bioihbjkbjnl/mcl2 huggingface dataset:
Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Condition: Malignant Brain Tumors
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for adults with primary malignant brain tumors that have not
      responded to standard therapy provide very limited benefit to the patient. The anti-cancer
      properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of
      adults with primary malignant brain tumors that have not responded to standard therapy.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with primary malignant brain tumors that have not
      responded to standard therapy.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in patients with primary malignant
           brain tumors that have not responded to standard therapy, as measured by an objective
           response to therapy (complete response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in patients with a
           primary malignant brain tumor.

      OVERVIEW: This is a single arm, open-label study in which adults with malignant brain tumors
      that have not responded to standard therapy receive gradually escalating doses of intravenous
      Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
      Treatment continues for at least 12 months in the absence of disease progression or
      unacceptable toxicity. After 12 months, patients with a complete or partial response or with
      stable disease may continue treatment.

      To determine objective response, tumor size is measured utilizing MRI scans, which are
      performed every 8 weeks for the first two years, every 3 months for the third and fourth
      years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult glioblastoma multiforme; adult anaplastic astrocytoma; adult anaplastic astrocytoma/Mixed
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
Condition: Menopause; Nutritional Intervention; Bone Diseases
MeSH terms: Bone Diseases
Study type: Interventional

Summary: 
      This is a 8-week, double-blinded, placebo-controlled, randomized intervention trial to
      investigate the effects of Mg and Zn supplementation on antioxidant status and bone hormonal
      parameters. Participants were randomly assigned to one of three treatment groups: Placebo
      group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg (MgG: 27 women); Zinc Group - 50
      mg/day of Zn (ZnG: 26 women).
    

Detailed description: 
      Seventy-eight healthy postmenopausal volunteers aged between 44 and 76 were recruited once
      had been informed about the protocol. This is a 8-week, double-blinded, placebo-controlled,
      randomized intervention trial to investigate the effects of Mg and Zn supplementation on
      antioxidant status and bone hormonal parameters. Participants were randomly assigned to one
      of three treatment groups: Placebo group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg
      (MgG: 27 women); Zinc Group - 50 mg/day of Zn (ZnG: 26 women).
    

Intervention name(s): Placebo Comparator; Zinc Supplement; Magnesium supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration of 1 daily capsule containing lactose; Oral administration of 1 daily capsule containing 50 mg/day of Zn; Oral administration of 1 daily capsule containing 500 mg/day of Magnesium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopuase; Zinc; Magnesium; Antioxidant; Bone loss; Nutritional intervention
Cytokine Removal by CRRT in Pediatric Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      This pilot study will compare the effect of diffusive versus convective Continuous Renal
      Replacement Therapy (CRRT) in children with sepsis who require CRRT.

      The hypothesis for the study is that convective forms of CRRT provide enhanced clearance of
      cytokines and improved clinical responses as compared to a diffusive CRRT modality.
    

Detailed description: 
      The purpose of this study is to test the hypothesis that convective forms of Continuous Renal
      Replacement Therapy (CRRT) provides enhanced clearance of cytokines compared to a diffusive
      CRRT modality. Also, we plan to test the hypothesis that patients who receive convective CRRT
      modalities demonstrate improved clinical responses to patients who receive a diffusive CRRT
      modality.
    

Intervention name(s): Continuous Renal Replacement Therapy
Intervention type(s): Procedure
Intervention description(s): Patients will be randomized to either arm for the first 24 hours of the study and then crossover to the second arm for the second 24 hours of the study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Renal Replacement Therapy (CRRT); Sepsis; Convection; Diffusion
A Study of JNJ-63733657 in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following
      single intravenous (IV) dose administration in healthy Chinese participants.
    


Intervention name(s): JNJ-63733657
Intervention type(s): Drug
Intervention description(s): JNJ-63733657 will be administered as an IV infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Airways Dysfunction Following WTC Dust Exposure
Condition: Pulmonary Diseases
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      In the weeks following the terrorist attacks of September 11, 2001, many patients presented
      to their physicians with complaints related to exposure to the debris. These included nose
      and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn,
      regurgitation, retrosternal chest burning) and respiratory symptoms (worsening cough,
      wheezing, shortness of breath, chest tightness, sleep disturbance). In addition, there was a
      disproportionate rate of self-reported worsening asthma symptoms in patients living in Lower
      New York 5-9 weeks after the attack; those with exposure to the dust cloud fared worse. The
      functional abnormalities of firefighters with exposures to dust at the WTC site has been
      recently described. However, the effects of WTC dust exposure on pulmonary function in
      residents and workers near the WTC site remain unclear. This study will retrospectively
      review the charts of all patients referred to the pulmonary function laboratory for
      evaluation of symptoms following exposure to WTC dust. The main objectives for this study
      will be to characterize the functional abnormalities in these subjects.
    


Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        study will retrospectively review the charts of all patients referred to the pulmonary
        function laboratory for evaluation of symptoms following exposure to WTC dust.
      
Keywords: Respiratory Function Tests; Oscillometry; World Trade Center Disaster; Environmental Exposure; Distal Airways
Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic profile, safety, and
      tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and
      subjects with mild, moderate, or severe hepatic impairment.
    

Detailed description: 
      pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of
      delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic
      impairment. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
    

Intervention name(s): Delafloxacin
Intervention type(s): Drug
Intervention description(s): Plasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
Intervention MeSH terms: Delafloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment, single dose, intravenous
Compare the Effect of INS Alone and Added LTRA in Treatment of SAR
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS)
      and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the
      treatment of severe allergic rhinitis (AR) . We performed a randomized, open-label study in
      46 seasonal AR subjects receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD
      alone (256ug) for 2 weeks. Visual analog scale (VAS) scores, nasal cavity volume (NCV), nasal
      airway resistance (NAR) and fractional exhaled nitric oxide (FeNO) were assessed before and
      at end of treatments as the primary treatment outcomes. Similarly, histamine, eosinophil
      cationic protein (ECP) and cysteinyl-leukotrienes (Cyslts) in nasal secretion and Th1/Th2
      cells in nasal mucosa were evaluated as the secondary treatment outcomes.
    


Intervention name(s): budesonide
Intervention type(s): Drug
Intervention description(s): SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days
Other intervention name(s): montelukast
Intervention MeSH terms: Budesonide; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: budesonide; montelukast; combination therapy; monotherapy
The Role of Milk Derived Peptides on Glycaemic Control
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study aims to ascertain the potential of novel milk derived hydrolysates to improve
      glycaemic control to promote metabolic health. A comprehensive characterisation of the
      metabolic response to these milk derived hydrolysates will ascertain the effect of the
      hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve
      insulin resistance in cell and animal models. Therefore the investigators aim is to test
      their efficacy in overweight, insulin resistant individuals at risk of developing type 2
      diabetes.
    

Detailed description: 
      Recent figures estimate 60% of Irish adults are overweight or obese. As obesity is associated
      with the development of insulin resistance, which precedes type 2 diabetes development by
      decades, novel food based solutions are required to improve glycaemic control and attenuate
      insulin resistance.

      In the current study insulin resistant individuals will undergo 4 study visits, 1 screening
      visit and 3 subsequent visits. At each of the 3 visits they will receive an oral lipid load
      consisting of 100mL soya bean oil, followed by either a water control; the hydrolysate being
      tested or the parent protein from which the hydrolysate was derived. After which they will
      undergo a 4 hour hyperinsulinemic-euglycaemic clamp at each visit to assess their insulin
      sensitivity.
    

Intervention name(s): Water Control; Milk derived hydrolysate; Parent Protein; Lipid Load
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp; Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp; Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp; 100mL oral lipid load
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin sensitivity; Obesity; Insulin resistance; Milk derived hydrolysate; Hyperinsulinemic-euglycaemic clamp
Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      The study seeks to determine the impact of assessing risk for osteoporosis in women on
      patient and physician behaviors through a pharmacist directed osteoporosis screening program.
      Women will be offered a heel ultrasound to screen for their bone density and may or may not
      be asked questions about their risk for bone fracture. Pharmacists will counsel and educate
      all women on ways to prevent the onset of osteoporosis. Women will be telephoned three months
      after the screening and asked a series of 10 questions to follow up on decisions made by
      their physicians or changes made to their health behaviors related to bone health.
    

Detailed description: 
      A maximum of 90 participants will be recruited and randomized to the FRAX® assessment
      intervention group or the control group to a total of 45 participants in each group. The
      number of participants was chosen based on the simple randomized design of the study and use
      of basic statistics (versus regression analysis). Subjects will be recruited from the
      employee population of Duquesne University, clients visiting the Spirit of Health mobile
      health unit, and the downtown Pittsburgh community and surrounding neighborhoods of Duquesne
      University. Participants will be recruited through posted flyers at these various screening
      venues. Data collected will be the T-score at baseline screening in both groups. The percent
      risk for fracture as determined by the FRAX® tool will be determined for the intervention
      group. After 3 months have elapsed, a questionnaire will be administered via telephone to
      both the intervention and control groups, a series of 12 yes/no questions. Fisher's exact
      test will be used to analyze the data. Data collected will be nominal data with n in each
      group at 45 for a total of 90 participants. Descriptive statistics will also be employed.
    

