bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: AXR-159; Vehicle
Intervention description: AXR-159 Ophthalmic Solution; AXR-159 Ophthalmic Solution Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel
      group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50
      mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately
      430 patients diagnosed with dry eye disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or older at screening visit

          -  Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using
             the logarithm of the minimum angle of resolution (LogMAR) in each eye

          -  Reported history of dry eye for at least 6 months

          -  Corneal fluorescein staining score ≥ 2

          -  Eye dryness score ≥ 40

          -  Total Ocular Surface Disease Index (OSDI) score > 18

        Exclusion Criteria:

          -  Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or
             uncontrolled systemic disease

          -  Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have
             previously undergone any glaucoma laser or surgical procedure.

          -  Corneal abnormality or disorder that impacts normal spreading of the tear film
             (keratoconus, pterygia, scarring) or compromised corneal integrity

          -  BCVA worse than 20/100 in either eye

          -  Current use of punctal plugs, anticipated insertion during the study, or a history of
             punctal cautery in either eye

          -  Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells

          -  Patients with clinically significant inflammation of the lid margin such as anterior
             blepharitis or ocular rosacea

          -  Recent (within the past 3 months) ocular surgery, trauma or herpes

          -  Use of contact lenses in either eye within one month prior to the screening visit or
             anticipated use during the study
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Condition: Atopic Dermatitis; Plaque Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Intervention: PF-07038124 ointment; Vehicle ointment
Intervention description: PF-07038124 ointment at 0.01% with QD dosing for 6 weeks; Vehicle ointment with QD dosing for 6 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: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: atopic dermatitis, plaque psoriasis

Summary:

      This study is being conducted to provide data on efficacy, safety, tolerability and PK of
      PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild
      to moderate plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an
             Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD
             covering 5% to 20% (inclusive) of BSA.

          -  Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for
             at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3
             (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.

        Exclusion Criteria:

          -  Presence of skin comorbidities that would interfere with study assessment or response
             to treatment.

          -  Current or recent history of severe, progressive, or uncontrolled renal, hepatic,
             hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or
             neurological disease.

          -  Other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk
             of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study.
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster; Autoimmune Diseases
Intervention: V212; Placebo
Intervention description: V212 viral antigen for HZ; Placebo comparator to V212 vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Shingles

Summary:

      This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with
      autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis,
      psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and
      other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will
      elicit significant VZV-specific immune responses at approximately 28 days after vaccination
      4. The statistical criterion for significance requires that the lower bound of the 2-sided
      95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with an autoimmune disease

          -  Clinically stable disease for at least 30 days before enrollment

          -  Not likely to undergo hematopoietic stem cell transplantation during the study period

          -  Receiving at least one parenteral or oral biologic agent, such as a Tumor Necrosis
             factor (TNF) alpha inhibitor, or a parenteral or oral non-biologic therapy, at a
             stable dose for at least 3 months, with no planned or anticipated changes

          -  History of varicella, antibodies to VZV, or residence for at least 30 years in a
             country with endemic VZV infection, or if participant is less than 30 years old,
             attended primary or secondary school in a country with endemic VZV infection

        Exclusion Criteria:

          -  Prior history of Herpes Zoster (shingles) within 1 year before enrollment

          -  Prior varicella or zoster vaccine

          -  Active central nervous system lupus erythematosus requiring therapeutic intervention
             within 90 days of enrollment

          -  Prior or planned therapy containing rituximab or other anti-Cluster of Differentiation
             (CD) 20 monoclonal antibodies from 3 months before enrollment through 28 days postdose
             4

          -  Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the
             time of enrollment
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Condition: Waldenstrom Macroglobulinaemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Ofatumumab
Intervention description: Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.
Intervention MeSH terms: Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Waldenstrom's Macroglobulinemia; Ofatumumab

Summary:

      Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic
      Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a
      non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients
      with Waldenstrom's Macroglobulinemia (WM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.

          -  Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.

          -  Adequate organ function.

          -  Detectable CD20 positive of the tumor cells.

          -  Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000
             mg/dL.

        Exclusion Criteria:

          -  Treatment of WM within the past 28 days.

          -  Treatment with rituximab or alemtuzamab within the past 3 months.

          -  Certain heart problems, chronic or current active infection not controlled with oral
             antibiotics, other current cancer or within last 5 years.

          -  Current participation in another interventional clinical study.

          -  Lactating or pregnant women or female patients of child-bearing potential (or male
             patients with such partners) not willing to use adequate contraception.

          -  Active cerebrovascular disease.
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Condition: Submental Fat; Healthy
Intervention: Placebo; ATX-101 (1 mg/cm^2); ATX-101 (2 mg/cm^2); ATX-101 (4 mg/cm^2)
Intervention description: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a long-term follow-up study of participants who completed Kythera-sponsored trials
      of ATX-101 (06-03, 07-07, 09-15)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101
             (06-03, 07-07, 09-15)

          -  Signed informed consent

          -  Willingness to comply with schedule and procedures of the study

        Exclusion Criteria:

          -  Subjects who have had or are undergoing treatment that may affect the evaluation of
             the submental area will be excluded
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
Condition: Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Intervention: 18F fluciclovine
Intervention description: 18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent Brain Metastases; Diagnostic; Positron Emission Tomography (PET) Scan

Summary:

      An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish
      Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in
      Detecting Recurrent Brain Metastases After Radiation Therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          2. Previous history of solid tumor brain metastasis of any origin

          3. Histopathological confirmation of the primary solid tumor or a metastatic site

          4. Previous radiation therapy of brain metastatic lesion(s)

          5. A reference lesion considered by the site investigator to be equivocal for recurrent
             brain metastasis

          6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI
             findings and is planned for craniotomy

        Exclusion Criteria:

        1. Patients with a history of active hematological malignancy
Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure
Condition: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
MeSH terms: Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine
Intervention description: 20 mg/m2 IV over 1 hour daily x 5 days.
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Azacytidine Failure; Decitabine

Summary:

      To study if decitabine can help to control Myelodysplastic Syndrome (MDS) in patients who
      have failed on therapy with azacytidine, the current standard of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or
             chronic myelomonocytic leukemia. Patients must have failed therapy with azacytidine.

          2. Performance status 0-2 (ECOG scale); adequate hepatic (bilirubin < 2 mg/dl) and renal
             functions (creatinine <2mg/dl); New York Heart Association (NYHA)cardiac status III-IV
             excluded.

          3. Signed informed consent.

          4. No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m*2 per dose).
             Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.

          5. Patients must have been off chemotherapy for 2 weeks prior to entering this study and
             recovered from the toxic effects of that therapy, unless there is evidence of rapidly
             progressive disease. Use of hydroxyurea for patients with rapidly proliferative
             disease is allowed for the first two weeks on therapy.

        Exclusion Criteria:

          1. Nursing and pregnant females are excluded. Patients of childbearing potential should
             practice effective methods of contraception. Should a woman become pregnant or suspect
             she is pregnant while participating in this study, she should inform her treating
             physician immediately.

          2. Patients with active and uncontrolled infections.

          3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.
Intrathecal Hydromorphone for Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Hydromorphone
Intervention description: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate the dose of hydromorphone which will relieve the pain of women in
      labor when delivered directly in the area around the spinal cord (i.e., intrathecal
      injection). The primary objective is to determine the dose of intrathecal hydromorphone that
      results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection
      in 50% of women. Secondary objectives include determining this dose at five and ten minutes
      after injection. Thirty women admitted to labor and delivery for planned vaginal delivery
      desiring epidural placement will be consented for the study. The starting dose of intrathecal
      hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical
      analysis will be used, meaning that each subsequent dose will be dependent upon the result
      obtained from the prior dose - ergo, if the initial subject has pain relief, the second
      subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain
      relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

      After the intrathecal injection is given and the epidural is placed, visual analogue pain
      scores will be assessed 60 minutes following injection. A pain score of less than three will
      be a positive result. A pain score of three or greater will be a negative result. Blood
      pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will
      also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy patients

          -  Labor

          -  Desires pain relief

        Exclusion Criteria:

          -  Any comorbidities other than obesity
Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pegilodecakin; Nivolumab
Intervention description: Pegilodecakin plus Nivolumab; Nivolumab Alone
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone
      in participants with metastatic non-small cell lung cancer as measured by objective response
      rate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must have histologically or cytologically confirmed Wild Type NSCLC that
             is stage IV / metastatic or recurrent

          2. Participants must have received at least one prior systemic therapy that was not an
             anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the
             disease

          3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion
             Score (TPS) 0% - 49%

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          5. Participants with measurable disease by spiral computed tomography (CT) or magnetic
             resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1
             criteria

          6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks
             prior to randomization

        Exclusion Criteria:

          1. Participants with active central nervous system (CNS) metastases or carcinomatous
             meningitis

          2. Participants with any serious or uncontrolled medical disorder or active infection
             with the hepatitis virus or the human immunodeficiency virus (HIV)

          3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior
             anti-cancer therapy (other than alopecia and fatigue) prior to randomization

          4. Participants that have received nivolumab

          5. Participants that have received therapy with anti-tumor vaccines or other
             immuno-stimulatory antitumor agents

          6. Participants with a history of severe hypersensitivity reactions to monoclonal
             antibodies

          7. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2,
             anti-CD-137, and/or anti CTLA-4 antibodies

          8. Participants receiving any investigational agent within 28 days of first
             administration of trial treatment

          9. Pregnant or lactating women
Laxative Effectiveness of a Phytotherapeutic Tea
Condition: Chronic Constipation
MeSH terms: Constipation
Intervention: Placebo; Klein Laxative Tea
Intervention description: In order to produce similar taste and color, 7 drops of caramel color and 10 drops of orange essence were mixed into 1.6 liters of boiling water. The patients received 150 ml of placebo 3 times a day for 5 days.; The laxative tea was prepared using 1 gram of grinded plant into 150 ml of water, left under infusion by 5 minutes. Patients received 150 ml of tea 3 times a day for 5 days.
Intervention MeSH terms: Laxatives; Cathartics
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: constipation; RCT; phytotherapy

Summary:

      The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative
      tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia
      angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with
      chronic constipation.
    

Eligibility criteria:

        Inclusion criteria:

          -  patients with 18 to 55 years old with chronic constipation according to the criteria
             of the American Association of Gastroenterology (AAG);

          -  patients should present good understanding and collaboration capacity, an not be in
             use of other medications with effects on the intestinal habit;

          -  patients with no abnormalities in the exams;

          -  willing to sign a written informed consent;

          -  women in fertile age should make use of appropriate anti-conception.

        Exclusion Criteria:

          -  pregnant or breast feeding women;

          -  patients with history of abuse of alcohol or use of drugs;

          -  significant or not-controlled disease, except constipation.