bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; Prevnar 13; PPSV23; Saline
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Placebo
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 444.0
Sex: All
Minimum age: 60 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy
      adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be
      randomized equally to receive either a single intramuscular dose of multivalent pneumococcal
      conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month
      later with a dose of PPSV23 (control group).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but
             not including, the 65th birthday) at enrollment.

          2. Healthy adults, including adults with preexisting stable disease, defined as disease
             not requiring significant change in therapy or requiring hospitalization within 3
             months before receipt of investigational product, as determined by medical history,
             physical examination, laboratory screening, and clinical judgment of the investigator.

          3. Female subjects who are not of childbearing potential.

        Exclusion Criteria:

          1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          2. History of microbiologically proven invasive disease caused by S pneumoniae.

          3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,
             in the investigator's opinion, excludes the subject from participating in the study.
A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: VVN539 Ophthalmic Solution 0.02%; VVN539 Ophthalmic Solution 0.04%; VVN539 Ophthalmic Solution Vehicle
Intervention description: Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days; Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days; Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-masked, randomized, parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple masking
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, parallel-comparison, multi-center, double-masked, randomized,
      vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy
      of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day [q.d.] in
      the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days, each.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older.

          -  Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are
             untreated, or if treated, in the opinion of the investigator are well controlled on 2
             or fewer ocular hypotensive medications prior to Visit 1.

          -  Unmedicated intraocular pressure of ≥ 22 mm Hg and ≤ 36 mm Hg in the study eye, with
             no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2.

          -  Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic
             Retinopathy Scale in each eye (equivalent to Snellen 20/200)

        Exclusion Criteria:

          -  Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the
             formulation or to topical anesthetics or fluorescein.

          -  Unmedicated IOP of > 36 mm Hg in either eye at any time point at Visit 2.
A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Condition: Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: PF-06650833; PF-06700841; PF-06826647; Placebo
Intervention description: 400 mg QD; 45 mg QD; 400 mg QD; placebo
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The treatment period is a parallel design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in
      participants with moderate to severe HS. The study will have a maximum duration of
      approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing
      Period and a 4 week Follow up Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female participants, between 18-75, with a diagnosis of moderate to severe
             Hidradenitis Suppurativa

        Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

          -  Infected with hepatitis B or hepatitis C viruses.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)
A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Mavyret
Intervention description: Patients will be on 8 weeks of Mavyret
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung
      transplant at NYULH who consent to participate in this study will receive a lung transplant
      from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the
      pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week
      treatment course. Patients will be monitored post-transplant for the development of viremia,
      and for the time course of clearance of viremia among those who develop viremia.
    

Eligibility criteria:

        Inclusion Criteria:

        Recipient criteria:

          -  Listed for an isolated lung transplant at NYU Langone Health

          -  Between 18-70 years of age

          -  Able to travel to the NYU Langone Health for routine post-transplant visits and study
             visits for a minimum of 6 months after transplantation

          -  No active illicit substance abuse

          -  Weight at least 40kg

          -  Women of childbearing potential must agree to use birth control in accordance with
             Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to
             the increased risk of birth defects and/or miscarriage

          -  Both men and women must agree to use at least one barrier method after transplant to
             prevent any secretion exchange

          -  Able and willing to provide informed consent

        Donor criteria:

          -  Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody

          -  Donor lung meets standard NYU Langone Health clinical criteria for procurement

        Exclusion Criteria:

        Recipient criteria:

          -  HIV positive

          -  HCV RNA positive or history of previously treated HCV

          -  Evidence of active hepatitis B infection or on active antiviral treatment for HBV

          -  Pregnant or nursing (lactating) women

          -  Use of strong CYP3A inducers

          -  Requires multi-organ transplant

        Donor criteria:

          -  Confirmed HIV positive

          -  Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable
             Hepatitis B virus DNA)

          -  Known previously failed treatment for HCV

          -  Donor age >60 years
Antiplatelet Therapy in HIV
Condition: HIV; Cardiovascular Diseases; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation
Intervention: Aspirin; Clopidogrel
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The proposed study will add to the growing understanding of platelet activity and platelet
      inhibition in subjects with HIV. It will examine the relationship between platelet activity
      and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy)
      in this high-risk cohort. Furthermore, it will provide important data on the mechanism of
      platelet activity and its inhibition using biomarkers of platelet activity, inflammation,
      immune activity and endothelial function and genetic expression profiling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infection

          -  Current Antiretroviral Therapy with no change in regimen in the 12 weeks prior to
             study entry and no plans to change ART for the study duration

          -  Ability to sign consent and comply with the protocol

        Exclusion Criteria:

          -  Known CD4+ T cell counts < 200 cells/mm3 during the 6 months prior to study entry

          -  Established cardiovascular disease (thereby necessitating antiplatelet therapy)

          -  NSAID use in the past week (including aspirin)

          -  Unable to be off NSAIDs for the duration of the trial

          -  Any antiplatelet or antithrombotic use

          -  Allergy to aspirin or clopidogrel

          -  Pregnancy

          -  Chronic kidney disease (GFR<45 ml/min)

          -  AIDS

          -  Active drug or alcohol use that would interfere with adherence to study requirements

          -  Any known bleeding disorder

          -  Use of regularly prescribed medication such as steroids, or immunosuppressive agents

          -  Known anemia (Hb <8mg/dL)

          -  Thrombocytopenia (platelet count <75) or thrombocytosis (Platelet count >600)
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ABBV-8E12; placebo for ABBV-8E12
Intervention description: ABBV-8E12 solution for IV infusion; placebo solution for intravenous (IV) infusion
Intervention MeSH terms: Tilavonemab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 453.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Early Alzheimer's Disease (AD); Mild Cognitive Impairment (MCI); Mild Alzheimer's Disease (AD); Tau; Early dementia; Tauopathies; AD; Neurodegenerative diseases; Memory loss; Nervous system diseases

Summary:

      This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early
      Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who meets the National Institute on Aging and the Alzheimer's Association
             (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

               -  Clinical Dementia Rating (CDR)-Global Score of 0.5

               -  Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive

               -  Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory
                  Index (RBANS - DMI) score of 85 or lower

          -  Subject has a positive amyloid positron emission tomography (PET) scan.

