bioihbjkbjnl/mcl2 huggingface dataset:
Rotavirus Vaccine Produced by Butantan Institute
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Intervention: rotavirus vaccine; placebo
Intervention description: 3 doses with 6 weeks interval; 3 doses with 6 weeks interval
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: brazilian pentavalent rotavirus vaccine; safety; tolerability; immunogenicity

Summary:

      The purpose of this study is to describe the safety, tolerability and immunogenicity of the
      pentavalent rotavirus vaccine produced by Butantan Institute.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male healthy

          -  Age ≥18-40 years

          -  Not taking immunosuppressive drugs

          -  No clinical history of gastrointestinal diseases or surgeries

          -  No history of cardiac, neurologic, immunologic or endocrine diseases

          -  Normal eligibility laboratory tests

          -  To be willing to participate and sign the informed consent form

          -  No participation in another clinical trial in the past 6 months

        Exclusion Criteria:

          -  Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrollment in this study
Paxil CR Bioequivalence Study Brazil - Fed Administration
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Intervention: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico; Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada
Intervention description: Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation); Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Intervention MeSH terms: Halofantrine; Paroxetine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Paroxetine reference/test; healthy volunteers; Fed condition

Summary:

      The study is prospective, open, randomized, crossover in steady state and the volunteers
      received multiple doses of the test drug and the reference drug (two periods of drug
      administration after standardized meals).
    

Eligibility criteria:

        EXCLUSION CRITERIA:

          -  hypersensitivity to the study drug or to compounds chemically related;

          -  history of serious adverse events;

          -  concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;

          -  History of liver, heart, gastrointestinal or renal illness;

          -  ECG findings not recommended according to the investigator judgement;

          -  The volunteer ingests more than 5 cups of coffee or tea a day.

        INCLUSION CRITERIA:

          -  Man and woman (since they are not pregnant or breastfeeding);

          -  age between 18 and 40 years;

          -  non-smoker and not addict;

          -  mass index between 18,5 and 27;

          -  good health conditions or without significant illness, by judgement of a legally
             qualified professional;

          -  sign the informed consent.
Transcranial Magnetic Stimulation to Improve Speech in Aphasia
Condition: Aphasia; Cerebrovascular Stroke
MeSH terms: Stroke; Aphasia
Intervention: Transcranial Magnetic Stimulation, Repetitive
Intervention description: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Transcranial Magnetic Stimulation, Repetitive; TMS; Treat Naming; Aphasia; Chronic Stroke; Randomized, Controlled Trial

Summary:

      The purpose of this study is to examine whether repetitive transcranial magnetic stimulation
      (rTMS) can be used to improve speech in chronic stroke patients with aphasia. Aphasia
      patients can have problems with speech production. The rTMS procedure allows painless,
      noninvasive stimulation of human cortex from outside the head.

      Chronic aphasia patients have been observed in our functional magnetic resonance brain
      imaging studies to have excess brain activation in brain areas possibly related to language
      on the right side of the brain (opposite side to where the stroke took place). It is expected
      that suppression of activity in the directly targeted brain region will have an overall
      modulating effect on the neural network for naming (and propositional speech) and will result
      in behavioral improvement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Right Handed

          -  Single, Left Hemisphere Cerebrovascular Stroke

          -  Must be at least 6 months poststroke onset

          -  Native Speaker of English

          -  Clinical Diagnosis of Aphasia

        Exclusion Criteria:

          -  Intracranial metallic body from prior neurosurgical procedure

          -  Implanted metallic devices: pacemaker, medication pump, vagal stimulator, deep brain
             stimulator, TENS unit or ventriculoperitoneal shunt

          -  Past history of seizure within 1 year

          -  Pregnancy

          -  History of substance abuse within last 6 months
A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: PF-02341066; PF-00299804; PF-02341066; PF-00299804
Intervention description: Arm 1: The starting dose will be 200 mg by mouth, twice a day of PF 02341066 in tablet form The dose of each drug in the combination [PF-02341066 and PF-00299804] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.; Arm 1: The starting dose will be 30 mg by mouth once a day of PF-0029804 in tablet form. The dose of each drug in the combination [PF-02341066 and PF-00299804] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.; Arm 2: With progressive disease the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).; Arm 2: The dose of 45 mg by mouth once a day of PF-00299804 in tablet form until progressive disease and then the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).
Intervention MeSH terms: Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 1 acquired resistance to erlotinib or gefitinib cMET inhibitor EGFR inhibitor panHER inhibitor combination trial Crizotinib

