bioihbjkbjnl/mcl2 huggingface dataset:
Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
Condition: Neoplasms
Intervention: PF-05212384 (also known as PKI-587)
Intervention description: Intravenous dosing once weekly infusion
Intervention MeSH terms: Gedatolisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Phase 1; Dose Finding; Solid Tumors; Tumors; PF-05212384

Summary:

      This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The
      purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a
      Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In
      Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and
      preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer,
      ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of
      brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who
      consent to provide tumor biopsies while participating in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of any solid tumor

          -  Incurable cancer, with disease progression following at least 1 therapy with no
             further standard treatment available in the opinion of the investigator.

          -  At least 1 evaluable lesion per RECIST criteria

        Exclusion Criteria:

          -  Clinically unstable primary or metastatic CNS tumors

          -  Subjects with known diabetes

          -  QTc interval greater than 470 ms.
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
Condition: Cancer; Neoplasm
Intervention: NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51
Intervention MeSH terms: Monatide (IMS 3015)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer vaccine; NY-ESO-1b peptide; CpG 7909; Montanide® ISA-51; LAGE-1; immune response; safety

Summary:

      This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with
      2 other agents to help stimulate the immune system. Peptides are small fragments of protein.
      NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been
      found on various types of cancer cells. The purpose is to stimulate the immune system to
      react against the peptides that are found on cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic, measurable cancer or resected high risk Stage
             III/IV; resected Stage II, III, or IV non-small cell lung cancer or esophageal cancer
             who have declined, failed, or completed standard therapy; tumor expression of NY-ESO-1
             or LAGE-1 antigen; HLA-A2 positive; Karnofsky performance status greater than or equal
             to 60%; hematology and biochemistry laboratory results within the limits normally
             expected for the patient population; age greater than or equal to 18.

        Exclusion Criteria:

          -  Clinically significant heart disease; other serious illnesses; patients with serious
             intercurrent illness, requiring hospitalization; patients taking immunosuppressive
             drugs; autoimmune disease; known HIV positivity; other active malignancy within 1 year
             prior to entry into the study; participation in chemotherapy, radiation therapy, or
             any other clinical trial involving another investigational agent within 4 weeks prior
             to enrollment; pregnancy or breastfeeding; women of childbearing potential: refusal or
             inability to use effective means of contraception.
Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
Condition: Bipolar Disorder; Psychosocial Intervention
MeSH terms: Bipolar Disorder
Intervention: Mobile intervention
Intervention description: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.
Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo.
Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This study uses a design known as a microrandomized trial. Whereas a multi-arm trial randomizes a subject to an intervention group only once at the start of the study, a microrandomized trial repeatedly randomizes a subject to an intervention group throughout the study. In addition to an overall effect of an intervention on proximal outcomes, a microrandomized trial allows one to determine if the effect is modified by momentary factors (e.g., current mood, day of the week, day in the study).
For the present study, every subject has a equal chance of being assigned to one of two intervention groups at each of 84 time points (2 daily x 42 days). At each time point, the two intervention groups are to either receive a prompt based on Acceptance and Commitment Therapy (ACT) or not receive such a prompt. Regardless of the assigned group, subjects are asked to assess their mood, stress, and activity at every time point prior to assignment to intervention group.
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mood; stress; sleep; circadian rhythm; medical adherence; acceptance and commitment therapy; microintervention

Summary:

      This study is a 6-week micro-randomized trial investigating the feasibility of a mobile
      health platform. Its long-term objective is to develop a mobile health platform for the
      translation of a psychosocial intervention for bipolar disorder (BP) into an effective and
      evidence-based adaptive intervention. In this aim of the study, investigators will evaluate
      how individuals with BP respond to a microintervention based in acceptance and commitment
      therapy (ACT) that is delivered with a mobile app.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals diagnosed with Bipolar Disorder

          -  have agreed to be contacted for future research

          -  have a smart-phone

          -  have a diagnosis of bipolar disorder.

