bioihbjkbjnl/mcl2 huggingface dataset:
Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer
Condition: Triple-negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of
      breast cancer cells in women with Stage I, II, or III triple negative breast cancer.
    

Detailed description: 
      Sporadic and germline BRCA mutation associated triple-negative breast cancer share several
      pathological and molecular similarities which have led to the exploration of DNA damaging
      agents like platinum compounds in patients with triple-negative breast cancer. Recent studies
      demonstrate that addition of neoadjuvant carboplatin to
      doxorubicin/cyclophosphamide/taxane-based chemotherapy improves pathological complete
      response in patients with stage I-III triple-negative breast cancer but also increase
      toxicity.

      A recent study reported encouraging pathological complete response rates with a
      non-anthracycline carboplatin plus docetaxel neoadjuvant chemotherapy regimen in a cohort of
      49 triple negative breast cancer patients. This chemotherapy regimen of carboplatin plus
      docetaxel yielded an overall pathological complete response rate of 65% in unselected
      triple-negative breast cancer with pathological complete response rates of 61% in sporadic
      and 77% in germline BRCA-associated triple-negative breast cancer. The chemotherapy regimen
      of carboplatin/docetaxel is well tolerated and should be studied further and compared with
      regimens that add carboplatin to the standard anthracycline/taxane containing regimens.

      This is the basis for the proposed randomized neoadjuvant phase II study to further estimate
      and compare pathological complete response rates of carboplatin plus docetaxel x 6 cycles to
      carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide x 4
      cycles in stage I-III triple negative-breast cancer.
    

Intervention name(s): Paclitaxel; Carboplatin; Doxorubicin; Cyclophosphamide; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): taxol; paraplatin; adriamycin; cytoxin, procytox; taxotere
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Carboplatin; Doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TNBC, breast cancer, neoadjuvant, carboplatin, docetaxel, paclitaxel, doxorubicin, cyclophosphamide
Taste Perception and Chronic Disease Risk
Condition: Cardiovascular Disease; Diabetes; Obesity; Metabolic Syndrome; Aging
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Chronic Disease
Study type: Observational

Summary: 
      The purpose of the Taste Perception Study is to assess variations in the ability to taste and
      perceive sensations from various stimuli in younger (18-49 years) and older (50-85 years)
      volunteers. The study's goal is to determine how these sensations influence what one likes to
      eat, and what one chooses to eat, and whether there is an association with dietary intake,
      body composition and chronic disease. Another objective of the study is to determine the
      association between variations in oral sensations and genes mediating sensory perception and
      dietary behaviours.
    

Detailed description: 
      The objective of the Taste Perception Study is to assess variations in oral sensations in
      younger (18-49 years; n=35) relative to older (50-85 years; n=35) subjects, and determine the
      association between variations in oral sensations and measures of chronic disease risk
      factors, body composition, habitual dietary intake and selected genes mediating sensory
      perception and dietary behaviors. Subjects who are participating in the Glycemic Index study
      (IRB #7196) will be asked for voluntarily participation in the proposed study. These
      volunteers will undergo 1-2 hours of standardized testing. These tests will involve tasting
      or smelling certain foods/beverages or ingredients in foods/beverages and rating the degree
      of liking/disliking, intensity and flavor or odor using a validated general Labeled magnitude
      scale. Volunteers will also be asked to complete a food preference survey and eating
      inventory questionnaire, as well as provide a DNA sample from a cheek swab or blood sample.
      These data will then be merged with the measures of chronic disease risk factors, body
      composition and habitual dietary intake data generated from the Glycemic index study in order
      to better understand if variations in oral sensations influence food preferences and patterns
      and subsequently chronic disease risk.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Biospecimen description: 
      Blood, and DNA
    
Keywords: Taste; general Labeled Magnitude Scale; Aging; Chronic Disease Risk; Smell
The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg
      tablets) on the QT/QTc interval.
    


Intervention name(s): HYD; Moxifloxacin; Placebo for HYD; Placebo for moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Hydrocodone bitartrate 80 mg (day 9), 120 mg (day 12), 160 mg [(1) 40 mg tablet + (1) 120 mg tablet] (day 15) extended-release tablets administered orally every 24 hours.; Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only.; Placebo to match HYD tablets administered orally every 24 hours.; Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.
Other intervention name(s): Avelox®
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Healthy volunteers; Opioid; ECG; QTcI
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to
      receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated
      interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to
      an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA
      level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a
      2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower
      limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of
      PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.

      Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400
      mg plus PEG+RBV for 12 weeks.
    


