bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
Condition: Reduction in Severity of Skin Scarring
MeSH terms: Cicatrix
Intervention: EXC 001 (currently called PF-06473871)
Intervention description: Single dose administered by injection at four different times
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Skin scarring; cicatrix; hypertrophic scar; hypertrophic scar prevention

Summary:

      The purpose of this study is to provide subjects who participated in prior studies of EXC 001
      the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults who have participated in previous studies of EXC 001.

          -  Healthy adults who have chosen to have their scars revised.

        Exclusion Criteria:

          -  Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or
             breast feeding.

          -  Participation in another clinical trial within 30 days prior to the start of the
             study.
Trial of Activity for Adolescent Girls (TAAG)
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Intervention: Trial of Activity for Adolescent Girls (TAAG)
Intervention description: Intervention activities were designed to create (1) environmental and organizational changes supportive of physical activity and (2) cues, messages, and incentives to be more active. The intervention was designed to establish more opportunities, improve social support and norms, and increase self-efficacy, outcome expectations, and behavioral skills to foster greater moderate-vigorous physical activity (MVPA). An innovative feature of TAAG was linking school and community agencies to promote activity programs for girls. Finally, a TAAG Program Champion component was developed to foster sustainability after the 2-year staff-directed intervention. TAAG investigators recruited and trained Program Champions during the staff-directed intervention phase to promote maintenance of the program.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8727.0
Sex: Female
Minimum age: 12 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      To test the effectiveness of a multicomponent school-based and community-linked intervention
      in preventing the decline in physical activity levels and cardiovascular fitness in girls in
      grades 6-8.
    

Eligibility criteria:

        School inclusion criteria:

          -  Public middle schools in which a majority of students lived in the surrounding
             community

          -  Enrollment of at least 90 8th-grade girls

          -  Yearly withdrawal rates less than 28%

          -  At least one semester of physical education required for each grade

          -  Willingness to sign a memorandum of understanding and accept random assignment of the
             school

        Student exclusion criteria:

          -  Limited English-speaking skills

          -  Unable to participate in physical education classes due to a medical condition or
             disability

          -  Contraindications for participating in a submaximal exercise test
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; GDC-0810
Intervention description: Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle.; GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of
      GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic
      estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-)
      breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the
      Sponsor and the enrollment in this study has been discontinued. Participants currently
      enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810
      as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity,
      withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the
      Sponsor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER-
             (defined by local guidelines) metastatic or inoperable, locally advance breast cancer

          -  Participants for whom endocrine therapy is recommended and treatment with cytotoxic
             chemotherapy is not indicated at time of entry into the study

          -  Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable
             disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic
             scans within 28 days of Day 1 of Cycle 1

          -  Participants with radiologic/objective evidence of breast cancer recurrence or
             progression while on or within 6 months after the end of adjuvant treatment with an
             AI, or progression while on or within 1 month after the end of prior AI treatment for
             locally advanced or metastatic breast cancer

        Exclusion Criteria:

          -  HER2-positive disease

          -  Prior treatment with fulvestrant

          -  Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine
             therapies for advanced or metastatic disease
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
Condition: Advanced/Metastatic Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ixabepilone, 32 mg/m^2; Paclitaxel, 200 mg/m^2; Carboplatin (area under the concentration curve [AUC] 6)
Intervention description: Intravenous (IV) solutions, ixabepilone, 32 mg/m^2; IV solutions, paclitaxel, 200 mg/m^2; Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether progression-free survival with ixabepilone
      is superior to that achieved with paclitaxel plus carboplatin in participants with advanced
      nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell,
             adenocarcinoma, large cell, or bronchoalveolar carcinoma)

          -  Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following
             surgery with or without radiation therapy

          -  Available paraffin-embedded tissue to measure the expression levels of βIII tubulin

          -  Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1
             target lesion situated outside any previous radiotherapy field

          -  Karnofsky performance status of 70-100

          -  Life expectancy of at least 3 months

          -  Men and women, ages 18 years and older

        Exclusion Criteria:

          -  Uncontrolled brain metastases

          -  Peripheral neuropathy greater than Grade 1

          -  Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to
             randomization date (less than 1 week from focal/palliative radiotherapy or minor
             surgery)

          -  Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of
             the cervix

          -  Known HIV-positive status

          -  Absolute neutrophil count lower than 1500 cells mm^3

          -  Total bilirubin level higher than upper limit of normal (ULN) as defined by the
             institution (with the exception of elevation due to Gilbert's syndrome)

          -  Aspartate transaminase or alanine transaminase level higher than 2.5*ULN

          -  Serum creatine level of 1.5 mg/dL or higher

          -  Renal function with a creatinine clearance of less than 50 mL/min (as calculated with
             the Cockcroft and Gault equation)

          -  Any prior antineoplastic systemic regimens.
Vitamin D Dose Finding Study
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections
Intervention: Cholecalciferol (Vit D3)
Intervention description: To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 5 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome; Vitamin D; HIV; Complementary therapies

Summary:

      Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune
      function, growth, muscle, bone, and inflammatory status in children, adolescents and adults
      with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy
      using clinically important outcomes, and this will overcome the critical barrier for use of
      vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit
      D supplementation may prove to be an effective and feasible treatment for symptoms and
      prevention of side effects for people of all ages living with HIV/AIDS in the US and around
      the world.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV seropositive diagnosed with standard techniques

          2. Age for perinatally-acquired HIV/AIDS Group (PA subjects): 5.0 to 24.9 y

          3. Age for non-perinatally-acquired HIV/AIDS Group (non-PA subjects): 15.0 to 24.9 y

          4. In usual state of good health (no hospitalizations, emergency room or unscheduled
             acute illness visits for 2 weeks prior)

          5. Subject and/or family commitment to the 3-month study

        Exclusion Criteria:

          1. Other chronic health conditions that may affect growth, dietary intake, and/or
             nutritional status

          2. Pregnancy

          3. Participation in another HIV intervention study with impact on 25D serum
             concentrations

          4. Use of vit D supplementation (subjects willing to discontinue supplementation will
             become eligible after a 2-month washout period)

          5. Baseline elevated serum calcium concentration

          6. Non-English speaking
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ZPL-3893787; Placebo
Intervention description: ZPL-3893787; Matched Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This was a randomized, double blind, placebo controlled, parallel group study in
      approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12
      and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30
      mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).
    

Eligibility criteria:

        Inclusion Criteria:

        Males and females aged 18-65 years inclusive with physician documented history or diagnosis
        of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be
        diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)

        Eczema Area and Severity Index (EASI) of ≥12 and <48.

        An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.

        A mean pruritus score of ≥ 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)

        Atopic dermatitis affecting ≥10% BSA

        Exclusion Criteria:

        AD of such severity (EASI >48) that the subject could not comply with the demands of the
        study and/or the subject is not a suitable candidate for a placebo-controlled study

        Have concurrent skin disease (e.g. acne) of such severity in the study area that it could
        interfere with the study evaluation or presence of skin comorbidities that may interfere
        with study assessments.

        Have an active skin infection or any other clinically apparent infections.

        Hypersensitivity to mometasone or to any other ingredients contained by the topical
        corticosteroid product used as rescue medication in the study.

        Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants,
        cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the
        Run In.

        Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular,
        rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose
        (over the preceding 3 months) of inhaled or intranasal CS may participate.

        Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids
        within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic
        rhinitis are acceptable.
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Iloprost PD-6; Iloprost PD-15
Intervention description: Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.; Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.
Intervention MeSH terms: Iloprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: PAH; iloprost; Ventavis; Pulmonary Arterial Hypertension; Actelion Pharmaceuticals; Cotherix

Summary:

      A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution
      delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18-85 years

          -  Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH)
             classified by one of the following: a) idiopathic pulmonary arterial hypertension
             (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one
             of the following connective tissue diseases and mild or no lung parenchymal disease:
             scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective
             tissue disease, c) PAH associated with repaired atrial septal defect (ASD),
             ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year
             post-operative from Screening, d) PAH associated with human immunodeficiency virus
             (HIV), or e) PAH associated with the use of anorexigens (e.g.
             fenfluramine-phentermine)

          -  On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4
             weeks prior to the Screening visit, using the I-neb AAD System equipped with Power
             Disc-6

        Exclusion Criteria:

          -  Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12
             weeks preceding the Screening visit

          -  Receipt of atrial septostomy within the 6 months preceding Screening

          -  History of left-sided heart disease

          -  Clinically relevant obstructive lung disease

          -  Chronic renal or liver disease

          -  Uncontrolled systemic hypertension or hypotension

          -  Cerebrovascular event within the 6 months preceding Screening
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
Condition: Lymphoma, Non-Hodgkin's
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: lenalidomide
Intervention description: once daily oral capsule
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Celgene; Revlimid; CC-5013; Non-hodgkin's lymphoma; Lenalidomide; CC5013; NHL

Summary:

      Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle.
      Treatment will continue until disease progression, or unacceptable adverse events develop
    

Eligibility criteria:

        Key Inclusion criteria

          -  Biopsy proven aggressive non-hodgkin's lymphoma

               -  Follicular center lymphoma Grade 3.

               -  Diffuse large B-cell lymphoma.

               -  Mantle cell lymphoma.

               -  Transformed lymphoma.

          -  Relapsed or refractory to previous therapy for lymphoma

          -  At least one prior combination chemotherapy regime

          -  Measurable disease on cross sectional imaging that is at least 2 cm in the longest
             diameter

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2

          -  Willing to follow the pregnancy precautions

        Key Exclusion criteria

          -  Any of the following laboratory abnormalities.

               -  Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5*10^9/L).

               -  Platelet count < 60,000/mm^3 (60*10^9/L).

               -  Calculated creatinine clearance of <50mL/min

               -  Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or
                  Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times
                  upper limit of normal (ULN).

               -  Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.

          -  Subjects who are candidates for and willing to undergo an autologous stem cell
             transplant.

          -  History of active Central Nervous System (CNS) lymphoma within the previous 6 months

          -  History of other malignancies within the past year

          -  Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C