bioihbjkbjnl/mcl2 huggingface dataset:
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
Condition: Iron Deficiency; Anemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify
      rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the
      food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance
      the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP
      need to be investigated. The primary objectives of the present study are: 1) to test whether
      the presence of citrate in iron fortified rice with FePP results in higher iron
      bioavailability, and 2) to test whether the presence of citrate in the rice grain during the
      extrusion and cooking process results in higher iron bioavailability compared with
      iron-fortified rice where citrate has been added shortly before consumption. As a secondary
      objective the investigators will compare the absorption from different FePP combinations with
      a reference meal fortified with ferrous sulphate. The investigator hypothesize that the
      addition of citrate enhances iron absorption and that the positive effect is greater when the
      citrate is added during the extrusion.

      The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to
      evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2)
      regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate
      added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at
      the time of consumption. Iron absorption will be measured as erythrocyte incorporation of
      stable iron isotopes at least 14 days after the administration of the isotopically labelled
      test meals. The iron absorption from the different meals within the same participant will be
      compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.

      The present study will provide important data where iron bioavailability from rice is
      accurately and directly measured using stable isotopic labels as absorption tracers. This
      direct data can be used to base decisions on the level of fortification, can potentially
      reduce costs and optimize iron delivery to the targeted population in iron fortification
      programs.
    


Intervention name(s): Administration of rice fortified with regular FePP; Administration of rice fortified with regular FePP with citrate added during extrusion; Administration of rice fortified with regular FePP and citrate added at consumption; Administration of rice fortified with ferrous sulphate
Intervention type(s): Other; Other; Other; Other
Intervention MeSH terms: Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy and safety of an investigational compound (MK0966) for the
      prevention of prostate cancer.
    

Detailed description: 
      The duration of treatment is 6 years.
    

Intervention name(s): rofecoxib; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Other intervention name(s): MK0966
Intervention MeSH terms: Rofecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone
      Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the
      Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to
      < 9 years of age.

      Objective:

        -  To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine,
           administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in
           children 6 months to < 9 years of age.

      Observational objectives:

        -  To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent
           vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP
           recommendations, in children 6 months to < 9 years of age.

        -  To submit available sera from each subject to Center for Biologics Evaluation and
           Research (CBER) for further analysis by the WHO, the Centers for Disease Control and
           Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation
           recommendations for subsequent influenza vaccines.
    

Detailed description: 
      Participants will be assigned to the appropriate age group based on the age at the time of
      enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom
      2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose
      during Visit 2 (28 days after Visit 1).

      Solicited adverse event (AE) information will be collected for 7 days after each vaccination,
      unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those
      subjects receiving 2 doses. Serious adverse event (SAE) information will be collected the
      study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day
      28 after the final vaccination.
    

Intervention name(s): Fluzone® Quadrivalent Influenza Vaccine, No Preservative; Fluzone® Quadrivalent Influenza Vaccine, No Preservative
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation); 0.5 mL, Intramuscular (2014-2015 formulation)
Other intervention name(s): Fluzone® Quadrivalent, No Preservative; Fluzone® Quadrivalent, No Preservative
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza virus vaccine; Quadrivalent Influenza Virus Vaccine (No Preservative); Fluzone®
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
Condition: Hepatitis B; Polio; Diphtheria; Pertussis; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Whooping Cough; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to provide immunogenicity and safety data of the investigational
      hexavalent vaccine when it is given concomitantly (the same day at separate injection sites)
      with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB
      vaccine at birth.

      Primary Objective:

      To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune
      response that is at least as good as the response following Infanrix™-Hexa in terms of
      seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6
      months), when co-administered with Prevnar®

      Secondary Objectives:

      Immunogenicity:

      To describe in each group the immunogenicity parameters to each vaccine component (for
      DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.

      Safety:

      To describe the overall safety after each injection.
    


