bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
Condition: Severe Asthma; Moderate or Severe Major Depressive Disorder
MeSH terms: Asthma; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Escitalopram
Intervention description: Placebo Matching Escitalopram; Active Escitalopram
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Asthma; Depression; Escitalopram

Summary:

      The purpose is to determine if: 1) Escitalopram treatment will be associated with less oral
      corticosteroid use than placebo in outpatients with severe asthma and moderate or severe
      major depressive disorder (MDD). 2) Escitalopram treatment will be associated with greater
      improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or
      severe MDD. 3) Escitalopram treatment will be associated with greater depressive symptom
      remission rates than placebo in outpatients with severe asthma and moderate or severe MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current HAM-D score of ≥ 20

          -  Patients with severe asthma (defined as asthma requiring three or more course of oral
             corticosteroids in the past year).

          -  No changes in asthma medications, oral corticosteroid use, or treatment for
             respiratory tract infections in the past week

          -  Needs to have taken ≥ 3 courses of oral corticosteroids, for asthma, in the past 12
             months.

          -  Both male and female

          -  English- or Spanish-speaking

        Exclusion Criteria:

          -  Current substance or alcohol abuse/dependence

          -  MDD with psychotic features (delusions, hallucinations, disorganized thought
             processes)

          -  Bipolar disorder

          -  Schizophrenia or schizoaffective disorder

          -  Substance-induced mood disorder and mood disorder secondary to a general medical
             condition

          -  Mental retardation or other severe cognitive impairment

          -  Prison or jail inmates

          -  Pregnant or nursing women or women of childbearing age who will not use The University
             of Texas Southwestern Medical Center - Institutional Review Board (UTSW IRB) approved
             methods of birth control or abstinence during the study

          -  Treatment-resistant depressed persons defined as having failed two adequate trials of
             antidepressants

          -  Current antipsychotic or antidepressant therapy or psychotherapy

          -  Initiation of other psychotropic medications or psychotherapy within past 2 weeks
             (e.g., anxiolytics, hypnotics)
Easypod United States User Trial
Condition: Growth Hormone Deficiency
Intervention: easypod; easypod
Intervention description: Subjects is aware that the device records injection information that can be viewed by user; Subjects is not aware that the device records injection information that can be viewed by user
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 42.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This study will help to determine whether an injection log on a recombinant human growth
      hormone (rhGH) delivery device improves subjects' adherence with injection schedules.
      Adherence will be compared between a group of subjects who are aware of the injection log on
      the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™
      injection log. It is the study hypothesis that subject non-adherence rate is different for
      those who are aware of the injection log capability versus those who are unaware of the
      injection log capability. Subject perception will also be evaluated by comparing the ease and
      convenience of use and subject preference for the easypod™ compared to two other rhGH pen
      injection devices.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be male or female from 10 to 18 years of age, inclusive, with open epiphyses

          -  Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6
             months

          -  Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer
             Genotropin® pen injection device for at least 6 months

          -  Be willing and able to comply with the protocol for the duration of the trial

          -  Have access to the Internet

          -  Be able to read, speak and understand English

          -  If female of childbearing potential, have a negative urine pregnancy test at Screening
             and use an acceptable form of birth control during the trial, including abstinence, a
             hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with
             spermicide

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for
             click.easy® cartridge)

          -  Severe illness during the previous 6 months

          -  Active malignancy (except non-melanomatous skin malignancies)

          -  Diabetes mellitus (type I or II)

          -  Pregnancy or lactation

          -  Any medical condition that, in the opinion of the Investigator, would jeopardize the
             subject's safety following exposure to the investigational device

          -  Participation in any other investigational study during the duration of participation
             in this trial
Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
Condition: Parkinson's Disease With End of Dose Wearing Off
MeSH terms: Parkinson Disease
Intervention: Carbidopa/levodopa/entacapone
Intervention description: Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Carbidopa, levodopa drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's disease, tremor

Summary:

      To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with
      end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and
      entacapone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were
             eligible to participate if the principal investigator considered the patient to be in
             otherwise good health.

          -  Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity,
             resting tremor, bradykinesia).

          -  All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD
             symptoms at the end of at least two daily doses of levodopa during waking hours).

