bioihbjkbjnl/mcl2 huggingface dataset:
Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
Condition: Breast Cancer; Estrogen Receptor; Her-2; Pgr
MeSH terms: Breast Neoplasms; Recurrence
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer. It may also help doctors predict whether cancer will come back after treatment.

      PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women
      with breast cancer treated with chemotherapy.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the prognostic utility of the Oncotype DX™ 21 gene profile for risk of relapse in
           women with node positive or high-risk node negative breast cancer.

        -  Identify individual genes whose RNA expression is associated with an increased risk of
           relapse in these patients.

        -  Perform an exploratory analysis of individual genes whose RNA expression is associated
           with an increased risk of relapse differentially in patients previously treated with
           docetaxel.

      OUTLINE: This is a multicenter study.

      Tissue samples are examined for association of RNA expression and clinical factors (e.g.,
      tumor size, nodal status, hormone receptor status, age, menopause status), as well as
      estrogen receptor, progesterone receptor, and HER-2/neu expression by immunohistochemistry
      and other studies.

      PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.
    

Intervention name(s): microarray analysis; protein expression analysis; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other; Other
Keywords: estrogen receptor; HER-2; PgR; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer
Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the proportion of patients who demonstrate no
      medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple
      sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based
      on real-world data.
    


Intervention name(s): Rebif; Tecfidera
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dimethyl Fumarate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data
        available from clinical chart review.
ATS-1 Needle Free Injection Device Study-a Device for Administering r-hGH (Saizen) to Treat Growth Hormone Deficiency
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a Phase I, open label, randomized, 2-period, 2-sequence, crossover study
      designed to assess the relative bioavailability of Saizen administered by the ATS-1
      needle-free injection device and a standard needle and syringe. Informed consent was obtained
      prior to screening. All screening assessments establishing subject eligibility were performed
      in the 21 days before dosing. Randomization Pre-dose on Day 1, subjects were randomized to
      one of the two treatment sequences: Sequence 1: SC Saizen administered by the Standard needle
      and syringe (Period 1) followed by the administration using the ATS-1 device (Period 2).
      Sequence 2: SC Saizen administered by the ATS-1 device (Period 1) followed by administration
      using the standard needle and syringe (Period 2).

      Subjects were resident at the Unit from approximately 19:00 on Day -1 until Day 2
      (approximately 30 hours (h) post dose) of each treatment period. An IV Stilamin infusion was
      commenced 1 h before. Saizen administration and stopped immediately after the last
      pharmacokinetic (PK) blood sample has been taken, i.e. a 25 h infusion. Stilamin was
      administered as a constant IV infusion at a rate of approximately 118 mg/h (40 mL/h), which
      corresponds to 1.65 mg/kg body weight/h for a person weighing 70kg. Dosing with Saizen
      occurred between approximately 0800 and 0900 h on Day 1 of each treatment period after an
      overnight fast of at least 10h. Subjects were dosed with Saizen at the same time on Day 1 in
      Periods 1 and 2. There was a minimum of 7-day washout between treatment periods 1 and 2.

      Laboratory safety tests, ECGs were taken at protocol specified time points and blood samples
      for the assessment of glucose and growth hormone were taken immediately predose and 1, 2, 3,
      4 4.5, 5, 5.5, 6, 7, 8, 12, 18 and 24 h post dose. A post-study visit took place 33+/- 3 days
      after dosing a treatment period 2.
    


Intervention name(s): ATS-1 needle free device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bio-equivalence study in healthy volunteers, indication; of product is growth hormone deficiency
A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317
Condition: Chikungunya Virus
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this multi-center, randomized, double blind, placebo controlled study is to
      evaluate the safety and immunogenicity of PXVX0317 in healthy adult and adolescent subjects.
    

Detailed description: 
      Coprimary Objectives:

        1. To evaluate the safety of PXVX0317 in healthy adult and adolescent participants 12 to
           <65 years of age.

        2. To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and
           placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant
           difference in seroresponse rate.

        3. To demonstrate the consistency of the anti-CHIKV SNA response across three lots of
           PXVX0317 at Day 22.

      Secondary Objectives:

        1. To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15, Day 183, and
           Day 8 as measured by GMT and seroresponse rate.

