bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
Condition: Papillomavirus Infections; Genital Diseases, Female
MeSH terms: Papillomavirus Infections; Genital Diseases; Genital Diseases, Female
Intervention: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20; Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40; Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80; Placebo (mcg) (Aluminum Adjuvant)225; Placebo (mcg) (Aluminum Adjuvant) 450
Intervention description: 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.; 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.; 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.; placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.; placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1158.0
Sex: Female
Minimum age: 16 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV 6/11/16/18 infection and related genital disease

Summary:

      This study was conducted in 2 parts. Part A was a randomized, double-blind,
      placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a
      randomized, double-blind (operating under in-house blinding procedures), placebo-controlled,
      multicenter, dose-ranging study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy females 16 to 23 years of age

          -  Not pregnant at enrollment and must have agreed to use effective contraception through
             Month 7 of the study

          -  Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative
             sexual intercourse occurred)

        Exclusion Criteria:

          -  No prior receipt of an Human Papillomavirus (HPV) vaccine

          -  No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment
             or receipt of live vaccines within 21 days prior to enrollment

          -  No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy
             showing cervical intraepithelial neoplasia (CIN)

          -  No prior history of genital warts or treatment for genital warts
Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
Condition: Evidence of Liver Transplantation; Rejection; ALEMTUZUMAB
Intervention: Alemtuzumab
Intervention description: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
Intervention MeSH terms: Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 4 Months
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Rejection

Summary:

      This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath,
      Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal
      transplant. Seventy-five subjects receiving primary or repeat intestine transplantation will
      be enrolled. Primary endpoints include the incidence and severity of biopsy-proven acute
      cellular rejection, the incidence of freedom from steroids at 5 years, and the incidence of
      subjects with steroid-free Tacrolimus at whole blood concentrations < 10 ng/ml. Secondary
      endpoints include a) incidence and severity of opportunistic infections (CMV and EBV),
      post-transplant lymphoproliferative disorder (PTLD), and chronic rejection b) use of
      non-immunosuppressive co-medications, c) time to repopulation of all lymphocyte subsets, d)
      longitudinal characterization of donor-specific alloreactivity in mixed lymphocyte responses
      (MLR), to identify the time at which it decreases to a level less than third-party-specific
      alloreactivity e) longitudinal expression (mRNA) of genes, to identify rejection- and
      non-rejection-specific genes and f) characterization of whole genome mutations, which show
      differences in parent-to-child transmission between rejectors and non-rejectors. This will
      identify rejection- and non-rejection-specific genes bearing genetic variants, which might
      impact on gene function, and complement candidate gene identification efforts based on SNP
      transmission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 0-25 years

          -  male and female

          -  Primary intestine transplantation, repeat intestine transplantation, and intestine
             transplantation in the setting of a previous or simultaneous liver transplantation

        Exclusion Criteria:

          -  documented non-compliance

          -  known hypersensitivity to egg protein

          -  pregnancy

          -  malignancy

          -  hepatitis C and B defined as anti-HCV antibody positive, and anti-Hepatitis B surface
             antigen or Hepatitis B core antibody positive or HBV DNA positive.
Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: vedolizumab
Intervention description: Vedolizumab for intravenous (IV) infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This was an open-label study to provide an opportunity for participants with Ulcerative
      Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve
      participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to
      determine the long term safety of vedolizumab in patients afflicted with these diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD)

               -  Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD

               -  Partial Mayo score of 2 - 7 for participants with UC

          -  Patient should be appropriate candidate for biologic therapy per guidelines

          -  Up-to-date on cancer screening

          -  No severe systemic disease

          -  Patients with evidence of abscess

          -  Agree to comply with study procedures including contraception

        Exclusion Criteria:

          -  Low lymphocyte counts

          -  History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other
             neurological illness

          -  Active or recent serious infections

          -  Recent treatment with biologic (i.e., Remicade) or investigational drug

          -  Impending surgery

          -  Any participants with vedolizumab human anti-human antibody (HAHA) titers ≥1:125 or
             with a previous immediate hypersensitivity reaction during or shortly after
             vedolizumab infusion
A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; erlotinib
Intervention description: 500 milligrams per meter squared (mg/m^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops; 150 mg, orally, once daily until progression or unacceptable toxicity develops
Intervention MeSH terms: Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the combination of erlotinib and pemetrexed versus
      either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time
      until the objective worsening of the disease) in patients who have never smoked and have
      locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a
      first-line chemotherapy treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer

          -  Patients must be non-smokers

          -  Patients must have at least one measurable lesion

          -  Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale

          -  Patients must have failed only one prior chemotherapy regimen and must be considered
             eligible for further chemotherapy following progression of their disease.

        Exclusion Criteria:

          -  Patients who have received treatment within the last 30 days with a drug that has not
             received regulatory approval for any indication

          -  Patients who have previously received treatment with drugs against the human epidermal
             growth factor receptors

          -  Patients who have previously received treatment with drugs which have similar targets
             as Pemetrexed

          -  Patients who have any known significant ophthalmologic abnormalities of the surface of
             the eye

          -  Patients who have a history of severe hypersensitivity reaction to erlotinib or
             pemetrexed
Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: eptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated)
Intervention description: 90 mcg/kg, injected i.v.; 5 mcg/kg, injected i.v.; 10 mcg/kg, injected i.v.; 20 mcg/kg, injected i.v.; 40 mcg/kg, injected i.v.; 80 mcg/kg, injected i.v.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.

      The aim of this trial is to evaluate the safety and efficacy of activated recombinant human
      factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older (at least 18 years in Croatia, France and United Kingdom
             (UK))

          -  Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor
             titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the
             past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response

          -  Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring
             haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds
             (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within
             the previous 12 months at trial entry

        Exclusion Criteria:

          -  Known allergy to rFVIIa, and/or suspected allergy to trial product

          -  Platelet count lower than 50,000 mm^3 based on medical records at trial entry (visit
             1)

          -  Any clinical signs or history of thromboembolic events

          -  Advanced atherosclerotic disease

          -  Severe liver disease based on medical records within the past 12 months at trial entry
             (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit
             of normal reference range

          -  Known active pseudo tumours (documented bleeding requiring treatment within the last 3
             months

          -  Subject had any (major) surgical procedure in the 30 days prior to screening into the
             trial. a. Catheter, ports and dental extractions do not count as surgeries and will
             not exclude the subject
Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone
Condition: Fragile X-associated Tremor/Ataxia Syndrome
MeSH terms: Ataxia; Cerebellar Ataxia; Tremor; Syndrome
Intervention: Allopregnanolone
Intervention description: Allopregnanolone is an endogenous inhibitory pregnane neurosteroid. It is synthesized from progesterone, and is a potent positive allosteric modulator of the action of γ-aminobutyric acid at GABAA receptor. Subjects will receive up to 12 infusions in the study. Subjects will all begin with 2.0 mg dosage. If tolerated, the next infusion will be 4.0 mg, and if that is tolerated, the next infusion will be 6.0 mg. Subject infusions will remain stable at the highest dosage tolerated for the remainder of the study. Each infusion will consist of 2.0 mg, 4.0 mg, or 6.0 mg aliquots of the 0.5 mg/ml allopregnanolone in 6% sulfobutylether-β-cyclodextrin with 0.9% sodium chloride injection solution.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a
      possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).
    

Eligibility criteria:

        Inclusion Criteria

          -  Fragile X premutation carrier status (55 to 200 CGG repeats in FMR1),

          -  Diagnosis of FXTAS including an intention tremor and/or ataxia and/or deficits on the
             BDS-2 demonstrating executive function deficits.

        Exclusion Criteria

          -  other genetic problems in addition to the premutation

          -  a history of significant brain trauma

          -  significant substance abuse

          -  inability to follow the protocol

          -  liver or kidney disease

          -  heart failure

          -  active cancer

          -  other serious systemic disease

          -  current use of phenytoin
Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
Condition: Tooth Erosion
MeSH terms: Tooth Erosion
Intervention: Sodium fluoride; Sodium monoflurophosphate; Sterile water
Intervention description: Test fluoride toothpaste and test fluoride mouth rinse; United Kingdom marketed fluoride toothpaste; Sterile water rinse
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: enamel erosion; tooth remineralization; tooth erosion

Summary:

      An in situ model will be used to evaluate and compare enamel remineralization of bovine
      enamel specimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An intact maxillary dental arch suitable for the retention of the palatal appliance
             and an intact mandibular dental arch - subjects may have fixed bridges replacing
             missing teeth

          -  No current active caries or periodontal disease that may compromise the study or the
             health of the subjects

          -  A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute
             and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

        Exclusion Criteria:

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients
Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis
Condition: Herpes Zoster Keratitis
MeSH terms: Herpes Simplex; Herpes Zoster; Herpes Zoster Ophthalmicus; Keratitis
Intervention: gancyclovir gel; Hypromellose gel
Intervention description: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.; 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.
Intervention MeSH terms: Ganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the
      treatment of herpes zoster keratitis. Half the patients will receive the study drug while the
      other half of the patients will receive the placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 and above

          -  have not been on gancyclovir gel or any other form of topical antiviral therapy for
             the past month

          -  able and willing to attend subsequent follow-up visits

        Exclusion Criteria:

          -  Associated retinitis

          -  patients who are allergic to gancyclovir

          -  patients who will require systemic or intra-vitreal gancyclovir therapy

          -  patients who are pregnant or breastfeeding
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: rituximab [MabThera/Rituxan]; Methotrexate; Cytarabine
Intervention description: 750mg/m2 iv; 8g/m2 iv; 2g/m2 iv
Intervention MeSH terms: Cytarabine; Rituximab; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus
      high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible
      patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus
      methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week
      11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample
      size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-80 years of age;

          -  histological diagnosis of primary central nervous system lymphoma;

          -  B-cell proliferation verified by positive staining for CD20;

          -  >=1 measurable lesion.

        Exclusion Criteria:

          -  prior chemotherapy, other than corticosteroids, >=6 weeks before and after diagnosis
             or surgery;

          -  history of prior cranial irradiation;

          -  evidence of plurisystemic non-Hodgkin's lymphoma;

          -  other active malignant disease (other than basal cell or squamous cell cancer of
             skin,or cancer in situ of cervix;

          -  uncontrolled active infection.
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
Condition: COVID-19
MeSH terms: COVID-19
Intervention: AT-527; Placebo; AT-527; Placebo
Intervention description: One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days; One placebo tablet administered every ~12 hours (twice a day) for a total of 5 days; Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days; Two placebo tablets administered every ~12 hours (twice a day) for a total of 5 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Blinded
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the safety, tolerability, antiviral activity and
      efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors
      for poor outcomes (such as obesity (BMI>30), hypertension, diabetes or asthma). Eligible
      subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo
      tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg
      BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard
      of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety
      observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Hospitalized or in a hospital-affiliated confinement facility

          -  SARS-CoV-2 positive

          -  Initial COVID-19 symptom onset within 5 days prior to Screening

          -  SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to
             maintain SpO2 ≥ 93%

          -  Must also have a history of at least one of the following known risk factors for poor
             outcomes: obesity (BMI>30), hypertension, diabetes or asthma.

        Key Exclusion Criteria:

          -  Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 <93% on room air or
             requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood
             pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300

          -  Requires mechanical ventilation

          -  Lobar or segmental consolidation on chest imaging.

          -  Treatment with other drugs thought to possibly have activity against SARS-CoV-2

          -  ALT or AST > 5 x upper limit of normal (ULN)

          -  Female subject is pregnant or breastfeeding

          -  Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day
             14 visit (Part B).