          -  Taking regular doses of immediate release carbidopa/levodopa

        Exclusion Criteria:

          -  Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose
             regimens of levodopa

          -  Female subjects who are pregnant, trying to become pregnant or nursing an infant

        Other protocol-defined inclusion/exclusion criteria applied to this study.
Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Intranasal fentanyl; morphine IM; IV morphine
Intervention description: 2mcg/kg fentanyl IN; 0.1 mg/kg morphine IM for postop pain; 0.1 mg/kg morphine IV
Intervention MeSH terms: Fentanyl; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: No
Keywords: otitis media; recurrent ear infections (otitis media)

Summary:

      The purpose of this study is to compare the difference in effect of three clinically common
      methods of providing pain medication during surgery for ventilating tubes placed for
      recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a
      muscle, and morphine injected in a vein.
    

Eligibility criteria:

        Inclusion Criteria:

          -  bilateral myringotomy

        Exclusion Criteria:

          -  ASA greater than 2

          -  history of bleeding disorder/thrombocytopenia

          -  history of allergy to morphine or fentanyl
UPMC OPTIMISE-C19 Trial, a COVID-19 Study
Condition: Covid19
MeSH terms: COVID-19
Intervention: Lilly Bamlanivimab; Regeneron Casirivimab + Imdevimab; Lilly Bamlanivimab + Etesevimab; Sotrovimab; Bebtelovimab
Intervention description: Administration of Lilly Bamlanivimab to COVID positive patients; Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients; Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients; Administration of Sotrovimab to COVID positive patients; Administration of Bebtelovimab to COVID positive patients
Intervention MeSH terms: Sotrovimab; Bamlanivimab; Casirivimab and imdevimab drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is an adaptive platform and as such is intended to study multiple interventions simultaneously, does not have a defined sample size, and is intended to move forward in perpetual fashion with domains and interventions being added and subtracted over time. For example, interventions will be added and subtracted depending on federal decisions regarding monoclonal antibodies, such as granting or revoking authorization for use.
Masking: None (Open Label)
Enrollment: 4571.0
Sex: All
Minimum age: 12 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: COVID; monoclonal antibodies

Summary:

      Multiple monoclonal antibodies (mABs) have been shown to reduce viral burden and improve
      clinical outcomes, have been granted FDA Emergency Use Authorization (EUA) for use in select
      populations, and are routinely used in the UPMC Health System, which has made expanded access
      a priority. However, the comparative effectiveness of these mABS is unknown. The National
      Academies of Sciences, Engineering, and Medicine has called for expanded access and clinical
      use of mABs, noting it is "critical to collect data and evaluate whether they are working as
      predicted". This pragmatic evaluation will determine the relative effects of the EUA-governed
      mABs versus each other. When U.S. government mAB policies change (e.g., FDA grants or revokes
      EUAs), UPMC Health System policies and the evaluated mABs will accordingly change.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COVID-19 positive patients

          -  Eligible for mAB under FDA EUA

        Exclusion Criteria:

          -  Death is deemed to be imminent or inevitable

          -  Previous participation in this REMAP within the last 90 days
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma; Low Tension Glaucoma
Intervention: brinzolamide 1%/brimonidine 0.2% fixed combination; Placebo; travoprost 0.004% ophthalmic solution
Intervention description: One drop applied topically to the affected eye(s) in the morning and evening; One drop applied topically to the affected eye(s) in the morning and evening; One drop applied topically to the affected eye(s) in the evening
Intervention MeSH terms: Brimonidine Tartrate; Travoprost; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: travoprost; brinzolamide 1%/brimonidine 0.2%; normal tension glaucoma; intraocular pressure; efficacy; safety

Summary:

      The purpose of this study was to determine the incremental intraocular pressure (IOP)
      lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with
      normal tension glaucoma that may benefit from further IOP lowering.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent

          -  Diagnosed with normal tension glaucoma

          -  Intraocular pressure measurements in at least 1 eye as specified in the protocol

          -  Willing and able to attend all study visits

        Exclusion Criteria:

          -  History of hypersensitivity to any of the study drugs

          -  Use of medications prohibited by the protocol

          -  Pregnant or nursing

          -  Of child-bearing potential unless using contraception, as specified in the protocol

          -  Any form of glaucoma other than open angle glaucoma in either eye

          -  Chronic, recurrent or severe inflammatory eye disease

          -  Ocular trauma or surgery within the past 6 months in either eye; ocular infection or
             laser surgery within the past 3 months in either eye (all from screening)

          -  Conditions which would make the patient, in the opinion of the Investigator,
             unsuitable for the study.
Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Placebo; Montelukast; Levocetirizine
Intervention description: Pharmaceutical form: Over-encapsulated tablet
Route of administration: Oral use; Pharmaceutical form: Over-encapsulated tablet
Concentration: 10 mg
Route of administration: Oral use; Pharmaceutical form: Over-encapsulated tablet
Concentration: 5 mg
Route of administration: Oral use
Intervention MeSH terms: Montelukast; Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Levocetirizine; Xyzal; Rhinitis; Allergic; Seasonal; Ragweed

