bioihbjkbjnl/mcl2 huggingface dataset:
Cardiac Safety Evaluation of P03277
Condition: Healthy Volunteers
Intervention: P03277 0.1 mmol/kg; Moxifloxacin 400mg; NaCl 0.9%; P03277 0.3 mmol/kg
Intervention description: Single intravenous bolus injection at 2 mL/sec; One tablet per os; Single intravenous bolus injection at 2 mL/sec; Single intravenous bolus injection at 2 mL/sec
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Williams design for a 4*4 cross over
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gadolinium-based contrast agent; Cardiac safety; ECG; Gadopiclenol

Summary:

      The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled
      and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.

      The primary objective is to assess the cardiac safety after administration of P03277 to 48
      healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg
      (supra-clinical dose) by evaluating the QT and QTc intervals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject assessed as healthy by a comprehensive clinical assessment (detailed medical
             history and complete physical examination)

          -  Subject with a Body Mass Index (BMI) > 19 kg/m² and < 28 kg/m² and a weight at least
             of 40 kg for female and 50 kg for male and at maximum of 100 kg

        Exclusion Criteria:

        -
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Condition: Norovirus Infection
MeSH terms: Caliciviridae Infections
Intervention: Norwalk GI.1 Virus
Intervention description: Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      There is a need for safe, highly infectious Norovirus inocula for use in Norovirus
      vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune
      response among vaccinated and unvaccinated subjects. The purpose of this study is to generate
      the infection and illness rate and immune response data necessary for the conduct of future
      investigation of Norovirus vaccine studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  General good health, without significant medical illness, based on medical history,
             physical examination, vital signs, and clinical laboratories (CBC, chemistry, and
             urinalysis) as determined by the investigator in consultation with the research
             monitor and sponsor

          -  Available for all planned visits and to spend at least 5 days in confinement

          -  Confirmed blood type (A or O)

          -  Demonstrated to be H type-1 antigen secretor positive (by saliva test)

          -  Body mass index between 17 and 30 at screening

          -  Female subjects must have a negative pregnancy test and either use contraceptives or
             be sterile

          -  Available to return for follow-up visits following discharge from the inpatient unit
             and deliver stool specimens to the investigator promptly

        Exclusion Criteria:

          -  Presence of significant medical condition

          -  Donation or use of blood or blood products within 4 weeks prior to challenge

          -  Diagnosed bleeding disorder or significant bruising or bleeding difficulties that
             could make blood draws problematic

          -  Abnormal stool pattern

          -  Any gastroenteritis within the past 2 weeks

          -  Occupational hazards, including having daily contact with children under the age of 5,
             women known to be pregnant, employment in the food service industry, health care
             workers, etc.
A Study of TAS-205 for Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: TAS-205; Placebo
Intervention description: Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals; Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: Male
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in
      patients with Duchenne Muscular Dystrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to give an informed consent. If applicable, able to give an informed assent.

          -  Male and >= 5 years and < 16 years of age.

          -  Bodyweight of >= 15.0 kg and < 75.0 kg.

          -  Phenotypic evidence of DMD.

          -  Able to take tablets.

          -  If taking oral glucocorticosteroids no significant change in total daily dosage or
             dosing regimen after enrollment.

          -  Confirmed the urinary PD marker over its criteria.

          -  Able to follow the study protocol.

        Exclusion Criteria:

          -  Current diagnosis or history of any drug allergy.

          -  A forced vital capacity (FVC) < 50% of predicted value.

          -  A left ventricular ejection fraction (EF) < 50% or fractional shortening (FS) < 25%
             based on echocardiogram (ECHO).

          -  Ongoing immunosuppressive therapy (other than corticosteroids).

          -  With severe disease such as hepatic disease, kidney disease and others.

          -  With any systemic allergic disease or any chronic inflammatory disease.

          -  Treated with any other investigational agents within 90 days.

