bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Intervention: Taliglucerase alfa
Intervention description: Taliglucerase alfa for infusion every two weeks for 24 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Gaucher disease; pediatrics

Summary:

      A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in
      pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher
      disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase)
      or PB-06-005 (naïve treatment with taliglucerase alfa).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of Protocol PB-06-002 or PB-06-005

          -  The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent

        Exclusion Criteria:

          -  Currently taking another investigational drug for any condition.

          -  Presence of neurological signs and symptoms characteristic of Gaucher disease with
             complex neuronopathic features other than longstanding oculomotor gaze palsy.

          -  Presence of any medical, emotional, behavioral or psychological condition that in the
             judgment of the Investigator would interfere with the subject's compliance with the
             requirements of the study.
Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies
Condition: Tumor Lysis Syndrome
MeSH terms: Hematologic Neoplasms; Tumor Lysis Syndrome; Syndrome
Intervention: Febuxostat; Allopurinol
Intervention description: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion); Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 346.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Febuxostat, Tumor lysis syndrome, leukemia, lymphoma

Summary:

      The purpose of this study is to determine whether febuxostat is superior to allopurinol in
      the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at
      intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo
      chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for first cytotoxic chemotherapy cycle, regardless of the line of
             treatment, because of hematologic malignancies at intermediate or high risk of TLS
             (according to the TLS risk stratification, Cairo M et al, British Journal of
             Haematology, 2010)candidate to Allopurinol treatment or have no access to Rasburicase

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3

          -  Life expectancy > 1 month

        Exclusion Criteria:

          -  Patients known to be hypersensitive to Febuxostat or Allopurinol or to any of the
             components of the formulations

          -  Patients with sUA levels ≥ 10 mg/dL at randomization

          -  Patients receiving Febuxostat, Allopurinol or any other urate lowering therapy (e.g.
             Rasburicase, probenecid) within 30 days prior to randomization

          -  Patients with severe renal and/or hepatic insufficiency

          -  Patients with diagnosis of LTLS or CTLS at randomization
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Condition: Knee Injury
MeSH terms: Knee Injuries
Intervention: Primary injury site; Backfill site
Intervention description: Autograft will be placed in the primary defect site.; Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: allograft; knee injury; cartilage injury

Summary:

      The objective of this study is to determine how effective a plug made out of human bone
      (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the
      patient has to their knee).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 55 years

          -  skeletally mature

          -  Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b,
             3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial
             Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with
             weight bearing and squatting, locking of joints and or swelling

          -  Functional meniscal tissue (defined as 5 mmor greater)

          -  A score of = or greater than 4 on the VAS questionnaire

        Exclusion Criteria:

          -  Associated tibial or patellar articular cartilage defect greater than 2 ICRS

          -  Osteoarthritis of either knee

          -  Mechanical axis malalignment of greater than 5 degrees

          -  Patellofemoral incongruity on Merchant view

          -  One or more multiple defects greater than 2.5 cm

          -  Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm

          -  Ligament treatments in the affected knee within one year prior to current study

          -  Previous surgical meniscus treatment in the affected knee in the last 6 months

          -  Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment

          -  use of any investigational therapy within 30 days prior to the first visit

          -  Corticosteroid or viscosupplementation within the past 3 months

          -  A score of 3 or less on the VAS questionnaire

          -  Active gout or pseudogout or systemic inflammatory condition

          -  Microfracture less than one year prior to current study
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Intervention: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC); 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 354.0
Sex: All
Minimum age: 28 Days
Maximum age: 54 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal conjugate vaccine

Summary:

      The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy
      infants in Brazil for safety and tolerability, and to determine the immune response to the
      vaccines.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy 1 month old infants

          -  Available for the duration of the study and reachable by telephone

          -  Able to complete two blood drawing procedures during the study

        Exclusion criteria:

          -  Previous vaccination, contraindication or history of allergic reaction to vaccine or
             vaccine components

          -  Bleeding disorder, immune deficiency or significant chronic or congenital disease

          -  Previous receipt of blood products or immune globulin
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB); Infliximab (INF) + MTX, DB; Placebo (PLA) + MTX, DB; PLA + MTX switched to ABA+ MTX, DB; ABA, open-label (OL)
Intervention description: Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.; Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.; Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.; Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months; Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
Intervention MeSH terms: Infliximab; Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 431.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if Abatacept or Infliximab in
      combination with Methotrexate demonstrate a greater reduction in disease activity over
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Rheumatoid Arthritis

          -  At least 3 months prior treatment with Methotrexate (MTX)

          -  At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1
             mg/dl

          -  Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

        Exclusion Criteria:

          -  participants who have failed more than 3 DMARDs

          -  participants previously treated with an approved biologic drug

          -  History of cancer in the last 5 years

          -  Severe or recurrent bacterial infection

          -  Any previous or current medical conditions that are contraindications to the use of
             TNF blocking agents

          -  Women of Child Bearing Potential
A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; rituximab [MabThera/Rituxan]
Intervention description: >=15 mg po/week; 1g iv on days 1 and 15
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the safety of MabThera plus methotrexate in patients with
      rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents.
      Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate
      >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  rheumatoid arthritis >=6 months;

          -  lack of response to 1-5 DMARDs or biological agents;

          -  rheumatoid factor positive.

