bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: AXR-159; Vehicle
Intervention description: AXR-159 Ophthalmic Solution; AXR-159 Ophthalmic Solution Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel
      group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50
      mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately
      430 patients diagnosed with dry eye disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or older at screening visit

          -  Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using
             the logarithm of the minimum angle of resolution (LogMAR) in each eye

          -  Reported history of dry eye for at least 6 months

          -  Corneal fluorescein staining score ≥ 2

          -  Eye dryness score ≥ 40

          -  Total Ocular Surface Disease Index (OSDI) score > 18

        Exclusion Criteria:

          -  Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or
             uncontrolled systemic disease

          -  Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have
             previously undergone any glaucoma laser or surgical procedure.

          -  Corneal abnormality or disorder that impacts normal spreading of the tear film
             (keratoconus, pterygia, scarring) or compromised corneal integrity

          -  BCVA worse than 20/100 in either eye

          -  Current use of punctal plugs, anticipated insertion during the study, or a history of
             punctal cautery in either eye

          -  Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells

          -  Patients with clinically significant inflammation of the lid margin such as anterior
             blepharitis or ocular rosacea

          -  Recent (within the past 3 months) ocular surgery, trauma or herpes

          -  Use of contact lenses in either eye within one month prior to the screening visit or
             anticipated use during the study
Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease
Condition: Chronic Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Immunosuppressive Therapy; Immunosuppressive Therapy; Survey Administration
Intervention description: Discontinued IST; Continued IST; Ancillary studies
Intervention MeSH terms: Immunosuppressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No

Summary:

      This randomized trial studies how well discontinuation or continuation of immunosuppressive
      therapy works in treating participants with chronic graft versus host disease. Continuation
      of immunosuppressive treatment may prevent graft-versus-host disease worsening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior first allogeneic stem cell transplant, with any graft source, donor type, and
             GVHD prophylaxis

          -  Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan
             to withdraw all systemic IST; hydrocortisone or prednisone continued for treatment of
             adrenal insufficiency is not considered a systemic IST

          -  No evidence of malignancy at the time of enrollment

          -  Agree to be evaluated at the transplant center or by local provider every 3 months for
             12 months after randomization

          -  Agreement to be contacted by phone or e-mail for health status evaluation for up to 3
             years

          -  Signed, informed consent

        Exclusion Criteria:

          -  Inability to comply with study procedures

          -  Pregancy
High Resolution PET-MRI Before Prostate Cancer HIFU
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 18F-Fluciclovine
Intervention description: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diagnostic imaging; High-Intensity Focused Ultrasound; HIFU; 18F-Fluciclovine; high resolution diffusion-weighted imaging

Summary:

      This prospective trial aims to determine if enhanced prostate imaging using two novel imaging
      technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers
      not seen on standard multiparametric prostate MRI in patients considered candidates for focal
      HIFU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prostate biopsy consisting of ≥ 10 tissue cores sampled

          -  PSA </=20 ng/mL

          -  cT1-cT2c

          -  Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to
             one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic
             biopsy cores positive and >/= 50% of core involvement in at least one core

          -  Patient considering focal HIFU therapy

        Exclusion Criteria:

          -  Previous local therapy for prostate cancer

          -  Inability to receive PET tracer

          -  Inability to receive MRI

          -  Suggestion of extracapsular extension or seminal vesicle invasion on imaging

          -  Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)

          -  Any other condition which, in the investigator's option, may make the patient a poor
             candidate for participation in a clinical trial.
Nicotinic Receptors and Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: DMXB-A-SR; Placebo
Intervention description: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR); Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random allocation to a treatment and placebo group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The pharmacist places the treatment or placebo into identical coded vials. Only the pharmacist and the statistician have the code to identify of the treatment.
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Drug Trial; Smoking; Smoking Cessation; Cognition; Mental Focus

Summary:

      The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene
      anabaseine sustained release) will provide clinical improvement in cognition in patients with
      schizophrenia who are smokers and who are non-smokers. The study drug may also maintain
      abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be selected to be 18 to 65 years old and in good general health.

