bioihbjkbjnl/mcl2 huggingface dataset:
Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
Condition: Kidney Injury; Proteinuria; Hypertension
MeSH terms: Proteinuria; Hypertension; Wounds and Injuries
Intervention: Isosorbide Mononitrate; Placebo oral tablet
Intervention description: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).; Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double blinded
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Kidney Injury; Proteinuria; Hypertension; Anti-VEGF

Summary:

      The purpose of this study is to test the hypothesis that isosorbide mononitrate prevents
      deterioration of renal function in patients receiving anti-angiogenic therapies that target
      vascular endothelial growth factor (VEGF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients on or enrolled for anti-VEGF therapy

          -  new-onset proteinuria, defined as a urine protein: creatinine ratio (UPC) of >500mg/g
             or hypertension (Systolic BP ≥ 140 mm Hg and/or diastolic BP ≥ 90 mm Hg) or a decrease
             in eGFR by ≥ 25% from baseline before starting therapy.

        Exclusion Criteria:

          -  Pregnant women

          -  Breast-feeding women.
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Vehicle; Sham; Cyclosporine New Ophthalmic Formulation
Intervention description: Vehicle of cyclosporine administered as per protocol; Sham administered to non-study eye as per protocol on Day 1; Cyclosporine New Ophthalmic Formulation administered as per protocol
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in
      patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied
      in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will
      participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was
      cancelled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe dry eye disease in both eyes

          -  Best-corrected visual acuity (BCVA) of 20/100 or better in each eye

        Exclusion Criteria:

          -  Use of any cyclosporine preparations within 3 months

          -  Use of topical medications, other than artificial tears, in the eyes within 1 month

          -  Use of contact lenses in either eye within 1 month

          -  Stage 2 only: Participation in Stage 1 of this study
NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: NKTR-102; irinotecan
Intervention description: IV every 3 weeks; IV every 3 weeks
Intervention MeSH terms: Irinotecan; Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colorectal cancer; Colorectal cancer, second line

Summary:

      This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect
      in patients with colorectal cancer. This study will also evaluate how the safety and
      anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for
      use in the US for treatment of patients with certain types of colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  metastatic colorectal cancer

          -  tumor with k-ras mutation

        Exclusion Criteria:

          -  More than 1 prior regimen for treatment of metastatic disease
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-126 Ophthalmic Solution 0.002% QD; Timolol Maleate Ophthalmic Solution 0.5% BID
Intervention description: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning; Timolol Maleate Ophthalmic Solution BID (morning and evening)
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma

Summary:

      Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop
      medications has been shown to be effective in delaying or preventing the progression of
      glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field
      loss.

      This study is being conducted to determine how well DE-126 ophthalmic solution works
      (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate
      the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle
      Glaucoma (POAG) or Ocular Hypertension (OHT).

      The IOP will be measured at 3 different times throughout the day, over 4 total visits during
      a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop
      taking current eye drops to lower IOP). Safety assessments will be done throughout the study,
      including ocular signs and symptoms, and vital signs. While the most important time-point to
      measure IOP in this study and evaluate efficacy will be at the final study visit (month 3),
      IOP values will also be evaluated at other visits throughout the 3-month treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with
             OHT

          -  Completed the required wait/washout period

          -  Qualifying Day 1 IOP measurement at 3 time-points in both eyes

        Exclusion Criteria:

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Subjects who cannot safely discontinue use of ocular hypotensive medications during
             the wait/washout period.

          -  History of ocular surgery specifically intended to lower IOP in either eye. Laser
             iridotomy in history is allowed

          -  Presence of advanced glaucoma in either eye
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients
Condition: Influenza; Multiple Myeloma; Waldenstrom's Macroglobulinemia; Plasma Cell Disorders; MGUS
MeSH terms: Influenza, Human; Multiple Myeloma; Waldenstrom Macroglobulinemia
Intervention: Fluzone High Dose Vaccine; Standard of care/Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: influenza; multiple myeloma; Waldenstrom's macroglobulinemia

Summary:

      The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster
      to all patients with monoclonal gammopathies (irrespective of age) will lead to
      seroconversion rates exceeding 50% and more importantly, will reduce influenza-related
      morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the
      end of the flu season
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form.

          -  Age ≥18 years at the time of signing the informed consent form.

