bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: [18F]MK-3328
Intervention description: IV dose of ~150 megabecquerel (MBq) [18F]MK-3328
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will estimate the radiochemical and radiation safety and assess the efficacy of
      [18F]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses
      will test whether [18F]MK-3328 is sufficiently safe and well-tolerated, based on an
      assessment of clinical and laboratory evaluations and adverse experiences in healthy
      participants, including healthy elderly (HE) participants, and Alzheimer's disease (AD)
      participants, to permit continued investigation. The study efficacy hypothesis will test
      whether [18F]MK-3328 can discriminate between AD participants and cognitively normal elderly
      control participants based on tracer volume of distribution, or one of its surrogates, in
      brain posterior cingulate gyrus.
    

Eligibility criteria:

        Inclusion Criteria:

        Part I:

          -  Participant is male or female of non-reproductive potential between 50 and 65 years
             old.

          -  Participant is less than 6'5" tall

          -  Participant is in good health

          -  Participant has been a non-smoker for at least 10 years

        Parts II and III:

          -  Male or female of non-reproductive potential at least 55 years of age

          -  Participant is cognitively normal (HE participants), or has probable mild-to moderate
             AD (AD participants)

          -  Participant is willing to have an arterial catheter placed in the radial artery (Part
             II only)

        Exclusion Criteria:

        Part I:

          -  Participant has a history of stroke, seizures, or neurological disorder

          -  Participant has or has a history of any disease or condition, or takes any medication
             that would interfere with assessment of the tracer or make participation unsafe or
             unduly uncomfortable

        Parts II and III:

          -  Participant has a history or current evidence of any neurological or neurodegenerative
             disorder other than AD that is associated with altered cognition

          -  Participant has or has a history of any disease or condition, or takes any medication
             that would interfere with assessment of the tracer or make participation unsafe or
             unduly uncomfortable

          -  Participant is living in a nursing home or skilled nursing facility
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
Condition: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: MEDI-573 (1 of 3 doses); Sorafenib
Intervention description: MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands; Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor
Intervention MeSH terms: Sorafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HCC, liver cancer, hepatocellular carcinoma, MEDI-573, anti-IGF

Summary:

      A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard
      of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years or minimum age of consent per local regulations at the time of
             screening

          -  Unresectable or metastatic hepatocellular carcinoma

          -  ECOG Performance Status ≤ 2

          -  Life expectancy of ≥ 3 months;

        Exclusion Criteria:

          -  Child-Pugh Score for Cirrhosis Mortality > 7 points

          -  Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic,
             targeted or experimental therapy

          -  Prior local treatment for HCC less than 4 weeks prior to initiating study treatment

          -  Active second malignancy

          -  Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to
             initiating study treatment

          -  Thrombotic or embolic events within 6 months prior to initiating study treatment

          -  Ongoing pancreatitis

          -  Uncontrolled or refractory ascites

          -  Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known
             leptomeningeal carcinomatosis

          -  Hepatic encephalopathy > Grade 1

          -  Active brain metastases with exceptions

          -  Poorly controlled diabetes mellitus

          -  Active coronary artery disease

          -  Uncontrolled hypertension
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
Condition: Arthritis
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Hip
Intervention: exercise; 2; Control
Intervention description: A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.; Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.; no exercise
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: older adults, falls, arthritis, aquatic, exercise

Summary:

      The objective of this project is to determine the effect of aquatic exercise and aquatic
      exercise combined with an education program on decreasing fall risk in older adults with hip
      osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and
      balance and the addition of the education session will enhance confidence in movement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  over age 65

          -  clinical diagnosis of hip osteoarthritis

        Exclusion Criteria:

          -  medical condition tha significantly decreases functional ability such that not safe to
             exercise in a community program

          -  already exercising in a moderate exercise program 2/week or more
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
Condition: Pharmacokinetics
Intervention: Colchicine; Grapefruit Juice; Colchicine
Intervention description: A single dose of 0.6 mg colchicine administered alone at 7:15 a.m. on Day 1; 240 mL of grapefruit juice ingested twice daily at 7:15 a.m. and 7:15 p.m. on Days 15 to 18.; A single dose of 0.6 mg colchicine administered with grapefruit juice at 7:15 a.m. on Day 18 after an overnight fast of at least 10 hours.
Intervention MeSH terms: Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; pharmacokinetics; grapefruit juice; furanocoumarins; cytochrome p450 3A4

Summary:

      Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the
      enzyme systems responsible for the metabolism of colchicine. This study will evaluate the
      effect of multiple daily consumptions of grapefruit juice on the pharmacokinetic profile of a
      single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and
      tolerability of this regimen in healthy volunteers. All study subjects will be monitored for
      adverse events throughout the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to colchicine
Crossover Study of the Safety and PK Properties of Proellex®
Condition: Pharmacokinetics
Intervention: Proellex
Intervention description: 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK; Pharmacokinetics

Summary:

      Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed
      and fasting states.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be able to speak, read, and understand English and be willing and able to
             provide written informed consent in English on an Institutional Review Board (IRB)

          -  Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35,
             inclusive

          -  Women of child-bearing potential must be willing to use effective non-hormonal,
             double-barrier method contraception during the study period and for a minimum of 30
             days after discontinuation of the study medication. Women who have had a hysterectomy
             will be allowed into the study

          -  Must have a negative urine pregnancy test at screening

          -  Able to swallow gelatin capsules

          -  Medically normal subjects with no significant abnormal findings at the screening
             physical examination as evaluated by the Principal Investigator that would interfere
             with the subject participating this study

          -  Must have agreed to not attempt to become pregnant at any time during study
             participation or for 30 days thereafter

          -  Other inclusion criteria may apply

        Exclusion Criteria:

          -  Symptomatic uterine fibroids or endometriosis

          -  Past or present history of any significant cardiovascular, renal, or hepatic disease
             requiring ongoing medical therapy or clinical intervention

          -  Past or present history of thrombophlebitis, thromboembolic disorders, or
             cerebrovascular accident

          -  Abnormal screening visit vital signs or clinical laboratory evaluation considered
             clinically significant by the Principal Investigator

          -  Significant organ abnormality or disease (based on the Principal Investigator's
             judgment) that would in the opinion of the Principal Investigator exclude the subject
             from participating

          -  Other exclusion criteria may apply
A Study of Evacetrapib in Japanese and Non-Japanese Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib; Pravastatin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Pravastatin; Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels
      in the blood when both drugs are taken at the same time. The study will also assess how well
      the body handles evacetrapib and pravastatin when given at the same time.

