bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Condition: Marburg Virus Disease
MeSH terms: Virus Diseases; Marburg Virus Disease
Intervention: galidesivir; placebo
Intervention description: galidesivir IV infusion; placebo IV infusion
Intervention MeSH terms: Galidesivir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics
      of galidesivir following administration of single doses by IV infusion
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  written informed consent

          -  males and non-pregnant, non-lactating females

          -  BMI 19.0-32.0

          -  willing to abide by contraceptive requirements

          -  normal vitals

          -  willing to abide by study procedures and restrictions

        Exclusion Criteria:

          -  clinically significant medical condition or medical history or psychiatric condition
             or history of psychiatric condition

          -  abnormal cardiac finding, or laboratory/urinalysis abnormality at screening

          -  known family history of sudden death or long QT syndrome, family or personal history
             of QT prolongation, or arrhythmia that required medical intervention

          -  current participation in any other investigational drug study or participation in an
             investigational drug study within 3 months of screening visit

          -  use of prescription, OTC, or herbal medications during study or use of any specified
             medications within 30 days prior to study

          -  Recent or current history of alcohol or drug abuse

          -  Regular use of tobacco or nicotine products

          -  Positive serology for HBV, HCV, or HIV

          -  history of severe adverse reaction to or known sensitivity to any drug

          -  pregnant, lactating, or planning to become pregnant within 30 days of the study. Male
             subjects with pregnant female partners are excluded
W-SUDs for COVID-19
Condition: Substance Use Disorders; Alcohol Use Disorder
MeSH terms: Substance-Related Disorders; Alcoholism
Intervention: Woebot Substance Use Disorder
Intervention description: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the efficacy of a substance use disorder intervention
      delivered via a mobile application in an adult population during the COVID-19 pandemic.

      This study that will test the comparative efficacy of the mobile-app based substance use
      disorder program to reduce substance use relative to a wait list control condition, and
      explore between group differences on quality of life indices as well as retention and
      engagement during COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All genders aged 18-65 years

          -  Access to a smartphone

          -  Available and committed to engage with app and complete assessments

          -  Be willing to provide email address (as this is how assessment incentives will be
             distributed),

          -  Literate in English (as W-SUDs conversational and video materials will be in English).

        Exclusion Criteria:

          -  Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of
             this population)

          -  History of severe drug/alcohol use

          -  History of opioid misuse without medication-assisted treatment

          -  Suicide attempt within the past year

          -  Opioid overdose within the past year
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
Condition: Alzheimer Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 240 megabecquerel (MBq) (6.5 mCi); positron emission tomography (PET) scan of the brain
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the
      preclinical, prodromal and dementia phases of Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or
             planned and MRI available

          -  Subjects in the MCI and AD groups required to have a reliable caregiver capable of
             providing information about the subjects' symptoms

        Exclusion Criteria:

          -  lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder

          -  history of electroconvulsive therapy

          -  MRI contraindicated

          -  claustrophobic or, otherwise, unable to tolerate the imaging procedure

          -  current clinically significant cardiovascular disease or clinically significant
             abnormalities on screening electrocardiogram

          -  history of additional risk factors for Torsades de Pointes

          -  current clinically significant infectious disease, endocrine or metabolic disease, or
             pulmonary, renal, or hepatic impairment that the investigator believes would affect
             study participation

          -  history of cancer (other than skin or in situ prostate cancer) within the previous 5
             years

          -  current drug or alcohol abuse/dependence

          -  history of alcohol abuse/dependence with 2 years of the onset of the symptoms of
             dementia

          -  females of childbearing potential who were not surgically sterile, not refraining from
             sexual activity, or not using reliable methods of contraception
A Trial of Habit Formation Theory for Exercise in Older Adults
Condition: Sedentary Behavior; Aging; Activity, Motor; Behavior, Health
Intervention: Goal setting; Action Planning; Self-monitoring of behavior; Behavioral Practice/Rehearsal; Habit Formation
Intervention description: Goal setting: set or agree on a goal defined in terms of behavior to be achieved.; Action planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity.; Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.; Behavioral rehearsal: prompt practice or rehearsal of walking one or more times in a context when the performance may not be necessary, in order to increase habit and skill.; Prompt rehearsal & repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Habit Formation; Physical Activity; Behavior Change; Virtual; Personalized Trial; Personalized; Feasibility

Summary:

      This personalized trial will evaluate the effects of five behavioral change techniques (BCTs)
      described in Habit Formation Theory (Goal setting, Action Planning, Self-Monitoring,
      Behavioral Practice/Rehearsal and Habit Formation) delivered by text message to enhance
      low-intensity walking by 2,000 more steps per day/5 days per week in healthy Northwell
      employees aged 45-75 years old.
    

