90 minutes. Parents will practice everyday the movements learned during the time of the study.
When the course of Infant Massage finished, Investigators will conduct the final evaluation of the baby, the same way as in the initial evaluation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Massage; Development
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2
      milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).
    


Intervention name(s): Etrasimod; Etrasimod; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Etrasimod 2 mg tablet by mouth, once daily; Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily; Etrasimod matching placebo tablet by mouth, once daily
Other intervention name(s): APD334; APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Placebo-Controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T-cell-mediated autoimmune skin disorder; Alopecia areata; Alopecia; APD334; Etrasimod; Hair loss
Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the bioequivalence of the combination of
      pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference
      tablet administered as a single total dose of 720:240 mg in healthy adults. The secondary
      objective is to assess the safety of the two formulations.
    

Detailed description: 
      This is a phase I, randomized, single dose, two-way cross-over study of two tablet
      formulations of the combination of pyronaridine and artesunate (180:60 mg). The study will
      include 42 healthy participants, comprising male and female adults.

      Participants will be randomized to receive either reference tablet formulation or
      to-be-marketed formulation first and then will be crossed over to receive the opposite
      Intervention. The study will consist of two single dose treatments of 720:240 mg tablets,
      separated by a washout period of 43 days.

      Participants will go to the clinic the evening before dosing (dosing days were Day 0 for
      period 1 and Day 43 for period 2) under fasting condition and remain in the hospital for 24
      hours after receiving dosing.

      Participants will stay in the hospital for 24 hours after their arrival at the clinic. They
      will return to the clinic at Day 2, 3, 5, 7, 14, 21, 28, 35 and 42 on an ambulatory basis. At
      Day 43, the dosing for the second sequence will start and a similar schedule of visits will
      be followed. Each participant will be followed-up for an additional 42 days after the start
      of the second study period, until the final visit (Day 85). The total duration of
      participation is 85 days plus a maximum of 2 weeks screening period.
    

Intervention name(s): pyronaridine artesunate clinical trial reference tablets; pyronaridine artesunate to-be-marketed tablets
Intervention type(s): Drug; Drug
Intervention description(s): Single total oral dose of 720:240 mg (4 tablets of 180:60 mg); Single total oral dose of 720:240 mg (4 tablets of 180:60 mg)
Other intervention name(s): Pyramax; PA; Pyramax; PA
Intervention MeSH terms: Artesunate; Pyronaridine; Pyronaridine tetraphosphate, artesunate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; anti-malarial; pyronaridine; pyronaridine artesunate (Pyramax); artemisinin based combination therapy (ACT)
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
Condition: Opioid Induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Chronic Pain; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety of single doses of oral
      naldemedine in adults physically dependent on opioids.
    

Detailed description: 
      A single dose of naldemedine or matching placebo will be administered orally to each cohort
      of 12 participants (9 treatments, 3 placebos) in the morning of Day 15 under fasted
      conditions. The first cohort will receive a 0.1 mg dose. Cohorts will continue to be enrolled
      at the next higher dose level until the highest dose level (3 mg) has been achieved or until
      the study is discontinued due to adverse events or Clinical Opioid Withdrawal Score of >8. A
      0.03 mg dose will also be tested. A 0.01 mg dose will be tested if 4 or more subjects
      experience 1 or more bowel movements within the 24 hour period post dose in the 0.03 mg
      dosing cohort.
    

Intervention name(s): Naldemedine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets or solution for oral administration; Tablets or solution for oral administration
Other intervention name(s): S-297995; Symproic®
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic pain; Opioid physical dependence
Long-term Efficacy and Safety Research of Left Bundle Branch Pacing
Condition: Atrioventricular Block; Left Bundle Branch Pacing
MeSH terms: Atrioventricular Block
Study type: Observational [Patient Registry]

Summary: 
      Patients with successful left bundle branch pacing in our center were included in this study
      from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and
      echocardiographic results were analyzed during 3 years follow-up. According to whether or not
      a potential was recorded and the specific potential characteristics at implantation, the
      patients were divided into 3 groups: left bundle branch potential group; Purkinje potential
      group; and no-potential group. During the 3 years follow-up, the investigators collected the
      ECG、UCG and pacemaker parameters to analyze.
    

Detailed description: 
      A total of 136 patients with a high percentage of ventricular pacing and successful left
      bundle branch pacing were included in this study from April 2018 to December 2019. Baseline
      data was collected, and pacing parameters, ECG and echocardiographic results were analyzed
      during 3 years follow-up. According to whether or not a potential was recorded and the
      specific potential characteristics at implantation, the patients were divided into 3 groups:
      left bundle branch potential group (L group) 31.6%; Purkinje potential group (P group) 10.3%;
      and no-potential group (N group) 58.1%. During the 3 years follow-up, the investigators
      collected the ECG、UCG and pacemaker parameters to analyze.
    

Intervention name(s): Cardiac pacemaker and Select Secure lead
Intervention type(s): Device
Intervention description(s): model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        From April 2018 to Dec 2019, consecutive patients who were predicted to require a high
        percentage of ventricular pacing in our center were enrolled in this study. Main
        indications for the enrolment of patients are atrioventricular block and heart failure (HF)
        combined with complete left bundle branch block (LBBB). All patients were accorded with
        indications for pacing therapy of 2013 European Society of Cardiology guidelines on cardiac
        pacing. The study conforms to the guiding principles of the Declaration of Helsinki and was
        approved by Ethics Committee of the Linyi People's Hospital. All patients signed the
        informed consent.
Iloprost in High Risk Cardiac Surgical Patients
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study effects of the intra operative, prophylactic inhalation of Iloprost (Ventavis)
      before and during extracorporal circulation on perioperative morbidity and outcome in high
      risk cardiac surgical patients is investigated in comparison to placebo.
    


