bioihbjkbjnl/mcl2 huggingface dataset:
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Cilofexor; Placebo
Intervention description: Tablets administered orally; Tablets administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and tolerability of escalating single- and multiple-oral
      doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of
      cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants
      will receive either cilofexor or cilofexor placebo.

      Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,
      blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to
      multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or
      pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily
      doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will
      consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated
      in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose
      already evaluated.

      This study is partially blinded (no one is blinded on Day -1).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy male and non-pregnant, non-lactating female volunteers

          -  Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m^2

          -  Normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered
             clinically insignificant by the investigator

          -  Normal renal function (estimated glomerular filtration rate calculated using the
             Cockcroft-Gault equation ≥ 80 mL/min)

          -  No significant medical history, and in good general health as determined by the
             investigator at screening evaluation performed no more than 28 days prior to the
             scheduled first dose.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants
Condition: Healthy
Intervention: Tirzepatide; Prefilled syringe (PFS); Auto-injector (AI)
Intervention description: Administered SC; PFS used to administer tirzepatide; AI used to administer tirzepatide
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the amount of tirzepatide that gets into the blood
      stream and how long it takes the body to get rid of it, when given as a solution formulation
      via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide
      will also be evaluated and information about any adverse effects experienced will be
      collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be about 14 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females of nonchildbearing potential as determined by medical
             history, physical examination, and other screening procedures

          -  Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared
             (kg/m²), inclusive, at screening

          -  Are agreeable to receiving study treatment by injections under the skin

        Exclusion Criteria:

          -  Have known allergies to tirzepatide or related compounds

          -  Have a personal or family history of medullary thyroid carcinoma or have multiple
             endocrine neoplasia syndrome type 2

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder
             (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which
             impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the
             exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1)
             analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have a prior history of malignant disease(s) in the past 5 years prior to screening

          -  Smoke more than the equivalent of 10 cigarettes per day

          -  Is a known user of drugs of abuse
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Condition: Distress; Depression; Grief
MeSH terms: Depression
Intervention: Psilocybin; Modified brief Supportive Expressive Group Therapy
Intervention description: One individual oral psilocybin treatment session; Ten sessions of twice-weekly manualized group therapy
Intervention MeSH terms: Psilocybin; N,N-Dimethyltryptamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: HIV/AIDS; Demoralization; Psilocybin; Group therapy

Summary:

      The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is
      a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).
    

Eligibility criteria:

        Inclusion Criterion:

          -  Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe
             demoralization.

        Exclusion Criteria:

          -  A physical, neurological or cognitive condition that makes participating in the study
             unsafe or unfeasible.

          -  Regular psychotropic medication use.

          -  Personal or family history of serious mental illness.

          -  Severe depression requiring immediate standard-of-care treatment.

          -  Exclusion by the clinical judgment of the study investigators.
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Sildenafil; Sildenafil
Intervention description: Orally Disintegrating Tablet, 50 mg, Single Dose; Orally Disintegrating Tablet, 50 mg, Single Dose
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability Food Effect Oral Dissolving Tablet (ODT)

Summary:

      This study will evaluate if an orally disintegrating tablet of sildenafil will have similar
      pharmacokinetic properties when given with food and without food.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Otherwise healthy male subjects age 45 years or older with or without erectile
             dysfunction.

          -  Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.

          -  Signed Informed Consent.

        Exclusion Criteria:

          -  Evidence or history of clinically significant abnormalities

          -  Have baseline orthostatic hypotension

          -  Positive drug screen, excessive alcohol and tobacco use
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812)
Intervention description: 0.5 mg/kg AAB-003, IV; 1 mg/kg AAB-003, IV; 2 mg/kg AAB-003, IV; 4 mg/kg AAB-003, IV; 8 mg/kg AAB-003, IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Randomized; Safety Study; Open Label

Summary:

      This is a study to evaluate the safety and tolerability of multiple doses of AAB-003
      (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete
      study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each
      patient's participation will last approximately 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of study B2601001

          -  MMSE 12 or greater

        Exclusion Criteria:

          -  Study B2601001 Week 32 MRI with clinically important exclusionary findings.

          -  Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.
Condition: Healthy
Intervention: Aztreonam-Avibactam
Intervention description: 500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours
Intervention MeSH terms: Aztreonam; Avibactam
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: no clinically relevant abnormalities

Summary:

      A Phase 1, single center, single arm, open-label study to assess the PK, safety and
      tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy
      Chinese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Chinese male and female participants

          -  No clinical relevant abnormalities

          -  willing and able to comply with all study procedures

          -  BMI:17.5-30.5

          -  Sign informed consent

        Exclusion Criteria:

          -  Any clinical significant illness

          -  History of alcohol abuse

          -  Use within 14 days prior the first study dose

          -  CL>80ml/min

          -  Abnormal vital signs, such 12-ECG, blood pressure and pulse rate

          -  Blood donation within 60days

          -  History of HIV, HBsAg, HBcAb, HCVAb

          -  Other medical or psychiatric may inappropriate for the study
Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone
Condition: Healthy
Intervention: Rosiglitazone 4 mg Tablets; Rosiglitazone 4 mg Tablets; Quinine Sulfate 324 mg Capsules
Intervention description: Rosiglitazone 4 mg tablet administered as a single oral dose on the morning of Day 1.; Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7.; Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7.
Intervention MeSH terms: Rosiglitazone; Quinine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: rosiglitazone; quinine sulfate; drug interactions; cytochrome p450