        2. To compare the GMT fold increase in anti-CHIKV SNA response and number and percentage of
           participants with an anti-CHIKV SNA titer >=15 and 4-fold rise over baseline, both at
           Day 8, 15, 22, and 183.
    

Intervention name(s): CHIKV VLP/adjuvant; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%; Placebo is comprised of formulation buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized in a 2:2:2:1 ratio within each age stratum (12 to <18, 18 to <46, and 46 to <65). This study will be conducted in the US, using up to 50 sites.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Chikungunya; VLP; PXVX0317; vaccine; immunogenicity
Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to identify the influence of resistance and aerobic exercise
      with different nutritional supplements in middle-aged men and women on various physiological
      measures. Throughout the study, the investigators examine body composition, body weight, food
      intake, fitness level, metabolism, and blood hormones.
    


Intervention name(s): Whey protein supplementation with exercise; Non protein supplementation with exercise (control)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Whey protein supplementation with resistance and aerobic exercise.; Non protein supplementation with resistance and aerobic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Measuring markers of metabolic syndrome in overweight and obese adults.
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
Condition: Staphylococcal Sepsis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety (including tolerability),
      pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a
      3-dose regimen on Study Days 0, 7, and 14.
    

Detailed description: 
      This Phase II study will be a randomized, double blind, placebo controlled study of BSYX-A110
      in very low birth weight neonates. A total of 80 infants will be dosed in this study.
      Participants will receive either BSYX-A110 or placebo, at 60 mg/kg or 90 mg/kg. The Study
      Drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days
      after the initial dose for all dose groups.
    

Intervention name(s): Pagibaximab (formerly BSYX-A110)
Intervention type(s): Drug
Intervention description(s): Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
Other intervention name(s): BSYX-A110; HU96-110; Pagibaximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Staphylococcal; Monoclonal antibodies; Very Low Birth Weight Infants; Prophylaxis
Soybean Oil Trial of cArdiovascular Risk
Condition: Cardiovascular Disease; Diabetes; Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study will determine the effects of different types of soybean oils on biomarkers of risk
      for cardiovascular disease and diabetes. There will be four 4-week diet periods in which
      participants will consume the following oils, within the context of a controlled diet:
      soybean oil, high-oleic soybean oil, blend of high oleic soybean oil & fully hydrogenated
      soybean oil, and blend of palm olein & palm stearin.
    


Intervention name(s): Soybean oil; High-oleic soybean oil; High-oleic soybean oil + fully hydrogenated soybean oil; Palm olein + palm stearin
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will be fed soybean oil as part of a controlled (typical American) diet.; Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.; Participants will be fed a blend of high-oleic soybean oil and fully hydrogenated soybean oil as part of a controlled (typical American) diet.; Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention
Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Testosterone replacement treatment is the most effective way of treating hypogonadism in men.
      Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this
      study will evaluate the efficacy and safety of this product.
    


Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of the following index inhibitors or
      inducers of CYP2C8 and/or CYP3A on the single-dose pharmacokinetics (PK) of ozanimod and its
      major active metabolite, CC112273, in healthy adult subjects: gemfibrozil (strong inhibitor
      of CYP2C8), rifampin (moderate inducer of CYP2C8 and strong inducer of CYP3A), and
      itraconazole (strong inhibitor of CYP3A).

      Study Design

      This is a Phase 1, randomized, parallel-group, open-label study with two parts, 1 and 2.
      Forty subjects will be enrolled in Part 1 and will be randomized into 1 of the 2 treatment
      groups, with 20 subjects in each treatment group. Sixty subjects will be enrolled in Part 2
      and will be randomized into 1 of the 3 treatment groups, with 20 subjects in each treatment
      group. . Study parts and treatment groups are as follow:

      Part 1:

        -  Treatment Group A (reference): A single dose of ozanimod.

        -  Treatment Group B (test): Gemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On
           Day 4, a single dose of ozanimod will be coadministered with the morning dose of
           gemfibrozil.

      Part 2:

        -  Treatment Group C (reference): A single dose of ozanimod.

        -  Treatment Group D (test): Itraconazole 200 mg once daily (QD) on Days 1 through 17. On
           Day 4, a single dose of ozanimod will be coadministered with itraconazole.

        -  Treatment Group E (test): Rifampin 600 mg QD on Days 1 through 21. On Day 8, a single
           dose of ozanimod will be coadministered with rifampin.

