bioihbjkbjnl/mcl2 huggingface dataset:
Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)
Condition: Neoplasms, Glandular and Epithelial; Diphtheria; Tetanus; Whooping Cough; Meningitis
MeSH terms: Tetanus; Diphtheria; Whooping Cough; Neoplasms, Glandular and Epithelial; Meningitis
Intervention: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine; Comparator: Menactra™ (Concomitant); Comparator: Adacel™ (Concomitant); Comparator: Menactra™ (Non-concomitant); Comparator: Adacel™
Intervention description: Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a
0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.; A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1; a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1; A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1; A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1042.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types
      6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined
      diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in
      adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity
      of the concomitant vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be healthy boys or girls, 11-17 years of age

          -  Must be a virgin with no intention of becoming sexually active during the study period

          -  Must have been properly vaccinated against diphtheria, tetanus and pertussis

        Exclusion Criteria:

          -  Must not have received a vaccine against diphtheria, tetanus and pertussis in the past
             5 years

          -  Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal
             vaccine
Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Dapagliflozin; Dapagliflozin; Placebo; Dapagliflozin; Dapagliflozin
Intervention description: tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I); Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I); Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I); Placebo; tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II); tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1240.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Dapagliflozin; efficacy; safety; add on to insulin; Oral AntiDiabetic; Type 2 diabetes

Summary:

      This study is being carried out to see if Dapagliflozin in addition to insulin is effective
      and safe in treating patients with type 2 diabetes when compared to placebo (identical
      looking inactive treatment) in addition to insulin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes

          -  Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at
             least 30 IU of injectable insulin per day either without any other oral antidiabetic
             drug or with a stable dose of oral antidiabetic drugs

        Exclusion Criteria:

          -  Type 1 Diabetes

          -  Treatment with more than two additional oral antidiabetic drugs

          -  Moderate and severe renal (kidney) failure or dysfunction
Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
Condition: Normal Pressure Hydrocephalus
MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure
Intervention: [18F]Flutemetamol
Intervention description: All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
Intervention MeSH terms: Flutemetamol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Amyloid; Normal pressure hydrocephalus (NPH); Positron Emission Tomography (PET); Standard uptake value ratios (SUVR)

Summary:

      To determine the level of association between the quantitative estimates of brain uptake of
      [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of
      amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement
      for NPH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is at least 50 years of age.

          -  The subjects' general health is adequate to comply with study procedures.

          -  The subject has been scheduled for a shunt placement procedure for the treatment of
             NPH.

        Exclusion Criteria:

          -  The subject has a contraindication for MRI or PET.

          -  The subject is pregnant or lactating.

          -  The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or
             to any of the excipients.

          -  The subject has participated in any clinical study using an investigational agent
             within 30 days of dosing.
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Condition: Asthma
MeSH terms: Asthma
Intervention: Vitamin D 3 cholecalciferol; Vitamin D3
Intervention description: Dosage form oral Dosage 4000IU Vitamin D 3 cholecalciferol; 4000 IU of vitamin D3 administered orally once a day during pregnancy
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 876.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Vitamin D; Randomized Control Trial

Summary:

      Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and
      children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema,
             allergic rhinitis in the biological father of the child

          -  Gestational age between 10 and 18 weeks at the time of randomization

          -  Maternal age between 18 and 39 years

          -  Not a current smoker

          -  English or Spanish speaking

          -  Intent to participate for the full 4 years (through Pregnancy and then until the 3rd
             birthday of the child)

        Exclusion Criteria:

          -  Not meeting inclusion criteria

          -  Gestational age greater than 18 weeks

          -  Presence of chronic medical conditions

          -  Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3

          -  Multiple gestation pregnancy (twins, triplets)

          -  Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Disease Progression
Intervention: pravastatin; Placebo
Intervention description: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years); Placebo daily
Intervention MeSH terms: Pravastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 8 Years
Maximum age: 22 Years
Healthy volunteers: No
Keywords: Autosomal dominant polycystic kidney disease; Cystic kidney disease; High blood pressure; Statin

Summary:

      The purpose of this study is to determine whether the medication pravastatin will ameliorate
      renal and cardiovascular disease over a 3-year period in children and young adults with
      autosomal dominant polycystic kidney disease (ADPKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 8-22 years

          -  Autosomal dominant polycystic kidney disease

          -  Normal kidney function

        Exclusion Criteria:

          -  Abnormal kidney function

          -  Past allergic history to medications used in study

          -  Liver disease

          -  Muscle disease/dystrophy

          -  Pregnancy, planned pregnancy, or lactation within study period

          -  Inability to cooperate with or clinical contraindication for magnetic resonance
             imaging
Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
Condition: Malignant Neoplasm
MeSH terms: Neoplasms; Stomatitis
Intervention: Dexamethasone; Placebo; Questionnaire; Quality-of-Life Assessment; Everolimus
Intervention description: Given as mouthwash; Given as mouthwash; Ancillary studies; Ancillary studies; Standard of care
Intervention MeSH terms: Dexamethasone; Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral
      stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced
      oral stomatitis so as to improve quality of life in cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without
             an endocrine agent. Patients about to receive everolimus for off label use for any
             cancer are also eligible.

          -  Not currently receiving chemotherapy or any other agent known to cause mucositis or
             stomatitis. Trastuzumab and ovarian function suppression are allowed.

          -  Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed
             at least 2 weeks prior to registration.

          -  Not currently suffering from stomatitis/mucositis or mouth ulcers. Patients should not
             have had any stomatitis or mouth pain for at least 7 days prior to registration.

          -  Patients should not receive any other agent which would be considered treatment for
             stomatitis or impact the primary endpoint.

          -  No history of candida infection (thrush) within the last 3 months.

          -  Not currently being treated with corticosteroids.

          -  No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%, although
             A1C is not needed for all patients, hemoglobin (Hgb)A1C < 8 is required for everyone
             with diabetes or suspected diabetes.

          -  Patients must be able to read and comprehend English. Local translation, including
             verbal translation of professionals (PROs) is not permitted.

          -  Not pregnant and not nursing, because this study involves an investigational agent
             whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn
             are unknown. Therefore, for women of childbearing potential only, a negative pregnancy
             test done =< 7 days prior to registration is required.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Enbrel 50 mg Prefilled Syringe; Enbrel 50 mg Autoinjector
Intervention description: Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe; Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 640.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of this study is to explore and compare the perceptions and satisfaction for two
      different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept
      Prefilled Syringe) in patients with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion:

          -  Diagnosis of RA according to the ACR-Criteria.

          -  Eligible for treatment with etanercept according to Summary of Product Characteristics
             (SmPC), and applicable local guidelines.

          -  Willing and able to self-inject etanercept.

        Exclusion:

          -  Prior experience of biologics and anti-TNF treatment for their RA including
             etanercept.

          -  Sepsis or risk of sepsis.

          -  Current or recent infections, including chronic or localized.
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: 68Ga-DOTATOC
Intervention description: The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
Intervention MeSH terms: Edotreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga)
      -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging
      techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT).
      Participants with histologically and/or clinically confirmed and/or suspected NET will be
      enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Patients of either gender, aged ≥18 years.

          -  Karnofsky status ≥60.

          -  Life expectancy of at least 12 weeks.

          -  Histologically and/or clinically confirmed and/or suspicious of NET.

          -  A diagnostic CT or MRI of the tumour region or suspected area within the previous 12
             weeks prior to dosing day is available.

          -  Somatostatin-analogue scintigraphy scan with result (positive or negative) within the
             last 12 weeks.

          -  Recent Blood test results up to 4-6 weeks as follows:

               1. White Blood Cell (WBC): >2*109/L

               2. Haemoglobin: >8.0g/Dl

               3. Platelets: >50x109/L

               4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline
                  phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal
                  (ULN)

               5. Bilirubin less than, or equal to, three times its ULN

          -  Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or
             older.

          -  Negative pregnancy test in women capable of child-bearing.

        Exclusion Criteria:

          -  Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of
             68Ga-DOTATOC.

          -  Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting
             Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If
             a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the
             injection of the study drug.

          -  Pregnant or breast-feeding women.

          -  Current somatic or psychiatric disease/condition that may interfere with the
             objectives and assessments of the study.
Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Condition: Bipolar Disorder; Substance Use Disorder
MeSH terms: Substance-Related Disorders; Bipolar Disorder
Intervention: Icariin
Intervention description: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study is being done to see if icariin will help with depression in patients with bipolar
      disorder and alcohol or cocaine use disorders. The pills used in this study contain 20%
      icariin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current BPD I, II or NOS and cocaine or alcohol use disorder with HAMD score of ≥ 15

          -  Cocaine or alcohol use with 5 days of initiating study drug

          -  Men and women

          -  Age 18-70 years

        Exclusion Criteria:

          -  Psychotic features

          -  Non-English speakers

          -  Treatment resistant depression defined as failure of a trial of antidepressants (≥ 4
             weeks at a therapeutic dose) in current episode

          -  Major medical condition including heart, lung, liver or renal disease, cancer,
             neurological or immunological conditions

          -  Vulnerable populations including prisoners, cognitively impaired individuals, and
             pregnant or nursing women

          -  Prior side effects or allergic reactions to icariin-containing preparations

          -  Change in psychotropic medications within 14 days of study entry

          -  Current suicidal ideation (plan and intent), a suicide attempt within the past 12
             months or history of > 1 lifetime suicide attempt
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
Condition: Fibrillation, Atrial
MeSH terms: Atrial Fibrillation
Intervention: omega-3-acid ethyl esters; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 663.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lovaza; Omega-3 fatty acids; Omacor; Paroxysmal atrial fibrillation

Summary:

      The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl
      esters) in patients with recurrent, symptomatic atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18 years or older

          -  History of symptomatic atrial fibrillation (either paroxysmal or persistent)

          -  Provide written informed consent and authorization for protected health information
             disclosure

        Exclusion Criteria:

          -  Permanent (chronic) atrial fibrillation

          -  Antiarrhythmic drug therapy which cannot be stopped

          -  Use of amiodarone with prior 6 months

          -  History of unsuccessful cardioversion

          -  History of certain cardiovascular conditions or cardiac surgery within prior 6 months

          -  History of stroke within prior 6 months

          -  Implanted cardio-defibrillator

          -  Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic
             conditions, or cancer (except non-melanoma skin cancer)

          -  Poorly controlled diabetes