bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: refined indigo naturalis ointment; crude indigo naturalis ointment
Intervention description: The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.; The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: psoriasis, indigo naturalis

Summary:

      To compare the efficacy and safety of refined indigo naturalis ointment with that of crude
      ointment in treating psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients were had received a diagnosis of plaque psoriasis based on clinical
             assessment by two dermatologists at least a one year prior to entry into the study;

          -  Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were
             adults aged 20 to 65 years;

          -  Patients were in good general health.

          -  Female patients of childbearing age agreed to continue using birth control measures
             for the duration of the study.

        Exclusion Criteria:

          -  Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced
             forms of psoriasis; total body surface involvement of more than 60%;

          -  Patients had a history of allergy to indigo naturalis.

          -  Patients were excluded if they have received systemic therapy within 4 weeks before
             enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2
             weeks before enrollment.

          -  Patients had included usage of medications that affect psoriasis during the study and
             unwillingness to comply with study protocol.
Enhancing Medication-based Analgesia in Humans
Condition: Pain; Cannabis; Opioid Use, Unspecified
Intervention: Within-subject test of blinded study medications
Intervention description: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: Each participant completed each of the 5 study conditions (identified here as arms).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clinical Trial, Phase II; Analgesia; Abuse Potential

Summary:

      This is a single-group, within-subject, double-blind, double-dummy, placebo and
      active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol)
      would enhance analgesia, subjective reports, and cognitive performance when compared to the
      FDA-approved opioid hydromorphone (Dilaudid).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-75

          -  Urine sample tests negative for common illicit substances of abuse, including cannabis

          -  Medically cleared to take study medications

          -  Are not pregnant or breast feeding

          -  Willing to comply with the study protocol.

        Exclusion Criteria:

          -  Meet DSM-5 criteria for alcohol/substance use disorder

          -  Taking opioids for pain

          -  Previous adverse reaction to a cannabinoid product

          -  Prescribed and taking stimulants or benzodiazepines

          -  Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain

          -  Self-report any illicit drug use in the past 7 days

          -  Presence of any clinically significant medical/psychiatric illness judged by the
             investigators to put subject at elevated risk for experiencing an adverse event

          -  History of seizure disorder

          -  Have a known allergy to the study medications or sesame seed oil

          -  Taking medications contraindicated with hydromorphone or dronabinol

          -  Have a history of clinically significant cardiac arrhythmias or vasopastic disease

          -  Have an abnormal and clinically-significant ECG
Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Placebo-matched-to-ivacaftor tablet
Intervention description: 150 milligram (mg) tablet orally every 12 hours up to 12 weeks.; Orally every 12 hours up to 4 weeks.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 24.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study is a multiple within participant crossover study to evaluate the effect of
      ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF)
      who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator
      (CFTR) function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with confirmed diagnosis of CF

          -  Clinical evidence of residual CFTR function based on any 1 of the following: 1)
             Clinically documented residual exocrine pancreatic function, 2) Sweat chloride value
             less than equal to (<=) 80 millimole per liter (mmol/L) at screening, or 3) Age of
             diagnosis greater than equal to (>=) 12 years and at least 1 copy of a CFTR mutation
             associated with residual CFTR function or defective mRNA splicing

          -  FEV1 >= 40 percent (%)

          -  12 years of age or older

          -  Willing to agree to meet the contraception requirements

          -  Able to swallow tablets

        Exclusion Criteria:

          -  A copy of any of the following CFTR mutations: G551D, G178R, S549N, S549R, G551S,
             G970R, G1244E, S1251N, S1255P, or G1349D

          -  Unable to perform spirometry

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1

          -  Ongoing participation in another therapeutic clinical study or prior participation in
             an investigational drug study within the 30 days prior to screening
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Tofacitinib 2 mg; Tofacitinib 5 mg; Tofacitinib 10 mg; Placebo
Intervention description: 4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks; 4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks; 4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks; 4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis; Spondylitis; Ankylosing; Spondyloarthritis; Spondyloarthropathy; Oral preparation

Summary:

      This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It
      is designed to obtain information on the efficacy and safety of 3 different doses of
      tofacitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of Ankylosing Spondylitis

          -  Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
             treatment or is intolerant to NSAIDs

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any
             biological agent
Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Etanercept; Placebo
Intervention description: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week; Hemodialysis patients will receive Saline by subcutaneous injection twice a week
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double Blind Study
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: etanercept; malnutrition; inflammation; hemodialysis

Summary:

      Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid
      arthritis. We are examining whether Etanercept is effective in improving the nutritional
      status of hemodialysis patients as a consequence of its ability to decrease inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of end stage renal disease

        Exclusion Criteria:

          -  History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within
             previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus
             erythematosis, presence of transcutaneous access (external catheter)
AGN-242428 in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: AGN-242428; Placebo
Intervention description: AGN-242428 administered as an oral capsule(s) once daily.; Placebo administered as an oral capsule(s) once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics
      and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe
      plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6
             months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening
             and baseline

          -  Severity of disease must be at least moderate, defined as Psoriasis Area and Severity
             Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10

          -  Participant is a candidate for phototherapy or systemic therapy for psoriasis

          -  Body weight of at least 55 kilograms (kg) (121 (pound) lbs)

        Exclusion Criteria:

          -  Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced
             psoriasis

          -  Psoriasis which has not been stable for the 4 weeks prior to screening and which is
             unstable at Study Day 1

          -  History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of
             bilirubin metabolism

          -  History of active mycobacterium tuberculosis (TB) infection or untreated or
             inadequately treated latent TB

