bioihbjkbjnl/mcl2 huggingface dataset:
Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Prasugrel; Clopidogrel; Placebo for Prasugrel; Placebo for Clopidogrel
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide information of the relative potency of prasugrel and
      clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects
      undergoing elective percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects greater than or equal to 18 years of age undergoing cardiac catheterization
             with planned percutaneous coronary intervention (if coronary anatomy is suitable) for
             an indication of chest pain +/or anginal equivalent felt by the treating physician to
             be related to coronary ischemia.

          -  At least one of the following (a through c):

               1. Functional study (exercise, or pharmacologic) within the past 8 weeks consistent
                  with ischemia as manifested by at least one of the following:

                    1. A reversible defect on nuclear imaging.

                    2. A reversible wall-motion abnormality by echocardiography.

                    3. Horizontal or down-sloping ST-depressions greater than 1 mm on
                       electrocardiogram (ECG) (if no imaging performed).

               2. Prior coronary revascularization [percutaneous coronary intervention (PCI) or
                  coronary artery bypass graft (CABG)].

               3. A cardiac catheterization with at least one coronary artery lesion amenable to
                  PCI (not yet performed) within 14 days prior to enrollment.

        Exclusion Criteria:

          -  Known creatine kinase-myocardial bands (CK-MB)or cardiac troponin greater than the
             upper limit of normal at time of screening

          -  Planned PCI for acute myocardial infarction (MI) or planned PCI within 48 hours of
             fibrinolytic therapy for ST segment elevation myocardial infarction (STEMI)

          -  Have cardiogenic shock at the time of screening (systolic blood pressure 90 mm Hg
             associated with clinical evidence of end-organ hypoperfusion, or subjects requiring
             vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with
             clinical evidence of end-organ hypoperfusion).

          -  Refractory ventricular arrhythmias

          -  Have New York Heart Association Class IV congestive heart failure
Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo (for Dupilumab); Topical Corticosteroid (TCS)
Intervention description: Dupilumab 300 mg once weekly (QW) for 4 weeks; Placebo (for Dupilumab) once weekly (QW) for 4 weeks; TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the safety of Dupilumab administered concomitantly
      with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis
      (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients aged 18 years or older

          2. Chronic AD that had been present for at least 2 years

        Exclusion Criteria:

          1. Prior treatment with Dupilumab

          2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS
             product used in the study

          3. AD lesions located on face, flexural, and genital areas

          4. Certain treatments and medical procedures, undertaken within a particular time frame
             prior to the baseline visit, preclude eligibility for participation in the study

          5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

          6. Treatment with an investigational drug within 8 weeks

          7. Known history of human immunodeficiency virus (HIV) infection

          8. Presence of certain laboratory abnormalities at the screening visit

          9. History of certain opportunistic infections or certain clinical parasite infections

         10. History of malignancy within 5 years before the baseline visit, with certain
             exceptions

         11. Pregnant or breast-feeding women

         12. Travel within 12 months of study start to areas endemic for parasitic infections, such
             as developing countries in Africa and the tropical and subtropical regions of Asia

         13. History of alcohol or drug abuse within 2 years of the screening visit

         14. Any medical or psychiatric condition which, in the opinion of the investigator or the
             sponsor's medical monitor, would place the patient at risk, interfere with
             participation in the study, or interfere with the interpretation of study results
A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PF-04171327 10 mg; Prednisone Placebo; PF-04171327 25 mg; Prednisone Placebo; Prednisone 5 mg; Placebo for PF-04171327; Placebo; Placebo for PF-04171327
Intervention description: PF-04171327 10 mg tablet every day for 14 days; Placebo for Prednisone 5 mg tablet every day for 14 days; PF-04171327 25 mg tablet every day for 14 days; Placebo for Prednisone 5 mg tablet every day for 14 days; Prednisone 5 mg tablet every day for 14 days; Placebo for PF-04171327 every day for 14 days; Placebo tablet every day for 14 days; Placebo tablet every day for 14 days
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis Glucocorticoids Prednisone

Summary:

      This study will investigate the safety and efficacy of an investigational drug, PF-04171327
      on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids
      while on background methotrexate. This study will also look at the response of chemical and
      biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK
      (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration
             of 3 months

          -  On stable dose of methotrexate for at least 6 weeks prior to screening

          -  Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6
             swollen joints and CRP ≥ 0.7 mg/dL

          -  Not currently receiving steroid medication

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Patients that have active infections, TB, HIV and/or Hepatitis B or C

          -  Patients that have a history of intolerance or significant adverse effects with the
             use of glucocorticoids
Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: pembrolizumab; Acalabrutinib
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with
      advanced head and neck squamous cell carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC
             of the oral cavity, oropharynx, hypopharynx, and larynx that that has either
             progressed during or after platinum-based chemotherapy administered for metastatic
             disease or has recurred during or within 6 months after the completion of
             platinum-based neoadjuvant or adjuvant therapy

          -  Presence of radiographically measurable disease as defined by RECIST 1.1

          -  ECOG performance status of 0 or 1

        Exclusion Criteria:

          -  Prior malignancy (other than HNSCC), except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years or which will not limit survival to < 2
             years

          -  Known central nervous system metastases and/or carcinomatous meningitis

          -  A life-threatening illness, medical condition (including psychiatric conditions) or
             organ system dysfunction which, in the investigator's opinion, could compromise the
             subject's safety

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of starting study
             drug
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Antidepressant + SPD489 (lisdexamfetamine dimesylate); Antidepressant + placebo
Intervention description: Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks; Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Antidepressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the
      treatment of major depressive disorder (MDD) as measured by mean change in total
      Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD

        Exclusion Criteria:

          -  History of non-response to multiple antidepressants
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
Condition: Hyperuricemia; Albuminuria; Type 2 Diabetes
MeSH terms: Albuminuria; Hyperuricemia
Intervention: Verinurad 9 mg+Febuxostat 80 mg; Placebo
Intervention description: Capsule administered orally, once daily for 24 weeks; Capsule administered orally, once daily for 24 weeks
Intervention MeSH terms: Febuxostat; Verinurad
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, double-dummy, placebo-controlled, parallel, independent groups, repeated measures, multi-center study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Verinurad capsules/matching placebo capsules and febuxostat/matching placebo capsules with randomization code printed on each label
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to evaluate signals of potential clinical
      benefit of the combination of Verinurad and Febuxostat in lowering concentrations of
      circulating uric acid and thus improving kidney or cardiovascular status of patients with
      hyperuricemia, albuminuria, and Type 2 diabetes (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum Uric Acid ≥6.0 mg/dL

          -  eGFR ≥30 mL/min/1.73 m2

          -  UACR between 30 mg/g and 3500 mg/g inclusive

          -  Diagnosed with T2DM

        Exclusion Criteria:

          -  Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs
             for hyperuricemia include all XO inhibitors (allopurinol, febuxostat and topiroxostat)
             and URAT1 inhibitors (lesinurad, verinurad, probenecid, and benzbromarone)

          -  Prior history of gout, unless prophylaxis therapy isn't required

          -  Patients who are pregnant, lactating, or planning to become pregnant

          -  Patients unsuitable or unable to undergo MRI assessment
Study of Ataluren in ≥2 to <5 Year-Old Male Participants With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Ataluren
Intervention description: White to off-white powder for oral suspension.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, multiple-dose, open-label study evaluating the safety, pharmacokinetics
      (PK), and pharmacodynamics (PD) of ataluren in participants aged ≥2 to <5 years old with
      Duchenne muscular dystrophy (DMD) caused by a nonsense mutation in the dystrophin gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males ≥2 to <5 years of age

          -  Body weight ≥12 kg

          -  Diagnosis of DMD

          -  Nonsense mutation in at least 1 allele of the dystrophin gene

        Exclusion Criteria:

          -  Participation in any other drug or device clinical investigation

          -  Ongoing use of prohibited concomitant medications
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
Condition: Acne Scars
MeSH terms: Acne Vulgaris; Atrophy
Intervention: Adapalene
Intervention description: Adapalene Gel 0.3%
Intervention MeSH terms: Adapalene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the
      treatment of atrophic acne scars.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects of any race, aged 18 to 50 years inclusive

          -  Subjects with a past history of acne and with moderate to severe facial atrophic acne
             scars

        Exclusion Criteria:

          -  Subjects with active inflammatory acne lesions

          -  Subjects with hypertrophic acne scars
An Open-Label Study of N-Acetyl Cysteine in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: N-Acetyl Cysteine
Intervention description: Dosage of orally administered N-Acetyl Cysteine is as follows:
Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: N-Acetyl Cysteine

Summary:

      The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC)
      in children with Autism.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will be eligible for this study if they participated in the Double-blind,
        randomized, placebo controlled study of N-Acetyl Cysteine in Autism study at Stanford
        University and meet all of the following criteria:

          1. Outpatients between 3.0 and 12.11 years of age inclusive

          2. Males and females who are physically healthy

          3. diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria,
             the Autism Diagnostic Interview-Revised, and expert clinical evaluation

          4. Clinical Global Impression Severity rating of 4

          5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy
             ratings, and interacts with subject on a regular basis

          6. Ability of subject to swallow the compound

          7. Stable concomitant medications for at least 2 weeks

          8. No planned changes in psychosocial interventions during the open-label N-Acetyl
             Cysteine trial

        Exclusion Criteria:

          1. Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia,
             schizoaffective disorder, or psychotic disorder, not otherwise specified

          2. Active medical problems: unstable seizures, significant physical illness (e.g.,
             serious liver or renal pathology)

          3. Pregnancy or sexually active females

          4. Subjects taking antioxidant agents and glutathione prodrugs will be excluded from the
             study except if they have been off these compounds for at least 4 weeks
Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
Condition: Head and Neck Cancer
MeSH terms: Thyroid Neoplasms
Intervention: Valproic Acid
Intervention description: OUTLINE: This is a pilot study.
Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.
Quality of life is assessed at the end of every week through a study diary.
Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.
Intervention MeSH terms: Valproic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive,
      which will allow for detection of tumor and make further ablation treatment effective.
    

Eligibility criteria:

        INCLUSION CRITERIA:

        DISEASE CHARACTERISTICS

          -  Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin
             that is radioiodine-unresponsive

          -  Cumulative dose of radioiodine < 800 mCi

          -  No radioiodine uptake on whole body scan within 18 months of enrollment

          -  Inoperable extensive locoregional tumor mass and/or metastatic spread

          -  Failed conventional therapy that included total thyroidectomy AND radioactive iodine I
             131 ablation

          -  Elevated thyroglobulin level (>2ng/ml on thyroid hormone, >10ng/ml off thyroid
             hormone)or Tg-antibody positive

        PATIENT CHARACTERISTICS

        -18 years or older

        Entry lab results:

          -  Hemoglobin > 8.0 gm/dl

          -  Absolute Neutrophil Count > 750 cells/mm3

          -  Platelet count > 75000/mm3

          -  BUN < 1.5 times upper limit of normal (ULN)

          -  Creatinine < 1.5 times ULN

          -  Total protein > 6.4

          -  Total bilirubin should be < 1.5 times ULN.

          -  AST (SGOT), ALT (SGPT), ALKP and amylase < 1.5 times ULN

          -  Amylase < 1.5 times ULN

          -  Albumin > 2.5

          -  Ammonia < 1.5 times ULN

        EXCLUSION CRITERIA:

          -  Not pregnant

          -  No nursing within the past 3 months

          -  No allergy to valproic acid

          -  No coexisting malignancy other than basal cell carcinoma

          -  No hepatic disease or significant dysfunction

          -  Karnofsky score > 80

          -  No pancreatitis

          -  No kidney dysfunction

          -  Fertile patients must use effective contraception
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Intervention: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Intervention description: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Trichotillomania

Summary:

      The goals of the study are to further design, develop, and test an awareness enhancement and
      monitoring device, which will be used in the self-awareness training and general treatment of
      patients with compulsive hair-pulling behaviors, or trichotillomania.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have active hair pulling over the month prior to enrollment

          -  Must have noticeable hair loss

          -  Must experience significant distress related to Trichotillomania

          -  Must primarily pull from the head area

          -  Subjects taking medications will be included

          -  Must be able to read/write English

        Exclusion Criteria:

          -  Current substance use diagnosis

          -  Chronic neurological disorder (other than chronic tics)

          -  Mental retardation

          -  Schizophrenia and other psychotic disorders

          -  Bipolar I disorder

          -  Prominent suicidal/homicidal ideation with imminent risk