bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
Condition: HIV-1-infection
Intervention: GS-9131; BIC; TAF; ARV regimen; DRV; RTV
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI); Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Intervention MeSH terms: GS-9131
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the short-term antiviral potency of
      GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered
      once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the
      proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1
      RNA) > 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive,
      ARV treatment experienced adult participants with nucleos(t)ide resistant virus.

      This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1
      Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an
      optional open-label extension.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Plasma HIV-1 RNA ≥ 500 copies/mL at screening Visit

          -  Currently taking a failing ARV regimen that contains 2 NRTIs and a NNRTI

          -  No prior or current ARV regimens containing integrase inhibitor (INSTI) or protease
             inhibitor (PI)

          -  Screening genotype must show at least the protocol defined resistance mutation profile

        Key Exclusion Criteria:

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to Day 1

          -  Participation in any other clinical trial, including observational studies, without
             prior approval from the sponsor is prohibited while participating in this trial

          -  Use of an investigational drug other than the study drug

          -  Individuals with chronic hepatitis B virus (HBV) infection are not permitted to
             participate

          -  Active tuberculosis infection

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
Condition: Lumbosacral Radicular Pain
Intervention: SP-102
Intervention description: Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: lumbosacral radicular pain; sciatica; leg pain

Summary:

      This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and
      safety/tolerability of SP-102 administered by epidural injection.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Able and willing to read, write, and understand the English language and provide
             English language written informed consent prior to beginning any study procedures.

          -  Age 18 to 70 years (inclusive) at the Screening Visit.

          -  A diagnosis of lumbosacral radicular pain (sciatica).

          -  Agrees to follow study-specific medication requirements.

          -  If sexually active and a female of child-bearing potential or a male capable of
             bearing a child, agrees to use an effective method of birth control during the study.

          -  Has reviewed all study specific materials and has, in the opinion of the Investigator,
             the abilities to understand and appropriately complete all study procedures.

        Main Exclusion Criteria:

          -  Has radiologic evidence of a condition that would compromise study outcomes.

          -  Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention
             while in the study.

          -  Has been diagnosed with insulin dependent diabetes mellitus.

          -  Presence of any other disorder, condition or circumstance (including secondary gain)
             that, in the opinion of the Investigator, has the potential to prevent study
             completion and/or to have a confounding effect on outcome assessments.

          -  Use of any investigational drug and/or device within 30 days, or is scheduled to
             receive an investigational drug other than blinded study drug during this study.

          -  Has a body mass index ≥40 kg/m2.
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Eye Diseases
Intervention: OC-01 (varenicline) nasal spray; Placebo (vehicle control) nasal spray
Intervention description: OC-01 (varenicline) nasal spray; Placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray
      as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult
      subjects with DED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to use an artificial tear substitute for dry eye symptoms
             within 6 months prior to visit 1.

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery (e.g.
             laser-assisted in-situ keratomileusis, laser epithelial keratomileusis,
             photorefractive keratectomy or corneal implant) within twelve months of Visit 1

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with DED are
             allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Condition: Urinary Incontinence; Overactive Bladder With Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: OnabotulinumtoxinA and Hydrogel admixture; Placebo and Hydrogel admixture
Intervention description: BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation; Placebo and Hydrogel admixture administered as a single intravesical instillation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in
      participants with overactive bladder and urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months

          -  Inadequate response or limiting side effects with pharmacotherapy for the treatment of
             OAB

        Exclusion Criteria:

          -  Overactive Bladder caused by neurological condition

          -  Patient has predominance of stress incontinence

          -  History or evidence of pelvic or urological abnormality

          -  Prior use of BOTOX for any urological condition
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Condition: Post Partum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Ketamine 0.5 mg/kg; Ketamine 0.2 mg/kg
Intervention description: single intravenous infusion of Ketamine (0.5 mg/kg); single intravenous infusion of Ketamine (0.2 mg/kg)
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Postpartum depression is a non-psychotic major or minor depressive episode that occurs during
      pregnancy or within 12 months of post-partum period. The nature of symptoms is same as
      depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal
      thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal
      depression affects children by increasing the risk of emotional and behavioral and physical
      health problems and cognitive difficulties. Thus early screening and intervention is critical
      in reducing the negative impact of PND in the mother and child, family and the community.

      The purpose of this study is to assess the safety, pharmacokinetics and antidepressant
      efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects, ages 18-45 years

          -  Experienced a major depressive episode in the postpartum period beginning within the
             first 4 weeks following delivery and with moderate or severe symptoms (>12 EPDS or >14
             HAM-D).

          -  No or partial response to adequate doses of SSRI medications to treat PND for longer
             than 6 weeks.

          -  PND patients will be requested to maintain the stable dose of antidepressants while
             enrolled in the study trial.

          -  Patients that can speak and read the English language, are able to understand the
             study procedures and sign the informed consent

        Exclusion Criteria:

          -  No current or past psychosis or severe personality disorder.

          -  No current substance abuse or dependence.

          -  No serious and imminent suicidal or homicidal risk.

          -  No recent or history of major and unstable medical problems that affect brain anatomy,
             neurochemistry, or function.

          -  Not diagnosed with cardiovascular disorders.

          -  No increased risk of laryngospasm or active upper respiratory infections.

          -  Not diagnosed with an intellectual disability or neurodegenerative diseases.