Intervention name(s): Sofosbuvir; Placebo to match sofosbuvir; PEG; RBV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sofosbuvir tablets were administered orally once daily.; Placebo tablets to match sofosbuvir were administered orally once daily.; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.; Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg).
Other intervention name(s): Sovaldi®; GS-7977; PSI-7977; Pegasys®; Copegus®
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C Virus; HCV; hepatitis; Genotype 1; Genotype 2; Genotype 3
Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and Food Effect on ALXN2050 Pharmacokinetics
Condition: Healthy Adult Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the Bioequivalence between 180 mg and 60 mg ALXN2050 Tablets and the
      Effect of Food on ALXN2050 Pharmacokinetics.
    

Detailed description: 
      This is a single-center, open-label, randomized, 3-period crossover study.

      Screening of participants will occur within 28 days prior to the first dose of study
      intervention.

      The study will comprise of 3 Treatment Periods: Treatment period 1, Treatment period 2,
      Treatment period 3. There will be a washout period of at least 4 days between the ALXN2050
      dose in each treatment period.

      Participants will be enrolled and will be randomized 1:1:1:1:1:1 to receive one of 6
      treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA).

      On the morning of Day 1 of each of the 3 periods, participants will receive one of the
      following treatments as per the randomization scheme.

        -  Treatment A: Dose B of ALXN2050 tablet under fasted conditions

        -  Treatment B: A single Dose A dose of ALXN2050 tablet under fasted conditions

        -  Treatment C: A single Dose A dose of ALXN2050 tablet with a high-fat meal

      Duration of study conduct (screening to follow-up): approximately 47 days.
    

Intervention name(s): Treatment A; Treatment B; Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.; Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.; Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.
Other intervention name(s): ACH-0145228; ACH-0145228; ACH-0145228
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Bioequivalence; Effect of Food
Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK2340272A in adults aged 18 to 60 years.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol amendment 1, October 2009. The
      impacted section is the outcomes measures section.
    

Intervention name(s): GSK2340272A; GSK2340269A
Intervention type(s): Biological; Biological
Intervention description(s): Two intramuscular injections in the deltoid region of the non-dominant arm.; Two intramuscular injections in the deltoid region of the non-dominant arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: GSK Bio's influenza vaccine GSK2340272A; influenza infection
Correlation Between Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) in Patients With Multiple Sclerosis (MS) in Argentina
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This observational study is being conducted to evaluate the usefulness of the MSFC and its
      relationship with EDSS scores in subjects with MS in Argentina.
    

Detailed description: 
      This observational, open-label study is being conducted to correlate change in EDSS score
      with the change in MSFC scores at the end of a 2-year follow-up period for subjects with MS
      in Argentina. Measurement of disability is an indispensable parameter in assessing the
      efficacy of experimental therapeutic agents in MS as well as in trying to determine possible
      individual evolution of the disease. Clinical scales are being used as primary or secondary
      outcome measures for recording disease progression in clinical trials. Kurtzke's EDSS is
      still used as a gold standard for measuring impairment and disability in MS. The MSFC is an
      examination-based quantitative scoring of neurological impairment. This study aims to
      establish a correlation between the usefulness of both scales.

      OBJECTIVES

      Primary Objective:

        -  To evaluate the change in MSFC score with change in EDSS scores at end of 2 year
           follow-up period for subjects with MS in Argentina

      Secondary Objectives:

        -  To evaluate the cross-sectional correlations in MSFC score at baseline and at 24 months
           with EDSS score at baseline and at 24 months

        -  To describe the MSFC score for MS phenotype in this population

        -  To evaluate the predictive validity of MSFC score of a subsequent EDSS change in a
           subgroup of MS patients in Argentina
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with MS in 20 sites across Argentina
      
Keywords: Relapsing-remitting multiple sclerosis (RRMS); primary progressive multiple sclerosis (PPMS); secondary progressive multiple sclerosis (SPMS); Multiple Sclerosis Functional Composite (MSFC); Expanded Disability Status Scale (EDSS)
Meal Distribution Across the Day in Female Nurses Working Shifts
Condition: Shift Work Type Circadian Rhythm Sleep Disorder; Imbalance of Constituents of Food Intake
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Observational

Summary: 
      This study assessed the meal distribution across the day (energy and macronutrient intake)
      and its relationship to the nutritional status of nursing professionals.
    

Detailed description: 
      221 female nursing professionals from Brazilian University hospital were classified in three
      shifts: day shift (n=112), night shift (n=55), and day-night shift (n=54).

      Food intake assessment (3-day 24-hour recall); Anthropometric variables (weight, height,
      waist circumference and hip circumference); Sleep time on working days and day off.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Woman who were part of Nursing Staff of University Hospital, and agreed to participate in
        the study. Each volunteer provided a full, written informed consent.
      