      Study Population Subjects will be healthy men and non-pregnant, non-lactating women, ages 18
      to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg); body mass index
      (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive.

      Length of Study The study duration ranges from 43 days to 50 days.
    


Intervention name(s): Ozanimod; Gemfibrozil; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ozanimod; Gemfibrozil; Itraconazole; Rifampin
Intervention MeSH terms: Itraconazole; Rifampin; Gemfibrozil; Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteer; Cytochrome P450 (CYP); ozanimod
Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults.
Condition: Colorectal Cancer; Colorectal Carcinoma; Colon Cleansing
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium
      picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing
      prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen.
      Approximately 484 patients will be randomised with the aim of achieving a minimum of 220
      patients in each of the 2 groups.
    


Intervention name(s): NER1006, Day Before-Only Dosing; SP+MS, Day Before-Only Dosing
Intervention type(s): Drug; Drug
Intervention description(s): The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose.; The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Effect of Vagus Stimulation on Peripheral Glucose Metabolism
Condition: Insulin Resistance; Glucose Intolerance
MeSH terms: Insulin Resistance; Glucose Intolerance
Study type: Interventional

Summary: 
      Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin
      resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells.
      Postprandial factors (such as insulin) are perceived by the human brain and induce signals
      that regulate glucose metabolism via the parasympathetic nervous system.

      Transcutaneous auricular vagus nerve stimulation (tVNS) can be used on the outer ear to
      stimulate the auricular branch of the vagus nerve in humans. Heart rate variability (HRV) in
      healthy people can be significantly increased via tVNS, indicating a shift from sympathetic
      activity to parasympathetic activity.

      The hypothesis is that this postprandial shift results in a change in peripheral glucose
      metabolism. In turn, the increased parasympathetic activity could potentially result in a
      change in postprandial insulin sensitivity or secretion.

      To test this hypothesis, this study investigates the effect of vagal stimulation versus sham
      stimulation on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy
      expenditure, and on parasympathetic tone (analysis of heart rate variability).
    


Intervention name(s): Transauricular vagus nerve stimulation; Transauricular sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Stimulation will be performed for 150 minutes (throughout the entire OGTT).; Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan
Condition: Malnutrition; Diarrhea; Pneumonia; Growth
MeSH terms: Pneumonia; Malnutrition; Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Information on the mechanisms of zinc is still in developing phase. Ecological and biological
      implications of long term zinc supplementation at population level requires assessment. The
      trial aims to assess the impact of routine supplementation of zinc among young growing
      children and evaluate its impact on intestinal microbial flora and relationship with gut
      mucosa integrity and co-morbidities.
    

Detailed description: 
      WHO has recommended the use of zinc for the treatment of acute diarrhea. Literature supports
      up-scaling of zinc supplementation programs to prevent childhood illnesses, such as diarrhea
      and respiratory infections, and its subsequent co-morbid conditions. As the potential
      mechanisms of action of zinc still remains to be established, this trial is proposed to
      evaluate the relationship of intestinal microbial flora, intestinal permeability, morbidity
      patterns and response to various enteric pathogens in a representative birth cohort randomly
      allocated to receive daily zinc and micronutrients from 6-18 months of age, and a control
      population.
    

Intervention name(s): Micronutrient Supplementation without Zinc; Micronutrient Supplementation with Zinc; Nutritional Counselling and Education
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid; This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate.; This will contain Nutritional Counselling and Education.
Intervention MeSH terms: Zinc; Trace Elements; Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malnutrition; Diarrhea; Pneumonia; Growth; Zinc Supplements; Microbiome
Atraumatic Restorative Treatment Sealants in First Permanent Molars
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this bi-center study was to evaluate the retention and caries-preventive effect of
      Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus
      non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is
      no difference in the retention rates of the two GIC, as well as in caries prevention between
      sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old
      schoolchildren were selected in two cities in Brazil. They were randomly divided into two
      groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first
      permanent molars included in the research and two molars were sealed with a GIC, while the
      other two molars remained unsealed. Clinical evaluations were performed up to 36 months by
      one independent examiner at each city.
    


Intervention name(s): Glass ionomer sealant; Non-sealant (toothbrushing)
Intervention type(s): Procedure; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Split-mouth design
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Dentition, Permanent; Glass Ionomer Cements