          -  Mothers that are currently breastfeeding.

          -  No current pregnancy.
Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers
Condition: Covid19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine Sulfate (HCQ)
Intervention description: Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: covid19; workers; prevention

Summary:

      The study proposes to conduct an open-label Phase II trial to evaluate the feasibility,
      safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of
      transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development
      of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider
      participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50
      years track record of safety of HCQ for treatment and prevention of various disease states.
      Early data on use of HCQ for COVID treatment suggests anti-viral activity and
      immunomodulatory properties for reducing inflammation associated with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Volunteers ages 18 to 99 years,

          -  Able to sign own informed consent form,

          -  Considered high-risk healthcare care providers in a hospital setting with active
             exposure to COVID-19 infection.

        High-risk healthcare providers are defined as those actively working during the study
        duration in the Emergency Department and in the Intensive Care Setting, for the purpose of
        this study.

        Exclusion Criteria:

          -  Inability to tolerate an oral medication or known allergy to chloroquine or
             hydroxychloroquine

          -  Pregnancy or breast-feeding

          -  Immunocompromised status, hepatic failure, electrolytic imbalance

          -  Creatinine clearance (CCL) <30 mL/min

          -  Prolonged QT interval (QTc > 450ms for males and QTc > 470 for females)

          -  Confirmed COVID-19 infection on baseline testing

          -  Has another known contraindication to treatment with the study drug, including
             retinopathy.
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
Condition: Advanced Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Dasatinib; Relatlimab; Ipilimumab; BMS-986205
Intervention description: Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab; Relatlimab; Dasatinib; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab, in combination with other
      therapies, is effective in patients with advanced Non-Small Cell lung cancer
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Advanced Non Small Cell Lung Cancer (NSCLC)

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1

          -  Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy
             treatment

          -  Must have at least 1 lesion with measurable disease

        Exclusion Criteria:

          -  Subjects with certain mutations that have not been treated with a targeted therapy
             prior to enrollment

          -  Subjects who need daily oxygen therapy

          -  People with autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Condition: Hypercholesterolemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: MK-0616; Placebo
Intervention description: MK-0616 administered orally; Placebo matching MK-0616 administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of MK-0616, an oral PCSK9
      inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with
      hypercholesterolemia. The primary hypothesis is that at least one of the four doses of
      MK-0616 tested in this study is superior to placebo on percent change from baseline in LDL-C
      at Week 8.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD
             risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a
             corresponding LDL-C that falls within the protocol-specified range at screening.

          -  Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days
             before screening, or has not received treatment with any lipid-lowering therapy for
             ≥30 days before screening.

          -  A female participant is not pregnant or breastfeeding, not a woman of child-bearing
             potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the
             intervention period and for at least 8 weeks after the last dose of study
             intervention.

        Exclusion Criteria:

          -  History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical
             criteria.

          -  History of nephrotic syndrome.

          -  History of unstable angina, a myocardial infarction, percutaneous transluminal
             coronary angioplasty, transient ischemic attack, or stroke within 3 months before
             Screening.

          -  Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at
             Screening.

          -  History of malignancy ≤3 years before screening, except for adequately treated basal
             cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe
             limitations relative to screening.

          -  Currently participating in or has previously participated in an interventional
             clinical study within 3 months before Screening.

          -  Has moderate or greater renal insufficiency.
Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients
Condition: Thrombotic Microangiopathies; Atypical Hemolytic Uremic Syndrome; Multiple Organ Dysfunction Syndrome
MeSH terms: Azotemia; Hemolytic-Uremic Syndrome; Atypical Hemolytic Uremic Syndrome; Vascular Diseases; Thrombotic Microangiopathies; Syndrome; Hemolysis; Multiple Organ Failure
Intervention: Eculizumab
Intervention description: Eculizumab will be administered as intravenous infusion (IV) over 60 minutes. The dosage form will be 300 mg single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free solution.
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Healthy volunteers: No
Keywords: Hematopoietic Stem Cell Transplant

Summary:

      Hematopoietic stem cell transplantation (HCT)-associated thrombotic microangiopathy (TMA) is
      an understudied complication of HCT that significantly affects transplant related morbidity
      and mortality. The investigators hypothesize that early intervention with complement blocker
      eculizumab will double survival in HCT recipients with high risk TMA, as compared to
      historical untreated controls. An optimal eculizumab dosing schedule can be determined for
      this population through eculizumab pharmacokinetic/pharmacodynamic (PK/PD) testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of any age undergoing allogeneic or autologous HCT

          -  Histologic TMA diagnosis OR clinical TMA diagnosis and presenting with high risk
             disease features including elevated plasma sC5b-9 above laboratory normal value
             (≥244ng/ml) and proteinuria measured as ≥30mg/dL of protein on random urinalysis x2 or
             protein/creatinine ratio ≥1mg/mg or patient receiving renal replacement therapy.

          -  Minimum weight of ≥ 5kg.

        Exclusion Criteria:

          -  Known hypersensitivity to any constituent of the study medication.

          -  Subjects with unresolved serious Neisseria meningitides infection or progressive
             severe infection.

          -  Patients with diagnosis of TTP as defined by ADAMST13 activity test <10%.

          -  Patients previously treated with eculizumab or other complement blocker for TMA within
             the 60 days prior to first dose of study treatment.