Eligibility criteria:

        Inclusion Criteria:

        Men and women who:

          -  Age 45 - 75 years old of age

          -  Fluent in English

          -  Employed in the Northwell Health system

          -  Community-dwelling

          -  Report they are in good general health, walk regularly and have never been informed by
             a clinician that it was not advisable/safe to participate in a low-intensity walking
             program

          -  Owns and can regularly access a smartphone capable of receiving text messages

          -  Owns and can regularly access an e-mail account

        Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct
        of the Trial

          -  < 45 years old or > 75 years old

          -  Unable to speak/comprehend English

          -  Not employed in Northwell Health system

          -  Have self-reported poor health, limited mobility and/or have been advised by a
             clinician not to increase their low-intensity walking

          -  Pregnancy

          -  Previous diagnosis of a serious mental health condition or psychiatric disorder, such
             as bipolar disorder
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
Condition: Covid19
MeSH terms: COVID-19
Intervention: BGB DXP593; Placebo
Intervention description: Administered intravenously (IV) as specified in the treatment arm; Placebo to match BGB-DXP593
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593
      administered intravenously as a single dose in healthy participants
    

Eligibility criteria:

        Key Inclusion Criteria :

          1. Participants are in good general health as determined by the investigator or medically
             qualified designee, based on a medical evaluation including medical history, physical
             examination, laboratory tests and cardiac monitoring

          2. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2
             (inclusive) Note: BMI = weight [kg] / (height [m])

          3. Negative serum IgG to the SARS-CoV-2

          4. Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the
             method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)

        Key Exclusion Criteria:

          1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
             endocrinological, hematological, or neurological disorders capable of significantly
             altering the absorption, metabolism, or elimination of drugs, constituting a risk to
             the participant when taking the study drug; or interfering with the interpretation of
             data

          2. Any history of a severe allergic reaction prior to enrollment that has a reasonable
             risk of recurrence during the study

          3. Have a medical history of SARS infection

          4. Any acute fever disease or infections

          5. Any chronic or clinically significant medical condition that, in the opinion of the
             investigator, would jeopardize the safety or rights of the participant, including but
             not limited to: diabetes mellitus type I, chronic hepatitis; or clinically significant
             forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune
             disease, psychiatric disorders, or heart disease

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
Condition: Advanced Hepatocellular Carcinoma; Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasms; Hepatic Cancer; Hepatic Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: H3B-6527
Intervention description: H3B-6527 by mouth once or twice daily at specified doses.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Hepatocellular Carcinoma; H3B-6527; Fibroblast growth factor receptor 4 (FGFR4); Fibroblast growth factor 19 (FGF19)

Summary:

      The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended
      Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics
      of H3B-6527.
    

Eligibility criteria:

        Inclusion criteria:

          1. Participants with hepatocellular carcinoma.

          2. Must have had at least one prior standard-of-care therapy, unless contraindicated.

          3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

          4. Must be willing to undergo a biopsy up to 8 weeks before administration of H3B-6527 on
             Cycle 1 Day 1 for part 2 (dose expansion).

          5. Adequate bone marrow and organ function.

        Exclusion criteria:

          1. Uncontrolled significant active infections, except hepatitis B virus (HBV) or
             hepatitis C virus (HCV).

          2. Known human immunodeficiency virus infection.

          3. Presence of gastric or esophageal varices requiring active treatment.

          4. Previous treatment with a selective FGF19-FGFR4 targeted therapy.

          5. Females of childbearing potential, or males who have not had a successful vasectomy,
             who are unable or unwilling to follow adequate contraceptive measures.

          6. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or
             glucose-galactose malabsorption.
First in Patient Study for PF-06840003 in Malignant Gliomas
Condition: Oligodendroglioma; Astrocytoma; Malignant Glioma
MeSH terms: Glioma; Astrocytoma; Oligodendroglioma
Intervention: PF-06840003
Intervention description: Daily Oral PF-06840003
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GBM; malignant glioma; glioma; anaplastic glioma; astrocytoma; IDO; IDO1; PF-06840003

Summary:

      This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in
      patients with malignant gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of WHO Grade IV glioblastoma or WHO Grade III anaplastic gliomas

          -  For patients with Grade IV GBM, recurrent disease at the time of the first or second
             recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent
             disease at the time of at least a first recurrence but no more than a fourth
             recurrence or progression

          -  Karnofsky performance score greater than or equal to 70%

          -  Adequate bone marrow, kidney and liver function

        Exclusion Criteria:

          -  History of CNS bleeding within 6 months of registration

          -  Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months
             of registration

          -  Requires treatment with high dose systemic corticosteroids defined as >2 mg/day

          -  Radiation therapy within 12 weeks of registration
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Condition: Postural Orthostatic Tachycardia Syndrome (POTS)
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Intervention: Angiotensin II
Intervention description: Angiotensin II infusion for 1 hour
Intervention MeSH terms: Angiotensin II; Giapreza; Angiotensinogen
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: POTS; Orthostatic intolerance

Summary:

      The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in
      the pathophysiology of postural tachycardia syndrome, and to provide an insight about the
      disease process in this disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction
             Center criteria

          -  Age between 18-64 years

          -  Male or females are eligible

          -  Able and willing to provide informed consent

          -  Healthy control subjects with no major medical problem (including postural tachycardia
             syndrome), free of medications during the study

        Exclusion Criteria:

          -  Overt cause of postural tachycardia e.g., dehydration

          -  Inability to give or withdraw informed consent

          -  Pregnancy

          -  Hypertension (BP > 140/90)

          -  Significant co-morbid condition

          -  Other factors which in the investigator's opinion would prevent the subject from
             completing the protocol
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Condition: Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Intervention: Sodium Oxybate (Xyrem)
Intervention description: Active Substance: Sodium Oxybate
Pharmaceutical form: Oral Solution
Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
Route of administration: Oral
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Endocrine Evaluation cataplexy; sodium oxybate (xyrem)

Summary:

      To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus
      on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine
      changes.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Narcoleptic patients with cataplexy

        Exclusion Criteria:

          -  Subjects not diagnosed with narcolepsy with cataplexy

        Exclusion Criteria:
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: AMG 598; Placebo; Liraglutide
Intervention description: AMG 598 administered by subcutaneous injection; Placebo matching to AMG 598 administered by subcutaneous injection; Liraglutide administered by subcutaneous injection. The starting dose is 0.6 mg/day, and increased by 0.6 mg/day dose increment every 7 days, up to the full dosage of 3.0 mg/day by week 5.
Intervention MeSH terms: Liraglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind study
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to assess the safety and tolerability of multiple doses
      of AMG 598 administered alone or in combination with liraglutide in adults with obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women with ages between 18 and 65 years old, inclusive, at time of signing
             consent

          -  Body mass index (BMI) between greater than or equal to 30.0 kg/m^2 and less than or
             equal to 40.0 kg/m^2 at screening

          -  Except for obesity, otherwise healthy or medically stable per protocol

          -  Have a stable body weight defined as less than 5 kg self-reported change during the
             previous 8 weeks prior to screening

          -  Other Inclusion criteria may apply

          -  Stable on liraglutide, depending on cohort

        Exclusion Criteria:

          -  History or clinical evidence of diabetes

          -  Inadequate organ function at screening

          -  Currently receiving treatment in another investigational device or drug study

          -  Women who are pregnant/lactating/breastfeeding or who plan to become
             pregnant/breastfeed while on study through 5 months after receiving the last dose of
             investigational product

          -  History or evidence of a clinically significant disorder, condition or disease that
             would pose a risk to subject safety or interfere with the study evaluation, procedures
             or completion

          -  A family or personal history of medullary thyroid carcinoma or multiple endocrine
             neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma;
             confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder
             disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for
             cohorts receiving liraglutide

          -  History of major depressive disorder

          -  Other Exclusion criteria may apply
A Study of LY3323795 in Healthy Participants
Condition: Healthy
Intervention: LY3323795; Itraconazole; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to investigate the safety of LY3323795 and the effects it
      has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy
      participants. The study has three parts. Each participant may only enroll in one part. The
      study will last 14 to 43 days, depending on the part. Screening must be completed prior to
      study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females of non-childbearing potential at time of screening

          -  Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0
             kg/m², inclusive

        Exclusion Criteria:

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product.

          -  Have a QT corrected for heart rate (QTc) (using Bazett's formula) interval value of
             greater than 450 millisecond (msec) (males) or greater than 470 msec (females)