Summary:

      Lung cancer tumors become resistant to the first generation epidermal growth factor receptor
      (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell
      signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can
      occur at the same time, in the same patient and even in the same tumor. This study combines a
      second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order
      to overcome resistance and treat this disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  advanced non small cell lung cancer (dose escalation phase)

          -  acquired resistance to erlotinib or gefitinib (expansion phase)

          -  mandatory entrance biopsy (expansion phase)

        Exclusion Criteria:

          -  interstitial lung disease

          -  unstable brain metastases

          -  leptomeningeal disease
A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
Condition: T Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Sorafenib
Intervention description: Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met.
Intervention MeSH terms: Sorafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: relapsed or refractory T cell lymphoma

Summary:

      This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell
      lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy
      (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other
      transformed T-cell lymphomas with the primary objective of studying the biological effects of
      the multikinase inhibitor, sorafenib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed T-cell lymphoma including PTCL, AITL, CTCL, ALCL (Alk+, and
             Alk-), and other transformed T-cell lymphomas

          -  Age > 18 years old

          -  Measureable disease, as defined by the Cheson criteria

          -  ECOG Performance Status of 0 or 1

          -  Life expectancy > 12 weeks

          -  Adequate bone marrow, liver and renal function

          -  Patients with hemoglobin < 8.5g/dL, or ANC 500-1000/mm3, or platelets
             50,000-75,000/mm3 (Grade 3), whose cytopenias are due to bone marrow involvement by
             T-cell lymphoma will also be eligible

        Exclusion Criteria:

          -  Prior treatment with sorafenib, or other agents with similar activity, i.e.
             bevacizumab, imatinib, sunitinib.

          -  Prior treatment with allogeneic stem cell transplant

          -  Cardiac disease: Congestive heart failure > class II NYHA.
Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps
Condition: Sinusitis; Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Intervention: Verapamil Hydrochloride Intranasal
Intervention description: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Intervention MeSH terms: Verapamil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce
      inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is
      characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial
      of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this
      study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP. The study was
      initially approved as a Phase Ib/II, but only the Phase Ib portion was completed as part of
      this protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the Mass Eye and Ear Sinus Center

          -  Age 18-80 yrs old

          -  Diagnosed with Chronic Rhinosinusitis with Nasal Polyps according to the EPOS 2012
             consensus criteria

          -  Post-operative with a Lund-Kennedy Poly score of <4

          -  Baseline SNOT-22 Score ≥ 30

        Exclusion Criteria:

          -  Patients with the following comorbidities:

          -  GI Hypomotility

          -  Heart Failure

          -  Liver Failure

          -  Kidney Disease

          -  Muscular Dystrophy

          -  Pregnant or Nursing Females

          -  Steroid Dependency

          -  Hypertrophic Cardiomyopathy

          -  Any Atrial or Ventricular arrhythmia (ie. Atrial fibrillation, atrial flutter, etc..)

          -  Resting Heart Rate less than 60 beats per minute

          -  Baseline Systolic Blood Pressure less than 110 mmHg

          -  Baseline Diastolic Blood Pressure less than 70 mmHg

          -  Baseline Mean Arterial Pressure Less than 60 mmHg

          -  PR interval less than 0.12 seconds

          -  Patients taking the following medications:

          -  Aspirin

          -  Beta-blockers

          -  Cimetidine(Tagamet)

          -  Clarithromycin(Biaxin)

          -  Cyclosporin

          -  Digoxin

          -  Disopyramide(Norpace)

          -  Diuretics

          -  Erythromycin

          -  Flecainide

          -  HIV Protease Inhibitors(Indinavir, Nelfinavir, Ritonavir)

          -  Quinidine

          -  Lithium

          -  Pioglitazone

          -  Rifampin

          -  St Johns Wort

          -  Patients with cardiac or conduction abnormality picked up by screening EKG

          -  Post-op patients with surgery within 3 months prior to enrollment.
CyberSenga: Internet-based HIV Prevention in Uganda
Condition: Sexual Abstinence; Condom Use
Intervention: CyberSenga
Intervention description: Internet-based HIV prevention program
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 366.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV prevention; technology; adolescent; developing countries

Summary:

      The investigators propose to design and test an Internet-based HIV prevention program for
      adolescents in Uganda.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrollment in grades Secondary 1 through 4 at a partner secondary school

          -  Having used a computer or the Internet at least once in the past year

          -  Not having been part of the intervention development activities

          -  Caregiver informed permission and adolescent informed assent

        Exclusion Criteria:

          -  none
A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies
Condition: Neoplasm, Malignant
MeSH terms: Neoplasms
Intervention: Sunitinib, Pemetrexed; Sunitinib, Pemetrexed
Intervention description: Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity.; Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity.
Intervention MeSH terms: Pemetrexed; Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Solid tumor; malignancy; sunitinib; pemetrexed; phase 1; neoplasms

Summary:

      This study will assess if the combination of sunitinib and pemetrexed is tolerable when
      coadministered at each recommended dose/schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of a solid malignancy that is refractory to standard therapy
             or for which no standard therapy exists.

          -  Patients has a good performance status (ECOG 0 or 1)

        Exclusion Criteria:

          -  Prior treatment with either pemetrexed or SU011248.

          -  Coughing up blood within 4 weeks before starting study treatment (small amounts okey).

          -  Hypertension that cannot be controlled by medications.
Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Intervention: H.pylori vaccines; Placebo Vaccine
Intervention description: 1 dose of H.pylori vaccine at 0, 1, and 2 months; Placebo Vaccine at 0, 1, and 2 months
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: helicobacter pylori infection; vaccination; adults

Summary:

      To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine,
      compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults 18 - 40 years of age in good health

          -  HP uninfected

          -  not pregnant and agree to use birth control throughout the study (females who can
             become pregnant)

        Exclusion Criteria:

          -  remote or current HP infection
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Purple Grape Juice; Apple Juice
Intervention description: 6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization; 6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 10 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: childhood cancers; cardiovascular disease; childhood cancer survivor

Summary:

      Rationale: Survivors of childhood cancer are at an increased risk of developing
      cardiovascular risk factors as well as early cardiovascular disease, likely due to the
      intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich
      source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and
      healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant
      capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.

      Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce
      oxidative stress and improve the vascular health of survivors of childhood cancer in the
      early stages of cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with cancer > 5 years ago

          -  Off-maintenance therapy for > 36 months

          -  Age 10-30 years

          -  Reside within a 50 mile radius of the University of Minnesota

        Exclusion Criteria:

          -  Pregnant or planning to become pregnant

          -  Start of oral contraceptives < or = 3 months prior to study enrollment

          -  Current smoker

          -  Diabetes (type 1 and 2)

          -  Antibiotic use < 2 weeks prior to study enrollment
A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir F 18
Intervention description: IV injection, 370MBq (10mCi)
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Summary:

      This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy
      volunteers provide the same results. The study will also test two different AV-45 injection
      methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).
    

Eligibility criteria:

        Inclusion Criteria (AD group):

          -  Greater than 50 years of age

          -  Probable AD according to the National Institute of Neurological and Communication
             Disorders and Stroke-Alzheimer's Disease and Related Disorders Association
             (NINCDS-ADRDA) criteria

          -  Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score
             ranging from 10 to 24, boundaries included, at screening

          -  History of cognitive decline gradual in onset and progressive over a period of at
             least 6 months

        Inclusion Criteria (healthy volunteer group):

          -  35 to 55 years of age, inclusive

          -  MMSE of 29 or greater

        Exclusion Criteria (both groups):

          -  Neurodegenerative disorders other than AD, including, but not limited to Parkinson's
             disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome,
             Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear
             palsy

          -  Diagnosis of other dementing / neurodegenerative disease

          -  Diagnosis of mixed dementia

          -  Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain
             infection, brain cancer, endocrine disease, or mental retardation

          -  Clinically significant infarct or possible multi-infarct dementia as defined by the
             NINCDS criteria

          -  Evidence on screening MRI or other biomarker that suggests alternate etiology for
             cognitive deficit (for healthy controls, evidence suggesting the presence of AD
             pathology)

          -  Clinically significant psychiatric disease

          -  History of epilepsy or convulsions

          -  Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances

          -  Current clinically significant cardiovascular disease

          -  Received investigational medication within the last 30 days