bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older
Condition: Pneumococcal Vaccines; Pneumococcal Conjugate Vaccine
Intervention: 13-valent pneumococcal conjugate vaccine; 23-valent pneumococcal polysaccharide vaccine
Intervention description: A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.; A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 764.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 13VPNC; 23VPS

Summary:

      The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a
      single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of
      23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy Japanese male and female adults aged 65 years old and older at time of
             enrollment. Subjects with preexisting stable disease, defined as disease not requiring
             significant change in therapy or hospitalization for worsening disease 12 weeks before
             receipt of the study vaccine, are eligible.

          2. Male and female subjects of childbearing potential must agree to use a highly
             effective method of contraception throughout the study or for at least 28 days after
             the last dose of the study vaccine whichever is longer.

        Exclusion Criteria:

          1. History of severe adverse reaction including hypersensitivity such as anaphylaxis
             associated with a vaccine or vaccine component.

          2. Previous vaccination with any licensed or experimental pneumococcal vaccine.

          3. Documented Streptococcus pneumoniae infection within the past 5 years.

          4. Residence in a nursing home, long-term care facility, or other institution or
             requirement of semiskilled nursing care.
Preoperative CHG Cloth on Healthy Subjects
Condition: Surgery
Intervention: Chlorhexidine Gluconate; Vehicle; DynaHex-2
Intervention description: comparison with other CHG products; Excipients of CHG product only.; 2% CHG solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 879.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preoperative surgical skin preparation

Summary:

      Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or Females

          -  16 years of age or older

          -  Signed informed consent

          -  Good Health

          -  Six inches of abdomen and groin areas without tattoos, or skin disorders

        Exclusion Criteria:

          -  Dermatological Conditions

          -  Sensitivity to latex

          -  Sensitivity to CHG
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Durvalumab; Tremelimumab (Regimen 1); Tremelimumab (Regimen 2); Sorafenib; Durvalumab (Regimen 1); Durvalumab (Regimen 2)
Intervention description: Durvalumab IV (intravenous infusion).; Tremelimumab IV (intravenous infusion).; Tremelimumab IV (intravenous infusion).; Sorafenib, as per standard of care; Durvalumab IV (intravenous infusion).; Durvalumab IV (intravenous infusion).
Intervention MeSH terms: Sorafenib; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1324.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma Non-Resectable

Summary:

      This is a randomized, open-label, multi-center, global, Phase III study to assess the
      efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab
      monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for
      unresectable HCC. The patients cannot be eligible for locoregional therapy
    

Eligibility criteria:

        Inclusion criteria

          -  HCC based on histopathological confirmation

          -  No prior systemic therapy for HCC

          -  Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional
             therapy) or stage C

          -  Child-Pugh Score class A

          -  ECOG performance status of 0 or 1 at enrollment

        Exclusion criteria

          -  Hepatic encephalopathy within past 12 months or requirement for medication to prevent
             or control encephalopathy

          -  Clinically meaningful ascites

          -  Main portal vein tumor thrombosis

          -  Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding)
             within 12 months

          -  HBV and HVC co-infection, or HBV and Hep D co-infection
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: BDP; Placebo
Intervention description: Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.; Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
Intervention MeSH terms: Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric Subjects

Summary:

      The purpose of this study is to compare the effect of 6 weeks of treatment with
      beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as
      assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability
      of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent/(assent - if applicable)

          -  Male or female subjects 6-11 years of age

          -  General good health

          -  A documented history of PAR to a relevant perennial allergen for a minimum of 12
             months

          -  Other criteria apply

        Exclusion Criteria:

          -  Pregnancy, nursing, or plans to become pregnant or donate gametes

          -  Participation in any investigational drug study within the 30 days preceding the
             Screening Visit 1 (SV1)

          -  Previous participation in a BDP nasal aerosol study as a randomized subject

          -  A known hypersensitivity to any corticosteroid or any of the excipients in the study
             medication formulation

          -  History of physical findings of nasal pathology, including nasal polyps or other
             clinically significant respiratory tract malformations

          -  History of a respiratory infection or disorder within the 14 days preceding the
             Screening Visit 1 (SV1)

          -  Use of any prohibited concomitant medications within the prescribed (per protocol)
             withdrawal periods prior to the Screening Visit 1 (SV1)

          -  Other criteria apply

          -  Current smoker or current user of tobacco products at any time during the study;
             history of smoking or use of tobacco products within the past year
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate nasal spray (MFNS); Matching placebo nasal spray
Intervention description: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days; Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 333.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study seeks to prospectively demonstrate that Nasonex is better than placebo in
      relieving nasal congestion in patients with seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject must be 12 years of age or older, of either sex, and of any race.

          -  A subject must have at least a 2-year history of SAR which exacerbates during the
             study season.

          -  A subject must have a positive skin prick test response to an appropriate seasonal
             allergen at Visit 1.

          -  A subject must be clinically symptomatic at the Screening and Baseline Visits.

        Exclusion Criteria:

          -  A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.

          -  A subject who has had an upper respiratory tract or sinus infection that required
             antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or
             who has had a viral upper respiratory infection within 7 days prior to the Screening
             Visit.

          -  A subject who has used any drug in an investigational protocol in the 30 days prior to
             the Screening Visit.

          -  A subject who is participating in any other clinical study.

          -  A subject who is part of the staff personnel directly involved with this study.

          -  A subject who is a family member (parent, spouse, or sibling) of the investigational
             study staff.

          -  A female subject who is breast-feeding, pregnant, or intends to become pregnant.

          -  A subject previously randomized into this study.

          -  A subject who has a family member (parent, spouse, or sibling) currently enrolled in
             this study.
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent pneumococcal conjugate vaccine
Intervention description: A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 6 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety, tolerability and immunogenicity of a single dose of
      13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are
      considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal
      vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese males and females aged 6 to <65 years at enrollment.

          -  Subjects with an increased risk of pneumococcal disease determined by documented
             medical history, physical examination, and clinical judgment of the investigator.

        Exclusion Criteria:

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt during study participation.

          -  End-stage disease including but not limited to metastatic malignancy, severe chronic
             obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal
             disease with or without dialysis.

          -  Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months
             before investigational product administration or history of HSCT, or potential for
             solid organ transplant or HSCT during study participation.

          -  Receipt of cytotoxic chemotherapy or blood products within 3 months before
             investigational product administration or anti-B-cell antibodies within 6 months
             before investigational product administration through completion of study
             participation.

          -  Any contraindication to vaccination or vaccine components, including previous
             anaphylactic reaction to any vaccine or vaccine-related components.

          -  Documented S pneumoniae infection within the past 5 years before investigational
             product administration.
In-vivo Efficacy of Patient Preoperative Prep
Condition: Surgical Skin Preparation
Intervention: ZuraPrep; ChloraPrep; ZP Vehicle
Intervention description: Apply topically.; Apply topically.; Apply topically.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to demonstrate the antimicrobial efficacy of the ZP
      Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good health

          -  Minimum skin flora baseline requirements on abdomen and groin

          -  Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder
             near or on the applicable test area.

        Exclusion Criteria:

          -  Topical or systemic antimicrobial exposure within 14 days prior to screening and
             treatment days, including antibiotics.

          -  Subjects with a history of skin sensitivity, skin allergies, or skin cancer.

          -  Subjects who are pregnant, attempting pregnancy or nursing.
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Previous treatment in DEB025 study
Intervention description: Follow-up after DEB025 active study
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C, chronic

Summary:

      Follow-up for viral activity, changes in liver function and safety in patients with no SVR24
      in feeder studies
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females aged ≥18

          2. Have previously completed a Novartis-sponsored hepatitis C study and received
             alisporivir or a direct antiviral agent (DAA)

          3. Have not achieved SVR24

        Exclusion Criteria:

          1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days
             of that medication, whichever is longer.

          2. Previous use of any course of hepatitis C therapy since the end of the
             Novartis-sponsored hepatitis C study
Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; insulin glargine
Intervention description: Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).; Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and
      safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with
      type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects
      continued at the same dose and dosing frequency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis

          -  Body Mass Index (BMI) below or equal to 35.0 kg/m^2

          -  Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs
             (OADs) for at least 12 weeks prior to randomisation with at least recommended
             maintenance dose according to local, approved labelling Allowed are: a. Previous short
             term insulin treatment up to 14 days; b. Treatment during hospitalization or during
             gestational diabetes is allowed for periods longer than 14 days)

        Exclusion Criteria:

          -  Anticipated change in concomitant medication known to interfere significantly with
             glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino
             oxidase (MAO) inhibitors

          -  Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or
             rosiglitazone within the last 12 weeks prior to randomisation

          -  Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke;
             decompensated heart failure New York Heart Association (NYHA) class III or IV;
             myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty
Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old
Condition: Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Intervention: Immediate Office Probing; Deferred Facility Probing
Intervention description: Nasolacrimal duct probing in an office setting with topical anesthesia and restraint of the infant.; Nasolacrimal duct probing performed under general anesthesia in a hospital outpatient surgery center or an ambulatory surgery center.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 6 Months
Maximum age: 10 Months
Healthy volunteers: No
Keywords: Nasolacrimal duct obstruction; Simple probing

Summary:

      The purpose of this study is:

      To determine the cost-effectiveness of treating NLDO using immediate office probing compared
      with deferred probing in a facility setting. As part of the primary objective, the study will
      determine the proportion of eyes experiencing spontaneous resolution among subjects
      randomized to the deferred probing group.

      The secondary objectives are:

        1. To determine the success proportion for eyes undergoing immediate office probing as an
           initial procedure.

        2. To determine the success proportion for eyes undergoing deferred facility probing as an
           initial procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6 to <10 months

          -  Onset of NLDO symptoms and/or signs prior to 6 months chronological age in study
             eye(s)

          -  Presence in study eye(s) of epiphora, increased tear film, and/or mucous discharge in
             the absence of an upper respiratory infection or an ocular surface irritation that
             investigator believes is due to NLDO

          -  At least one open punctum present in study eye(s)

        A history of NLDO treatment with lacrimal massage, topical antibiotics or steroids, or
        systemic antibiotics is permitted.

        Exclusion Criteria:

          -  History of nasolacrimal duct surgery including probing, nasolacrimal intubation,
             balloon catheter dilation, or dacryocystorhinostomy in study eye(s) History of trauma
             to the lacrimal drainage system of the study eye(s)

          -  Glaucoma in study eye(s)

          -  Corneal surface disease in study eye(s)

          -  Microphthalmia in study eye(s)

          -  Down Syndrome

          -  Craniosynostosis

          -  Goldenhar sequence

          -  Clefting syndromes

          -  Hemifacial microsomia

          -  Midline facial anomalies