        Exclusion Criteria:

          -  other chronic inflammatory articular disease or systemic rheumatic disease;

          -  joint or bone surgery during 8 weeks prior to randomization;

          -  previous treatment with any cell-depleting therapy.
Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: 13 valent pneumococcal conjugate vaccine; 13 valent pneumococcal conjugate vaccine
Intervention description: TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5; TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1116.0
Sex: All
Minimum age: 50 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal Conjugate Vaccine

Summary:

      This study is to evaluate the safety, tolerability and immune response when 13-valent
      pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are
      given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal
      polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also
      evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of
      13vPnC given 5 years after the first dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 50 to 59 years

          -  Determined by medical history, physical examination and clinical judgement to be
             eligible for the study

          -  Able to complete electronic diary

          -  Available for the 5 year 9 month duration of the study

        Exclusion Criteria:

          -  Previous vaccination with any licensed or experimental pneumococcal vaccine

          -  Allergic to egg proteins and chicken proteins

          -  History of Guillian-Barre syndrome

          -  Vaccination with TIV within 6 months before study start

          -  Vaccination with diphtheria-containing vaccine within 6 months of study start

          -  Serious chronic disorders including immunodeficiency or metastatic malignancy

          -  Known or suspected hypersensitivity to any vaccine or vaccine component
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Condition: Biliary Tract Neoplasms
MeSH terms: Biliary Tract Neoplasms
Intervention: Durvalumab; Placebo
Intervention description: IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.; IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Intervention MeSH terms: Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Durvalumab in Combination with Gemcitabine plus Cisplatin Placebo in Combination with Gemcitabine plus Cisplatin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 810.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: First-Line Advanced Biliary Tract Cancers (BTC); Durvalumab; Gemcitabine/Cisplatin; Placebo

Summary:

      Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line
      Advanced Biliary Tract Cancer (TOPAZ-1)
    

Eligibility criteria:

        Inclusion

          1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including
             cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.

          2. Patients with previously untreated disease if unresectable or metastatic at initial
             diagnosis will be eligible.

          3. Patient with recurrent disease >6 months after curative surgery or >6 months after the
             completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.

          4. WHO/ECOG PS of 0 or 1

        Exclusion

          1. History of another primary malignancy

          2. Brain metastases or spinal cord compression

          3. Uncontrolled intercurrent illness

          4. Major surgical procedure within 28 days prior to the first dose of IP.

          5. Prior locoregional therapy such as radioembolization
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
Condition: Infertility
MeSH terms: Infertility
Intervention: highly purified human chorionic gonadotropin; recombinant human chorionic gonadotropin
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 176.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No

Summary:

      This trial is investigating the efficacy and safety of highly purified human chorionic
      gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of
      final follicular maturation in women undergoing controlled ovarian stimulation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal females between the ages of 18 and 39 years

          -  Documented history of infertility

          -  Body mass index (BMI) between 17.5 and 32.0 kg/m2

          -  Regular menstrual cycles

        Exclusion Criteria:

          -  Known endometriosis stage III and IV

          -  Known polycystic ovarian syndrome (PCOS)

          -  History of recurrent miscarriage

          -  History of more than three previous controlled ovarian stimulation cycles
A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Sildenafil citrate; Sildenafil citrate; Sildenafil citrate
Intervention description: Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight >20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight >45 kg: 80 mg 3 times a day (tid); Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg; Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight >20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight >45 kg: 40 mg 3 times a day (tid)
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: children

Summary:

      Active treatment, dose-blinded extension study evaluating the safety and long term efficacy
      of sildenafil citrate in children with PAH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must complete the 16 Week double-blind efficacy study A1481131.

        Exclusion Criteria:

          -  Any patient who did not complete Study A1481131.
Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo); Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin); Placebo
Intervention description: Applied to the entire face twice daily for 10 weeks; Applied to the entire face twice daily for 10 weeks; Placebo
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1555.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel
      Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical
      Gel (Clindamycin- Benzoyl Peroxide Gel).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women, 12 to 65 years of age

          -  Willing to participate and sign provide written consent

          -  Moderate to severe acne

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or
             lincomycin

          -  Use of systemic, topical or facial products which may interfere with the study

          -  Participation in any clinical study in the 30 days prior to study entry

          -  Prolonged exposure to sunlight or excessive exposure to UV lights

          -  Chronic use of NSAIDS
Ginkgo Biloba Prevention Trial in Older Individuals
Condition: Dementia; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Ginkgo biloba; Placebo
Intervention description: 120mg twice a day; One pill twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3069.0
Sex: All
Minimum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence
      of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and
      functional disability, reducing incidence of cardiovascular disease, and decreasing total
      mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-demented participants

          -  Willing to participate in a seven-year follow-up trial of Ginkgo Biloba

          -  English is their usual language

          -  Willing informant who has frequent contact with the participant

        Exclusion Criteria:

          -  Currently on anticoagulant therapy

          -  Cancer diagnosed and treated within the past two years (except for skin cancer)

          -  Participant with class III - IV congestive heart failure

          -  Currently being treated with psychopharmacological drugs for depression

          -  Hospitalized for depression within the last year

          -  Taking Aricept (or similar agents) for cognitive problems or dementia

          -  Baseline blood creatinine >2

          -  Baseline SGGT is a marker of liver function (3 x normal>or=90 IU)

          -  Baseline hematocrit<30

          -  Baseline white blood count>or=15,000