          -  Positive QuantiFERON test for TB infection at screening

          -  Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to
             baseline

          -  Positive drug and/or alcohol test at screening (with the exception of marijuana).
             Retesting in the case of a positive alcohol test is allowed at the discretion of the
             sponsor

          -  Current treatment or history of treatment with any anti-Tumor Necrosis Factor alpha
             (TNFα) biologic therapy within 3 months or 5 half-lives of study, and/or all other
             biologics within 6 months of study (Day 1)

          -  Efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the
             failures occurred within 1 year of the initiation of the therapy of the first biologic
             agent

          -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin
             (TBL) exceeding 1.5 times the upper limit of normal (ULN) at screening.
AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: AN2728 ointment, 2%; Ointment Vehicle
Intervention description: AN2728 ointment, 2%, applied twice daily for 12 weeks; Ointment Vehicle, applied twice daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis

Summary:

      The purpose of this study is to determine whether AN2728 topical ointment is a safe and
      effective treatment for mild-to-moderate plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of
             total body surface area (BSA) excluding face, scalp, and genitals

          -  Willingness and ability to apply study medication as directed, comply with study
             instructions, and commit to attending all study visits

          -  Women of childbearing potential must agree to use contraception for the entire study
             period

        Exclusion Criteria:

          -  Any dermatological conditions that could interfere with clinical evaluations

          -  Concurrent or recent use of certain topical or systemic medications without a
             sufficient washout period

          -  Significant confounding conditions as assessed by study doctor

          -  Participated in any other trial of an investigational drug within 30 days or
             participation in a research study concurrent with this study

          -  Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)

          -  Use of a beta-blocking medication (e.g., propranolol) if the dose has not been
             stabilized for at least 3 months

          -  Pregnancy or lactation
Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Gefitinib
Intervention description: 500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.; 75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity; 250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity
Intervention MeSH terms: Pemetrexed; Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of chemotherapy followed
      sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small
      cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified
      as 'never smoker' since it is suggested that these patients are more likely to respond
      favorably to treatment with gefitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or
             IV)

          -  Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological
             therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at
             least 4 weeks prior to study enrolment.

          -  Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

        Exclusion Criteria:

          -  Concurrent administration of any other tumor therapy

          -  Other co-existing malignancies

          -  Pregnancy or breast feeding

          -  Serious concomitant disorders

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Atorvastatin; AEGR-733
Intervention description: atorvastatin 20 mg tablets, daily dosing, for 8 weeks.; 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hyperlipidemia

Summary:

      Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus
      monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy
      parameter is percent change in LDL-C after 8 weeks of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  M/F 18-70

          -  0-1 risk factor, mean LDL-C -/> 160 and -/< 250 mg/dL (Visit 2 & 3)

          -  2+ risk factors, mean LDL-C -/> 130 & -/< 250 mg/dL (Visit 2 & 3)

          -  Fasting mean TGs -/< 400 mg/dL

          -  Understanding and compliance of protocol

          -  sign consent

        Exclusion Criteria:

          -  Females pregnant, lactating, or CBP who have not been using acceptable contraceptive
             methods over previous 3 months

          -  Uncontrolled hypertension >180/95 at screening

          -  Hx of chronic renal insufficiency (serum creatinine > 2.5 mg/dL)

          -  Hx of liver disease or transaminases > 1.5 X ULN

          -  Positive for Hepatitis B or C

          -  Major surgery within past 3 mos

          -  Cardiac insufficiency defined as functional Class II-Class IV

          -  Hx of malignancy within previous 5 years

          -  Participation in another investigational drug study within past 6 wks

          -  Serious or unstable medical or psychological condition

          -  Regular alcohol use > 1 drink per day

          -  Regular consumers of grapefruit juice or medications known to be metabolized by CYP
             3A4

          -  Use of other lipid-lowering meds (washout permitted)

          -  Acute CVD

          -  Diabetes Mellitus

          -  Fasting glucose >110 mg/dL

          -  BMI -/> 40 kg/m2

          -  Significant gastrointestinal symptoms such as IBS

          -  Use of fish oils, niacin, herbal wt. loss products (washout permitted)
A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: ATI-50002 high dose; ATI-50002 low dose; Placebo
Intervention description: Topical solution; Topical solution; Topical solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Primary:

      • To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical
      Solution, compared to vehicle in subjects with alopecia areata (AA)

      Secondary:

      • To evaluate key clinical outcome assessments
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current
             areas of spontaneous regrowth.

          2. Have a Severity of Alopecia Tool (SALT) score of at least 15% up to 95% total scalp
             hair loss determined by the study investigator at baseline.

          3. Have a duration of the current episode of scalp hair loss of a minimum of 6 months and
             a maximum of 12 years.

          4. If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy
             test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2)
             and agree to: use a highly effective method of birth control for the duration of the
             study; not be planning a pregnancy during the study duration and use contraception for
             30 days after last application of study medication.

        Exclusion Criteria:

          1. Females who are nursing, pregnant, or planning to become pregnant for the duration of
             the study and up to 30 days after the last application of study medication.

          2. Diffuse alopecia areata.

          3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic
             alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia,
             etc.).

          4. Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a
             history of skin disease on the scalp that in the opinion of the investigator would
             interfere with the study assessments of efficacy or safety.

          5. Active scalp trauma or other condition affecting the scalp that, in the investigator's
             opinion, may affect the course of AA or interfere with the study conduct or
             evaluations.

          6. The presence of a permanent or difficult to remove hairpiece or wig that will, in the
             opinion of the investigator, interfere with study assessments if not removed at each
             visit.