bioihbjkbjnl/mcl2 huggingface dataset:
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.
    

Detailed description: 
      This is a randomized, vehicle controlled, double blind study in subjects with axillary
      hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production
      of topically applied BBI-4000 for 14 days.

      Safety will be assessed though vital signs, physical exam, adverse events, local skin
      reactions and laboratory tests (blood chemistry and hematology).

      Efficacy will be assessed though the gravimetrically measured sweat production and the
      Hyperhidrosis Disease Severity Score (HDSS).

      Pharmacokinetic information will also be collected.
    

Intervention name(s): BBI-4000
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bronchoscopy Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects
Condition: Respiratory Diseases
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      The purpose of this research study is to collect cells and liquid from the air passages of
      healthy adults, both smokers and non-smokers. These samples will be used for test-tube
      studies to explore mechanisms of diseases of the respiratory tract, and to compare the
      samples between people who smoke cigarettes and people who don't. Obtaining these samples
      requires an invasive procedure called "bronchoscopy".
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Current cigarette smokers who are otherwise healthy (no lung disease or other chronic
        illness and healthy controls
      
Biospecimen description: 
      Whole blood, Bronchial Lavage Fluid (BALF), cytology brushings
    
Keywords: Healthy smokers; Current cigarette smokers; No lung disease
Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery
Condition: Neoplasms, Head and Neck
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial
      comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with
      head and neck cancer following surgery. Lapatinib or placebo will be administered
      post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib
      or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing
      the recurrence of the disease in these high-risk patients.
    

Detailed description: 
      A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of
      Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by
      Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous
      Cell Carcinoma of the Head and Neck (SCCHN)
    

Intervention name(s): Lapatinib; Chemoradiation; Placebo
Intervention type(s): Drug; Radiation; Other
Intervention description(s): Dual ErbB1/2 inhibitor; Radiation plus platinum based chemotherapy; Placebo
Intervention MeSH terms: Lapatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cancer of the Head and Neck; Neck cancer; Adjuvant; Head and neck cancer; High-risk head and neck cancer; Post-surgery; Head cancer
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The
      long-acting insulin has showed to improve glycemic variability however the behavior of
      insulin glargine versus insulin degludec is unknown.
    

Detailed description: 
      Cross-over, double dummy, randomized, clinical trial was carried out. The sample size was
      calculated using the formula for clinical trials of mean differences with an "n" of 6
      patients per group was obtained. Patients between 30 and 65 years of age will be included
      with T2DM, without hyperglycemic drugs, hemoglobin A1c (A1C) 6.5 to 11.0 % and with written
      signature consent. They were assigned randomly by sealed envelope either to received insulin
      Degludec (Novo Nordisk A/S. Bagsvaerd, Denmark) or insulin Glargine (Sanofi-Aventis
      Deutschland GmbH. Frankfurt, Germany) [10 international units (IU) subcutaneous (SC) every 24
      hours for six days], patients who were administered initially insulin Degludec corresponded
      then insulin Glargine and vice versa, with a washout period of 14 days between each
      intervention.

      The clinical findings and laboratory tests included a metabolic profile and biosafety, which
      will be made at baseline. Body weight, body mass index and blood pressure were performed
      during the initial visit, likewise, interstitial glucose concentrations by ambulatory
      continuous glucose monitoring system (Guardian®, Medtronic MiniMed, Northridge), through
      which the mean amplitude of glucose excursions (MAGE) and area under the curve of glucose
      were calculated, which served to assess the glycemic variability. Adverse events and
      adherence to treatment are documented. Statistical analysis: Mann-Whitney U test, Chi2,
      Fisher exact test. It is considered with significance at p <0.05.
    

Intervention name(s): Insulin Degludec; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Insulin Degludec 10 IU SC every 24 hours for 6 days; Insulin Glargine 10 IU SC every 24 hours for 6 days
Other intervention name(s): Tresiba ® (Novo Nordisk A/S. Bagsvaerd, Denmark); Lantus ® (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading
      Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in
      Chinese Healthy Volunteers
    


Intervention name(s): Group 1: Compound Edaravone/Placebo Injection; Group 2: Compound Edaravone/Placebo Injection; Group 3: Compound Edaravone/Placebo Injection; Group 4: Compound Edaravone/Placebo Injection; Group 5: Compound Edaravone/Placebo Injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Compound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min; Compound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min; Compound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min; Compound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min; Maximum tolerated dose of drug / placebo for a single intravenous infusion for 30 minutes three times a day at an interval of 8 h until the last dose on the morning of Day 3, after which the sequential test drug 30 mg-600 mg / placebo will be administered daily from Day 3 night Intravenous infusion, 30 minutes at 12-hour intervals until morning on Day 7
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Edaravone; Compound edaravone injection
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness
      and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes.
      Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch
      therapies for the next 3 months.

      Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness
      and improving blood flow.
    


Intervention name(s): Atorvastatin 20 mg daily for 3 months
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Diabetes; Children; Adolescents; Arterial Compliance; Physiology Cardiovascular Endothelium
Simulated Driving Study in Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was a multi center, randomized, double blind, active and placebo controlled,
      parallel group study to assess simulated driving performance in XP13512 treated subjects with
      Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose
      of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the
      placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of
      an agent known to have sedative properties, while the other 3 groups received a DPH placebo.
    

Detailed description: 
      This study was a multicenter, randomized, double blind, active and placebo controlled,
      parallel group study. Eligible subjects were randomized in a 1:1:1:1 ratio to 1 of the
      following 4 treatment groups:

      A) XP13512 Placebo + Diphenhydramine Placebo (Pbo) B) XP13512 1200 mg/day + Diphenhydramine
      Placebo (1200 mg) C) XP13512 1800 mg/day + Diphenhydramine Placebo (1800 mg) D) XP13512
      Placebo + 50 mg Diphenhydramine (Pbo/DPH)
    

Intervention name(s): XP13512; Diphenhydramine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): XP13512 once daily for 16 days; one 50 mg dose of diphenhydramine (DPH) on day 16; XP13512 placebo once daily for 16 days
Other intervention name(s): GSK1838262; Gabapentin Enacarbil (GEn)
Intervention MeSH terms: Diphenhydramine; Promethazine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intraoperative Lung-Protective Ventilation in Neurosurgery
Condition: Ventilator-induced Lung Injury
MeSH terms: Lung Injury; Ventilator-Induced Lung Injury
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effectiveness of lung-protective ventilation
      during general anesthesia for neurosurgical procedures on postoperative pulmonary outcome,
      compared with traditional ventilation.
    

Detailed description: 
      After screened for preoperative risk classification of postoperative respiratory
      complications,360 patients undergoing elective neurosurgery are randomly assigned to two
      groups, lung-protective ventilation (L) and traditional ventilation(T).Patients are
      mechanical ventilated with either a tidal volume of 10-12 ml/kg ideal body weight (IBW,T) or
      6-8ml/kg IBW with 6-8 cm H2O PEEP(L),both with recruitment maneuver (RM).Each RM consists of
      applying a continuous positive airway pressure of 30 cmH2O for 30 seconds. Postoperative
      pulmonary complications are compared between groups.
    

Intervention name(s): lung-protective ventilation
Intervention type(s): Other
Intervention description(s): mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Protective mechanical ventilation; ventilator-induced lung injury; neurosurgery
ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox
Condition: Anemia
MeSH terms: Iron Overload
Study type: Observational

Summary: 
      This registry will evaluate long-term safety and efficacy of deferasirox in children with
      transfusional iron overload.
    


Intervention name(s): Deferasirox
Intervention type(s): Drug
Intervention MeSH terms: Deferasirox
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 unselected children aged from 2 to <6 years at enrolment with chronic iron overload due
        to repeated blood transfusions. The participating countries were selected on the basis of
        both a high incidence of young children with thalassemia or other transfusion dependent
        anemias and on the basis that the drug is approved and 'on the market' in the country
        selected.
      
Keywords: Iron overload; children; deferasirox; Transfusion-dependent anemia
A Pilot Study of Rapid Haplotyping Procedure for Personalized Dosing of Dichloroacetate (DCA) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to identify and analyze the frequency of GSTZ1 haplotypes in a
      healthy adult population and determine the pharmacokinetics of Dichloroacetate (DCA)
      metabolism based on haplotype analysis.

      The DCA drug is the first targeted treatment for Pyruvate Dehydrogenase Complex Deficiency
      (PDCD).

      This pilot study, focuses on developing a high throughput, sensitive and accurate screening
      test for determining glutathione transferase zeta 1 (GSTZ1) haplotype status in individuals
      who would be treated with DCA.
    