        Exclusion Criteria:

        -
A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006)
Condition: Neoplasms; Solid Tumors; Bone Cancer; Kidney Tumor; Neuroblastoma
MeSH terms: Neoplasms; Neuroblastoma; Kidney Neoplasms; Bone Neoplasms
Intervention: Temozolomide; Vincristine; Ifosfamide; Irinotecan; Robatumumab; Doxorubicin; Cyclophosphamide; Etoposide
Intervention MeSH terms: Cyclophosphamide; Temozolomide; Ifosfamide; Doxorubicin; Irinotecan; Etoposide; Vincristine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH
      717454, MK-7454) administered in combination with chemotherapy in pediatric participants with
      solid tumors, to be conducted in conformance with Good Clinical Practices. This study will
      evaluate the safety, tolerability and dose-finding of robatumumab when administered in
      combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and
      vincristine (Arm B), or ifosfamide and etoposide (Arm C).

      The primary study hypothesis is that robatumumab can be safely administered in combination
      with chemotherapy regimens in pediatric participants with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be <= 21 years of age (older participants may be allowed on study on a
             case-by-case basis); may be of either sex, and of any race/ethnicity.

          -  Must have histologic confirmation of the advanced solid tumor, except for brainstem
             tumors.

          -  Must have Karnofsky performance score of >=50 (if participant is >16 years of age) or
             a Lansky score of >50 (if participant is <=16 years of age).

          -  Must have adequate organ function during Screening.

          -  Must be able to adhere to dose and visit schedules.

        Exclusion Criteria:

          -  Must not have a history of another malignancy.

          -  Must not have uncontrolled diabetes mellitus.

          -  Must not have persistent, unresolved common terminology criteria for adverse events
             (CTCAE) Grade >=2 drug-related toxicity associated with previous treatment.

          -  Must not have known hypersensitivity to other antibodies, or any accompanying
             excipients associated with these medications.

          -  If female, must not be breast-feeding, pregnant, intending to become pregnant, or have
             a positive pregnancy test at Screening.

          -  Must not be known to have human immunodeficiency virus (HIV) infection or known
             HIV-related malignancy.

          -  Must not be known to have active Hepatitis B, or Hepatitis C.

          -  Must not have any serious or uncontrolled infection.
Computer Vision System for the Blind Veteran
Condition: Blindness
MeSH terms: Blindness
Intervention: initial system; modified system
Intervention description: The computer vision system is used to assist blind subject to navigate an extended path with multiple turns within a hospital setting.The initial prototype system would have been successfully tested for outdoor navigation and basic object recognition tasks.; The problems associated with the initial system were identified and modified. This modified system was tested with a second separate group of subjects. The redesigned system is used to assist blind subject to navigate the same extended path with multiple turns within a hospital setting.
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a feasibility study involving a small number of blind subject to evaluate the
      effectiveness of using a software and associated hardware components to assist the blind in
      identifying and locating objects of interests and to assist in way finding tasks. After the
      system has been successfully tested by the blindfolded engineers, it will be evaluated in a
      small number of blind subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 and over

          -  legally blind

        Exclusion Criteria:

          -  decreased hearing

          -  unable to understand or follow instructions

          -  inability to walk and stand for 10 minutes
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
Condition: Focus: Nutritional Requirements for Infants
Intervention: Arachidonic acid (25 mg/100 kcal ); Arachidonic acid (34 mg/100 kcal); Placebo
Intervention description: 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 14 Days
Maximum age: 21 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nutrient; nutrition; arachidonic acid; essential fatty acids

Summary:

      The immune system of newborn infants is immature with low activity of both innate and
      acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary
      fatty acids are one nutritional factor noted to play a role in immune function. The omega-6
      long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA
      (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The
      balance or relative amounts of ARA and DHA have been associated with immune response. Some
      commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and
      DHA has not been determined with respect to immune function. This study will assess two
      levels of ARA and the impact on immune response in healthy, term infants and whether genes
      that influence essential fatty acid metabolism alter the nutritional requirement of infants.
    

Eligibility criteria:

        Inclusion criteria:

          -  healthy term infants

          -  birth weight, length and head circumference between the 5th and 95th percentile for
             gestational age (according to the National Center for Health Statistics growth charts)

          -  receiving >80% for their intake by mouth from commercial infant formula

          -  low-risk for allergy based on a negative family history.

