bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: Phenytoin; placebo
Intervention description: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.; 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
Intervention MeSH terms: Phenytoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: participant , investigator
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it
      presents as subacute monocular visual loss that develops over several days.

      As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term
      beneficial effect on vision.

      There are a number of factors that contribute to nerve fibre damage including increased level
      of sodium, so blocking sodium entry could help to protect them against damage.

      The main objective of the study is determine whether phenytoin (which blocks sodium entry)
      can protect nerve fibre and improve final visual function after optic neuritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)

          -  willing to receive a steroidal regimen

          -  no pathologic finding in first oct

          -  no pathology and history of optic neuritis in contralateral eye

          -  <14 days since onset visual loss

        Exclusion Criteria:

          -  Contraindication or known allergy to Phenytoin

          -  Use of a calcium channel or sodium channel blocker in the past 2 months

          -  Corticosteroid use in the past 2 months

          -  Pregnancy

          -  Significant cardiac, renal or liver abnormalities

          -  Prior clinical episode of optic neuritis in either eye

          -  Bilateral acute optic neuritis

          -  Known ocular or neurological conditions or abnormalities other than refractive error
             that impair visual function

          -  Refractive error of greater than +5 or -5 diopters

          -  Any condition that may interfere with performance of Optical Coherence Tomography
             (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not
             related to optic neuritis as detected on the OCT reading
Efficacy and Safety of TD-1473 in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo; TD-1473
Intervention description: Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.; TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.
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
Healthy volunteers: No
Keywords: TD-1473; Janus kinase inhibitor; JAK inhibitor; Inflammatory Bowel Disease; IBD; Crohn's Disease; Intestinal restriction

Summary:

      A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with
      moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years of age at screening

          -  Males and females with clinical evidence of Crohn's disease for at least 3 months
             duration at screening

          -  Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's
             Disease Activity Index (CDAI) score of 220-450 inclusive

          -  SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of
             the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD]

          -  Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to
             conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as
             azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy,
             anti-IL-12/23 (anti-interleukin), anti-integrin).

          -  Additional inclusion criteria apply

        Exclusion Criteria:

          -  Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy

          -  Has a current bacterial, parasitic, fungal, or viral infection

          -  Has clinically significant abnormalities in laboratory evaluations

          -  Prior exposure or potential exposure to a JAK inhibitor that was stopped due to
             intolerance or lack of efficacy

          -  Subject has participated in another clinical trial of an investigational drug (or
             medical device) within 30 days prior to Screening or 5x the half-life of the
             investigational drug, whichever is longer, or is currently participating in another
             trial of an investigational drug (or medical device)

          -  Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e.,
             anti-TNF, anti-integrin, and anti-IL12/23)

          -  Additional exclusion criteria apply
A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
Condition: Various Advanced Cancer
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor
      size in subjects with metastatic or unresectable bladder cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of metastatic or surgically unresectable transitional cell carcinoma of the
             urothelium involving the bladder,urethra,ureter or renal pelvis

          -  Measurable disease by CT or MRI

          -  Progression or recurrence after treatment

          -  i) With at least 1 platinum-containing chemotherapy regimen for metastatic or
             surgically unresectable locally advanced urothelial cancer, or

          -  ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a
             platinum agent in the setting of cystectomy for localized muscle-invasive urothelial
             cancer

          -  Subject that have received more than 2 prior lines of chemotherapy must not have liver
             metastases

          -  Tumor tissues (archived or new biopsy) must be provided for biomarker analysis

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

        Exclusion Criteria:

          -  Subjects with active cancer that has spread to the central nervous system

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured

          -  Subject with active, known or suspected autoimmune disease

          -  Subjects with a condition requiring systemic treatment with either corticosteroids
             (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
             day of study drug administration

          -  Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic
             T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody
             or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

        Exclusion laboratory criteria:

          -  Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
             ribonucleic acid (HCV antibody) indicating acute or chronic infection

          -  Known history of testing positive for human Immunodeficiency virus (HIV) or known
             acquired Immunodeficiency syndrome (AIDS)

        Other protocol-defined inclusion/exclusion criteria apply
Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: Debio 1347
Intervention description: Debio 1347 oral tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the efficacy of Debio 1347 in terms of
      objective response rate (ORR) in participants with solid tumors harboring fibroblast growth
      factor receptor (FGFR)1-3 gene fusion/rearrangement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologically confirmed advanced solid tumor

          -  Radiographic progression on prior systemic therapy; prior localized therapy (i.e.,
             radiation, ablation, embolization) is allowed provided radiographic progression
             out-of-field or in the treatment, field is shown

          -  Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene
             fusion/rearrangement potentially leading to a functional FGFR aberrant protein,
             identified through local and/or central molecular assay

        Exclusion Criteria:

          -  History of hypersensitivity to any of the excipients in the Debio 1347 formulation

          -  History and/or current evidence of ectopic mineralization/calcification, including but
             not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting
             calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon
             calcifications

          -  Administration of any investigational agent within 2 weeks prior to initial dosing
             with Debio 1347 (3 weeks for immune checkpoint inhibitors)
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: SB480848 40mg EC Tablet; SB480848 80mg EC Tablet; SB480848 160mg EC Tablet; SB480848 Placebo Tablet
Intervention description: 1 tablet once a day; 1 tablet once a day; 1 tablet once a day; 1 tablet once a day
Intervention MeSH terms: Darapladib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SB-480848; Dyslipidaemia

Summary:

      The primary objective of this study is to examine the effects of SB-480848 on plasma
      lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a
      4-week treatment with SB-480848.
    

