bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Intervention: Entrectinib Test Formulation (F1); Entrectinib Reference Formulation (F06)
Intervention description: Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.; Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.
Intervention MeSH terms: Entrectinib
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: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study aims to investigate the relative bioavailability, safety, and tolerability of
      entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and
      female participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy in the opinion of the investigator. Healthy is defined by the absence of
             evidence of any active disease or clinically significant medical condition based on a
             detailed medical history and examination

          -  Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus
             (HIV)

          -  Females must not be pregnant or breastfeeding, and females of childbearing potential
             will agree to use highly-effective contraception. Females of childbearing potential
             must also agree to refrain from donating eggs during the treatment period and for 6
             weeks after the final dose of study drug

          -  Males must agree to use contraception and to refrain from sperm donation from check-in
             (Day -1 of Period 1) to 90 days after the final dose of study drug

        Exclusion Criteria:

          -  History of gastrointestinal surgery or other gastrointestinal disorder that might
             affect absorption of medicines from the gastrointestinal tract

          -  Presence of a clinically significant disease, illness, medical condition or disorder,
             or any other medical history determined by the investigator to be clinically
             significant and relevant. Ongoing chronic disorders which are not considered
             clinically significant are permissible providing they are stable

          -  Clinically significant change in health status, as judged by the investigator, or any
             major illness within the 4 weeks before screening, or clinically significant acute
             infection or febrile illness within the 14 days before screening

          -  Participation in any other clinical study involving an investigational medicinal
             product (IMP) or device within 30 days or 5 half-lives (if known), whichever is
             longer, before screening
Woebot for Substance Use Disorders
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Intervention: Woebot-SUDs (W-SUDs)
Intervention description: Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Phase 1 of this study aims to develop a digitally-delivered substance use disorder program
      through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient
      satisfaction with and the acceptability of W-SUDs as a substance use management tool.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All genders

          -  18-65 years

          -  Must have access to a smartphone and able to download the W-SUDs app

          -  Committed to engage with app and complete assessments

          -  Be willing to provide email address (to distribute incentives)

          -  Be literate in English (as W-SUDs conversational and video materials will be in
             English)

          -  Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs
             for problematic use

        Exclusion Criteria:

          -  Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of
             this population)

          -  Suicide attempt or within the past year

          -  Drug or alcohol overdose within the past year
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
Condition: Malignant Central Nervous System Neoplasm; Metastatic Malignant Neoplasm in the Central Nervous System
MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: Gadolinium; Hyperpolarized Carbon C 13 Pyruvate; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopic Imaging
Intervention description: gadolinium enhanced MRI; Given IV; Undergo MRI; Undergo MRSI
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic
      resonance imaging works in detecting lactate and bicarbonate in participants with central
      nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be
      used to measure the metabolic state of malignant brain tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a known diagnosis of central nervous system (CNS) malignancy, including
             metastases, with known enhancement on magnetic resonance (MR) who are otherwise
             eligible to undergo MRI

          -  Glomerular filtration rate (GFR) > 30 ml/min

          -  No allergy to gadolinium

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Refusal to have an IV placed for injection

          -  Acute major illness (e.g., unstable angina, etc.) or other condition that makes
             participation unsafe, per the investigator?s judgement

          -  Total bilirubin > 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN

          -  Gamma-glutamyltransferase (GGT) > 2.5 x ULN

          -  Pregnant or breast-feeding

          -  Cardiovascular risk, including:

               -  Poorly controlled hypertension, defined as either systolic > 170 or diastolic >
                  110

               -  Congestive heart failure

               -  Myocardial infarction within the past year

               -  QT prolongation, defined as pretreatment corrected QT interval (QTc) > 440 msec
                  in males or > 460 msec in females
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amgen; Phase 1; Postmenopausal; Japanese

Summary:

      The main purpose of this study is to assess the safety, tolerability and potential immune
      response to romosozumab following single subcutaneous (SC; injection under the skin) dose
      administration in healthy postmenopausal Japanese and non-Japanese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese subjects must be first (4 grandparents, biologic parents and subject born in
             Japan), second (4 grandparents and biological parents born in Japan) or third (4
             grandparents born in Japan) generation Japanese

          -  Body mass index ≤ 25 kg/m², inclusive at screening

          -  Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea
             confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks
             postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in
             medical history (verified with an operative note, if available)

        Exclusion Criteria:

          -  Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine
             (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5

          -  History of vertebral fracture or fragility fracture of the wrist, humerus, hip or
             pelvis;

          -  Diagnosed with any condition that will affect bone metabolism
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Intervention: HER-2 pulsed Dendritic Cell Vaccine
Intervention description: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Invasive Breast Cancer; Breast Cancer; Immunotherapy; Vaccine; Dendritic Cell

Summary:

      The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1
      vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will
      have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without
      trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram,
      laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine
      administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women over Age 18 years.

          -  Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than
             or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered
             NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+
             FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1
             year from their last treatment and have no evidence of disease.

          -  Deemed to require anti-estrogen therapy for treatment of their breast cancer can
             continue anti-estrogen therapy during vaccinations.

          -  Women of childbearing age with a negative pregnancy test documented prior to
             enrollment.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

          -  Willing to use birth control if necessary.

          -  Have voluntarily signed a written Informed Consent in accordance with institutional
             policies after its contents have been fully explained to them.

        Exclusion Criteria:

          -  Pregnant or lactating.

          -  Positive for positive HIV or hepatitis C at baseline.

          -  Patients with coagulopathies, including thrombocytopenia with platelet count less than
             75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.

          -  Major cardiac illness MUGA less than 50% EF.

          -  Pre-existing medical illnesses or medications which might interfere with the study as
             determined by Principal Investigator (PI).
A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants
Condition: Healthy
Intervention: Mirikizumab
Intervention description: Reference and test formulations of mirikizumab administered as a SC injection.
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare two different formulations of mirikizumab in healthy
      participants. This study will compare how much of each formulation gets into the blood stream
      and how long it takes the body to remove it. Information about any side effects that may
      occur will also be collected. Participants will remain in the study for about 12 weeks, after
      receiving study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined through medical history and
             physical examination

        Exclusion Criteria:

          -  Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and
             14 units/week (females)

          -  Must not show evidence of active or latent tuberculosis (TB)

          -  Must not have received live vaccine(s) (including attenuated live vaccines and those
             administered intranasally) within 8 weeks of screening, or intend to during the study

          -  Must not have been treated with steroids within 1 month of screening, or intend to
             during the study

          -  Must not be immunocompromised

          -  Must not have received treatment with biologic agents (e.g. monoclonal antibodies,
             including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior
             to Day 1

          -  Must not have clinically significant multiple or severe drug allergies, or intolerance
             to topical corticosteroids, or severe post treatment hypersensitivity reactions

          -  Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except
             for basal cell or squamous epithelial carcinomas of the skin that have been resected
             with no evidence of metastatic disease for 3 years

          -  Must not have had breast cancer within the past 10 years

          -  Must not have significant allergies to humanized monoclonal antibodies

          -  Must not have clinically significant multiple or severe drug allergies, or intolerance
             to topical corticosteroids, or severe post treatment hypersensitivity reactions
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: Nasal Glucagon; Intramuscular Glucagon
Intervention description: Administered nasally; Administered IM
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal
      glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in
      participants with type 1 diabetes mellitus (T1DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily
             insulin since the time of diagnosis

        Exclusion Criteria:

          -  Have a history of hypersensitivity to glucagon or any related products or severe
             hypersensitivity reactions (such as angioedema) to any drugs

          -  Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma

          -  Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance
             of another person in the 1 month prior to enrolling in the study)

          -  Have a history of epilepsy or seizure disorder

          -  Are women who are pregnant or lactating

          -  Have, except for the current regimen of insulin therapy and concomitant medication,
             regular use of or intended use of any over-the-counter or prescription medications or
             nutritional supplements that treat hyperglycemia or insulin resistance or that promote
             weight loss within 14 days before dosing

          -  Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs

          -  Require daily insulin treatment greater than (>)1.5 unit/kilograms (U/kg)/body weight
Thrombosomes® in Bleeding Thrombocytopenic Patients
Condition: Thrombocytopenia; Hematologic Diseases; Bone Marrow Aplasia
MeSH terms: Thrombocytopenia; Hematologic Diseases; Anemia, Aplastic; Hemorrhage
Intervention: Thrombosomes
Intervention description: Freeze-dried platelets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: thrombocytopenia; bleeding

Summary:

      The study evaluates the safety and potential early signals of efficacy of allogeneic
      Thrombosomes in bleeding thrombocytopenic patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults up to 74 y/o with any of following: acute leukemia (ALL or AML),
             myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone
             marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤
             70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral
             or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.

          -  Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with
             Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4
             weeks of screening. The Grade 1 subset includes patients who have either epistaxis,
             hematuria, oral petechiae, or bleeding at invasive or other wound sites.

          -  No platelet inhibitor drugs within 5 days prior to infusion and through Day 6
             follow-up period.

        Exclusion Criteria:

          -  History or condition related to thrombosis, embolism or vascular occlusion/ischemia,
             including but not limited to: transient ischemic attack, stroke, myocardial
             infarction, stent placement, valve replacement and/or repair

          -  Currently with an active acute infection, or suspected infection, a single oral
             temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in
             past 24 h. Subjects on prophylactic antibiotics are not excluded from study

          -  Coagulopathy or receiving anticoagulants that result in PT (prothrombin time) or aPTT
             (activated partial thromboplastin time) values greater than 1.3 X upper limit of
             normal or elevated D-dimer of decreased fibrinogen

          -  History of any inherited coagulation or platelet function, disorder or ITP (idiopathic
             thrombocytopenic purpura), TTP (thrombotic thrombocytopenic purpura), or HUS
             (hemolytic-uremic syndrome)

          -  Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion

          -  Treatment with an investigational drug within 1 month of infusion, other than for
             treatment of their underlying disease
Safety Evaluation of Advantage Anti-Caries Varnish
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Varnish
Intervention description: Topical application to the teeth
Intervention MeSH terms: Imidacloprid
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 36 Months
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy

        Exclusion Criteria:

          -  Weight less than 15 kg or hypersensitivity to iodine