      This study has two periods in fixed order. Each participant will enroll in both periods. This
      study will last approximately 25 days, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy participants, as determined by medical history and physical
             examination

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)

          -  Japanese participants must be first generation Japanese
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Condition: Candida Infection; Premature Infant
MeSH terms: Candidiasis
Intervention: Medium-Chain Triglyceride (MCT) Oil
Intervention description: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No

Summary:

      This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to
      feedings in premature infants will reduce the amount of yeast (Candida) detectable in their
      stool. Infants who have Candida in their stool are eligible to participate. Half of the
      enrolled infants will have additional MCT oil added to their feedings and half will not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premature infant admitted to the Neonatal Intensive Care Unit at Women & Infants
             Hospital

          -  Receiving full enteral feeds of either preterm or transitional formula or fortified
             breast milk

          -  Anticipated to have a minimum stay of two weeks

        Exclusion Criteria:

          -  Prior exposure to antifungal drugs
A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide
Condition: Overweight; Obesity; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Acetaminophen
Intervention description: Tirzepatide administered SC.; Acetaminophen administered orally.
Intervention MeSH terms: Acetaminophen; Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn more about how tirzepatide affects stomach emptying in
      overweight/very overweight participants. Participants include those without diabetes and
      those with type 2 diabetes.

      The study will last about 13 weeks for each participant, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²),
             inclusive at screening

          -  For nondiabetic subjects: as determined by medical history, physical examination, and
             safety assessments at screening

          -  For participants with a confirmed type 2 diabetes diagnosis: The condition must be
             managed either by diet and exercise alone or on a stable dose of metformin for the
             past 3 months

          -  Willing and agreeable to commit to the duration of the study and undergo study
             procedures as instructed by the clinic staff

        Key Exclusion Criteria

          -  Have undergone gastric bypass or bariatric surgery

          -  Have received prescription drugs or over the counter drugs that promote weight loss in
             the past 6 months prior to screening

          -  For participants with a confirmed type 2 diabetes diagnosis: Have experienced more
             than 1 episode of severe low blood sugar that require emergency treatment,
             hospitalization or third parties to administer rescue treatment, in the past 6 months

          -  Have any lifetime history of a suicide attempt

          -  Have other medical conditions or medical history that make participation in the study
             unsafe or which may interfere in the interpretation of the results of the study

          -  Unwilling to comply with smoking and alcohol restrictions during the study
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-06412562 3mg BID; PF-06412562 9mg BID; PF-06412562 45mg BID; Placebo
Intervention description: PF-06412562; PF-06412562; PF-06412562; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This study is designed to investigate the safety, tolerability pharmacokinetics and
      pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets
      in subjects with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with schizophrenia both male and female

          2. Evidence of stable schizophrenia symptomatology for at least 3 months (no
             hospitalizations for schizophrenia, no increase in level of psychiatric care due to
             worsening of symptoms of schizophrenia, etc).

          3. Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine
             (oral or depot) on a stable medication treatment regimen for for at least 2 months
             prior to Day 1, including concomitant psychotropic medications.

        Exclusion Criteria:

          1. History of seizure

          2. Pregnant or nursing females

          3. Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease
             (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies
             at time of screening and at the time of dosing).
Healthy Minds Program App Dosage
Condition: Depression; Anxiety; Psychological Distress
MeSH terms: Depression
Intervention: HMP app
Intervention description: The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to two groups in a 1:1 ratio
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: depression; anxiety; behavioral symptoms

Summary:

      The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app
      on participants experiencing depression and/or anxiety. Participants will be assigned to use
      the HMP app 5- or 15-minutes per day for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Access to a smartphone or device capable of downloading HMP app

          -  Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4
             weeks

          -  Able to speak, read, and write in English

          -  PROMIS Depression or PROMIS Anxiety >55

        Exclusion Criteria:

          -  Meditation retreat experience

          -  Regular meditation practice (weekly practice for over 1 year OR daily practice within
             the previous 6 months)

          -  Previous practice under the instruction of a meditation teacher, other than in the
             context of an introductory course

          -  PROMIS Depression >70

          -  AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for
             non-men (any other genders)
INSORB Versus Subcuticular Sutures at Cesarean Section
Condition: Cesarean Section; Pregnancy
Intervention: Insorb absorbable staples; Absorbable sutures
Intervention description: Placement of Insorb absorbable staples at cesarean section; placement of absorbable sutures at cesarean section
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: Female
Minimum age: 16 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: cesarean section; insorb staples; absorbable staples; transverse skin incision

Summary:

      The proposed study is a randomized controlled trial with two arms. All patients admitted to
      Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered
      entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,
      the patient will be randomized at time of cesarean section to receive skin closure by either
      the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the
      standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment
      score (PSAS) will be obtained during this visit. The patient will then be contacted by
      telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)
      assessing her satisfaction with the resulting scar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  cesarean section via transverse skin incision informed consent

        Exclusion Criteria:

          -  vertical skin incision