Keywords: shift work; nutritional status; nursing professionals; meal distribution; food intake
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
Condition: Chronic HBV Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose
      phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B
      virus. This study aims to evaluate the safety, tolerability and pharmacokinetics of HH-003
      injection in treatment-naive participants chronically infected with hepatitis B virus.
    


Intervention name(s): HH-003 injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HH-003 injection is administrated via I.V. infusion; Placebo is administrated via I.V. infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Gathering information about metabolic syndrome from young patients who have
      survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.

      PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have
      survived acute lymphoblastic leukemia and in healthy sibling volunteers.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the prevalence of the metabolic syndrome (MS) and its component traits (i.e.,
           obesity, hypertension, dyslipidemia, and insulin resistance) in survivors of childhood
           acute lymphoblastic leukemia and in healthy sibling volunteers.

        -  Identify host- and treatment-related risk factors for MS.

      OUTLINE: This is a multicenter study.

      Patients' medical charts are reviewed and patients undergo anthropometric measuring (height
      and weight for BMI calculation and waist and hip circumferences) and blood pressure testing.
      Patients also complete questionnaires on their physical activity, diet, and family history
      over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin,
      interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin.

      Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are
      seen in the clinic). They also complete a baseline medical history and questionnaires on
      their physical activity and diet.
    

Intervention name(s): laboratory biomarker analysis; medical chart review; metabolic assessment; questionnaire administration; assessment of therapy complications
Intervention type(s): Other; Other; Other; Other; Procedure
Intervention description(s): will be obtained at a single clinic visit
Other intervention name(s): none noted; none noted; none noted; none noted; none noted
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A minimum target accrual at each institution is 25 subjects for each treatment modality and
        25 siblings, for a total of 75 study participants at VCH. An attempt will be made to
        approach equal numbers of male and female survivors.
      
Biospecimen description: 
      Banked DNA
    
Keywords: cancer survivor; healthy, no evidence of disease; long-term effects secondary to cancer therapy in children; childhood acute lymphoblastic leukemia in remission
Single Ascending Dose of GAP-134 as a 24-hour IV Infusion in Healthy Japanese Males
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial
      assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after
      administration of ascending single intravenous (IV) doses to healthy Japanese male subjects.
    

Detailed description: 
      Atrial Fibrillation (AF) is the most commonly occurring sustained arrhythmia in clinical
      practice. AF is a serious disorder associated with an increased risk of stroke, morbidity and
      mortality, and the number of patients is estimated to double within the next 4 decades. The
      currently available antiarrhythmic drugs have limited efficacy and are associated with
      serious side effects of which potentially lethal ventricular proarrhythmias are one of the
      major concerns. Thus, there is a large unmet clinical need for efficacious and safe
      antiarrhythmic drugs for the treatment of AF.

      The classical orientation of antiarrhythmic therapy has been to modulate cardiac ion channels
      (sodium, potassium or calcium) or the autonomic nervous system. However, numerous
      experimental and clinical studies have suggested that cardiac conduction slowing and impaired
      gap junction intercellular communication (GJIC) are important in the pathogenesis of cardiac
      arrhythmias, including AF. General conduction slowing or the presence of small islands of
      intra-atrial conduction block resulting from a decreased gap junction conductance, altered
      gap junction expression and heterogeneous spatial distribution of gap junctions may provide
      turning points for the multiple waves, and thereby promote re-entry of impulses. In
      recognition of this, several authors have proposed gap junction modulation as a potential new
      target in the treatment of AF. GAP-134 is an antiarrhythmic dipeptide that has demonstrated
      in vitro and in vivo efficacy in mouse and dog models of arrhythmia. GAP-134 has no apparent
      proarrhythmic activity or hemodynamic compromise and does not show any significant binding in
      a panel of >60 different receptors and ion channels. If determined to be safe and effective
      the indication sought for GAP-134 will be the prevention of post operative atrial
      fibrillation.
    

Intervention name(s): GAP-134
Intervention type(s): Drug
Intervention description(s): 24-Hour IV infusion, SAD
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Breath Analysis in Obstructive Sleep Apnoea
Condition: Obstructive Sleep Apnoea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Clinical trial in patients with obstructive sleep apnoea that are randomised to either
      continue or withdraw continuous positive airway pressure therapy to identify a
      disease-specific exhaled breath pattern by mass spectrometry.
    

Detailed description: 
      Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive
      airway pressure [CPAP]) including 30 OSA patients to define the effects of CPAP withdrawal
      (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for
      identification of OSA specific markers.
    

Intervention name(s): Placebo-CPAP device; CPAP
Intervention type(s): Device; Device
Intervention description(s): short-term CPAP withdrawal by the use of Placebo-CPAP; Patients continue therapeutic CPAP therapy
Other intervention name(s): subtherapeutic CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: OSA; CPAP; exhaled breath