bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Condition: Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms
MeSH terms: Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms
Intervention: doxorubicin HCL liposome; bevacizumab; carboplatin
Intervention description: 30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
Intervention MeSH terms: Bevacizumab; Carboplatin; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian cancer; fallopian tube cancer; primary peritoneal cancer; DOXIL; carboplatin; bevacizumab

Summary:

      The purpose of this study is to evaluate the response rate (Complete Response (CR) and
      Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in
      patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal
      cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten
      28-day cycles. Patients will be followed for six months following treatment to assess
      progression-free survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal
             cancer

          -  Relapse-free interval of >6 months afer completion of first line platinum-based
             chemotherapy

          -  Measurable disease (at least one lesion that can be accurately measured in a least 1
             dimension)

          -  Adequate bone marrow function, renal, and liver function. Normal cardiac function

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

        Exclusion Criteria:

          -  No patients who have received more than 1 previous regimen of chemotherapy
             (maintenance is not considered a second regimen)

          -  No patients receiving immunotherapy or radiotherapy or patients who have received
             prior radiotherapy to any portion of the abdominal cavity or pelvis

          -  No patients who require parenteral hydration or nutrition or have clinical signs or
             symptoms of gastrointestinal bowel obstruction or perforation

          -  No patients with previous or current malignancy other than basal cell or squamous cell
             carcinoma of the skin

          -  No patients with clinically significant cardiovascular disease

          -  No patients with a history of bevacizumab or other VEGF or VEGF receptor-targeted
             agent use.
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Condition: Carcinoma, Basal Cell
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: cemiplimab
Intervention description: Regimen as per protocol
Intervention MeSH terms: Cemiplimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to estimate the objective response rate (ORR) for metastatic Basal
      Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when
      treated with cemiplimab as a monotherapy
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Confirmed diagnosis of invasive BCC

          -  Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
             therapy

          -  At least 1 measurable lesion

          -  ≥18 years of age

          -  Hepatic function, renal function, bone marrow function in defined lab-value-ranges

          -  Anticipated life expectancy >12 weeks

          -  Consent to provide archived tumor biopsy material (all patients)

          -  Group 2: consent to undergo research biopsies

          -  Group 2: must not be a candidate for radiation therapy or surgery

          -  Comply with study procedures and site visits

          -  Sign Subject Information Sheet and Informed Consent Form

        Key Exclusion Criteria:

          -  Ongoing or recent significant autoimmune disease

          -  Prior treatment with specific pathway-blockers (PD-1/PD-L1)

          -  Prior treatment with immune-modulating agents within 28 days before cemiplimab

          -  Untreated brain metastasis that may be considered active

          -  Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
             treatment with cemiplimab

          -  Active infections requiring therapy, including HIV, hepatitis

          -  Pneumonitis within the last 5 years

          -  Cancer treatment other than radiation therapy, including investigational or standard
             of care, within 30 days prior to treatment with cemiplimab

          -  Documented allergic reactions or similar to antibody treatments

          -  Concurrent malignancies other than BCC, other than those with negligible risk of
             metastases or death

          -  Any acute or chronic psychiatric problems

          -  Having received a solid organ transplantation

          -  Inability to undergo contrast radiological assessments

          -  Breastfeeding, pregnant, women of childbearing potential not using contraception

        Note: Other protocol-defined inclusion/exclusion criteria apply
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: 75mg SHP647 (PF-00547659); 225mg SHP647 (PF-00547659)
Intervention description: 75 mg sterile liquid injected subcutaneously every 4 weeks.; 225 mg sterile liquid injected subcutaneously every 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No
Keywords: Anti-TNF Refractory; Active Ulcerative Colitis; Immunosuppressant Refractory

Summary:

      Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will
      receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of
      the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18 and 66 years of age.

          -  Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84
             day (12 week) induction period.

        Exclusion Criteria:

          -  Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced
             serious event(s) related to the investigational product, an unstable medical
             condition, or any other reason, in the opinion of the investigator, would preclude
             entry or participation in this study.

