bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Intervention: PF-04449913; Low dose ARA-C (LDAC); PF-04449913; Decitabine; PF-04449913; Daunorubicin; Cytarabine; PF-04449913; Daunorubicin; Cytarabine; PF-04449913; Low dose ARA-C (LDAC)
Intervention description: PF-04449913 administered orally and continuously for 28-days.; Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.; PF-04449913 administered orally and continuously for 28 days.; Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days; PF-04449913 administered orally and continuously for 28 days; Daunorubicin given using 60 mg/m2 for 3-days; Cytarabine 100 mg/m2 on days 1 through 7; PF-04449913 administered orally and continuously for 28 days; Daunorubicin given using 60 mg/m2 for 3-days; Cytarabine 100 mg/m2 on days 1 through 7; PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913); Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
Intervention MeSH terms: Cytarabine; Decitabine; Daunorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hedgehog Inhibitor; Acute Myeloid Leukemia; Myelodysplastic syndrome; Intensive chemotherapy; LDAC; glasdegib

Summary:

      This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute
      Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents
      used to treat these diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO
             2008 Classification and previously untreated.

          -  Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who
             may have had one prior regimen with commercially available agents for the treatment of
             their prior hematologic disease. The patients may not have had a prior therapy for
             their AML.

          -  AML patients include de novo AML, AML evolving from MDS or other AHD and AML after
             previous cytotoxic therapy or radiation (secondary AML)

          -  For a diagnosis of AML, a bone marrow blast count of 20% or more is required.

          -  For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have
             10-19% bone marrow blasts

          -  Adequate Organ Function

          -  ECOG Performance Status 0, 1, or 2

        Exclusion Criteria:

          -  AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic
             translocation.

          -  Patients with known active uncontrolled central nervous system (CNS) leukemia.
Azithromycin Treatment for the Airway Microbiome in Asthma
Condition: Asthma Chronic
MeSH terms: Asthma
Intervention: Azithromycin; Placebo
Intervention description: 8 weeks of Azithromycin (250 mg) once daily by mouth; Placebo
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Azithromycin; Microbiome; Sputum

Summary:

      The purpose of this study to determine whether the bacteria inside the lungs of people with
      asthma can be modified (changed) if they are given an antibiotic and if this change is
      associated with an improvement in asthma symptoms.
    

Eligibility criteria:

        Inclusion criteria (All participants):

          1. Age 18 - 55 years

          2. Able to provide informed consent

          3. Smoking history < 10 pack-years

        Inclusion Criteria for subjects with poorly controlled asthma

          1. Methacholine PC20 < 16 mg/ml or PD 20 < 400 mcg/ml or albuterol response > 12% on FEV1
             after 4 puffs of albuterol

          2. Currently prescribed ICS + LABA

          3. Meet definition for Th2-low asthma: peripheral blood eosinophil count < 300 and
             exhaled nitric oxide level < 30 ppb.

        Exclusion Criteria (All participants)

          1. History of allergy or intolerance to any medications used in this study

          2. Medication exclusions:

               1. Current use of medications that prolong QTc interval

               2. Current use of omalizumab or other ant-IgE therapies

               3. Current use of anti-IL 5 therapies

               4. Current use of anticoagulants

          3. Prednsione or other oral steroids within past 3 months

          4. Pregnancy or lactation, or plans to become pregnant

          5. Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)

          6. Pre-existing liver disease by history

          7. Smoking within the last 6 months

          8. Exacerbation of asthma in past 3 months

          9. Affected by a hearing disorder

         10. Clinically significant medical condition (e.g., heart failure, seizure disorder) which
             may in-crease risk as determined by study investigator

         11. Corrected QT interval > 450 msec. Patients with known cardiac history or prolonged QT
             interval on a screening EKG are excluded given the small but real potential for
             macrolide-related side effects
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
Topical Treatment and Prevalence of P. Acnes
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Intervention: Clindamycin 1% Gel; Benzoyl peroxide 5% gel; BenzaClin 5%-1% Topical Gel
Intervention description: topical clindamycin; topical benzoyl peroxide; Topical clindamycin and benzoyl peroxide together
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Healthy volunteers
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Propionibacterium Acnes; Surgical Site Infection; Shoulder

Summary:

      This study is about preventing surgical site infections of the shoulder. We hope to learn if
      clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can
      affect growth of Propionibacterium acnes in the dermal layer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy volunteer

          -  age > 18

        Exclusion Criteria:

          -  history of antibiotic use in the last month

          -  active acne on the back

          -  non-English speakers (the study personnel do not have adequate training to converse
             and consent in other languages)
A Study of INCB050465 in Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: Parsaclisib
Intervention description: Parsaclisib administered orally once daily at the protocol-defined dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Sjögren's syndrome; PI3Kδ inhibitor

Summary:

      The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of
      Sjögren's syndrome (SS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary SS diagnosed according to the revised American-European Consensus Group (AECG)
             criteria.

          -  Minimum score of 2 on the SGUS score for parotid and submandibular glands.

          -  EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5.

          -  Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.

          -  Symptomatic oral dryness score of at least 5 on patient questionnaire.

          -  Willingness to avoid pregnancy or fathering children based on protocol-defined
             criteria.

        Exclusion Criteria:

          -  Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of
             a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus
             erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis,
             dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined
             autoimmune rheumatologic disorder).

          -  Concurrent conditions and history of other diseases per protocol-defined criteria.

          -  Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or
             T-spot.TB test.

          -  Positive serology test results for HIV antibody, hepatitis B surface antigen,
             hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with
             positive HCV-RNA).

          -  Severely impaired liver function (Child-Pugh Class C).

          -  Prior or ongoing therapy with protocol-defined drugs.