          -  Positive reaction in hepatitis B surface antigen (HbsAg), hepatitis C antibody test
             (HCV), or human immunodeficiency virus (HIV) test.
A Dose-escalating Clinical Trial With KH176
Condition: MELAS; LHON; Leigh Syndrome; Mitochondrial Disease; Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
MeSH terms: Leigh Disease; Mitochondrial Diseases
Intervention: KH176; placebo
Intervention MeSH terms: 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders
      affecting both children and adults. KH176 is a novel chemical entity currently under
      development for the treatment of inherited mitochondrial diseases, including MELAS
      (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease
      and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox
      modulating agent targeting the reactive oxygen species which are important in the
      pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a
      favourable safety profile in the pre-clinical testing, the safety, tolerability and
      pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in
      healthy male subjects in this trial
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy as assessed by medical history, physical examination, Vital Signs, Clinical
             Laboratory, ECG

        Exclusion Criteria:

          -  Allergies,

          -  Concomitant medication,

          -  concomitant disease,

          -  relevant surgery,

          -  recent blood donation
Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: d6-25-hydroxyvitamin D3
Intervention description: intravenous administration of stable isotope-labeled D6-25(OH)D3
Intervention MeSH terms: Hydroxycholecalciferols; Calcifediol
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cystic fibrosis; vitamin d catabolism

Summary:

      The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard
      pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic
      clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of
      this work is to provide the first comprehensive characterization of vitamin D metabolism in
      CF patients and promote novel hypotheses for subsequent studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Serum total 25(OH)D 10-50 ng/mL

          -  Diagnosis of cystic fibrosis in accordance with CF Foundation Guidelines; OR, normal
             CONTROL

        Exclusion Criteria:

          -  Primary hyperparathyroidism

          -  Gastric bypass

          -  Tuberculosis or sarcoidosis

          -  Current pregnancy

          -  Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic
             encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)

          -  History of kidney transplantation or end stage renal disease treated with dialysis

          -  Use of vitamin D3 or vitamin D2 supplements exceeding a mean daily dose of 400 IU,
             within 3 months (wash-out allowed)

          -  Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce
             CYP24A1 within 4 weeks (wash-out allowed)

          -  Serum calcium > 10.1 mg/dL

          -  Hemoglobin < 9 g/dL
A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart; positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers,
      MCI and AD subjects provide the same results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Volunteers

               -  Male or female subjects ≥ 50 years of age

               -  Mini-mental state examination (MMSE) ≥ 29

          -  MCI Subjects

               -  Male or female subjects ≥ 50 years of age

               -  MMSE ≥ 24

               -  Have MCI consistent with National Institute on Aging-Alzheimer's Association
                  (NIA-AA) working group's diagnostic guidelines for AD

               -  Have a study partner that can report on subject's activities of daily living

          -  Probable AD Subjects

               -  Male or female subjects ≥ 50 years of age

               -  MMSE > 10

               -  Meet clinical criteria for probable AD based on the NIA-AA working group's
                  diagnostic guidelines for AD

               -  Have a study partner that can report on subject's activities of daily living

        Exclusion Criteria:

          -  Current clinically significant psychiatric disease

          -  Evidence of structural brain abnormalities

          -  Evidence of dementing illness other than AD

          -  Current clinically significant cardiovascular disease or ECG abnormalities, or
             additional risk factors for Torsades de Pointes

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer

          -  History of alcohol or substance abuse or dependence

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have received or participated in a trial with investigational medications in the past
             30 days

          -  have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session.
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
Condition: HIV
MeSH terms: Renal Insufficiency
Intervention: Bictegravir
Intervention description: 75 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1; Renally Impaired

Summary:

      The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral
      bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched,
      healthy controls with normal renal function. Each participant in the renal impairment groups
      will be matched for age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40
      kg/m^2)] with a participant in the control group.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  All Individuals:

               -  Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening

          -  Individuals with impaired renal function

               -  Chronic stable renal impairment without recent clinical change

                    -  Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min

                    -  Moderate: CrCl = 30 - 59 mL/min

                    -  Severe: CrCl = 15 - 29 mL/min

          -  Healthy individuals

               -  CrCl ≥ 90 mL/min

        Key Exclusion Criteria:

          -  All Individuals:

               -  Pregnant or lactating females

               -  HIV positive or chronic hepatitis B infected

          -  Individuals with impaired renal function

               -  Chronic liver disease

               -  Dialysis or anticipated use of dialysis

               -  Renal transplant

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Staccato Prochlorperazine Single Dose PK Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Prochlorperazine 0.5 mg IV over 5 sec; Inhaled prochlorperazine 0.625 mg; Inhaled prochlorperazine 1.25 mg; Inhaled prochlorperazine 2.5 mg; Inhaled prochlorperazine 5 mg; Inhaled prochlorperazine 10 mg; Inhaled placebo; Prochlorperazine 10 mg IV over 5 sec
Intervention description: IV Prochlorperazine for bioavailability; Inhaled Staccato Prochlorperazine 0.625 mg; Inhaled Staccato Prochlorperazine 1.25 mg; Inhaled Staccato Prochlorperazine 2.5 mg; InhaledStaccato Prochlorperazine 5 mg; InhaledStaccato Prochlorperazine 10 mg; Inhaled Staccato Placebo (0 mg); Prochlorperazine 10 mg IV over 5 sec for patient qualification
Intervention MeSH terms: Prochlorperazine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stage 1: open-label, single-dose stage with 3 treatment periods divided into 2 phases Stage 2: double-blind, placebo-controlled, dose-escalation treatment period
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Stage 2 was a double-blind, placebo-controlled, 4 step dose-escalation trial
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine, Prochlorperazine aerosol

Summary:

      The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of
      inhaled prochlorperazine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in
             good general health as determined by medical history, physical examination, 12-lead
             ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of
             the Principal Investigator.

        Exclusion Criteria:

          -  Subjects with a known history of allergy or intolerance to phenothiazines or related
             drugs or who have any disease, by history, physical examination, or laboratory
             abnormalities that in the investigator's opinion, would present undue risk to the
             subject, or may confound the interpretation of study results.
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)
Single Ascending Dose Study of AMG 570 in Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: AMG 570; AMG 570 Matching Placebo
Intervention description: 7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.; Placebo administered as single dose subcutaneous in healthy volunteers.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Lupus; Healthy Volunteer; Safety Study; Placebo Control; Phase 1

Summary:

      The purpose of this study is to obtain initial information on the safety and tolerability
      (effects good or bad), pharmacokinetics (what the body does to the drug), and
      pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy as determined by the investigator

          -  Normal or clinically acceptable electrocardiogram (ECG)

          -  Female subjects must be of documented non-reproductive potential

          -  Subjects must be current for all vaccinations

          -  Other inclusion criteria may apply

        Exclusion Criteria:

          -  Current or chronic history of liver disease

          -  History of active infections

          -  History of significant respiratory disorder

          -  Evidence of renal disease

          -  Other exclusion criteria may apply
Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)
Condition: Elder Abuse
Intervention: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Intervention description: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: VOICES Elder Abuse Intervention
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To test an interactive intervention to screen for Elder Abuse and Mistreatment (EM) in the
      Primary Care (PC) setting to promote self-identification and self-disclosure of EM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 60 years or older

          -  Alert and oriented to person and place

          -  Abbreviated Mental Test (AMT-4) score of 4

          -  Able to consent and communicate in English

          -  Agrees and able to use the iPad

        Exclusion Criteria:

          -  subjects who live in nursing homes or other long-term care sitting and do not reside
             in community setting

          -  patients will be excluded if they cannot safely undergo the studies required for
             participation

          -  subjects with clear signs of EM

          -  Patient or clinician refusal to participate

          -  severe hearing and vision impairment

          -  COVID-19 positive