bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib cream; Vehicle Cream
Intervention description: Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitiligo; depigmenting disorder; topical JAK inhibitor

Summary:

      The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in
      vitiligo by assessing the change in biomarkers.
    

Eligibility criteria:

        Inclusion Criteria

          -  A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5%
             BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body
             vitiligo area (facial and nonfacial) should not exceed 50% BSA.

          -  At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance,
             pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.

          -  Agree to discontinue all agents used to treat vitiligo from screening through the
             final safety follow-up visit. Over-the-counter preparations deemed acceptable by the
             investigator and camouflage makeups are permitted.

        Exclusion Criteria

          -  No pigmented hair within any of the vitiligo areas on the face.

          -  Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or
             other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy,
             postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus,
             chemical leukoderma, and tinea versicolor).

          -  Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or
             other pigmented areas except hydroquinone.

          -  Any other skin disease that, in the opinion of the investigator, would interfere with
             the study medication application or study assessments.

          -  Conditions at baseline that would interfere with evaluation of vitiligo.

          -  Use of any protocol-defined treatments within the indicated washout period before
             baseline.
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Condition: Colonoscopy
Intervention: BLI800 - Dose 1; BLI800 - Dose 2
Intervention description: BLI800 oral solution; BLI800 oral solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: colonoscopy; pediatric

Summary:

      The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a
      bowel preparation prior to colonoscopy in pediatric patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female between the ages of 12 to 17

          -  Weight more than 40kg

          -  Undergoing colonoscopy for routinely accepted indications

          -  If female, and of child-bearing potential, subject must use an acceptable form of
             birth control or remain abstinent for the duration of the study.

          -  Negative pregnancy test at screening, if applicable

          -  In the Investigator's judgment, caregiver is mentally competent to provide informed
             consent for their child to participate in the study.

        Exclusion Criteria:

          -  Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute
             peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel
             perforation, toxic colitis or megacolon.

          -  Subjects who had previous significant gastrointestinal surgeries.

          -  Subjects with increased risk of bowel perforation, including connective tissue
             disorders, toxic dilation of the bowel or recent bowel surgery.

          -  Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with
             clinically significant electrolyte abnormalities based on Visit 1 laboratory results

          -  Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.

          -  Subjects with a prior history of renal, liver or cardiac insufficiency

          -  Subjects required to take any other oral medication within 3 hours of dosing until
             completion of both doses.

          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          -  Subjects with tendency for nausea and/or vomiting, or that have known swallowing
             disorders.

          -  Subjects for whom intake of substances is likely to affect gastrointestinal motility
             or urinary flow rate.

          -  Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Topical Steroid Treatment for Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Fluticasone; Placebo
Intervention description: Aerosolized swallowed fluticasone 880 mg twice a day; Placebo inhaler swallowed twice a day for 6 weeks
Intervention MeSH terms: Fluticasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Eosinophilic Esophagitis; Fluticasone; Dysphagia

Summary:

      This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic
      esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the
      esophagus becomes filled with large numbers of eosinophils, a type of white blood cell.
      Patients who have this condition have difficulty in swallowing (dysphagia) solid food.

      Prior to treatment the patients had biopsies of their esophagus and took questionnaires
      regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken
      from the esophagus to measure any changes in the tissue from before treatment. The primary
      endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia
      Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue)
      response to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 20 eosinophils / hpf on biopsies from mid esophagus (hpf = high-powered field)

          -  Abnormal dysphagia questionnaire (question 1a "yes", question 1c > "moderate" and
             question 2 > "less than once a week") on Mayo Dysphagia Questionnaire.

