bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two
      formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as
      3-dose primary vaccination during the first 6 months of life followed by a booster dose in
      the second year of life. To comply with the routine infant immunisation program, the licensed
      GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants
      with the pneumococcal study vaccines.
    

Detailed description: 
      The purpose of this study is to assess the immunogenicity of the two formulations of GSK
      Biologicals' pneumococcal vaccine 2830929A (11-valent vaccine or 11Pn vaccine) and 2830930A
      (12-valent vaccine or 12Pn vaccine), when administered as 3-dose primary vaccination during
      the first 6 months of life followed by a booster dose in the second year of life, when
      compared to immune responses to the licensed vaccines Synflorix™ and Prevnar 13™, and to
      assess the reactogenicity and safety of these two same investigational formulations when
      administered according to this schedule. To comply with the routine infant immunisation
      program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine will be
      co-administered in infants with the pneumococcal study vaccines.
    

Intervention name(s): Pneumococcal conjugate vaccine GSK2830929A; Pneumococcal conjugate vaccine GSK2830930A; Synflorix™; Prevnar 13™; Infanrix hexa™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Streptococcus pneumoniae; Haemophilus influenzae; Pneumococcal vaccine; Infants; Safety; Immunogenicity
Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents
Condition: Insulin Sensitivity; Insulin Tolerance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in
      adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance,
      triacylglycerol (TAG), and cholesterol concentrations.
    

Detailed description: 
      This counterbalanced study consisted of two trials including 1) high fructose (HF) trial and,
      2) a high glucose (HG) trial. Each trial was blind to the participant, performed in a random
      order, and was 15 d in length. During days 1-14 of each trial, the participants consumed
      either 710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g
      glucose) for 2-wk (HF trial) or 710 ml per day of a HG-sweetened beverage (sweetened with 50
      g glucose and 15 g fructose) for 2-wk (HG trial) on top of their normal diet. In addition,
      the participants were instructed to maintain their normal physical activity levels during
      each trial (which were measured with an accelerometer). On day 15 of each trial, the
      participants reported to the lab after a ~ 11 h overnight fast for metabolic testing. During
      this testing day, the participants remained in the lab for 12 h and consumed three liquid
      meals (one meal every 4 h and HF meals during HF trial and HG meals during HG trial), while
      blood samples were taken every 15 or 30 min throughout the 12 h testing day. During testing,
      the participants remained physically inactive (< 3,000 steps).
    

Intervention name(s): high fructose sweetened beverage; High Glucose sweetened beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 710 ml per day of a HF-sweetened beverage; HG-sweetened beverage
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sugar sweetened beverages; metabolism; endocrine; lipids; blood glucose
The Effects of Synaquell on Brain Function
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for
      effects on brain function.
    

Detailed description: 
      Ice Hockey players will be administered Synaquell over the course of one season. Each player
      will be administered Synaquell or a placebo twice, daily. They will be tested during the
      preseason and the postseason to compare changes in cognitive measures. This is an optimal
      population, as Synaquell was designed for contact sport athletes and others sustaining
      frequent head impacts.
    

Intervention name(s): Synaquell; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7.9 grams of Synaquell are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).; 7.9 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Ice Hockey; Cognitive Function; Cognition; Brain; Supplement; Contact Sport Athletes
Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)
Condition: Human Papilloma Virus Infection
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Interventional

Summary: 
      This study is a cross-sectional study to evaluate accuracy of high-risk DNA-HPV testing using
      HPV Diagnostic Kit (Bio Farma) compared to Standard Kit (COBAS® 6800 HPV from Roche Molecular
      Systems) RT-PCR based in urine and cervical swab specimens.
    


Intervention name(s): HPV Diagnostic Kit (Bio Farma)
Intervention type(s): Diagnostic Test
Intervention description(s): Urine samples (30 ml): collected from each subjects using urine pot. Cervical swab: collected from each subject using cyto brush and stored in special container which preservatives fluid.
Other intervention name(s): COBAS 6800 HPV from Roche Molecular Systems
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study intends to investigate the use of fractional doses of sanofi pasteur's
      IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the
      non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full
      doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio
      types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14
      weeks of age.
    