Intervention name(s): Iloprost (Ventavis); Isotonic Sodium Chloride solution 0.9 % (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Twice 20 µg at day 0 (total dose 40 µg) intraoperatively; Twice at day 0 intraoperatively
Other intervention name(s): Ventavis
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Iloprost; pulmonary hypertension; cardio pulmonary morbidity; high risk cardiac surgical patients
Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
Condition: Head and Neck Cancer; Radiation Toxicity
MeSH terms: Oropharyngeal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating
      patients who have stage II or stage III oropharyngeal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Assess target coverage and major salivary gland sparing in patients with stage II or III
           oropharyngeal cancer treated with intensity-modulated radiotherapy.

        -  Determine the nature and prevalence of acute and late side effects of this treatment in
           these patients.

        -  Determine the rate and pattern of locoregional tumor recurrence in these patients after
           this treatment.

      OUTLINE: This is a multicenter study.

      Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5
      days a week for 6 weeks, in an effort to spare major salivary glands.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27
      months.
    

Intervention name(s): radioprotection; radiation therapy
Intervention type(s): Drug; Radiation
Primary purpose: Treatment
Keywords: stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; radiation toxicity
Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits
Condition: Healthy
Study type: Interventional

Summary: 
      Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols
      cocoa
    

Detailed description: 
      Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols
      cocoa.
    

Intervention name(s): Cocoa Pure; Placebo
Intervention type(s): Other; Other
Intervention description(s): Cocoa Pure.; Placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: volunteers
Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies
Condition: Idiopathic Inflammatory Myopathies
MeSH terms: Muscular Diseases; Myositis
Study type: Interventional

Summary: 
      1. To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs).

        2. To assess whether EIM parameters are reflective of disease severity, based on clinical
           outcome measures of IIMs.
    

Detailed description: 
      1. To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs)
           There are structural and compositional changes in muscles, such as edema, adipose
           infiltration, and/or atrophy, in IIMs. Electrical impedance myography (EIM) is sensitive
           to such changes. EIM parameters will be different when compared to healthy controls in
           IIMs.

        2. To assess whether EIM parameters are reflective of disease severity, based on clinical
           outcome measures of IIMs.

      Clinical outcome measures reflect on disease severity which is an indirect measure of muscle
      involvement in IIMs. If EIM parameters correlate with clinical outcome measure, it would
      indirectly prove that EIM can reflect disease severity in IIMs
    

Intervention name(s): electrical impedance myography; healthy control group
Intervention type(s): Device; Other
Intervention description(s): Electrical impedance myography (EIM) is a new electrodiagnostic method of quantitative muscle evaluation. It utilizes concepts of bio impedance, the ability of biological tissue to impede externally applied electrical current.; healthy control
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to estimate the impact of sex on relative survival and excess
      mortality following acute myocardial infarction (AMI) using a population-based cohort within
      a relative survival framework. Patient-level data concerning demographics, co-morbidity,
      cardiovascular risk factors and treatments at discharge were extracted from the Swedish
      Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated
      According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for
      patients hospitalized with acute coronary syndrome. Patients were followed-up for their vital
      status after AMI hospitalisation, with censoring at the end of follow-up on the 31st of
      December, 2013.
    

Detailed description: 
      Details of SWEDEHEART and data validation have been described previously. Cases of acute
      myocardial infarction were defined as STEMI and NSTEMI according to the current European
      Society of Cardiology, American College of Cardiology and American Heart Association
      guidelines and determined at local level by the attending Consultant.
    

Intervention name(s): Excess mortality
Intervention type(s): Other
Intervention description(s): Relative survival was defined as the observed survival among patients with STEMI and NSTEMI divided by the expected survival in the age, sex and year matched populace of Sweden.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged over 18 years who had been hospitalised following acute myocardial infarction
        between 1st January, 2003 and 31st December, 2013
Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop
      the growth of cancer cells, either by killing the cells or by stopping them from dividing.
      Sometimes, the cancer may not need treatment until it progresses. In this case, observation
      may be sufficient. It is not yet known whether fludarabine is more effective than observation
      in treating chronic lymphocytic leukemia.

      PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works
      compared to observation only in treating patients with stage 0, stage I, or stage II B-cell
      chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Identify prognostic factors that predict a short survival in patients with stage 0-II
           B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.

      OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs
      low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk
      group are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive fludarabine.

        -  Arm II: Patients undergo observation only.

      PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.
    

Intervention name(s): Fludarabine
Intervention type(s): Drug
Intervention description(s): Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Other intervention name(s): Fludura
Intervention MeSH terms: Fludarabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell chronic lymphocytic leukemia; stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia
Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants
Condition: Infant
Study type: Interventional

Summary: 
      In this study the investigators hypothesized that the chronic intake of
      fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus
      vaccination and bifidobacteria in infants.
    


Intervention name(s): Follow-on formula supplemented with fructo-oligosaccharides; Follow-on formula enriched with placebo (maltodextrins)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Follow-on formula supplemented with fructo-oligosaccharides; Follow-on formula enriched with placebo (maltodextrins)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)