bioihbjkbjnl/mcl2 huggingface dataset:
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
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: 1511.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42
             to ≤98 days) at the time of consent (the day of birth is considered day of life 1).

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          -  Major known congenital malformation or serious chronic disorder.
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461; ALKS 5461 Placebo
Intervention description: Samidorphan + buprenorphine, administered sublingually; Placebo tablet, administered sublingually
Intervention MeSH terms: Naltrexone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alkermes; Major Depressive Disorder; Treatment Refractory MDD; ALKS 5461

Summary:

      This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in
      adults who have treatment refractory MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a Major Depressive Disorder (MDD) primary diagnosis

          -  Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2

          -  Be willing and able to follow the study procedures and visits as outlined in the
             protocol (including agreeing not to enroll in any other clinical trials)

          -  Have inadequate responses to antidepressant therapy (ADT) in the current Major
             Depressive Episode (MDE)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Has any finding that would compromise the safety of the subject or affect their
             ability to adhere to the protocol visit schedule or fulfill visit requirements

          -  Has any other significant medical condition (eg, neurological, psychiatric, or
             metabolic) or clinical symptom that could unduly risk the subject or affect the
             interpretation of study data

          -  Has any current primary diagnosis other than MDD, where primary diagnosis is defined
             as the primary source of current distress and functional impairment

          -  Has experienced hallucinations, delusions, or any psychotic symptoms in the current
             MDE

          -  Has been hospitalized for MDD within 3 months before screening

          -  Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days prior to screening

          -  Has received electroconvulsive therapy treatment within the last 2 years or within the
             current MDE or failed a course of electroconvulsive treatment at any time

          -  Has a significant risk for suicide

          -  Has a positive breath alcohol test at screening

          -  Has a positive test for drugs of abuse at screening or visit 2

          -  Is pregnant, planning to become pregnant, or is breastfeeding during the study

          -  Additional criteria may apply
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Women With Osteoporosis
MeSH terms: Osteoporosis
Intervention: Romosozumab; Alendronate; Placebo to Romosozumab; Placebo to Alendronate
Intervention description: Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.; Alendronate 70 mg tablet taken once a week; Administered by subcutaneous injection once a month during the double-blind treatment phase.; Matching placebo tablet taken once a week during the double-blind treatment phase.
Intervention MeSH terms: Alendronate; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4093.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Summary:

      The purpose of this study is to determine if treatment is effective in preventing fractures
      in women with postmenopausal osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Postmenopausal women who meet at least one of the following bone mineral density (BMD) and
        fracture criteria:

          -  BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:

               -  at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral
                  fracture OR

               -  at least 2 mild (SQ1) vertebral fractures OR

          -  BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:

               -  at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR

               -  a fracture of the proximal femur that occurred within 3 to 24 months prior to
                  randomization.

        Exclusion Criteria:

          -  History of metabolic or bone disease (except osteoporosis)

          -  Use of agents affecting bone metabolism

          -  Vitamin D insufficiency

          -  History of solid organ or bone marrow transplants

          -  Hyper- or hypocalcemia

          -  Hyper- or hypothyroidism

          -  Hyper- or hypoparathyroidism

          -  Possible signs of intolerance to alendronate
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Wilate
Intervention description: von Willebrand factor / Factor VIII (plasma derived)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      A prospective, non-controlled, international, multi-centre phase 3 study to investigate the
      pharmacokinetics, efficacy, safety, and immunogenicity of Wilate in previously treated
      children with severe haemophilia A
    

Eligibility criteria:

        Inclusion Criteria:

          1. Severe haemophilia A (<1% FVIII:C) according to medical history

          2. Male patients aged 1 to <12 years

          3. Previous treatment with a FVIII concentrate for at least 50 exposure days (EDs)

          4. Immunocompetence (CD4+ count >200/μL)

          5. Voluntarily given, fully informed written and signed consent obtained by the patient's
             parent(s) or legal guardian and, depending on the children's developmental stage and
             intellectual capacity, informed assent by the patients before any study-related
             procedures are performed

        The interval between the Screening Visit and the PK Visit should not exceed 30 days. If the
        30-day interval is exceeded, determination of the CD4+ count is to be repeated and must be
        >200/μL for patients to be enrolled (i.e., inclusion criterion no. 4).

        Exclusion Criteria:

          1. Any coagulation disorders other than haemophilia A

          2. History of FVIII inhibitor activity (≥0.6 BU) or detectable FVIII inhibitory
             antibodies (≥0.6 BU using the Nijmegen modification of the Bethesda assay) at
             screening, as determined by the central laboratory

          3. Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate
             transaminase [ASAT] levels >5 times of upper limit of normal, creatinine >120 μmol/L)

          4. Patients receiving or scheduled to receive immunomodulating drugs (other than
             antiretroviral chemotherapy), such as alpha-interferon, prednisone (equivalent to >10
             mg/day), or similar drugs
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 611.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      The purpose of this study is to measure the effectiveness and safety of TD 4208, an
      investigational drug being developed to treat people with moderate to very severe COPD,
      compared to placebo, a treatment without activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older

        Exclusion Criteria:

          -  Females who are pregnant, lactating, breast-feeding or planning to become pregnant
             during the study
OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Condition: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 438.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of post-surgical inflammation and pain in subjects who had undergone cataract
      extraction with intraocular lens implantation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a cataract and is expected to undergo clear corneal cataract surgery with
             phacoemulsification and implantation of posterior chamber lens

          -  Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or
             better in both eyes

        Exclusion Criteria:

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination

          -  Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination
Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
Condition: Polycystic Kidney Disease, Adult
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Lixivaptan
Intervention description: Oral vasopressin V2 receptor antagonist
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single group, open-label study
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, open-label, roll-over study to demonstrate the continued hepatic and
      non-hepatic safety and renal efficacy of lixivaptan in participants with ADPKD who previously
      experienced abnormal liver chemistry test results while treated with tolvaptan, were
      permanently discontinued from the drug for that reason, and subsequently completed study
      PA-ADPKD-303, the open-label lead-in study with lixivaptan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with ADPKD who completed study PA-ADPKD-303

          -  Continued control of hypertension without the use of a diuretic

          -  Continued adherence to prohibitions on concomitant medications stated in the study
             PA-ADPKD-303 protocol

          -  Willing to practice acceptable methods of birth control (both males who have partners
             of child-bearing potential and females of childbearing potential).

          -  Able to provide informed consent.

        Exclusion Criteria:

          -  Any contraindication to continued treatment with lixivaptan

          -  Clinically significant incontinence, overactive bladder, or urinary retention (e.g.,
             benign prostatic hyperplasia)

          -  New York Heart Association Functional Class 3 or 4 heart failure or other significant
             cardiac or electrocardiogram (ECG) findings that could pose a safety risk to the
             participant

          -  Hypovolemia on physical examination at Screening

          -  The following laboratory results based on serum drawn at Visit 24 of PA-ADPKD-303:

               -  Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values
                  >1.5 × ULN

               -  Total bilirubin values >1.5 × ULN

          -  eGFR <20 mL/min/1.73 m^2 based on laboratory results from Visit 26 of PA-ADPKD-303

          -  A finding at Screening that precludes safe participation in the study or participants
             who are likely to be non-compliant with study procedures in the opinion of the
             Investigator or medical monitor
Study of Safety of RVL-1201 in Treatment of Blepharoptosis
Condition: Blepharoptosis
MeSH terms: Blepharoptosis
Intervention: RVL-1201; Vehicle ophthalmic solution
Intervention description: RVL-1201 ophthalmic solution, 0.1%; Vehicle placebo ophthalmic solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 234.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment
      of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female 9 years of age or older

          2. Females must not be pregnant or planning to get pregnant and must use acceptable form
             of contraception

          3. Must be able to self-administer study medication

          4. Must be able to understand and sign an Informed Consent Form (ICF). For minor
             subjects, the subject's parent or legal guardian must provide permission by signing an
             ICF on behalf of the subject and the subject should provide assent.

        Exclusion Criteria:

          1. Congenital ptosis

          2. Horner syndrome

          3. Myasthenia gravis

          4. Mechanical ptosis

          5. Previous ptosis surgery

          6. Resting heart rate outside the normal range

          7. Hypertension with resting diastolic blood pressure

          8. Pregnancy or lactation
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Experimental: Tezepelumab; Placebo
Intervention description: Tezepelumab subcutaneous injection; Placebo subcutaneous injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-Blind
Enrollment: 1061.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Summary:

      A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to
      Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe
      Uncontrolled Asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age. 12-80

          -  Documented physician-diagnosed asthma for at least 12 months

          -  Subjects who have received a physician-prescribed asthma controller medication with
             medium or high dose ICS for at least 12 months.

          -  Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500
             µg fluticasone propionate dry powder formulation equivalent total daily dose) for at
             least 3 months.

          -  At least one additional maintenance asthma controller medication is required according
             to standard practice of care and must be documented for at least 3 months.

          -  Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs)

          -  Evidence of asthma as documented by either: Documented historical reversibility of
             FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol)
             reversibility of FEV1 ≥12% and ≥200 mL during screening.

          -  Documented history of at least 2 asthma exacerbation events within 12 months.

          -  ACQ-6 score ≥1.5 at screening and on day of randomization

        Exclusion Criteria:

          -  Pulmonary disease other than asthma.

          -  History of cancer.

          -  History of a clinically significant infection.

          -  Current smokers or subjects with smoking history ≥10 pack-years and subjects using
             vaping products, including electronic cigarettes.

          -  History of chronic alcohol or drug abuse within 12 months.

          -  Hepatitis B, C or HIV.

          -  Pregnant or breastfeeding.

          -  History of anaphylaxis following any biologic therapy.

          -  Subject randomized in the current study or previous tezepelumab studies.
SpaceOAR System Pivotal Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: SpaceOAR System
Intervention description: Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 222.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Spacer

Summary:

      Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum
      and prostate in men undergoing radiation therapy (IG-IMRT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects greater than 18 years old

          -  Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate
             and must be planning to undergo IMRT

          -  Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6
             months of the baseline/screening visit with Gleason Score less than or equal to 7

          -  Subjects Screening/Baseline laboratory testing must meet the following laboratory
             value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum
             creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of
             institution normal, and serum bilirubin less than 2.0 mg/dl

          -  Subject or authorized representative, has been informed of the nature of the study and
             has provided written informed consent, approved by the appropriate Institutional
             Review Board (IRB) of the respective clinical site

        Exclusion Criteria:

          -  Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline
             visit

          -  Subjects with extracapsular extension of the prostate cancer, with greater than 50% of
             the number of biopsy cores positive for cancer, metastatic disease, other ongoing
             cancers which will be treated during the study, or subjects for whom pelvic lymph node
             radiotherapy is planned

          -  Subjects with any prior invasive malignancy (except non-melanomatous skin cancer)
             unless the subject has been disease free for a minimum of 5 years.

          -  Subjects who are indicated for androgen deprivation therapy or who have been treated
             with androgen therapy within the prior 3 months.