        Exclusion Criteria:

          -  Clinical evidence of infectious process potentially contributing to dysphagia (e.g.,
             candidiasis, cytomegalovirus, herpes)

          -  Systemic or topical steroid therapy for any reason over the past 3 months

          -  Previous steroid treatment for Eosinophilic Esophagitis

          -  Intolerance to steroid therapy in the past

          -  Other cause of dysphagia identified at endoscopy (e.g., reflux esophagitis, stricture,
             web, ring, achalasia, esophageal neoplasm)

          -  Dilatation of esophagus at time of index endoscopy
Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: PF-02545920; Placebo; PF-02545920; Placebo
Intervention description: Dose will be titrated up every 2 days by 5mg increments: 5mg Days 1-2, 10mg days 3-4, 15mg days 5-6, and reach 20 mg from Days 7 to Day28.
Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Treatment for 28 days.; - Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Dosing for 28 days.; 5mg dose
Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Dosing for 28 days.; Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Dosing for 28 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920
      in Subjects with Early Huntington's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of Huntington's Disease

          -  a CAG repeat expansion equal or great than 39

          -  a Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score equal or greater
             than 5 and less than 60

          -  a UHDRS Total Functional Capacity equal or greater than 9

        Exclusion Criteria:

          -  Subjects with evidence or history of severe acute or chronic medical condition or
             laboratory abnormality, or significant neurological disorder other than HD.

          -  Treatment with any antipsychotic medication within 5 weeks of enrollment
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study will evaluate the safety and efficacy of Tarceva
      (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell
      lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants
      will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity
      occurs. At the investigator's discretion, participants may receive Tarceva beyond disease
      progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/= 18 years of age

          -  Stage IV or recurrent non-small cell lung cancer (NSCLC)

          -  Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor
             (EGFR), (except T790M single mutation only)

          -  Measurable disease (at least one lesion >= 10 mm in longest diameter)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Adequate hematological, renal and liver function

        Exclusion Criteria:

          -  Patients with T790M single mutation only

          -  Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g.
             erlotinib, gefitinib, cetuximab, trastuzumab

          -  Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease

          -  Symptomatic or uncontrolled central nervous system (CNS) metastases

          -  Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,
             or basal or squamous cell carcinoma of the skin, or surgically treated localized
             prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast

          -  Any significant ophthalmologic abnormality

          -  Pre-existing parenchymal lung disease such as pulmonary fibrosis

          -  Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin
             is recommended instead)
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Condition: Non-melanoma Skin Cancer
MeSH terms: Skin Neoplasms
Intervention: HP802-247; Bacitracin Ointment
Intervention description: High dose HP 802-247, applied at each visit (Week 1-13) or until healed; One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Intervention MeSH terms: Bacitracin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Wound; non-melanoma skin cancer; Mohs micrographic surgery; Head or neck

Summary:

      This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide informed consent.

          -  Age ≥ 18 years and of either sex.

          -  Type I, II, or III skin as assessed by the Fitzpatrick Scale.

          -  Willing to comply with protocol instructions, including allowing all study
             assessments.

          -  Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic
             surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long
             axis if not circular.

          -  Acceptable state of health and nutrition, in the opinion of the Investigator.

        Exclusion Criteria:

          -  History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin,
             bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or
             amphotericin B.

          -  Therapy with blood-thinning agents including aspirin within 14 days of the Baseline
             Visit (these may be resumed post-surgery).

          -  Subjects with platelet or coagulation disorders.

          -  Therapy with another investigational agent within thirty (30) days of Screening, or
             during the study.

          -  Current systemic therapy with cytotoxic drugs.

          -  Current therapy with chronic (> 10 days) oral corticosteroids.

          -  In the opinion of the Investigator the subject has a current life expectancy of less
             than 1 year.
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: 11C-acetate; [18F]Fluoro-2-deoxy-2-D-glucose; Cardiac MRI
Intervention description: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate; For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG; Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pulmonary hypertension; right ventricular function; 11C acetate; FDG; ranolazine

Summary:

      This study is looking at differences in metabolism and functional imaging between pulmonary
      hypertension subjects with normal right ventricular function and persistent right ventricular
      dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

        Participation in the companion treatment protocol "A randomized, double-blind, placebo
        controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects
        with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative
        study of cellular metabolism in subjects with pulmonary hypertension with and without right
        ventricular dysfunction"

        Exclusion Criteria:

          -  Pregnancy or lactation: Women of childbearing potential must have a negative urine or
             blood pregnancy test on the day of the PET/CT scan.