Eligibility criteria:

        Inclusion criteria:

        Dyslipidemic subject who is currently undergoing statin therapy and no change in
        lipid-lowering therapy or dose during the 4 week prior to randomization

        Exclusion criteria:

          1. Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined
             as:

             A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary
             revascularization [(percutaneous coronary intervention (PCI) or coronary artery bypass
             graft (CABG)] D)Stroke of any etiology E)Peripheral arterial disease with critical
             limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene)
             F)Resuscitated cardiac arrest

          2. Planned CABG or planned PCI or planned major non-cardiac surgery within study period

          3. No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening

          4. Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to
             randomization

          5. Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening
Two and Three Dimensional Contrast-enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Recurrence
Intervention: Optison
Intervention description: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cryosurgery; ultrasonography

Summary:

      The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound (CEUS)
      can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation
      compared to contrast enhanced CT or MR (the standard evaluation). This study involves the
      off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the
      vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine
      post-cryoablation vascularity changes to screen for recurrent disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously received cryotherapy of RCC.

          -  Be scheduled for contrast-enhanced MRI/CT to monitoring of RCC recurrence as part of
             their 8, 12, 18, 24, or 36 month CT/MRI follow up.

          -  Be at least 18 years of age.

          -  Be medically stable.

          -  If a female of child-bearing age, must have a negative pregnancy test.

          -  Have signed Informed Consent to participate in the study.

        Exclusion Criteria:

          -  Females who are pregnant or nursing.

          -  Patients who are medically unstable, patients who are seriously or terminally ill, and
             patients whose clinical course is unpredictable. For example:

          -  Patients on life support or in a critical care unit.

          -  Patients with unstable occlusive disease (eg, crescendo angina)

          -  Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular
             tachycardia.

          -  Patients with uncontrolled congestive heart failure (NYHA Class IV)

          -  Patients with recent cerebral hemorrhage.

          -  Patients with known sensitivities to albumin, blood, or blood products

          -  Patients who have undergone surgery within 24 hours prior to the study sonographic
             examination.

          -  Patients with known hypersensitivity to perflutren

          -  Patients with cardiac shunts.

          -  Patients with congenital heart defects.

          -  Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary
             emboli.

          -  Patients with respiratory distress syndrome.
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Bermekimab; Placebo
Intervention description: Participants will receive bermekimab IV.; Participants will receive placebo IV.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of Bermekimab, compared with placebo,
      in participants with moderate-to-severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first
             administration of study intervention as determined by the investigator through
             participant interview and/or review of the medical history

          -  Have a history of inadequate response to treatment for AD with topical medications or
             for whom topical treatments are otherwise medically inadvisable (example, due to
             important side effects or safety risks)

          -  Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16
             at screening and at baseline

          -  Must sign an informed consent form (ICF) indicating that he or she understands the
             purpose of, and procedures required for, the study and is willing to participate in
             the study

          -  Must be willing to undergo 4 skin biopsies

          -  Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline

          -  Have an involved body surface area (BSA) >=10 percent (%) at screening and at baseline

        Exclusion Criteria:

          -  Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled
             renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
             hematologic, rheumatologic, psychiatric, or metabolic disturbances

          -  Has ever received any Human interleukin-1 (IL-1) antagonist (example, including but
             not limited to anakinra, rilonacept)
Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
Condition: Surgery
Intervention: Acetaminophen; Ibuprofen 600 mg; Oxycodone
Intervention description: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed); 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed); The number of tablets of oxycodone prescribed is the only difference between the two arms.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized to receive one of two prescription regimens.
Masking: Single (Outcomes Assessor)
Masking description: The treating provider and the patient know their prescription. The outcomes assessor will be blinded when administering the postoperative surveys.
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ambulatory; narcotics; opioids; postoperative; gynecology; laparoscopy; pain; surgery

Summary:

      Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the
      opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing
      in the post-operative period. There is wide variation in the prescribing practices for
      post-operative pain control and there is no standard of care for pain control after minor
      laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to
      show that on average half of the opioids prescribed are unused by the patient. The aim of the
      study is to evaluate two opioid prescription regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be over 18 years of age

          -  Scheduled for outpatient gynecologic laparoscopy

        Exclusion Criteria:

          -  Significant renal or liver disease is present that would alter prescribing patterns

          -  Chronic opioid use or abuse

          -  Allergy to acetaminophen, ibuprofen, other nsaids or narcotic medications

          -  Conversion of surgery to exploratory laparotomy
Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: PRT-2761 0.5%; PRT-2761 1%; Patanol; Pred-forte; PRT-2761 0%
Intervention description: Six drops in each eye over a 17 day period.; Six drops in each eye over a 17 day period.; Six drops in each eye over a 17 day period.; Four drops in each eye over a 3 day period.; Six drops in each eye over a 17 day period.
Intervention MeSH terms: Prednisolone acetate; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic
      solution for the treatment of the signs and symptoms of acute and chronic allergic
      conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years old

          -  be willing and able to avoid all disallowed medications and contact lenses

          -  must have a pregnancy test if of childbearing potential

          -  must be able to read an eye chart from 10 feet away

        Exclusion Criteria:

          -  must not have any allergies to the study medications

          -  must not have any ocular or non ocular condition that investigator feels will
             interfere with study parameters

          -  must not have used an investigational drug or device in the past 30 days or
             concurrently enrolled in another investigational trial
Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ruxolitinib
Intervention description: Ruxolitinib 1.5% cream BID for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: psoriasis

Summary:

      This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in
      patients with active, stable plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have psoriatic lesions measuring protocol specific BSA

        Exclusion Criteria:

          -  Lesions solely involving the palms of the hands, the soles of the feet, the
             intertriginious areas, the scalp or the face

          -  Pustular psoriasis or erythroderma