Summary:

      Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is
      an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine
      sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age

          -  Non-smoking

          -  Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive
             measures)

          -  Body mass index (BMI) less than or equal to 32

          -  Medically healthy on the basis of medical history and physical examination

          -  Hemoglobin > or = to 11.5g/dL

          -  Completion of the screening process within 28 days prior to dosing

          -  Provision of voluntary written informed consent

        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 quinine sulfate or rosiglitazone
Two Way Bioequivalence Study Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Intervention: Ondansetron (ODFS); Ondansetron (ODT)
Intervention description: Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS); Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)
Intervention MeSH terms: Ondansetron
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg
      with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study
      participants under fed conditions.

      The purpose is to monitor clinical status, adverse events, laboratory investigations and to
      assess relative safety and tolerance of ondansetron formulations under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  provide written informed consent.

          -  healthy adult within 18-45 years of age (inclusive).

          -  Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.

          -  systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more
             than or equal to 90 mm Hg.

          -  normal health as determined by medical history and physical examination performed
             within 15 days prior to the dosing of period 1.

          -  Normal ECG, chest X-ray and vital signs.

          -  If study volunteer is a female and is of child bearing potential practicing an
             acceptable method of birth control for the duration of the study.

        Exclusion Criteria:

          -  The study participants were excluded based on the following criteria:

               -  incapable of understanding the informed consent.

               -  history of hypersensitivity or idiosyncratic reaction to study drug or any other
                  related drug.

               -  evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal
                  function

               -  volunteers with a history of tuberculosis, epilepsy, asthma (during past 5
                  years), diabetes, psychosis or glaucoma .

               -  smokes regularly more than ten cigarettes daily

               -  taken over the counter or prescribed medications

               -  history of any psychiatric illness, which may impair the ability to provide
                  written, informed consent or full participation.

               -  history of alcohol or substance abuse within the last 5 years.

               -  clinically significant abnormal values of laboratory parameters.

               -  positive urine screen for drugs of abuse at the time of admission check-in for
                  each period.
An fMRI Study Of Brain Response In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Pregabalin, then placebo; Placebo, then pregabalin
Intervention description: Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.; Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
Intervention MeSH terms: Pregabalin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging

Summary:

      The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by
      evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance
      imaging) is an efficient way to show whether new pain medications are effective in treating
      fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women must have pain due to fibromyalgia

          -  Fibromyalgia must have been diagnosed at least 6 months prior to be eligible for this
             study

        Exclusion Criteria:

          -  Patients with severe depression or other serious illness, who are left-handed, or who
             are pregnant or nursing are not eligible for this study.
A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
Condition: Healthy Volunteers
Intervention: Dexlansoprazole
Intervention description: Dexlansoprazole delayed-release capsule.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the pharmacokinetics after a single dose of
      dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult man or woman of Chinese descent.

          2. Is aged 18 to 45 years, inclusive, at the time of informed consent and study
             medication dose.

          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0
             kilogram per square meter (kg/m^2), inclusive at Screening Visit.

        Exclusion Criteria:

          1. Has a known hypersensitivity to any component of the formulation of dexlansoprazole or
             other drug with the same mechanism of action (including lansoprazole, omeprazole,
             esomeprazole, rabeprazole, ilaprazole, or pantoprazole), or related compounds.

          2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain
             from alcohol for 48 hours prior to Check-in (Day -1) throughout the confinement and
             for 48 hours prior to each clinic visit and drugs throughout the study.

          3. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to
             Check-in (Day -1) or is unwilling to abstain from these products for the duration of
             the study.

          4. Has poor peripheral venous access.

          5. Has donated blood products (such as plasma), whole blood or had a significant blood
             loss (450 millimeter [mL]) within 56 days of Day 1.
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
Condition: Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Sarcoma
MeSH terms: Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms; Lung Neoplasms
Intervention: figitumumab; pegvisomant
Intervention description: IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year; growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: advanced solid tumors cancer refractory cancer figitumumab pegvisomant

Summary:

      This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus
      Pegvisomant for treatment of advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥18 years of age with advanced solid tumors for which the combination of
             figitumumab and pegvisomant are reasonable treatment options.

          -  Patients between the ages of 10 and 18 years with advanced sarcomas for which there is
             no available curative therapy or therapy proven to prolong survival with an acceptable
             quality of life will be included in the Sarcoma Expansion Cohort.

          -  Adequate recovery from prior therapies.

          -  Adequate organ function (i.e. bone marrow, kidney, liver)

          -  Total IGF-1 ≥100 ng/ml (13 nmol/L).

        Exclusion Criteria:

          -  Concurrent treatment with any anti-tumor agents.

          -  Pregnant or breastfeeding females.

          -  Significant past history or active cardiac disease

          -  Active infection

          -  History of diabetes mellitus.

          -  Glycosylated hemoglobin >5.7