          -  Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR)
             criteria for schizophrenia or schizoaffective disorder.

          -  Smokers will smoke at least 20 cigarettes per day.

          -  Non-smokers will also be enrolled.

          -  Subjects will have normal:

               -  vital signs,

               -  hematology,

               -  serum chemistries,

               -  EKG, and

               -  urinalysis with a negative drug screen before entry into the study.

          -  Subjects will be fluent in English.

          -  Smoking subjects will be interested in stopping smoking in the near future and not
             interested in nicotine replacement therapy.

        Exclusion Criteria:

          -  Subjects with histories of:

               -  neurological illness,

               -  liver disease,

               -  severe hypertension (cut-off blood pressure 160/100) or

               -  cardiac disease, or

               -  renal failure (cut-off creatinine above 1.4).

          -  Subjects who currently meet DSM-IV-TR criteria for substance dependence other than
             nicotine, cannabis, or alcohol will be excluded.

          -  Women who are capable of pregnancy and not on acceptable forms of birth control will
             be excluded.

          -  Subjects being treated with Clozapine will be excluded.
Study of VVN001 Ophthalmic Solution in Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: VVN001 Ophthalmic Solution 1%; VVN001 Ophthalmic Solution 5%; Vehicle
Intervention description: VVN001 Ophthalmic Solution 1%; VVN001 Ophthalmic Solution 5%; VVN001 Ophthalmic Solution Vehicle
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 parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-masked
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled,
      parallel-group study designed to evaluate the safety and tolerability and to explore the
      efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent prior to any study-related procedures .

          -  Are 18 years of age or older.

          -  Are willing and able to follow instructions and willing to be present for the required
             study visits for the duration of the study.

          -  Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in
             the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic
             Retinopathy Study (ETDRS) at the screening visit and randomization visit.

          -  Have a history of dry eye disease in both eyes

          -  Are currently using artificial tears and have been using within 30 days of the
             screening visit.

          -  Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes
             (0-100 point VAS)

          -  Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the
             following criteria in the study eye and the same eye at Visit 1 and Visit 2:

          -  Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)

          -  Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.

        Exclusion Criteria:

          -  Have a known hypersensitivity or contraindication to the IP or components of IP.

          -  Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.

          -  Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening
             visit or are being treated with eye drops for glaucoma in the study eye. Or the
             subject has had laser or surgery for glaucoma in the study eye within 90 days of the
             study.
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Anifrolumab
Intervention description: Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is an Open Label Extension study.
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus

Summary:

      The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in
      adults with moderate to severe active systemic lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be willing to use 2 methods of effective contraception

          -  Must have venous access

          -  Must be willing to forego participation in other clinical trials for SLE.

        Exclusion Criteria:

          -  Any concurrent condition that in the opinion of the investigator would interfere with
             the evaluation of the investigational product

          -  Major surgery within 8 weeks before signing informed consent form (ICF)

          -  Elective major surgery planned during the study period

          -  Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day,
             Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or
             intramuscular methotrexate > 25 mg/week

          -  A live or attenuated vaccine within 4 weeks of signing the ICF

          -  Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Condition: Keratoconus; Corneal Diseases; Eye Diseases; Photosensitizing Agents
MeSH terms: Eye Diseases; Keratoconus; Corneal Diseases; Dermatitis, Phototoxic
Intervention: CXLO Corneal Strengthening Solution and UVA Illumination Device
Intervention description: CXLO Corneal Strengthening Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Visual acuity will be evaluated by an observer who is masked as to the treatment protocol to which study subjects have been assigned.
Enrollment: 2228.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: Keratoconus; Forme fruste keratoconus; Post-LASIK ectasia; Pellucid marginal degeneration; Forme fruste pellucid marginal degeneration; Diurnal fluctuation post-radial keratotomy; Terrien's marginal degeneration

Summary:

