bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Immunogenicity and Compatibility With DTP of a Typhoid Fever Vaccine in Infants
Condition: Typhoid Fever
MeSH terms: Typhoid Fever; Fever
Intervention: Vi-rEPA conjugate vaccine for typhoid fever; Hib-TT; DTP
Intervention description: Vi-rEPA contains a 25 ug/dose of Vi (Sanofi-Pasteur Lot 130) and rEPA in 0.2 N NaCl, 10 mM phosphate PH 7.2 and 0.01% thimerosal.; Hib-TT is Hemophilus influenzae type b-tetanus toxoid conjugate vaccine (ActHib, NDC#49281-545-05 Sanofi-Pasteur, France) in single-dose vials containing 10 ugof Hib CP conjugated to 24 ug of tetanus toxoid; DTP, diphtheria, tetanus toxoid and pertussis vaccine were from the Ministry of Health, Vietnam for routine infant immunization
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: All
Healthy volunteers: No
Keywords: Antibody; Reactions; Vaccine; Conjugate Vaccine; Typhoid Fever; Trial; Safety; Immunogenicity; Comparability; DTP

Summary:

      The purpose of this study is to evaluate the safety, immunogenicity, and compatibility of our
      Vi-rEPA conjugate administered to infants with their routine vaccinations.

      We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to
      receive Vi-rEPA plus DTP, Hib-TT (not yet used in Vietnam) plus DTP, or DTP alone. Consent is
      obtained following interviews of mothers during prenatal visits, or after delivery. All
      vaccines will be administered at 2, 4, and 6 months. A booster of Vi-rEPA or Hib-TT conjugate
      will be administered at 12 months of age and reactions monitored at 6, 24 and 48 hours after
      each injection. Maternal and cord blood samples are collected during labor and at delivery.
      Blood will be taken at 7, and 12 months of age from all study infants and at 13 months from
      infants injected with Vi-rEPA or with Hib-TT at 12 months. The blood samples will be assayed
      for Vi, Hib, diphtheria, tetanus and pertussis antibodies.

      The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above
      schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the
      efficacy trial conducted in Dong Thap Province, Vietnam.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy full-term newborns.

          -  Birth weights of >=2500 grams.

        Exclusion criteria:

          -  Newborns without maternal and cord blood samples

          -  Newborns born to mothers with serious medical problems.
Dose Ranging Study of OTO-201 in AOMT
Condition: Acute Otitis Media; AOMT
MeSH terms: Otitis; Otitis Media
Intervention: 6 mg ciprofloxacin; 12 mg ciprofloxacin; Sham
Intervention description: Single administration of OTO-201; Single administration of OTO-201
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 95.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute otitis media with tympanostomy tubes; OTIPRIO

Summary:

      Dose Ranging Study of OTO-201 in AOMT
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)

          -  Subject's caregiver is willing to comply with the protocol an attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of sensorineural hearing loss

          -  Subject has tympanic membrane perforation other than the surgical tympanostomy tube
             perforation

          -  Subject has a history of known immunodeficiency disease
Kudzu Treatment for Alcohol Abuse
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Intervention: Kudzu; Placebo
Intervention description: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session.; Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcohol consumption; Kudzu extract

Summary:

      This is a study designed to test whether a single administration of kudzu extract (2 mg) will
      significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session
      when given as pretreatment 2 ½ hours before the drinking session.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of understanding and complying with the protocol

          -  Good physical and mental health (normal physical exam, ECG, blood and urine
             chemistries)

          -  Body Mass Index between 18-30, inclusive

          -  Age 21-40 years

          -  Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported
             pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic
             beverages in one sitting)

          -  Have a stable living situation with current postal address

        Exclusion Criteria:

          -  Concurrent diagnosis of Axis I disorder

          -  Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug
             dependence acceptable only if greater than 3 years.

          -  Immediate family history pattern of alcoholism or problem drinking (parents or
             siblings)

          -  Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is
             acceptable.

          -  Subjects cannot be actively seeking treatment for any drug or alcohol dependence.

          -  Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are
             acceptable if the use criteria is met.

          -  Maintained on an antipsychotic or antidepressant medication; taking prescription
             medications except certain short-term anti fungal agents and some tropical creams for
             dermal conditions.

          -  Tobacco use greater than 5 cigarettes per day

          -  History of major head trauma resulting in cognitive impairment or history of seizure
             disorder

          -  Heavy caffeine use (greater than 500 mg on a regular, daily basis)

          -  Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine
             aminotransferase (ALT) > 3x the upper limit of normal

          -  For female volunteers, a positive pregnancy test
A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: GSK189075; placebo
Intervention description: investigational drug; placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: type 1 Diabetes mellitus, pharmacokinetics,; pharmacodynamics; Adult male and females,

Summary:

      The purpose of this research study is to look at concentrations of GSK189075 in blood when
      single doses of the drug are taken by mouth in combination with basal insulin. The clinical
      effects of the drug in combination with insulin on the body will also be studied. The results
      will help determine doses of GSK189075 can be studied in the future in the type I diabetes
      mellitus population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male/female, 18 to 55 years old

          -  Diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous
             insulin pump

          -  Willing and able to follow all study-related instructions provided by the site staff.

          -  Willing to provide signed informed consent.

        Exclusion Criteria:

          -  Pregnant or a nursing female.

          -  Have a past or current disease such as heart, liver, kidney, blood, brain, or other
             disease.

          -  Have HIV or hepatitis, or have alcohol or drugs in your system at the screening visit.

          -  Have a history of alcohol abuse or have an eating disorder

          -  Have been in another research study in the last month or have taken certain
             medications in the 1 week before study drug would be taken.
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
Condition: Post Bariatric Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: Lyo avexitide; Liq avexitide
Intervention description: Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc); Liquid avexitide (Liq avexitide) administered subcutaneously (sc)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bariatric surgery complications; Glucose Metabolism Disorders; Exendin (9-39); GLP-1

Summary:

      This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous
      exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous
      formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare
      disease with unmet clinical need.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-bariatric surgery more than 6 months prior to signing the informed consent

          -  Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms
             associated with a capillary blood glucose of ≤55 mg/dL, and resolution with glucose or
             carbohydrate administration.

          -  Symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test
             (OGTT), as defined by the presence of plasma glucose ≤55 mg/dL with concomitant
             autonomic and/or neuroglycopenic symptoms.

        Exclusion Criteria:

          -  Patients currently using sulfonylureas or other medications that may interfere with
             glucose metabolism within 5 half-lives of drug.

          -  Participation in any clinical investigation within 4 weeks prior to dosing

          -  History of or current insulinoma

          -  Active infection or significant acute illness within 2 weeks prior to dosing

          -  Female patients who are pregnant or lactating

          -  Women of childbearing potential and not utilizing effective contraceptive methods

          -  Inadequate end organ function
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: TMC435; Placebo; Peg-IFN-alfa-2a (P); Ribavirin (R)
Intervention description: One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.; One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.; 180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.; 1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon alpha-2; Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; Peginterferon alpha-2a; PegIFNalpha-2a; RBV; Ribavirin; Placebo; TMC435-TIDP16-C206; TMC435-C206; TMC435; HCV

Summary:

      The purpose of this study is to determine the efficacy, safety and tolerability of different
      regimens of TMC435 with standard treatment compared to standard treatment alone in
      participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed
      previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C
             virus (HCV) and HCV RNA positive

          -  Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater
             than10000 IU/mL

          -  Patient must have failed at least 1 prior course of peg interferon
             (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)

          -  Must be willing to use 2 effective methods of birth control for up to 7 months after
             last dose of study medication

        Exclusion Criteria:

          -  Has an evidence of decompensated liver disease

          -  Co-infection with any other Hepatitis C virus genotype or co-infection with the human
             immunodeficiency virus (HIV)

          -  Has a medical condition which is a contraindication to Peg-INF or RBV therapy

          -  Have had history of, or any current medical condition which could impact the safety of
             the patient in the study
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: sunitinib malate dose escalation; sunitinib malate
Intervention description: sunitinib starting dose will be 15mg/m^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).; sunitinib 50mg daily on Schedule 4/2
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 6 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Children and young adults with GIST; sunitinib malate; pharmacokinetics; tumor response; overall survival; tumor KIT mutation status

Summary:

      Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with
      sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be
      studied in these patients. In addition, tumor responses and overall survival will be
      assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosis of GIST.

          -  Patients must have demonstrated either disease progression or intolerance to imatinib
             mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain
             imatinib in their country

          -  Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable
             disease.

        Exclusion Criteria:

          -  Current treatment with another investigational agent.

          -  Prior sunitinib treatment.

          -  Prior therapy with known risk for cardiovascular complications.
Family History Study of Alcohol Consumption Using Memantine
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: memantine; Memantine; Placebo
Intervention description: Memantine 20 mg once per day for 7 days; Memantine 40 mg once per day for 7 days; Placebo once per day for 7 days
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 111.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Alcohol Drinking; Memantine

Summary:

      The purpose of this study is to evaluate the effects of the study medication, memantine
      (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which
      participants are given an initial drink of alcohol followed by the choice to drink up to 12
      more drinks over a three-hour period. We hypothesize that memantine will reduce craving and
      number of drinks consumed prior to and after exposure to the initial drink of alcohol and
      during the three hour drinking period. We will also evaluate the influence of family history
      of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21-50

          -  Able to read English at 6th grade level or higher and to complete study evaluations

          -  Regular alcohol drinker

        Exclusion Criteria:

          -  Individuals who are seeking alcohol treatment

          -  Medical conditions that would contraindicate the use of memantine

          -  Regular use of other substances
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
Condition: Hepatitis C; HCV; Chronic Hepatitis C Infection; Hepatitis C Genotype 1
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450; ABT-072; ABT-333; Ritonavir; Peginterferon alpha-2a; Ribavirin; Placebo
Intervention description: 50 mg capsules co-administered with ritonavir; 50 mg tablet; 400 mg tablet; 100 mg capsules co-administered with ABT-450; Syringe, 180 µg/0.5 mL for subcutaneous injections; 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day; Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level
Intervention MeSH terms: Ritonavir; Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of
      multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072
      in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level
             greater than or equal to 100,000 IU/mL) at screening

          -  Liver biopsy within 3 years with histology consistent with HCV-induced liver damage,
             with no evidence of cirrhosis or liver pathology due to any cause other than chronic
             HCV

          -  Treatment naïve male or female between the ages of 18 and 65

          -  Females must be post-menopausal for more than 2 years or surgically sterile

          -  Negative screen for drugs and alcohol

          -  Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus
             antibodies (anti-HIV Ab)

          -  No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers
             or inhibitors within 1 month of dosing

          -  Be in a condition of general good health, as perceived by the investigator, other than
             HCV infection

        Exclusion Criteria:

          -  Significant sensitivity to any drug

          -  Use of herbal supplements within 2 weeks prior to study drug dosing

          -  History of major depression within 2 years

          -  Prior treatment with any investigational or commercially available anti-HCV agents

          -  Abnormal laboratory tests
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)
Condition: Healthy Volunteers
Intervention: PRT064445/Enoxaparin; Placebo/Enoxaparin; Placebo
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women between the ages of 18 and 45 years old

        Exclusion Criteria:

          -  History (including family history) or symptoms of, or risk factors for bleeding

          -  History (including family history) of or risk factors for a hypercoagulable or
             thrombotic condition

          -  Absolute/relative contraindication to anticoagulation or treatment with specific
             anticoagulants

          -  History of major surgery, severe trauma or bone fracture within 3 months prior to
             dosing; or planned surgery within 1 month after dosing.