          -  Receipt of any live vaccine in the 30 days before screening.

          -  No major surgery within 30 days before screening. Inadequate recovery from toxicity
             and/or complications from a major surgery before starting therapy.

          -  Current alcohol or drug use that, in the opinion of the investigator, will interfere
             with the participant's ability to comply with the dose regimen and study evaluations.

          -  Laboratory values at screening outside the protocol-defined ranges.
Rasagiline Rescue in Alzheimer's Disease Clinical Trial
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rasagiline; Placebo
Intervention MeSH terms: Rasagiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of
      concept three-site study, to evaluate the effect of Rasagiline in the regional brain
      metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 50 to 90 of age inclusive.

          -  Diagnosis of probable AD (NINCDS-ADRDA criteria)

          -  Positive fluoro-deoxyglucose PET ([18F]-FDG PET) scan compatible with AD as determined
             by the ADM Diagnostics LLC (ADMdx) Criteria at screening

          -  Mini Mental Status Exam = 12 - 22 (inclusive)

          -  Must have a study partner who is able and willing to comply with all required study
             procedures.

          -  Have at least eight years of education and should have previously (in pre-AD
             condition) been capable of reading, writing, and communicating effectively with others
             in English.

          -  If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of
             these agents has been stable for at least 3 months prior to screening

        Exclusion Criteria:

          -  Any non-AD neurological disease

          -  MRI findings indication of a non-AD diagnosis

          -  Screening laboratory studies that are 1.5 times above or below the highest and lowest
             range of normal for each test respectively

          -  History of melanoma; history of malignancy within the past five years with the
             exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized
             prostate cancer
Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy
Condition: Breast Cancer; Skin Reactions Secondary to Radiation Therapy
MeSH terms: Breast Neoplasms; Dermatitis; Radiodermatitis
Intervention: Dakin's solution; radiation therapy; questionnaire administration; laboratory biomarker analysis
Intervention description: Applied topically; Undergo radiation therapy; Ancillary studies; Optional correlative studies
Intervention MeSH terms: Sodium Hypochlorite; Eusol; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in
      patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin
      condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's
      solution may help reduce dermatitis caused by radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with breast cancer who plan to undergo radiation therapy to the breast or chest
             wall

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Women with scleroderma or discoid lupus

          -  Women with inflammatory breast cancer as evidenced by clinical assessment

          -  Women with breast cancer involving the skin

          -  Women who have undergone prior radiotherapy to the chest wall and/or breast
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Condition: Narcolepsy; Cataplexy Narcolepsy; Excessive Sleepiness
MeSH terms: Narcolepsy; Cataplexy; Sleepiness
Intervention: AXS-12 (Reboxetine); Placebo
Intervention description: Dosed orally, twice daily for up to 3 weeks; Dosed orally, twice daily for up to 3 weeks
Intervention MeSH terms: Reboxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CONCERT; AXS-12; EDS; Cataplexy; Narcolepsy; Axsome; Reboxetine

Summary:

      CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine
      Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter
      trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be
      randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg
      daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo
      for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and
      measures of other symptoms of narcolepsy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female subjects between 18 and 70 years of age, inclusive

          -  Primary diagnosis of narcolepsy with cataplexy

          -  Willing and able to comply with the study requirements

        Exclusion Criteria:

          -  Other clinically significant conditions potentially causing EDS

          -  Clinically significant psychiatric disorders
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Bortezomib; Dexamethasone
Intervention MeSH terms: Dexamethasone; Lenalidomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Newly diagnosed

Summary:

      This research study is a Phase II clinical trial. Phase II clinical trials test the
      effectiveness of an investigational combination of drugs. The purpose is to learn whether the
      combination of drugs works in treating a specific cancer. "Investigational" means that the
      combination of drugs is still being studied. It also means that research doctors are trying
      to find out more about it. Examples of what they want to learn about are the safest dose to
      use, the side effects it may cause, and if the combination of drugs works for treating
      different types of cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented symptomatic myeloma, with organ damage related to myeloma

          -  Myeloma that is measurable either by serum or urine evaluation of the monoclonal
             component or by assay of serum free light chains

          -  Must commit to complete abstinence from heterosexual contact or begin two acceptable
             method of birth control, one highly effective method and one additional effective
             (barrier) method

        Exclusion Criteria:

          -  Eligible for autologous stem cell transplantation

          -  HIV positive on combination antiretroviral therapy

          -  Pregnant or breastfeeding

          -  Treated with any prior systemic therapy

          -  Primary amyloidosis or myeloma complicated by amyloidosis

          -  Receiving other investigational agents within 14 days of the start of this trial or
             during this trial

          -  Known brain metastases

          -  Poor tolerability or known allergy to any of the study drugs or similar compounds

          -  Intercurrent illness

          -  Previous history of another malignant condition except for basal cell carcinoma or
             stage I cervical cancer

          -  Inability to comply with an anti-thrombotic treatment regimen

          -  Peripheral neuropathy greater than or equal to grade 2
Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Ipilimumab; Placebo
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to
      evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed squamous cell head and neck cancer

          -  Widespread (metastatic) disease, or returned after previous treatment (recurrent)

          -  Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and
             HPV [Human Papilloma Virus (oropharynx only)]

          -  Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

        Exclusion Criteria:

          -  Previous treatment for metastatic or recurrent disease

          -  Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx,
             salivary gland, skin

          -  Any non-squamous subtype

          -  Active autoimmune disease

          -  Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus

          -  Previous treatment with checkpoint inhibitor drugs

          -  Active CNS metastases or carcinomatous meningitis

        Other protocol-defined inclusion/exclusion criteria apply