Intervention name(s): FRAX Assessment Tool
Intervention type(s): Other
Intervention description(s): FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.
Other intervention name(s): WHO FRAX Risk Assessment Tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Osteoporosis; Pharmacist; Behavior Change; FRAX; Osteopenia
Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives
Condition: Dental Fluorosis
MeSH terms: Fluorosis, Dental; Fluoride Poisoning
Study type: Interventional
Phase: Phase 1

Summary: 
      The risk of dental fluorosis development is related to the systemic exposure to fluoride
      during enamel formation. Currently, diet and fluoride toothpastes are the main sources of
      fluoride to children at the age-risk for fluorosis development. However, when estimating the
      risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the
      systemic fluoride bioavailability. Since some toothpaste formulations may contain part of
      fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride
      in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult
      volunteers will ingest a standardized dose of total fluoride from commercially available
      toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic
      bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after
      ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.
    


Intervention name(s): Purified water; Fresh MFP/CaCO3 toothpaste; Fresh NaF/SiO2 toothpaste; Aged NaF/SiO2 toothpaste; Aged MFP/CaCO3 toothpaste
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ingestion of 30 mL of purified water; Ingestion of 31.9 mg of a fresh toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.; Ingestion of 49.5 mg of a fresh toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.; Ingestion of 49.5 mg of a toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.; Ingestion of 31.9 mg of a toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.
Intervention MeSH terms: Calcium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: toothpastes; dental fluorosis; fluoride; bioavailability
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed
      children living in western Kenya and aged 12-47 months
    

Detailed description: 
      Study consists of 3 cohorts (12 to 23 months, 24 to 35 months, and 36 to 47 months). Within
      each cohort subjects were randomized in a 2:1 ration to receive one of three dose levels of
      FMP1/AS02A (Cohort A, 10 ug; Cohort B, 25 ug; Cohort C, 50 ug) or Imovax Rabies vaccine.
      Immunization was staggered among dose cohorts; subjects in Cohort B received their first
      immunization only after the Local Medical Monitor and Data Safety Monitoring Board reviewed
      Cohort A safety data for the eight-day follow-up period following their first immunization.
      The same procedure was followed for the immunization of Cohort C. This will be conducted in
      western Kenya a the Walter Reed Project Lumbewa Clinic.
    

Intervention name(s): FMP1/AS02A Malaria vaccine; Imovax Rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Subjects vaccinated with FMP1/AS02 vaccine; Subjects vaccinated on corresponding FMP1/AS02A vaccination days
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vaccine; Phase 1; Plasmodium falciparum; Malaria; Merozoite surface protein-1; MSP-1; Falciparum malaria protein 1; FMP-1; AS02A
Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A new inactivated polio vaccine based on attenuated poliovirus strains was developed to
      transfer the technology to manufacturers in low- and middle-income countries. This vaccine
      was produced in different dosages and in different formulations. In healthy adults the safety
      of the highest dose was comparable to that of the existing inactivated polio vaccine. The
      purpose of this trial is to determine the safety of the different dosages and formulations of
      the vaccine in infants. The second goal of this study is to analyse the immune response after
      three doses in infants.
    

Detailed description: 
      The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted
      Sabin-IPV produced with the production process set up for technology transfer by the National
      Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine
      Institute (NVI).

        -  The primary objective is to evaluate safety (local and systemic reactions) of
           intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy infants.

        -  The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and
           adjuvanted Sabin-IPV in infants.
    

Intervention name(s): IPV; Low dose Sabin-IPV; Low dose adjuvanted Sabin-IPV; Middle dose Sabin-IPV; Middle dose adjuvanted Sabin-IPV; High dose Sabin-IPV; High dose adjuvanted Sabin-IPV
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): IPV (NVI); Inactivated poliomyelitis vaccine; Inactivated poliovirus vaccine; Inactivated polio vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccination; Inactivated poliomyelitis vaccine; poliomyelitis; Sabin strains
Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma
Condition: Esophageal Squamous Cell Carcinoma; Enteral Nutrition Therapy; Chemoradiotherapy
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, prospective, multicenter study.
    

Detailed description: 
      This is a randomized, prospective, multicenter study. The aim of this study was to compare
      the changes of body weight,survival,toxicity,quality of life and opportunistic infection
      frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after
      chemoradiotherapy with or without enteral nutrition therapy.
    

Intervention name(s): Enteral nutrition; radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.; Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week.
Radiotherapy dose：95% gross tumor volume（GTV-T） 60-66 Gy /30-33f，GTV-N 60-66 Gy /30-33f，CTV-T 50-54 Gy /25-27f，CTV-N 50-54 Gy /25-27f.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment