bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: CP-690,550 Eye drops; CP-690,550 Eye drops; CP-690,550 Eye drops; CP-690,550 Eye drops-vehicle; Sodium Hyaluronate
Intervention description: Ophthalmic topical solution, low dose, dosed once/day, 8 weeks; Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks; Ophthalmic topical solution, high dose, dosed once/day, 8 weeks; Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks; Ophthalmic topical solution, dosed 6 times/day, 8 weeks
Intervention MeSH terms: Ophthalmic Solutions; Tofacitinib; Hyaluronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 285.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Dry eye

Summary:

      The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye
      drops in patients with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjective symptoms of dry eye for at least 6 months

          -  Signs of moderate to severe dry eye (corneal staining score and schirmer test without
             anesthesia)

        Exclusion Criteria:

          -  Women who are nursing, pregnant or planning pregnancy during the study

          -  Participation in other studies within 30 days of screening visit

          -  Ocular disorders that may confound interpretation of study results
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: VT-1161; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 259.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Several properties of VT-1161 suggest that it might be a safer and more effective treatment
      for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal
      medicines.

      This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail
      onychomycosis and consists of a screening phase, a 24-week treatment phase in which the
      patient will take either active drug, placebo or a combination of the 2 (according to random
      assignment), an initial observational phase of 36 weeks and an additional observational study
      extension of 9 months.

      The additional 9-month observational study extension was added with a protocol amendment and
      patient participation was optional.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of
        nail.

        Positive culture for dermatophytes and positive KOH.

        Nail ≤ 3 mm thick at the distal end.

        At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.

        Subjects must be able to swallow tablets.

        Women of childbearing potential and males must use acceptable birth control methods
        throughout the study.

        Key Exclusion Criteria:

        Presence of subungual hematoma or melanonychia.

        Presence of dermatophytoma/nail streaks and severe onychorrhexis.

        Significant dystrophy or anatomic abnormalities of the great toenail.

        Presence of any other infections of the foot.

        Evidence of clinically significant major organ disease.

        Poorly controlled diabetes mellitus.

        Onychomycosis involving more than 8 toe nails.

        Recent use of systemic antifungal therapy.

        Recent of any topical antifungal nail therapy.

        Recent use of systemic corticosteroid therapy.

        Recent use of immunosuppressive medication.

        History of prolonged QT intervals.

        Known human immunodeficiency virus (HIV) infection.

        Known significant renal or hepatic impairment.

        Known history of intolerance or hypersensitivity to azole antifungal drugs.
Molecular Profiling in Lung Cancer Patients
Condition: Non-Small Cell Lung Cancer; Carcinoma
MeSH terms: Lung Neoplasms
Intervention: pemetrexed; cisplatin; Radical Non-Small Cell Lung Cancer (NSCLC) surgery
Intervention description: 500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs; 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs; All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant
      chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC)
      is to look at various genes present in participants' blood and tumor tissue to see if there
      is any link between the levels or changes in the genes and how participants with lung cancer
      respond to pemetrexed and cisplatin treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  pathologic documentation of non-small cell lung cancer (NSCLC)

          -  tumor must be accessible by bronchoscopy for tumor tissue sample collection

          -  patients must have lung cancer with clinical stage IB, II, IIIA

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  patients must not have received prior systemic chemotherapy or radiation therapy for
             NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed
             between prior surgery and enrolment)

        Exclusion Criteria:

          -  bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast
             tumors)

          -  pregnant or breast feeding patients

          -  patients who have received treatment within the last 30 days with a drug that has not
             received regulatory approval for any indication at the time of study entry

          -  patients with history or presence of other malignancy except in situ carcinoma of the
             skin or prior malignancy treated more than 5 years before without recurrence
             (excluding melanoma, breast cancer and hypernephroma)

          -  unwillingness to take folic acid or vitamin B12 supplementation
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551
Intervention description: Applied twice daily for 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 122-0551; steroid; HPA

Summary:

      Adrenal suppression effects of corticosteroids are among the most important safety concerns
      for this group of products. This study is designed to determine the adrenal effects of the
      investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of
      the formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis

          -  Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy
             within 30 days prior to initiation of treatment

          -  Subject has used systemic corticosteroids or topical, inhaled, intranasal
             corticosteroids within 30 days and 14 days, respectively, prior to study screening

          -  Subject has had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to initiation of treatment

          -  Subject has used topical psoriatic therapy including tar, anthralin, retinoids,
             vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment

          -  Subject has used emollients/moisturizers on areas to be treated within one day prior
             to initiation of treatment

          -  Subject is currently using lithium or Plaquenil (hydroxychloroquine)

          -  Subject is currently using a beta-blocking medication (e.g., propranolol) or
             angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has
             not been stabilized

          -  Subject is pregnant, nursing or planning a pregnancy during the study period

          -  Subject is currently enrolled in an investigational drug, biologic or device study

          -  Subject has received an investigational drug, biologic or an investigational device
             within 30 days prior to study start

          -  Subject has been previously enrolled in this study and treated with the test article

          -  Subject has an irregular sleep schedule or works night shifts
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
Condition: Systemic Sclerosis, Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Fibrosis
Intervention: STI571
Intervention description: STI571 tablets taken orally once a day
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic sclerosis, scleroderma, fibrosis, STI571, imatinib

Summary:

      This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in
      participants with systemic sclerosis. Other purposes of the study were to investigate whether
      STI571 is effective in improving lung functions and other test results called biomarkers.
      Whether STI571 is well-absorbed in systemic sclerosis participants' gut was also investigated
      by testing the drug level in the blood (pharmacokinetics).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants who are equal to or older than 18 years of age and who
             have early diffuse cutaneous systemic sclerosis (Disease duration < 18 months from the
             first non-Raynaud's symptom)

          -  Participants with a modified Rodnans Skin Score (MRSS) of at least 20 in the absence
             of trunk involvement or a MRSS of at least 16 in patients with trunk involvement

          -  Female patients of childbearing potential practicing two acceptable forms of
             contraception

        Exclusion Criteria:

          -  SSc patients with a MRSS greater than 35

          -  Concurrent connective tissue diseases other than systemic sclerosis

          -  Significant pre-existing heart, liver, lungs, digestive system, blood and other
             diseases, cancer

          -  Conditions that might mimic the potential side effects of STI571 (blood conditions,
             liver damage, chronic diarrhea, edema)

          -  Concurrent medical therapies (or during last 6 weeks before first dosing) that may
             potentially influence outcome of the study

          -  Allergic to the study medication

          -  Pregnancy

          -  Breast feeding
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
Condition: Alpha-1 Antitrypsin Deficiency; Emphysema; Chronic Obstructive Pulmonary Disease
MeSH terms: Alpha 1-Antitrypsin Deficiency; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Intervention: Aspirin; Placebo; Withdrawal from alpha1 antitrypsin replacement therapy
Intervention description: 81mg aspirin taken once per day in the morning; placebo taken once per day in the morning; After the completion of the randomization to aspirin and placebo, participants who are on alpha1 replacement therapy are asked to withhold their usual alpha1 antitrypsin replacement therapy for 5 weeks. This is not randomized.
Intervention MeSH terms: Aspirin; Alpha 1-Antitrypsin; Protein C Inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: alpha-1 antitrypsin deficiency; Emphysema; chronic obstructive pulmonary disease

Summary:

      The aim of this study is to test whether aspirin improves endothelial function in alpha-1
      antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood
      flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alpha-1 antitrypsin deficiency (PiZZ genotype)

          -  40 years of age or older

          -  Evidence of emphysema on CT scan as read by a Radiologist

        Exclusion Criteria:

          -  Platelet count < 150,000/dL, history of intracranial hemorrhage or severe GI bleed,
             use of systemic anticoagulant, physician prescribed use of antiplatelet drug
             (including aspirin and P2Y12 receptor inhibitors), or known severe liver disease

          -  Immunosuppression by use of medications (including oral prednisone), or those with
             immunomodulatory disease (organ transplantation, autoimmune conditions or
             actively-treated malignancy)

          -  Known atrial fibrillation or left ventricular (LV) systolic heart failure

          -  Contraindication to MRI, including pregnancy, weight > 300 lbs (due to weight limits
             of the machine), those with pacemakers, aneurysm clips, cochlear implants or other
             implanted electronic devices, or severe claustrophobia;

          -  Chronic renal insufficiency (estimated GFR < 45 L/min/1.73 m2 or self report) due to
             slightly increased risk of nephrogenic systemic fibrosis from gadolinium
             administration and aspirin-related renal insufficiency

          -  Exacerbation of respiratory symptoms within the previous 6 weeks, such as that
             requiring hospitalization, oral prednisone or antibiotics to control symptoms.
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
Condition: NASH - Nonalcoholic Steatohepatitis; Fibrosis, Liver; NAFLD - Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Intervention: CRV431 75mg; Placebo (1 softgel); CRV431 225mg; Placebo (3 softgels)
Intervention description: 1 x 75mg softgel capsule; 1 x placebo softgel capsule; 3 x 75mg softgel capsule; 3 x placebo softgel capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, single-blind
Masking: Single (Participant)
Masking description: placebo-controlled
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Anti-fibrotic

Summary:

      This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431
      in presumed NASH F2/F3 subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female between 18 and 75 years of age (inclusive).

          -  Capable of giving written informed consent and able to effectively communicate with
             the investigator and study personnel.

          -  Presumed F2/F3 NASH to include: AST >20 IU/L, Pro-C3 >15.5 ng/mL, enhanced liver
             fibrosis (ELF) score >9.8, and FibroScan >8.5 kPa values.

        Key Exclusion Criteria:

          -  Pregnant or breastfeeding or planning to become pregnant during the study period.

          -  Known allergy to CRV431, cyclosporine, or any of their inactive ingredients.

          -  Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies
             (HCVAb) or human immunodeficiency virus antibodies (HIVAb).

          -  Well documented causes of chronic liver disease according to standard diagnostic
             procedures to include any history or presence of decompensated cirrhosis.

          -  Subjects with a platelet count <150,000/mL.

          -  Subjects with hemoglobin A1c(HbA1c) >9.5%.

          -  Weight loss of more than 5% within 3 months prior to randomization.

          -  Subjects with a blood pressure to include a systolic pressure >150 or a diastolic
             pressure >90.

          -  At Screening, an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 mL
             (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method)
             and/or a Kidney Disease Improving Global Outcomes (KDIGO) category of >G2.

          -  Subjects with a history of organ transplantation. Corneal transplantation will be
             allowed.
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Hypercalciuria
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypercalciuria
Intervention: Chlorthalidone
Intervention description: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Intervention MeSH terms: Chlorthalidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: type 1 diabetes; hypercalciuria

Summary:

      This open-label study will determine if chlorthalidone is safe and effective for the use of
      reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T1D

          -  Age 12-21 years

          -  Tanner Stage 2 or greater pubertal development

          -  Urine calcium excretion ≥ 4 mg/kg/day

          -  Able to swallow pills

        Exclusion Criteria:

          -  BMI > 99th percentile for age (<18 years) or BMI >35 kg/m2 (≥ 18 years)

          -  Coexistent conditions that may affect calcium metabolism including:

               -  celiac disease

               -  Graves' Disease

               -  Addison's disease

               -  hypo- or hyperparathyroidism

          -  History of diabetes related complications including:

               -  neuropathy

               -  retinopathy

               -  nephropathy

               -  gastroparesis

          -  History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past
             month

          -  History of any diuretic use within the past month

          -  Laboratory abnormalities on screening bloodwork including:

               -  estimated glomerular filtration rate <90 mL/min per 1.73 m2 of body surface area

               -  serum calcium >10.5 mg/dL

               -  serum potassium <3.5 mmol/L

          -  Systolic or diastolic blood pressure <5th percentile for age and sex50 for age <18
             years or systolic <90 mmHg or diastolic blood pressure <60 mmHG for age ≥18 years
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate + SPD503 (Guanfacine hydrochloride); Amphetamine + SPD503
Intervention MeSH terms: Guanfacine; Methylphenidate; Amphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and tolerability of administering SPD503
      (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for
      treatment of ADHD in children and adolescents aged 6-17
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a primary diagnosis of ADHD

          -  Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for
             at least 1 month, with sub-optimal control in the Investigator's opinion

          -  Male or non-pregnant female subject who agrees to comply with any applicable
             contraceptive requirements

        Exclusion Criteria:

          -  Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild
             anxiety) with significant symptoms

          -  History of seizure during the last 2 years

          -  Subject has any specific cardiac condition or family history of significant cardiac
             condition

          -  Subject is pregnant or lactating