          -  Diagnosis of any monoclonal gammopathy: Monoclonal Gammopathy of Undetermined
             Significance (MGUS), asymptomatic / active multiple myeloma, asymptomatic / active
             Waldenstrӧm Macroglobulinemia (WM).

        Exclusion Criteria:

          -  Any serious egg allergy or prior serious adverse reaction to an influenza vaccine.

          -  Use of any other influenza vaccine for the 2015 to 2016 flu season.

          -  Women who are pregnant or plan to become pregnant in the study period.
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
Condition: Autoimmune Hemolytic Anemia
MeSH terms: Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis
Intervention: Parsaclisib
Intervention description: Parsaclisib administered orally.
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
Healthy volunteers: No
Keywords: autoimmune hemolytic anemia; phosphatidylinositol 3-kinase (PI3K) inhibitor

Summary:

      The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered
      orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin
      and evidence of ongoing hemolysis that requires treatment intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence
             of anti-erythrocyte antibodies, detectable by the direct antiglobulin test.

          -  Participants who have disease progression after treatment with standard therapies that
             are known to confer clinical benefit, or who are intolerant to treatment, or who
             refuse standard treatment. There is no limit to the number of prior treatment
             regimens.

          -  Hemoglobin 7 to 10 g/dL.

          -  No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying
             conditions.

          -  Eastern Cooperative Oncology Group performance status of 0 to 2.

          -  Willingness to avoid pregnancy or fathering children.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women.

          -  Concurrent conditions and history of other protocol-specified diseases.

          -  ANC < 1.5 × 10^9/L.

          -  Platelet count < 100 × 10^9/L.

          -  Severely impaired liver function.

          -  Impaired renal function with estimated creatinine clearance less than 45 mL/min.

          -  Anti-phospholipid antibodies positive or elevated anti-streptolysin antibodies.

          -  Positive serology test results for hepatitis B surface antigen or core antibody, or
             hepatitis C virus antibody with detectable RNA at screening, consistent with active or
             chronic infection.

          -  Known HIV infection or positivity on immunoassay.

          -  History or presence of an abnormal ECG that, in the investigator's opinion, is
             clinically meaningful.

          -  Known hypersensitivity or severe reaction to parsaclisib or its excipients.
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
Condition: Sjögren Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: Remibrutinib; Placebo
Intervention description: Remibrutinib 100 mg was administered orally as two 50 mg hard gelatin capsules. Patients in the remibrutinib 100 mg bid dose group took 2 capsules of active medication in the morning and 2 capsules of active medication in the evening. Patients in the remibrutinib 100 mg qd dose group took 2 capsules of active medication in the morning and 2 capsules of the placebo in the evening.; Placebo was administered orally as two hard gelatin capsules. Patients in the placebo dose group took 2 capsules of placebo in the morning and 2 capsules of placebo in the evening.
Intervention MeSH terms: Remibrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: LOU064; remibrutinib; Sjogren Syndrome; Dry Eye Syndromes; Pathological Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Summary:

      This was an adaptive design phase 2 study to establish safety and efficacy; and to
      characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's
      syndrome. LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of SjS according to the 2016 ACR/EULAR criteria

          -  Screening ESSDAI (based on weighted score) ≥ 5 derived from 8 domains

          -  Screening ESSPRI ≥ 5

          -  Seropositive for anti-Ro/SSA antibodies at or within 3 months prior to screening

          -  Unstimulated salivary flow > 0 mL/min.

        Exclusion Criteria:

          -  Sjögren's Syndrome overlap syndromes with another autoimmune disease as primary
             illness

          -  DMARDs or kinase inhibitors within 3 months prior to baseline above certain doses OR
             maintained during study

          -  Rituximab or other B cell depleting drug within 12 months of Screening .

          -  Current use of prednisone or equivalent > 15mg/d or dose change within 2 weeks prior
             to Screening

          -  Use of medication known to cause, as a major side effect, dry mouth / eyes

          -  HIV, Hepatitis C, Hepatitis B, known or suspected history of an ongoing, chronic or
             recurrent infectious disease such as tuberculosis
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OTX-DED; OTX-DED; OTX-DED
Intervention description: 0.2mg dexamethasone ophthalmic insert; 0.3mg dexamethasone ophthalmic insert; Hydrogel vehicle ophthalmic insert
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dexamethasone ophthalmic insert

Summary:

      To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and
      symptoms of dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dry Eye Disease diagnosis

          -  VAS eye dryness severity score ≥ 40.