Detailed description: 
      Pyruvate dehydrogenase complex (PDC) deficiency (PDCD) is a rare disease of mitochondrial
      energy failure with the life of expectancy of affected children severely truncated. Treatment
      of PDCD remains a serious, unmet challenge. Dichloroacetate (DCA) represents the first
      targeted therapy for PDCD by stimulating residual PDC activity. Cumulative experience with
      DCA has revealed dose accumulation in a subset of the population. This can be abated through
      personalized dosing of DCA, assigned by haplotype variation in the gene encoding glutathione
      transferase zeta 1 (GSTZ1), which biotransforms DCA to glyoxylate. Haplotype variations in
      GSTZ1 influence the kinetics and dynamics of chronically administered DCA. A single dose of
      DCA has a bioavailability approaching unity and is widely distributed throughout the body.
      The plasma half-life (t ½) is ~1 hr in drug-naïve subjects. Gender does not influence DCA
      kinetics or metabolism. The major route of biotransformation is via dehalogenation to
      glyoxylate by glutathione transferase zeta 1 (GSTZ1). DCA is a mechanism-based inhibitor of
      GSTZ1, so repeated administration results in increased plasma t ½ and decreased clearance.
    

Intervention name(s): Dichloroacetate (DCA); GSTZ1 haplotyping
Intervention type(s): Drug; Other
Intervention description(s): Dichloroacetate (DCA) 25 mg/kg oral solution will be administered daily for 5 days.; One teaspoon of blood is collected by standard phlebotomy. Cheek cells are collected by standard brushing. Samples will be analyzed at two independent laboratories to validate methods for GSTZ1 haplotype analysis.
Other intervention name(s): Blood collection; Cheek cell collection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients
Condition: Pediatric Solid Organ Transplant Patients
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I trial in which the both the safety and immunogenicity of the standard dose
      flu vaccine will be compared with high dose flu vaccine in children that have undergone solid
      organ transplantation (SOT).
    

Detailed description: 
      A prospective, randomized, double-blind phase 1 safety and immunogenicity study of the HD
      compared with the SD TIV in pediatric patients between the ages of three and 17 yr that have
      undergone SOT (Clin-Trials.gov. NCT01525004) was conducted. Subjects were randomized in a 2:1
      fashion to receive 0.5 mL of either the HD (60 μg) or SD (15 μg) TIV intramuscularly.
      Subjects <9 yr of age received either one or two doses of the vaccine based on ACIP
      recommendations [19]. The study was approved by Institutional Review Boards at both
      institutions (Vanderbilt University, Nashville, TN, and the University of Pittsburgh,
      Pittsburgh, PA) and conducted during the 2011-2012 influenza season. Subjects were randomly
      allocated to either the HD or SD group by a computer-generated allocation system.
      Participants, their families, and research staff who performed clinical evaluations remained
      blinded to the child's assigned dosage, while designated unblinded nurses administered the
      requisite vaccine.
    

Intervention name(s): High-Dose trivalent inactivated influenza vaccine; Standard dose trivalent inactivated influenza vaccine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.; 0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Solid organ transplant; Flu vaccine
Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: An interactive computer program may be more effective than a brochure in
      increasing colorectal cancer screening among African Americans.

      PURPOSE: This randomized clinical trial is studying an interactive computer program to see
      how well it works compared with a brochure in increasing colorectal cancer screening among
      African Americans.
    

Detailed description: 
      OBJECTIVES:

        -  Compare rates of participation in fecal occult blood testing and endoscopic screening
           (colonoscopy or sigmoidoscopy) among African-Americans who receive an interactive
           computer intervention (ICI) versus a non-tailored colorectal cancer screening brochure.

        -  Examine mediators and moderators of intervention effectiveness as depicted in the
           conceptual model.

      OUTLINE: This is a multicenter study.

      Participants are stratified according to site, age (≤ 65 years old vs > 65 years old) and
      gender. Participants are randomized to one of two arms.

        -  Arm I (non-tailored colorectal cancer screening brochure): Participants undergo a
           baseline interview via telephone and receive a colorectal cancer screening brochure in
           the clinic prior to visit with healthcare provider. Participants then undergo telephone
           interviews at 1 week, 6 months, and 15 months.

        -  Arm II (interactive computer intervention [ICI]): Participants undergo a baseline
           interview via telephone and complete an ICI in the clinic prior to visit with healthcare
           provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15
           months.
    

Intervention name(s): Non-tailored CRC screening brochure; Interactive computer intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: colon cancer; rectal cancer
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
Condition: AIDS Dementia Complex; Neuromuscular Diseases; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; AIDS Dementia Complex; Dementia; Neuromuscular Diseases; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the
      treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a
      lymphotropic and neurotropic virus which can affect both the central and peripheral nervous
      systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent
      state, with the potential for continuous reinfection of other body systems. Therefore,
      effective therapeutic efforts against HIV infection should provide effective antiviral
      activity within the nervous system.
    


Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Primary purpose: Treatment
Keywords: Pilot Projects; Neuromuscular Diseases; Drug Evaluation; Acquired Immunodeficiency Syndrome; AIDS Dementia Complex; AIDS-Related Complex; Zidovudine