          -  Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.

          -  The subject has an identified, reliable, study partner (e.g., family member).

          -  If using medications to treat symptoms related to AD, doses must be stable for at
             least 12 weeks prior to randomization.

        Exclusion Criteria:

          -  Subject has any contraindications or inability to tolerate brain magnetic resonance
             imaging (MRI), PET scans or lumbar puncture.

          -  Subject has evidence of any other clinically significant neurological disorder other
             than early AD.

          -  In the opinion of the investigator, the subject has any clinically significant or
             uncontrolled medical or psychiatric illness, or has had an infection requiring medical
             intervention in the past 30 days.

          -  Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
             attack or required intervention for any of these conditions within 6 months of
             Screening.
A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients
Condition: Stem Cell Transplant Complications
MeSH terms: Sepsis
Intervention: Chlorhexidine Gluconate 2% Wipe; Placebo Wipe
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after
      hematopoietic stem cell transplant in prevention of central line associated blood stream
      infections. Half of the participants will use 2% CHG washcloths and other half will use
      placebo washcloths.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for
             transplant

          -  Age 18 and up

        Exclusion Criteria:

          -  Experienced an allergy or rash related to use of chlorhexidine washcloths or other
             chlorhexidine products

          -  Extensive open wounds
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
Condition: Systemic Sclerosis, Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Fibrosis
Intervention: STI571
Intervention description: STI571 tablets taken orally once a day
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic sclerosis, scleroderma, fibrosis, STI571, imatinib

Summary:

      This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in
      participants with systemic sclerosis. Other purposes of the study were to investigate whether
      STI571 is effective in improving lung functions and other test results called biomarkers.
      Whether STI571 is well-absorbed in systemic sclerosis participants' gut was also investigated
      by testing the drug level in the blood (pharmacokinetics).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants who are equal to or older than 18 years of age and who
             have early diffuse cutaneous systemic sclerosis (Disease duration < 18 months from the
             first non-Raynaud's symptom)

          -  Participants with a modified Rodnans Skin Score (MRSS) of at least 20 in the absence
             of trunk involvement or a MRSS of at least 16 in patients with trunk involvement

          -  Female patients of childbearing potential practicing two acceptable forms of
             contraception

        Exclusion Criteria:

          -  SSc patients with a MRSS greater than 35

          -  Concurrent connective tissue diseases other than systemic sclerosis

          -  Significant pre-existing heart, liver, lungs, digestive system, blood and other
             diseases, cancer

          -  Conditions that might mimic the potential side effects of STI571 (blood conditions,
             liver damage, chronic diarrhea, edema)

          -  Concurrent medical therapies (or during last 6 weeks before first dosing) that may
             potentially influence outcome of the study

          -  Allergic to the study medication

          -  Pregnancy

          -  Breast feeding
The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
Condition: Nonproliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: AKB-9778; Placebo
Intervention description: Subcutaneous AKB-9778 15mg; Subcutaneous Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of subcutaneously
      administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with
      moderate to severe non-proliferative diabetic retinopathy (NPDR).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adults 18 through 80 years of age (inclusive)

          -  Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)

          -  No evidence of central involved diabetic macular edema

          -  ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better)

        Key Exclusion Criteria:

          -  Ocular disease other than DR that may cause substantial reduction in visual acuity,
             including iris neovascularization, retinal detachment, visually significant epiretinal
             membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other
             retinal inflammatory or infectious diseases

          -  Evidence of neovascularization on clinical examination or imaging

          -  Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening

          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality
             that may increase the risk associated with study participation
Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
Condition: HIV; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: PRO 140; Historical data
Intervention description: CCR5 Antagonist; Historical data (i.e., time to HIV-1 RNA viral load > 500 copies/mL of 29 days).
Intervention MeSH terms: Leronlimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Treatment Substitution; PRO 140; PRO140; CytoDyn; Amarex

Summary:

      This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of
      PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on
      combination antiretroviral therapy.

      Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140
      monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one
      week overlap of existing retroviral regimen and PRO 140 at the beginning of the study
      treatment, and one week overlap at the end of the treatment in subjects who do not experience
      virologic failure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females, age ≥18 years

          2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay

          3. On stable antiretroviral therapy for last 12 months

          4. Subject has two or more potential alternative antiretroviral regimen options to
             consider.

          5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12
             months prior to Screening Visit

          6. Nadir CD4 cell count of >200 cells/mm3

        Exclusion Criteria:

          1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA
             Assay at the Screening Visit

          2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen
             (HBsAg)

          3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993
             Centers for Disease Control and Prevention (CDC) AIDS surveillance definition

          4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including
             PRO 140.

          5. Any other clinical condition that, in the Investigator's judgment, would potentially
             compromise study compliance or the ability to evaluate safety/efficacy