Summary:

      To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of
      seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an
      environmental exposure unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years

          -  Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR)
             related symptoms (mean value), as defined by the protocol

        Exclusion Criteria:

          -  Any clinically significant condition that might interfere with the treatment
             evaluation, both for efficacy and safety

          -  Have used forbidden concomitant medications as defined by the protocol
Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL
Condition: Cataract
MeSH terms: Cataract
Intervention: AcrySof® ReSTOR® Aspheric IOL
Intervention description: AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: AcrySof; ReSTOR; Aspheric IOL; Cataract

Summary:

      This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed
      pre-operatively, and at subsequent visits (following the implantation of the intraocular lens
      in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 years or older;

          -  need spherical correction between 10-30 Diopters (D);

          -  corneal astigmatism less than 0.75D as measured by keratometry;

          -  willing to sign an Informed Consent Form and complete all visits;

          -  pupil dilation greater than 6mm;

          -  expected Visual Acuity (measured in logMAR)=0.3 or better

        Exclusion Criteria:

          -  Women of childbearing potential;

          -  irregular corneal astigmatism;

          -  keratopathy/keratectasia;

          -  cornea inflammation or edema;

          -  cornea reshaping surgery;

          -  corneal dystrophy;corneal transplant;

          -  amblyopia;

          -  glaucoma;

          -  Retinal Pigment Epitheliopathy (RPE)/Macular changes;

          -  proliferative diabetic retinopathy
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
Condition: Graft Rejection; Kidney Failure
MeSH terms: Renal Insufficiency
Intervention: cyclosporine or tacrolimus; sirolimus
Intervention description: Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.; Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
Intervention MeSH terms: Cyclosporine; Sirolimus; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Transplant; Kidney Failure

Summary:

      The primary purpose of this study is to determine whether converting from calcineurin
      inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing
      calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients
      with mild to moderate renal dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cardiac transplant recipients age 18 years or older receiving cyclosporine or
             tacrolimus since the time of transplant.

          -  12 months after cardiac transplantation but less than 96 months post-transplantation.

        Exclusion Criteria:

          -  Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after
             kidney transplant recipients).

          -  Prior or current use of sirolimus or everolimus unless administration was part of a
             "CNI holiday" lasting no more than 10 days.

          -  History of acute rejection within the last 3 months, malignancy within the last 5
             years (except for adequately treated basal cell or squamous cell carcinoma of the
             skin), and human immunodeficiency virus (HIV) patients.
A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Duloxetine hydrochloride; Placebo
Intervention description: 60 mg once or twice a day, by mouth; placebo capsule by mouth
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 339.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An eight-week, randomized, double blind, two parallel groups, study to assess clinical
      response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for
      severe depression.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female patients of ≥ 18 years of age that meet criteria for severe Major Depressive
        Disorder, without psychotic features (according to Diagnostic and Statistical Manual of
        Mental Disorders Fourth Edition, [DSM-IV] and confirmed by Mini International
        Neuropsychiatric Interview [MINI]).

          -  With a total score Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 30 and 6-item
             Hamilton Depression Rating Scale (HAMD-6) ≥ 12 and Clinical Global Impression of
             Severity (CGI-Severity) ≥ 4 at both screening and baseline.

          -  Requirement of hospitalization (not for social or other non-medical reasons) at
             screening visit and at least up to Visit 4.

          -  Patients willing and able to comply with the requirement for hospitalization and with
             all scheduled visits, tests and procedures required by the protocol.

          -  Informed consent document must be signed at screening visit, in accordance with Good
             Clinical Practice (GCP) and local regulatory requirements, prior to any study
             procedure.

        Exclusion Criteria:

          -  More than two previous episodes of major depression that did not respond (according to
             investigator's opinion) to adequate doses and duration of two different antidepressant
             therapies.

          -  Lack of response to at least two antidepressant therapies given at adequate doses for
             at least 6 weeks for the current depressive episode.

          -  Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than
             anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major
             Depressive Disorder, in the investigator's judgment.

          -  Any previous diagnosis of a bipolar disorder, schizophrenia or OCD.

          -  Depression with catatonic features (according to DSM-IV), depression with post-partum
             onset, or organic mental disorders.

          -  The presence of an Axis II disorder