Intervention name(s): DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines; DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): Prevnar®; Infanrix™-Hexa; Prevnar®
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatitis B; Polio; Diphtheria; Pertussis; H. influenzae type b
Clinical Evidence of pH Dependent ß2 Adrenergic Transport Mechanisms in the Airway
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study was to determine if airway pH has an effect on albuterol-induced
      vasodilation in the airway. Methods: Ten healthy volunteers performed the following
      respiratory maneuvers: quiet breathing, hypocapnic hyperventilation, hypercapnic
      hyperventilation, and eucapnic hyperventilation
    

Detailed description: 
      The lungs provide a unique absorptive surface for drug delivery. Many inhaled drugs are
      rapidly absorbed into the airway because of their lipophilic chemical characteristics.
      However, the majority of the currently used β2-adrenergic bronchodilators cannot freely
      diffuse across the epithelial cell membrane because of their transient or permanent positive
      charge at physiological pH. Inhaled albuterol, a β2-adrenergic agonist used widely for the
      treatment of obstructive airway disease, is charged positively in neutral or acidic
      conditions and thus requires active transport across the airway epithelium. Previous studies
      in the lab have shown that albuterol uptake into airway epithelia occurs via a pH sensitive
      cation transporter (OCTN2). The vasodilator response to an inhaled β2-adrenergic agonist
      could be an expression of epithelial cation transport. The investigators propose that the
      magnitude and duration of vasodilation in the airway caused by an inhaled hydrophilic
      β2-adrenergic agonist such as albuterol may be altered by changes in airway pH. The purpose
      of this protocol is to determine the effect of ASL pH on the response of Qaw to inhaled
      albuterol by manipulating airway pH through ventilatory maneuvers in health subjects:
      hyperventilation to raise pH and ventilation with CO2 bleed-in to lower pH.
    

Intervention name(s): quiet breathing; Hypocapnic Hyperventilation; Hypercapnic Hyperventilation; eucapnic hyperventilation
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Subjects were instructed to breath normally at room air.; hypocapnic hyperventilation, the subjects were instructed to breathe fast and deep until their end-tidal pCO2 fell to 30 mmHg, corresponding to a systemic pH increase of about 0.1 pH units.; For hypercapnic hyperventilation, a modification of a previously described procedure (15). While monitoring SaO2 using pulse oximetry and end-tidal CO2 by mass-spectrometry on a breath by breath basis, CO2 was bled into the inspired air to achieve an end-tidal pCO2 of at least 55 mmHg; For eucapnic hyperventilation, the subjects were instructed to increase their ventilation to the highest level of ventilation recorded in the previous two hyperventilation maneuvers, while CO2 was bled into the inspired air to maintain end-tidal pCO2 at 40 mmHg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: airway blood flow; albuterol; acidosis; alkalosis
Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      Severe trauma induces massive metabolic changes that are characterized by hypermetabolism
      with increased energy expenditure and catabolism. Early enteral and, if necessary, parenteral
      feeding is a major focus of modern intensive care medicine.

      After acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of
      muscle mass in the area below the level of injury. This dramatic muscle atrophy again leads
      to a decrease in energy expenditure. Whereas other survivors of severe trauma typically
      regain muscle mass during rehabilitation, spinal cord injury patients typically continue to
      lose muscle mass over time, which also leads to changes in body composition. The time course
      of these changes is not known. Continuing nutrition without adaption to the reduced energy
      expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury
      patients to the known unfavorable metabolic consequences. Knowledge of the time course of
      these changes would help to provide adequate caloric intake to the patients and improve our
      ability for nutrition counseling.

      The investigators plan a prospective clinical trial in 25 acute spinal cord injury patients
      to determine the changes in energy expenditure and body composition. Major inclusion criteria
      are acute traumatic spinal cord injury, age 18-70, neurological level above L1, AIS (American
      Spinal Injury Association Impairment Scale) A, B or C.

      Measurements of energy expenditure, body composition and nutritional markers in venous blood
      are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of rehabilitation
      (at the latest after 26 weeks).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of a spinal cord injury rehabilitation centre
      
Biospecimen description: 
      whole blood
    
Keywords: Spinal Cord Injury
Safety of Intravenous Thrombolysis for Wake-up Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV
      t-PA) in ischemic stroke patients who present to the emergency department (ED) after
      awakening with the symptoms of suspected ischemic stroke.
    

Detailed description: 
      This is an open label, multi-center, safety study of acute treatment with IV alteplase in
      ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study
      is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of
      treatment with IV t-PA. Clinical improvement defined as a decrease in the National Institutes
      of Health Stroke Scale (NIHSS) score at 24 hours, 3 days and 90 days and modified Rankin
      Scale (mRS) score at 3 and 90 days. For patients that have computed tomographic angiogram
      (CTA) and computed tomographic perfusion (CTP), the incidence of large vessel occlusion will
      be quantified.
    

Intervention name(s): Alteplase (iv t-PA)
Intervention type(s): Drug
Intervention description(s): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.
Other intervention name(s): Activase®; Alteplase; tissue plasminogen activator; t-PA
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wake-Up Stroke; Ischemic stroke; ischemic stroke patients who wake-up with their symptoms
Examining the Efficacy of Orbitofrontal Cortex rTMS for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This trial will compare the efficacy of active inhibitory OFC-rTMS to sham OFC-rTMS in major
      depression. The trial will include structural and functional MRI, EEG, and behavioral
      measures obtained before, during, and after treatment.
    


Intervention name(s): Continuous theta-burst stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Preserving Function Among Disability Applicants
Condition: Disability
Study type: Interventional
Phase: Phase 1

Summary: 
      To test the hypothesis that veterans counseled around managing their benefits will work more
      and have a better quality of life than those receiving non-specific counseling.
    

Detailed description: 
      The aim is to develop and test the efficacy of Benefits Counseling to improve quality of life
      among veterans who apply for VA benefits. Benefits Counseling involves providing claimants
      information about rehabilitation and work-related activities, benefits determination and
      management, and available substance abuse treatment . Benefits Counseling is designed to
      increase motivation to be active and promote engagement in substance abuse treatment. After
      enrolling 15 participants in an open-label pilot phase, 300 veterans who are not receiving
      benefits and are applying to VBA for disability benefits will be randomly assigned to
      Benefits Counseling or the control condition, VA Orientation, and both groups will be
      followed for one year.

      The primary outcome measures will be observer-rated and self-rated quality of life. Secondary
      outcome measures will include substance use and treatment utilization.
    

Intervention name(s): Benefits Counseling; VA Orientation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Help deciding whether to work; Orientation to services available at VA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: disability; substance abuse; vocational rehabilitation; case management
CSD170302: Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes
Condition: Smoking
Study type: Interventional

Summary: 
      To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four
      different marketed electronic cigarettes. Furthermore, to measure overall product liking by
      subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in
      the future.
    

Detailed description: 
      This will be a single-center, randomized, open-label, parallel study during which up to 140
      healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled.
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The
      study will involve the use of four (4) marketed EC products in tobacco consumers who are
      exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,
      intermittent EC users).
    

Intervention name(s): FT21018; FT21033; FT21034; FT21035
Intervention type(s): Other; Other; Other; Other
Intervention description(s): An electronic cigarette; An electronic cigarette; An electronic cigarette; An electronic cigarette
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose of the study is to determine if Cimzia is safe and effective in subjects who have
      received previous treatment with a TNF-alpha inhibitor other than Cimzia.
    

Detailed description: 
      This is a Phase IV, randomized, multi-center, double-blind, parallel-group 12-week study of
      Cimzia with concomitant methotrexate (MTX) or other DMARD compared to MTX or other DMARD
      alone in patients with an inadequate secondary therapeutic response to a TNF-alpha inhibitor
      as defined above and active rheumatoid arthritis (RA) followed by a 12-week open-label phase
      with concomitant MTX or other DMARD and Cimzia.

      Subjects must washout from the previous TNF inhibitor for at least 4 weeks prior to the
      baseline visit. Subjects unable to tolerate MTX must have been on a stable dose of another
      non-biologic DMARD for at least 3 months. Subjects' diagnosis of RA must be based on the 1987
      Revised American Rheumatism Association Criteria for the Classification of Rheumatoid
      Arthritis.

      Subjects will be screened for eligibility and, up to 28 days later, at the baseline visit,
      randomized to one of two treatment groups (2:1): Cimzia or placebo (in addition to
      concomitant MTX or other DMARD). All subjects will continue MTX/other DMARD at the same dose
      utilized prior to study entry.

      After the Week 12 study visit, all subjects will have the opportunity to continue in the
      study on open-label Cimzia treatment (using an induction regimen for all subjects, regardless
      of their treatment in the blinded phase).
    

Intervention name(s): Cimzia; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): prefilled 200mg Cimzia syringe SC q 2 weeks; prefilled saline syringe
Other intervention name(s): 1 ml liquid product containing 200mg of Certolizumab Pegol; 1 ml Sodium Cloride 0.9%
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; anti-TNF therapy