Intervention name(s): Inactivated Poliomyelitis vaccine (IMOVAX); Inactivated Poliomyelitis vaccine (IMOVAX)
Intervention type(s): Biological; Biological
Intervention description(s): Fractional dose (1/5th) 0.1 mL, intradermally; A full dose, 0.5 mL, intramuscular
Other intervention name(s): IMOVAX Polio (IPV) vaccine; IMOVAX Polio (IPV) vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Poliomyelitis; intradermal
Vortioxetine in Patients With Depression and Early Dementia
Condition: Major Depressive Disorder; Dementia
MeSH terms: Dementia; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients
      with depression and early dementia
    


Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Vortioxetine 5, 10 and 20 mg/day, tablets, orally Patients will receive 5 mg vortioxetine once daily for one week. At visit 3, the dose will be increased to 10 mg/day for all patients. Thereafter the dose may be adjusted to 5, 10 or 20 mg/day.
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells and shrink
      tumors so they can be removed during surgery.

      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery
      in treating women who have locally advanced, inflammatory, or large surgically removable
      breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and
      epirubicin in women with locally advanced or inflammatory or large operable breast cancer.
      II. Determine the maximum tolerated dose of this regimen in this patient population.

      OUTLINE: This is a multicenter dose escalation study of capecitabine. Patients receive
      neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily
      on days 1-14. Treatment continues every 21 days for a maximum of 6 courses in the absence of
      disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
      doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is
      defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
      limiting toxicity.

      PROJECTED ACCRUAL: A total of 3-33 patients will be accrued for this study.
    

Intervention name(s): capecitabine; cyclophosphamide; epirubicin hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Capecitabine; Epirubicin
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; inflammatory breast cancer
Characterization of Cleft Lip and Palate Conditions in Guatemala
Condition: Cleft Lip; Cleft Palate; Cleft Lip and Palate
MeSH terms: Cleft Palate; Cleft Lip
Study type: Observational

Summary: 
      The purpose of this study is to compare types of and risk factors for cleft lip and palate in
      a Guatemalan population to a United States population.
    

Detailed description: 
      Demographic, surgical, and cleft type data from US patients were gathered via chart review of
      the electronic medical record. Data from Guatemalan patients was gathered orally from patient
      caregivers in their native language. Consent was also given orally in the caregivers native
      language. All data was de-identified prior to analysis.
    

Intervention name(s): NA - survey instrument
Intervention type(s): Other
Intervention description(s): Survey instrument was administered verbally to parents of the Guatemalan cohort.
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children with isolated cleft lip and/or palate scheduled for cleft-related surgery at
        either the Children's Hospital of Philadelphia or Smiles for Guatemala during the
        previously described time frames
Dose, Safety, and Pathogenicity of a New Influenza H1N1 Challenge Strain
Condition: Influenza A H1N1
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      A total of up to 90 participants may be given H1N1 influenza challenge virus.

      In Part A, 40 participants will be randomly allocated to one of two groups to be given one of
      two virus doses (Virus Dose 1 or Virus Dose 2).

      Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose
      2, or another virus dose (e.g., Virus Dose 3)
    

Detailed description: 
      Influenza viruses are associated with significant human disease and cause annual epidemics
      during autumn and winter. Although most people recover within 1 to 2 weeks without requiring
      medical attention, seasonal influenza yearly results in approximately 3 to 5 million cases of
      severe illness and up to 500,000 deaths worldwide, particularly among the very young,
      elderly, and chronically ill.

      The H1N1 virus used for the challenge virus originated from a cell-culture derived candidate
      vaccine virus (ccCVV), provided by the Centers for Disease Control an Prevention (CDC) in the
      USA.

      In Part A, 40 participants will be randomly allocated to one of two groups to be given one of
      two virus doses (Virus Dose 1 or Virus Dose 2).

      Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose
      2, or another virus dose (e.g., Virus Dose 3)
    

Intervention name(s): Infectious Titre 1; Infectious Titre 2; Infectious Titre 3; Infectious Titre 4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Approximately 10^5.5 TCID50/mL (titre may be adjusted based on stock titre); Approximately 10^4.5 TCID50/mL (titre may be adjusted based on stock titre); To be determined (TBD), depending on outcome of Part A; TBD, depending on outcome of Part A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Influenza; Human Challenge Trial; H1N1; Flu
Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and immune response of
      different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with
      gemcitabine and to determine the recommended phase II dose.
    

Detailed description: 
      Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor
      angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2
      expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in
      vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have
      HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved
      against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore
      synergistic effect between vaccine therapy and chemotherapy will be expected. In this
      clinical trial, we evaluate the safety, tolerability and immune response of different doses
      of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to
      determine the recommended phase II dose of peptide.
    

Intervention name(s): VEGFR2-169 and gemcitabine
Intervention type(s): Biological
Intervention description(s): Escalating doses of VEGFR2-169 will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles(doses of 0.5,1.0,2.0mg/body are planned). Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days 1,8 and 15. Repeated cycles of VEGFR2-169 and gemcitabine will be administered until patients develop progressive disease or unacceptable toxicity,or for maximum 2 cycles, whichever occurs first.
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
Condition: Dengue Virus
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses can cause dengue fever and other serious health conditions, primarily
      affecting people living in tropical regions of the world. There are four types of dengue
      virus, and infection with one does not offer protection against the others. This study will
      test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes
      a response in people's immune system and is safe.
    

Detailed description: 
      The dengue virus causes approximately 50 million cases of dengue fever and 1.5 million cases
      of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS)
      every year. There are four subtypes of the virus, and infection with one offers no protection
      from infection by the others. In fact, most cases of DHS and DSS occur in people infected by
      more than one subtype. In areas of the world where multiple subtypes of dengue are common,
      vaccines must be developed against each of the subtypes of dengue virus. This study will
      examine the safety and immune response of an investigational vaccine for preventing infection
      with DEN1.

      Participation in this study will last about 6 weeks. Participants will be randomly assigned
      to be injected with either the investigational study vaccine or a placebo. Participants will
      have a five in six chance of receiving the vaccine. The first study visit will take place on
      the vaccination day, on which participants will undergo a physical examination, blood draw,
      and pregnancy test, and then receive the vaccine. Participants will be given a thermometer
      and temperature card, and be told to record their temperature three times per day for 16 days
      after vaccination. Participants will come to follow-up visits every other day for the 16 days
      after vaccination, and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42).
      Assessments completed during these visits will include a questionnaire about how the
      participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical
      exam. Blood drawn will be analyzed to check participants' health, determine the amount of
      vaccine and antibodies in the blood, test markers in white blood cells and genes, and look
      for proteins that are important for fighting dengue infection.
    

Intervention name(s): Investigational Vaccine for DEN1; Placebo injection
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU); Subcutaneous injection of placebo
Other intervention name(s): rDEN1∆30 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Dengue Hemorrhagic Fever
A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of
      implementing the provisional design of the full scale TOM trial (e.g., the six month
      treatment period, the impact of the smoking cessation intervention).

      There is no active hypothesis for the Vanguard Protocol.
    

Detailed description: 
      The protocol is a small scale pilot of the full-scale TOM trial, and it will utilize a
      placebo design and incorporates 4 treatment arms. In the Vanguard Protocol all participants
      are to complete a 4 week run-in with Advair 100/50, followed by randomization to 1 of 4 arms
      of study treatment. The 4 drug treatment combinations are (2 inhalers, 2 pills):

        -  Advair 250/50, Placebo, Placebo, Placebo

        -  Advair 100/50 and montelukast, Placebo, Placebo

        -  Advair 100/50 and theophylline, Placebo, Placebo

        -  Advair 100/50 and ipratropium, Placebo, Placebo The 24 week treatment phase will be
           followed by a 4 week washout period on Advair 100/50. There is no crossover.
    

Intervention name(s): Fluticasone 250 mg/salmeterol 50 mg; Montelukast 10mg; Theophylline 400 mg; ipratropium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo; Participants will be assigned to montelukast once a day for 24 weeks.; Participants will be assigned to theophylline once a day for 24 weeks; Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
Other intervention name(s): Advair(fluticasone/salmeterol)250/50; Singulair; Atrovent
Intervention MeSH terms: Fluticasone; Xhance; Theophylline; Salmeterol Xinafoate; Ipratropium; Fluticasone-Salmeterol Drug Combination; Montelukast
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma,smokers