          -  Severe anxiety or claustrophobia prohibiting completion of imaging

          -  Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)

          -  Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any
             other contraindication to MRI.

          -  Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Dapirolizumab pegol (DZP)
Intervention description: Solution for infusion, 0,9% saline; Solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus (SLE); Dapirolizumab Pegol (DZP)

Summary:

      The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab
      Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic
      Lupus Erythematosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus
             International Collaborating Clinics (SLICC) classification criteria

          -  Moderate to severe SLE disease activity

          -  Evidence for at least 1 of the following SLE markers:

               -  Anti-dsDNA antibodies confirmed by central laboratory or

               -  Low complement confirmed by central laboratory or

               -  Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the
                  following: Historical positivity for anti-dsDNA or Positivity for extractable
                  nuclear antigen (anti-ENA) confirmed by central laboratory

          -  The subject is receiving stable SLE standard-of-care medication

        Exclusion Criteria:

          -  Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE

          -  Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the
             opinion of the Investigator, would prevent the subject from completing protocol
             required procedures and assessments.

          -  New or worsening Class III or IV lupus nephritis

          -  Chronic kidney failure stage 3b

          -  Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell
             deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or
             during the study

          -  Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)

          -  Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent
             TB (LTB) infection

          -  Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion
             (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the
             final dose of study drug

          -  History of thromboembolic events within 12 months of screening

          -  Subject has used protocol defined prohibited medications
Safety Study of Replagal® Therapy in Children With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: Replagal (agalsidase alfa)
Intervention description: 0.2 mg/kg administered over 40 minutes every other week (EOW)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: agalsidase alfa; Replagal; Enzyme Replacement Therapy

Summary:

      The purpose of this study is to assess the safety of Replagal in children with Fabry disease
      who who have not previously been treated with enzyme replacement therapy (ERT).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must meet all of the following criteria to be enrolled in this study.

          1. All patients must be diagnosed with Fabry disease by the following criteria:

               -  Male Patients: The patient is a hemizygous male with Fabry disease as confirmed
                  by a deficiency of alfa-galactosidase A activity measured in serum, leukocytes,
                  or fibroblasts or has a confirmed mutation of the alfa-galactosidase-A gene.

               -  Female Patients: The patient is a heterozygous female with Fabry disease as
                  confirmed by a mutation of the alfa-galactosidase A gene.

             Note: If the diagnosis of Fabry disease is previously documented in the patient's
             medical record, screening tests do not need to be repeated.

          2. The patient is 7 to <18 years of age

          3. The patient is ERT-naïve

          4. Adequate general health (as determined by the Investigators) to undergo the specified
             phlebotomy regimen and protocol-related procedures and no safety or medical
             contraindications for participation

          5. The minor child must assent to participate in the protocol and the parent(s) or
             legally authorized representative(s) must have voluntarily signed an Institutional
             Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form
             after all relevant aspects of the study have been explained and discussed with the
             child and the child's parent(s) or legally authorized representative(s)

        Exclusion Criteria:

        Patients who meet any of the following criteria will be excluded from the study.

          1. Patient and/or the patient's parent(s) or legally authorized representative(s) are
             unable to understand the nature, scope, and possible consequences of the study

          2. Patient is unable to comply with the protocol, eg, uncooperative with protocol
             schedule, refusal to agree to all of the study procedures, inability to return for
             evaluations, or is otherwise unlikely to complete the study, as determined by the
             Investigator or the medical monitor.

          3. Otherwise unsuitable for the study, in the opinion of the Investigator.