      This study will assess changes in visual acuity and corneal symmetry after corneal collagen
      cross-linking (CXL) of asymmetric corneas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of at least one of the following conditions:

               1. Keratoconus

               2. Forme fruste keratoconus

               3. Post-LASIK ectasia

               4. Pellucid marginal degeneration

               5. Forme fruste pellucid marginal degeneration

               6. Diurnal fluctuation post-radial keratotomy

               7. Terrien's marginal degeneration

        Exclusion Criteria:

          1. Corneal thickness < 375 microns measured by ultrasound or Pentacam.

          2. Contraindications or hypersensitivities to any study medications or their components.

          3. Pregnancy or breastfeeding.

          4. Any history of herpes simplex corneal disease in an eye to be treated.

          5. Nystagmus or any other condition that would, in the judgement of the investigator,
             prevent a steady gaze during the treatment.

          6. Inability to cooperate with diagnostic tests.

          7. Enrollment in another ophthalmic clinical trial.
BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Placebo; Placebo; BI 409306; Donepezil
Intervention description: for blinding purposes
Intervention MeSH terms: Donepezil; BI 409306
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 329.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The study is designed to compare the effects of BI 409306 compared to placebo in patients
      with cognitive impairment due to Alzheimer's Disease
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with early signs of dementia of Alzheimer Type

          -  Male and female patients with an age of at least 55 years

          -  Previous use of Alzheimer's Disease (AD) medications (AChEIs, memantine) is allowed up
             3 month prior to screening. Patients who are currently taking AChEIs are eligible as
             long as they have been using a stable dose for at least 3 months prior to screening
             and no change is foreseen for the duration of the study. This dose must be consistent
             with the product label in the concerned country. Patients currently taking memantine
             are excluded.

          -  Patients must have at least 6 years of formal education and fluency in the test
             language as verbally confirmed by the patient and documented by the study
             investigator.

          -  Patients must have a reliable study partner (per investigator judgement, for instance
             a family member, partner etc., guardian or, if applicable, a legal representative)

        Exclusion criteria:

          -  Cognitive impairment or dementia with any etiology other than Alzheimer's Disease (AD)

          -  Substantial concomitant cerebrovascular disease (defined by a history of a stroke /
             intracranial haemorrhagia) temporally related to the onset of worsening of cognitive
             impairment per investigator judgement

          -  Medical history or diagnosis of any of symptomatic and unstable/uncontrolled
             conditions per investigator judgement

          -  Any other psychiatric disorders such as schizophrenia, or mental retardation

          -  Previous participation in investigational drug studies of mild cognitive
             impairment/Dementia of Alzheimer Type (DAT) within three months prior to screening.
             Having received active treatment in any other study targeting disease modification of
             AD like Aß immunization and tau therapies. Previous participation in studies with
             non-prescription medications, vitamins or other nutritional formulations is allowed.

          -  Clinically significant uncompensated hearing loss in the judgment of the investigator.
             Use of hearing aids is allowed.
Integrated Biomarker And Imaging Study - 2
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: SB-480848; SB-480848 matching placebo
Intervention description: SB-480848 is available as enteric-coated, free-base micronized tablet; Placebo is available as enteric-coated, free-base micronized tablet
Intervention MeSH terms: Darapladib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Coronary artery disease; Lipoprotein-associated Phospholipase A2; palpography; hs-CRP; endothelial function; intravascular ultrasound

Summary:

      IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented
      coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers,
      safety and tolerability.
    

Eligibility criteria:

        Inclusion criteria:

          -  Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic
             catheterization

          -  Suitable non-intervened coronary artery with IVUS

          -  Antiplatelet therapy

        Exclusion criteria:

          -  Clinical instability

          -  Previous CABG (Coronary Artery By-pass Graft) surgery

          -  Planned major surgery

          -  Recent stroke

          -  Abnormal QTc

          -  Renal or hepatic impairment

          -  Uncontrolled hypertension

          -  Use of corticosteroids

          -  Class III or IV heart failure

          -  Asthma