        Exclusion criteria:

          -  corticosteroid use

          -  red cell or plasma transfusions

          -  IV lipid emulsions prior to study entry

          -  major congenital malformations

          -  systemic or congenital infection

          -  significant neonatal morbidity

          -  maternal autoimmune disorders

          -  acute illness precluding oral feedings or conditions requiring feedings other than
             standard formula
Staccato Loxapine Thorough QT/QTc Study
Condition: Thorough QT/QTc Study
Intervention: Inhaled loxapine; Inhaled placebo; Oral moxifloxacin; Oral placebo
Intervention description: Inhaled Staccato Loxapine 10 mg single dose; Inhaled Staccato placebo single dose; Oral moxifloxacin 400 mg; Oral placebo similar in appearance to moxifloxacin 400 mg
Intervention MeSH terms: Moxifloxacin; Loxapine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind, double dummy
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Staccato loxapine; QT/QTc; healthy volunteers; Thorough QT/QTc study; ADASUVE; inhaled loxapine

Summary:

      The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato
      Loxapine administered to healthy volunteers in a 3 period crossover study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are in good general health and agree to use a medically acceptable and
             effective birth control method throughout the study.

        Exclusion Criteria:

          -  Subjects who have taken prescription or nonprescription medication within 5 days of
             treatment,

          -  Subjects who have had an acute illness within the last 5 days of treatment,

          -  Subjects who are smokers, OR

          -  Subjects who have an ECG abnormality at baseline.
Fenofibrate Bioequivalence Study (0767-031)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: fenofibrate (U.S. formulation); fenofibrate (UK formulation)
Intervention description: Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.; Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
Intervention MeSH terms: Fenofibrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine definitive bioequivalence of the United States (U.S.) and United
      Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy
      adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Subject is willing to follow all study guidelines

        Exclusion Criteria:

          -  Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or
             other major diseases or chronic conditions that would confound the results of the
             study or make participation unsafe

          -  Female subject is receiving oral contraceptives or hormone replacement therapy
Single Dose Partial Breast Radiotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Radiosurgery
Intervention description: Single dose or radiation in 15Gy, 18Gy or 21Gy
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cancer of Breast; Cancer of the Breast; Neoplasms, Breast; Single dose radiation; Radiotherapy; Preoperative

Summary:

      This study seeks to determine the maximum tolerated dose of a single-dose partial breast
      radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be
      performed within 3 weeks (+/- 1 week) of completing radiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in
             situ or invasive ductal (or other favorable histology) carcinoma of the breast

          -  Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging
             evidence of multicentric or multifocal disease, no pregnant women, and no comorbid
             conditions precluding surgery)

          -  Clinical T1N0M0

          -  55 years of age or older

          -  Estrogen receptor (ER) positive,

          -  No evidence of lymphovascular space invasion on initial biopsy

          -  Not pregnant. If not post-menopausal must adhere to birth control measures

          -  White blood cell count > 3000, Hemoglobin > 9, platelets >100000

          -  Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min

        Exclusion Criteria:

          -  Neoadjuvant chemotherapy

          -  Breast implants

          -  Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus,
             rheumatoid arthritis, scleroderma)

          -  Patients unable to receive study treatment planning secondary to body habitus or
             inability to lie flat on the stomach at length

          -  HER-2/neu positive

          -  Positive serum pregnancy test
A Study of LY3009104 in Healthy Participants
Condition: Healthy Participants
Intervention: LY3009104; Placebo; moxifloxacin
Intervention description: administered orally; Administered orally; Administered orally
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This will be a 2-part, randomized, participant- and investigator-blind study in healthy males
      and females.

      Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that
      yields drug exposures slightly exceeding typical exposures anticipated from repeated
      administration of an efficacious dose to participants. The concentration of the drug in the
      blood stream will be measured and information about any side effects that may occur will also
      be collected.

      Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the
      heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females as determined by medical history and physical
             examination. Are drug free, disease free, and no cardiac abnormalities.

          -  Have clinical laboratory test results within normal reference range for the population
             or investigator site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator.

          -  Have a clinically normal screening ECG with a measurable QT interval as judged by the
             investigator, and which in Part B allows accurate measurements of QT interval.

        Exclusion Criteria:

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data.

          -  Have an abnormality in the 12-lead ECG that, in the opinion of the investigator,
             increases the risks associated with participating in the study or affects or confounds
             the corrected QT (QTc) analysis or have QTc greater than 450 milliseconds (msec).

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening.