bioihbjkbjnl/mcl2 huggingface dataset:
A Study of ADX-102 in Subjects With Allergic Conjunctivitis
Condition: Conjunctivitis, Allergic
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: ADX-102 Ophthalmic Drops (0.5%); ADX-102 Ophthalmic Drops (0.1%); Vehicle of ADX-102 Ophthalmic Drops
Intervention description: ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.; ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.; Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADX-102; Allergic Conjunctivitis

Summary:

      A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the
      Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102
      Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic
      Conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years of age of either gender and any race

          -  have a positive history of ocular allergies and a positive skin test reaction to a
             seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog
             dander, dust mites, cockroach) as confirmed by an allergic skin test within the past
             24 months

          -  have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using
             an ETDRS chart

        Exclusion Criteria:

          -  have known contraindications or sensitivities to the use of the investigational
             product or any of its components

          -  have any ocular condition that, in the opinion of the investigator, could affect the
             subject's safety or trial parameters (including but not limited to narrow angle
             glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis,
             pterygium or a diagnosis of dry eye)

          -  have had ocular surgical intervention within three (3) months prior to Visit 1 or
             during the study and/or a history of refractive surgery within the past six (6) months

          -  have a known history of retinal detachment, diabetic retinopathy, or active retinal
             disease

          -  have the presence of an active ocular infection (bacterial, viral or fungal) or
             positive history of an ocular herpetic infection at any visit

          -  be a female who is currently pregnant, planning a pregnancy, lactating, not using a
             medically acceptable form of birth control throughout the study duration and for 14
             days prior to the installation of investigational product, or has a positive urine
             pregnancy test at Visit 1
Oral Nitrite in Adults With Metabolic Syndrome and Hypertension
Condition: Metabolic Syndrome; Hypertension
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome
Intervention: 14Nitrogen Sodium Nitrite
Intervention description: oral formulation of sodium nitrite 40 mg three times a day for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This research study is being conducted to examine the effects of daily inorganic nitrite
      treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese
      adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy
      may have a major impact on the prevention and treatment of both diabetes and cardiovascular
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-60 years

          -  Body mass index (BMI) greater than or equal to 30 kg/m^2

          -  Hypertension: defined as systolic blood pressure (SBP) greater than or equal to 130
             and/or diastolic blood pressure (DBP) greater than or equal to 85 mm Hg

          -  Waist circumference: greater than 102 cm in men, greater than 88 cm in women

        Exclusion Criteria:

          -  Positive urine pregnancy test or breastfeeding

          -  Concurrent use of medications affecting glucose metabolism (oral hypoglycemics,
             insulin, atypical antipsychotics)

          -  Recent addition or change in dosing of hormonal contraceptive medications [oral
             contraceptive pill (OCP), intrauterine device (IUD), DepoProvera]

          -  Current use of greater than or equal to 3 anti-hypertensive agents regardless of blood
             pressure control or normotensive on a single or double agent

          -  Current use of phosphodiesterase-5 inhibitors or organic nitrates

          -  Not stable on treatments for the prior three months or not planning to remain on
             current dose of medications for blood pressure, contraception, etc.

          -  Known chronic psychiatric or medical conditions including diabetes, liver or kidney
             disease or obesity syndromes

          -  Thyroid-stimulating hormone (TSH) greater than 8 milli-International unit/mL

          -  Smoker

          -  Anemia (central lab hemoglobin less than 11g/dL)
Virtual Patient Behavioral Response Training for Family Caregivers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Caring Response App; Traditional Educational/Resources Program
Intervention description: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.; Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Our study is designed to help caregivers of someone with Alzheimer's Disease and related
      dementia to understand and deal with the difficult behaviors of a person with dementia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Care for an individual with Alzheimer's Disease or other dementia.

          -  Own a smartphone or tablet and have Internet access.

          -  Minimum age of 18 years old.

          -  Spend at least 8 hours/week caring for a person with dementia.

        Exclusion Criteria:

          -  Severe psychological or physical illness.

          -  Inability to read and follow English instructions.

          -  High level of depressive symptoms.

          -  Unwillingness to participate in all aspects of the study.
Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: erlotinib hydrochloride; gemcitabine hydrochloride
Intervention description: given orally; given IV
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 70 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. It is not yet known whether gemcitabine and erlotinib are more effective when given
      alone or together in treating non-small cell lung cancer.

      PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how
      well they work when given alone or together as first-line therapy in treating older patients
      with stage IIIB or stage IV non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria Histologic or cytologic diagnosis of stage NSCLC ECOG Performance Status
        (PS) 0-2 Absolute Neutrophil Count (ANC) ≥ 1.5 Platelets ≥ 100,000 Hemoglobin ≥ 8.0 g/dl
        Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 2.5 upper limit of
        institutional normal (ULN) Alkaline phosphatase ≤ 4 x ULN Total Bilirubin below or equal to
        upper institutional normal limits Serum Creatinine ≤ 1.5 x ULN Patients may have received 1
        prior treatment in the adjuvant setting, but time since prior chemotherapy must be ≥1 year.
        Although the protocol specifically says adjuvant therapy, we believe neoadjuvant is similar
        and patients who have received neo-adjuvant (pre-operative) rather than classic adjuvant
        (post-operative) therapy are similar and should not be distinguished. Therefore, patients
        may have received

        1 prior treatment in the neo-adjuvant setting as well. Treated brain metastases are
        eligible provided the patient is asymptomatic and meets the above criteria, including PS.
        Measurable disease by RECIST criteria Ability to give informed consent

        Exclusion Criteria Patients with a history of severe hypersensitivity to gemcitabine.
        Incompletely healed from previous oncologic or other major surgery. Pregnancy or breast
        feeding (women of childbearing potential are not expected to be enrolled in this study
        given minimum age) Patients with severe co-morbid illness. Patients unable to participate
        in the QOL assessments.
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: placebo; PF-00489791; PF-00489791; PF-00489791
Intervention description: placebo, oral, tablets, once daily, for 28 days; PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days; PF-00489791 4 mg, oral, tablets, once daily, for 28 days; PF-00489791 10 mg, oral, tablets, once daily, for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Clinical Trial; Randomized Controlled Trial; Humans; Cyclic Nucleotide Phosphodiesterases Type 5

Summary:

      The purpose of this study is to evaluate the safety and blood pressure lowering effect of
      different doses of PF-00489791 in patients with mild to moderate high blood pressure
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and/or Females of non-childbearing potential between 18 and 70 years of age

          2. History of mild to moderate hypertension

        Exclusion Criteria:

          1. Type 1 or 2 diabetes on prescribed medications

          2. Secondary, severe, or malignant hypertension

          3. History of a significant cardiovascular event within the last 12 months of enrollment
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; Risankizumab
Intervention description: subcutaneous (SC) injection; subcutaneous (SC) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Atopic dermatitis, Atopic dermatitis (atopic eczema)

Summary:

      The purpose of this study is to assess the safety and efficacy of risankizumab for the
      treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults who are ≥ 18 years old and, where locally permissible and approved, adolescent
             subjects who are at least 12 years old

          -  a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to
             Baseline and subject meets Hanifin and Rajka criteria

          -  moderate to severe AD at the Baseline Visit

          -  history of inadequate response to previous topical corticosteroid and/or topical
             calcineurin inhibitor treatments or a medical inability to receive these treatments

        Exclusion Criteria:

          -  prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor

          -  concurrent treatment with systemic therapy for AD (biologic or non-biologic) or
             topical and/or phototherapy treatments
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
Condition: Hypertriglyceridemia; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hypertriglyceridemia
Intervention: ISIS 678354; Placebo
Intervention description: ISIS 678354 solution for SC injection.; Sterile Normal Saline (0.9% NaCl).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: AKCEA-APOCIII-LRx; IONIS-APOCIII-LRx; Dyslipidemia; Metabolic Disease; Hyperlipidemia; Cardiac Disease; Lipid Metabolism Disorders; Triglycerides High; Vascular Diseases

Summary:

      This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to
      evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of
      different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG)
      levels in participants with hypertriglyceridemia and established CVD or at a high risk for
      CVD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or
             peripheral artery disease).

          -  Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per
             deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equal to (≤)
             500 mg/dL (≥ 5.7 mmol/L) at Screening.

          -  Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit.

          -  Must be on standard-of-care preventative therapy for known CVD risk factors.

        Key Exclusion Criteria:

          -  Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or
             stroke/transient ischemic attack (TIA).

          -  Within 3 months of Screening: coronary, carotid, or peripheral arterial
             revascularization, major non-cardiac surgery, or lipoprotein apheresis.

          -  Heart failure New York Heart Association (NYHA) class IV.

          -  Type 1 diabetes mellitus.

          -  Type 2 diabetes mellitus with any of the following:

               -  Newly diagnosed within 12 weeks of Screening.

               -  Glycated hemoglobin (HbA1c) ≥ 9.0% at Screening.

               -  Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of
                  new medication within 12 weeks of Screening [with the exception of ± 10 units of
                  insulin].

          -  Body Mass Index (BMI) greater than (>) 40 kilograms per square meter (kg/m^2).
Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Plasma Cell Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Crizotinib
Intervention description: Given PO
Intervention MeSH terms: Crizotinib; Tyrosine Protein Kinase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crizotinib; ROS1; NCI-MATCH; Tyrosine kinase inhibitor

Summary:

      This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose
      cancer has a genetic change called ROS1 translocation. Crizotinib may block a protein called
      ROS1, which may be needed for cancer cell growth. Researchers hope to learn if crizotinib
      will shrink this type of cancer or stop its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients must be positive for translocation or inversion events involving the ROS1
             gene via the MATCH Master Protocol

          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

        Exclusion Criteria:

          -  Patients must not have NSCLC with ROS1 rearrangements

          -  Patients with a history of interstitial lung disease or pneumonitis are excluded

          -  Patients must not have known hypersensitivity to crizotinib or compounds of similar
             chemical or biologic composition

          -  Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will
             be excluded

          -  Patients must not have had prior therapy with any ROS1 inhibitor including crizotinib,
             ceritinib, foretinib, cabozantinib, AP26113, ASP3026, WZ-5-126, TAE684, KIST301072,
             KIST301080, AZD1480, PF-06463922, RXDX-101 and PF-3922
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
Condition: HSV-2
Intervention: AIC316; AIC316; AIC316; AIC316; Placebo
Intervention description: Oral administration; Oral administration; Oral administration; Oral administration; Oral administration
Intervention MeSH terms: Pritelivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention
      of reactivation of genital herpes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, Immunocompetent men and women in good health of any ethnic group

          -  History of recurrent episodes of genital herpes for at least 12 months

          -  Seropositive for Herpes Simplex Virus HSV Type 2

          -  Body Mass Index (BMI) between 18 and 35 kg/m2

        Exclusion Criteria:

          -  Present episode of genital herpes

          -  Intake of systemic drug against HSV or any topical application against HSV within 7
             days before randomization for the trial

          -  Intake of systemic corticosteroids, other immunomodulating agents or any
             investigational agent within 3 months before randomization for the trial

          -  Positive results in any of the virology tests for human immunodeficiency virus
             antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg)
             or hepatitis B core antibody (HBc-Ab)
A Study of Acute Myocardial Infarction Using FDY-5301
Condition: Acute Myocardial Infarction; STEMI
MeSH terms: Myocardial Infarction; Infarction
Intervention: FDY-5301; Placebo
Intervention description: FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.; Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of
      three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-80 year old male subjects

          2. 18 to 80 year old female subjects who are not of child-bearing potential.

          3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG
             criteria (ST-elevation at the J-point in two contiguous leads with the cut-off points:
             ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other
             leads), within 12 hours of symptom onset.

        Written informed consent prior to study participation (either by the subject or a legally
        authorized representative of the subject)

        Exclusion Criteria:

          1. Previous myocardial infarction

          2. Left bundle branch block (LBBB)

          3. Previous coronary artery bypass graft surgery (CABG)

          4. Major hemodynamic instability or uncontrolled ventricular arrhythmias

          5. Known contraindication to CMR

          6. Patients with known thyroid disease

          7. Subjects with past or current renal impairment requiring dialysis

          8. Pregnant or females of child bearing potential

          9. Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2

         10. Use of investigational drugs or devices within 30 days prior to enrollment into the
             study.

         11. Life expectancy of less than 1 year due to non-cardiac pathology

         12. Any clinically significant abnormality identified at the time of screening that in the
             judgment of the Investigator or any sub-Investigator would preclude safe completion of
             the study