        Exclusion Criteria:

          -  Are unwilling to discontinue use of contact lenses

          -  Are unwilling to withhold use of artificial tears.
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
Condition: Cushing's Syndrome; Ectopic Corticotropin Syndrome; Adrenal Adenoma; Adrenal Carcinoma; AIMAH; PPNAD
MeSH terms: Adenoma; Adrenocortical Adenoma; Adrenocortical Carcinoma; ACTH Syndrome, Ectopic; Cushing Syndrome; Syndrome
Intervention: Osilodrostat
Intervention description: Osirodrostat 1mg, 5mg & 10mg in the form of film-coated tablets was used for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Cushing's syndrome; osilodrostat; LCI699; ectopic corticotropin syndrome; adrenal adenoma; adrenal carcinoma; ACTH-Independent Macronodular Adrenal Hyperplasia; AIMAH; Primary Pigmented Nodular Adrenal Dysplasia; PPNAD

Summary:

      The study aim was to investigate the efficacy and safety of Osilodrostat in patients with
      Cushing's syndrome due to causes other than Cushing's disease in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with confirmed Cushing's syndrome [i.e. ectopic corticotropin syndrome,
             adrenal adenoma, adrenal carcinoma, ACTH-Independent Macronodular Adrenal Hyperplasia
             (AIMAH), or Primary Pigmented Nodular Adrenal Dysplasia (PPNAD)]

          -  For patients on medical treatment for hypercortisolism due to Cushing's syndrome, the
             washout periods had to be completed prior to baseline efficacy assessments

        Exclusion Criteria:

          -  Patients with Cushing's disease

          -  History of hypersensitivity to osilodrostat or to drugs of similar chemical classes

          -  History of malignancy of any organ system, treated or untreated, within the past 5
             years

          -  Patients receiving treatment for within 4 weeks or ≤5 x half-life of the agent
             (whichever is longer) before first dose of osilodrostat

          -  Patients with risk factors for QTc prolongation or Torsade de Pointes
Translational Neuroscience Optimization of GlyT1 Inhibitor
Condition: Cognitive Impairments Associated With Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-03463275; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of
      stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this
      study is to test the efficacy of treatment with one of two does of a glycine transporter
      inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function.
      Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I)
      and placebo twice daily in addition to their antipsychotic medication for 2 treatment
      periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout
      period lasting approximately 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1) Males or females 21 to 65 years of age (inclusive).

          -  2) Diagnosis of Schizophrenia or Schizoaffective Disorder

          -  3) Able to provide written informed consent.

          -  4) Only CYP2D6 extensive metabolizers.

        Exclusion Criteria:

          -  1) No ongoing acute medical issues

          -  2) Clinically significant ECG abnormality

          -  3) Blood donation within eight weeks of the start of the study

          -  4) Current treatment with Clozapine
Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
Condition: Childhood Glaucoma
MeSH terms: Glaucoma
Intervention: Latanoprost, Dorzolamide
Intervention description: Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)
Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost
Intervention MeSH terms: Dorzolamide; Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 1 Month
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Intraocular pressure; Latanoprost; Dorzolamide

Summary:

      Objectives:

      The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a
      selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to
      surgical procedures. Safety will be assessed, too.In the first version of the protocol 96
      eyes were forecasted to complete the enrolment. The protocol was then amended and now to
      complete the study 68 eyes should be included. This number of eyes could be achieved by
      recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for
      the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children of either sexes, aged 0-12 years

          -  Diagnosis of mono- or bilateral primary congenital glaucoma

          -  IOP greater than or equal to 22 mmHg and lower than 27 mmHg

          -  Only one previous ocular hypotensive surgical procedure for treatment of glaucoma
             among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin
             C) (only for medical treatment at least one month before)

          -  Parent informed consent to data processing (at registration)

          -  Parent informed consent before any study procedure

        Exclusion Criteria:

          -  Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma,
             steroid-induced glaucoma, etc.)

          -  Presence of concomitant abnormalities of the anterior segment of the eye (cataract,
             iridocorneal dysgenesia, congenital uveal ectropion uvea, etc.)

          -  Previous treatment with the study drugs

          -  Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease,
             renal failure, etc.) that needs treatment with drugs, that could influence IOP
             (steroids, beta-blockers, angiotensin-converting-enzyme inhibitor -inhibitors
             diuretics, etc.)

          -  Abnormalities of the cornea that could influence IOP readings (marked cornea edema)