          -  Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or
             Methotrexate (MTX).
Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects
Condition: Poisoning by BCG Vaccine
MeSH terms: Poisoning
Intervention: Hyaluronic Acid; BCG (Immucist®)
Intervention description: Add hyaluronic acid to BCG Treatment; Usual BCG treatment
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BCG; hyaluronic acid; non-muscle invasive bladder cancer; non bacterial cystitis

Summary:

      The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in
      reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial
      cell carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven non-muscle invasive bladder cancer;

          -  Indication to intravesical instillation of BCG according to EAU guidelines;

          -  Age > 18 years;

          -  Willingness, to participate to the study;

          -  Written informed consent.

        Exclusion Criteria:

          -  Previous or ongoing BCG or different intravesical instillations;

          -  Urinary tract infections (UTI) or other known pathologies of the lower urinary tract;

          -  Indication for a radical cystectomy;

          -  Severe systemic disorders, including neurological pathologies, kidney, liver or heart
             failure;

          -  Contraindications to BCG use.
GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: obinutuzumab (RO5072759); rituximab
Intervention description: 1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.; 375 mg/m^2 rituximab IV infusion once a week for 4 weeks.
Intervention MeSH terms: Rituximab; Obinutuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101
      (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma.
      Patients will be randomized to receive either GA101 or rituximab, given as four weekly
      infusions. At the conclusion of the initial trial patients may be eligible to continue
      therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age

          -  relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma

          -  documented history of response of >/= 6 months duration from last rituximab-containing
             regimen

          -  clinical indication for treatment as determined by the investigator

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

        Exclusion Criteria:

          -  prior use of any investigational monoclonal antibody within 6 months of study start

          -  prior use of any anti-cancer vaccine

          -  prior use of rituximab within 8 weeks of study entry

          -  radioimmunotherapy within 3 months prior to study entry

          -  Central Nervous System (CNS) lymphoma or evidence of transformation to high-grade or
             diffuse large B-cell lymphoma
Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis
Condition: Conjunctivitis, Allergic
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Mapracorat; Vehicle
Intervention description: administered daily to each eye for 2 weeks following allergen challenge using a CAC model; administered daily to each eye for 2 weeks following allergen challenge using a CAC model
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 236.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the dose response, and efficacy of Mapracorat
      ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs
      associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  positive history of ocular allergies and a positive skin test reaction

          -  positive bilateral CAC reaction

        Exclusion Criteria:

          -  have known contraindications or sensitivities to the use of any of the study
             medications(s) or their components.

          -  have any ocular condition or significant illness that, in the opinion of the
             investigator, could affect the subject's safety or trial parameters.

          -  had ocular surgical intervention within three (3) months prior to Visit 1 or during
             the study and/or a history of refractive surgery within the past 3 months;

          -  a known history of retinal detachment, diabetic retinopathy, or active retinal
             disease;

          -  the presence of an active ocular infection or positive history of an ocular herpetic
             infection at any visit.

          -  use of any disallowed medications during the period indicated prior to Visit 1 and
             during the study.

          -  have planned surgery during the trial period or within 30 days after.

          -  have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any
             type of glaucoma at Visit 1
A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
Condition: Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell
Intervention: brentuximab vedotin; rituximab
Intervention description: 1.8 mg/kg every 3 weeks by IV infusion; 375 mg/m2 every 3 weeks by IV infusion
Intervention MeSH terms: Rituximab; Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 176.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Lymphoma, Large B-Cell, Diffuse; Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases; Lymphoma; Lymphoma, B-Cell; Lymphoma, T-Cell

Summary:

      This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and
      safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin
      lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab
      vedotin in combination with rituximab in patients with relapsed or refractory diffuse large
      B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression
      and response in DLBCL (Part C).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed NHL (DLBCL only for Parts B and C)

          -  Relapsed or refractory disease following at least 1 prior systemic therapy

          -  Measurable disease of at least 1.5 cm as documented by CT

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

        Exclusion Criteria:

          -  History of another primary invasive malignancy that has not been in remission for at
             least 3 years

          -  Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis
             fungoides

          -  B cell lymphoma previously treated with only single-agent rituximab (for patients
             receiving brentuximab vedotin only) or corticosteroids as monotherapy

          -  Known cerebral/meningeal disease
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GW642444; Placebo
Intervention description: GW642444H; Placebo administered twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD); COPD

Summary:

      The compound GW642444 has previously been found to be well tolerated with no significant side
      effects in subjects with asthma and healthy volunteers. This study will assess the safety and
      tolerability of GW642444 in subjects with COPD in order to obtain information to support
      dosing in a broader population of subjects with COPD
    

Eligibility criteria:

        Inclusion criteria:

          -  females must be of non-childbearing potential

          -  moderately severe COPD

        Exclusion criteria:

          -  Subjects with a main diagnosis of asthma

          -  subjects with poorly controlled COPD

          -  subjects with significant heart, renal, endocrine, psychiatric, immunological or
             neurological disease.
Pharmacokinetics of Advantage Anti-Caries Varnish
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Anti-caries varnish
Intervention description: topical tooth varnish
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label exposure--response study
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adults; povidone iodine; sodium fluoride

Summary:

      The study aim is to characterize the kinetics of iodine and fluoride following topical
      application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC
             medications.

        Exclusion Criteria:

          -  Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions,
             sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism,
             hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular
             thread with heart disease, multi nodular goiter, Graves disease, or autoimmune
             thyroiditis
Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
Condition: Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ; Male Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Breast Neoplasms, Male; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular
Intervention: omega-3 fatty acid; placebo; laboratory biomarker analysis
Intervention description: Given PO; Given PO; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II clinical trial studies how well omega-3 fatty acid works in treating patients
      with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from
      breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the
      effects of omega-3 fatty acid on tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular
             carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])

          -  Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day
             of enrollment

          -  Ability to understand and the willingness to sign an Institutional Review Board
             (IRB)-approved written informed consent document

          -  Tumor measures at least 1 centimeter on imaging or physical exam

        Exclusion Criteria:

          -  Any patient with surgery scheduled < 7days after biopsy

          -  Patients who are unable to refrain from the use of any NSAID or full-dose
             acetylsalicylic acid (ASA)-containing NSAID while taking study drug

          -  Patients who will receive neoadjuvant chemotherapy are not eligible

          -  Patients who are currently taking omega-3 fatty acids, as they are unable to be
             randomized to placebo

          -  Patients who have previously taken omega-3 fatty acid within 1 month prior to study
             enrollment

          -  Patients with an allergy or known hypersensitivity to fish
Treatment of Anxiety and Anorexia Nervosa in Adolescents
Condition: Anxiety; Anorexia Nervosa
MeSH terms: Anorexia; Anxiety Disorders; Anorexia Nervosa
Intervention: Fish oil; Placebo pill
Intervention description: Participants will take 4 capsules daily; Participants will take 4 capsules daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Anxiety; Anorexia nervosa; Adolescents; Fish oil

Summary:

      Adolescents with anorexia nervosa frequently have associated anxiety, and standard
      medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week
      trial examining the safety, tolerability, and effectiveness of fish oil nutritional
      supplements for anxiety in adolescents with anorexia nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

        Females admitted to Nationwide Children's Hospital Eating Disorder Partial Hospitalization
        Program

        Exclusion Criteria:

          1. Inability to take pills

          2. Co-morbid medical conditions affecting appetite and weight (e.g., inflammatory bowel
             disease, cancer, cystic fibrosis)

          3. Co-morbid psychiatric conditions affecting appetite and weight (e.g., bipolar
             disorder, substance abuse)

          4. Currently taking fish oil supplements

          5. Inability to participate in study for 12 consecutive weeks.