bioihbjkbjnl/mcl2 huggingface dataset:
RDEA3170 and Allopurinol Combination Study in Gout Subjects
Condition: Gout
MeSH terms: Gout
Intervention: RDEA3170 10 mg; allopurinol 300 mg
Intervention MeSH terms: Allopurinol; Verinurad
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male
      subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics
      (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets one or more criteria for the diagnosis of gout as per the American
             Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary
             Gout.

          -  Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45
             kg/m2.

          -  Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL

          -  Subject is free of any clinically significant disease or medical condition, per the
             Investigator's judgment.

        Exclusion Criteria:

          -  Subject is unable to take colchicine for gout flare prophylaxis.

          -  Subject has a history or suspicion of kidney stones.

          -  Subject has an estimated creatinine clearance < 60 mL/min calculated by the
             Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.

          -  Subject is on unstable doses of chronic medications. Subjects taking medications for
             chronic medical conditions must be on stable doses during the course of the study,
             including the Screening period. Dose adjustments are allowed if deemed medically
             necessary by the investigator and following discussion with the medical monitor

          -  Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose
             linked transporter-2 inhibitors are permitted if the dose is stable for at least 14
             days prior to study medication dosing.

          -  Subject is unable or unwilling to comply with the study requirements or has a
             situation or condition that, in the opinion of the Investigator, may interfere with
             participation in the study.
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; dose level 1; dose level 2; dose level 3; dose level 4
Intervention description: intravenous infusion on three consecutive months; intravenous infusion on three consecutive months; intravenous infusion on three consecutive months; intravenous infusion on three consecutive months; intravenous infusion on 3 consecutive months
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921

Summary:

      This study will evaluate the safety and tolerability of PF-04236921 administered monthly as
      three intravenous infusions. Each group of patients will be assigned to a dose level; Safety
      and tolerability of a low dose level will be required before proceeding to successively
      higher dose levels. Blood tests will be performed to measure the amount of drug and changes
      in measures of inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Rheumatoid Arthritis on a stable dose of methotrexate

          -  Rheumatoid Arthritis disease activity as assessed by blood tests

        Exclusion Criteria:

          -  Serious or uncontrolled medical conditions

          -  Current or recent treatment with disease-modifying drugs other than methotrexate
             including but not limited to leflunomide, sulfasalazine, etanercept, infliximab,
             adalimumab, abatacept, rituximab

          -  Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent
Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Condition: Conjunctival Neoplasms
MeSH terms: Conjunctival Neoplasms
Intervention: ranibizumab
Intervention description: Subconjunctival injection of drug every 2 to 4 weeks
Intervention MeSH terms: Ranibizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety and tolerability of subconjunctival injection
      of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and
      severity of adverse events.

      Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant
      conjunctival neoplasia by evaluating tumor destruction or reduction as documented by
      slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 21 years

          -  Tumors whose treatment with standard therapy would cause significant visual morbidity

          -  Diagnosis of biopsy proven malignant conjunctival neoplasia and are

          -  Recurrent disease

          -  Multi-focal disease

          -  Diffuse disease

        Exclusion Criteria:

          -  Extension of tumor into eye or orbit.

          -  Regional spread or metastatic disease

          -  Pregnancy (positive pregnancy test) or lactation.

          -  Premenopausal women not using adequate contraception. The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

          -  Current infection or inflammation in either eye

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated

          -  Participation in another simultaneous medical investigation or trial
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma
Condition: Advanced Adult Hepatocellular Carcinoma; Hepatocellular Carcinoma Metastatic
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: AZD9150
Intervention description: Intravenous infusion over 3 hours.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Child-Pugh A to B7,; Advanced/Metastatic Hepatocellular Carcinoma,; AZD9150,; Antisense Oligonucleotide Inhibitor of STAT3

Summary:

      This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability,
      pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with
      advanced/metastatic hepatocellular carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years. Patient from Japan and Taiwan aged at least 20 years

          -  Histologically or cytologically confirmed HCC (with the exception of fibrolamellar
             carcinoma or mixed variants of HCC with fibrolamellar histology OR clinically
             diagnosed HCC for patients with difficulty in obtaining histological diagnosis)

          -  Relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example
             due to comorbidity)

          -  Metastatic or locally advanced meeting ANY of the criteria below:

          -  HCC not suitable to receive local therapy

          -  Disease recurred or was refractory to last therapy (local or systemic)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration
             over the previous 2 weeks and minimum life expectancy of 8 weeks

        Exclusion Criteria:

          -  More than 2 prior systemic treatments for HCC

          -  Prior grade 3 hematologic toxicity related to treatment with a JAK or STAT3 inhibitor

          -  Presence of hepatic encephalopathy within 4 weeks of 1st dose

          -  Uncontrolled massive ascites

          -  High likelihood of bleeding
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Semaglutide; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 117.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This is a study for participants with type 2 diabetes mellitus. The main purpose of this
      study is to learn more about how tirzepatide, semaglutide and placebo affect the body's
      ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks,
      including a 28-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T2DM for at least 6 months

          -  Treated with diet and exercise and stable dose(s) of metformin, with or without 1
             additional stable dose of oral antihyperglycemia medication other than metformin, 3
             months prior to study entry

          -  Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin
             only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia
             medications other than metformin

          -  Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² )
             inclusive, at screening; are of stable weight (±5%) >3 months prior to screening

        Exclusion Criteria:

          -  Have a history of proliferative retinopathy or maculopathy as determined by the
             investigator based on a recent (<1.5 years) ophthalmologic examination

          -  Impaired renal estimated glomerular filtration rate (eGFR) <45 milliliters per minute
             per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease
             Epidemiology Collaboration (CKD-EPI)

          -  Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine,
             hematological or neurological disorders capable of significantly altering the
             absorption, metabolism or elimination of drugs; of constituting a risk when taking the
             study drug; or of interfering with the interpretation of data
Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy
Condition: Healthy Participants and Patients With Narcolepsy
MeSH terms: Narcolepsy
Intervention: TAK-925; Placebo
Intervention description: TAK-925 Intravenous Infusion; TAK-925 Placebo Intravenous Infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of
      TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy
      elderly participants and patients with type 1 narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy adult participants and Healthy elderly participants:

        - Participant weighs at least 50 kilogram (kg) (Healthy adults participants) / 40 kg
        (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per
        square meter (kg/m^2), inclusive at Screening.

        Narcolepsy patients:

          -  Patient weighs at least 40 kg inclusive at Screening.

          -  A diagnosis of narcolepsy Type 1, as defined by the International Classification of
             Sleep Disorders, Third Edition (ICSD-3).

          -  HLA narcolepsy test positivity.

          -  At Day -1, Epworth sleepiness scale (ESS) score greater than or equal to (>=) 10

          -  Blood pressure less than (<) 140 systolic and < 90 diastolic. The patient may have a
             history of hypertension and be on antihypertensive medication treatment as long as the
             BP meets these criteria.

        Exclusion Criteria:

        All Participants:

          -  Participant has a history of drug abuse (defined as any illicit drug use) or a history
             of alcohol abuse within 2 years prior to the Screening visit.

          -  Past or current epilepsy, convulsion, tremor or the disorders of related symptoms.

          -  Has a lifetime history of major psychiatric disorder, such as major depressive
             disorder, bipolar disorder, or schizophrenia.

        HV (only Cohort 4):

        - Participant has had CSF collection performed within 14 days prior to check-in (Day -1).

        Narcolepsy patients

          -  Medical disorder associated with excessive sleepiness other than narcolepsy (including
             sleep apnea syndrome).

          -  Excessive caffeine (greater than [>] 400 milligram per day [mg/day]) use one week
             prior to study.
Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06763809; Vehicle; Calcipotriene/calcipotriol; Betamethasone
Intervention description: Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%; Vehicle matching PF-06763809.; Calcipotriene/calcipotriol 50 ug/mL solution; Betamethasone 1 mg/g solution
Intervention MeSH terms: Betamethasone; Calcipotriene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Topical

Summary:

      The study is a randomized, double blinded, vehicle and active comparator controlled, multiple
      dose study in subjects with chronic plaque psoriasis. The study will have approximately 15
      completers. Each subjects will receive three different topical doses of PF 06763809, PF
      06763809 vehicle, and two active comparators. These will be applied to six different
      treatment fields for 18 days. The total duration of participation in the study will be
      approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval
      from Screening to the Follow up phone call visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to
             moderate severity sufficient for six treatment fields located in up to three plaque
             areas

          -  Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

        Exclusion Criteria:

          -  History of skin sensitivity to topical prescription or non prescription products such
             as creams, lotions and cosmetics

          -  Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular
             psoriasis

          -  Treatment with any biologics within 3 months prior to Day 1 of the study and during
             the study
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Condition: Healthy
Intervention: afatinib; ritonavir + afatinib; ritonavir + afatinib
Intervention description: standard therapeutic dose; simultaneous intake of ritonavir and afatinib on second treatment day; on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet
Intervention MeSH terms: Ritonavir; Afatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of
      afatinib depending on the timepoint of ritonavir administration
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male subjects

        Exclusion criteria:

        1. any relevant deviation from healthy conditions
Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-07081532; Placebo; Clopidogrel
Intervention description: Investigational Drug once daily for up to 42 days; multiple ascending dose design.; Placebo once daily for up to 42 days.; Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
Intervention MeSH terms: Clopidogrel
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: double-blind (investigator- and participant-blind), sponsor-open
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, placebo-controlled, double-blind (investigator- and
      participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with
      Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic
      participants with obesity (Part B). Study participants will receive an investigational
      product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional;
      Part C, optional).

      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on
      metformin and optionally in non-diabetic obese participants.
    

Eligibility criteria:

        Key Inclusion Criteria for participants enrolling with T2DM:

          -  Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at
             least 2 months prior to screening visit and use of no other medications for glycemic
             control.

          -  HbA1c value between 7.0% and 10.5%, inclusive.

        Key Exclusion Criterion for participants enrolling with T2DM:

        -Type 1 Diabetes or secondary forms of diabetes.

        Key Inclusion Criterion for participants enrolling with obesity:

        -Obese (as indicated by screening BMI) non-diabetic adults.

        Key Exclusion Criterion for participants enrolling with obesity:

        --Type 1 or Type 2 Diabetes or secondary forms of diabetes.
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
Condition: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
Intervention: AZD3293; Placebo
Intervention description: Oral solution; Oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AZD3293; Healthy volunteers; Young volunteers; Elderly volunteers; Japanese volunteers; Phase 1; Single and multiple ascending dose study

Summary:

      This study consists of two parts, ie, single dose part with young healthy subjects (Part 1)
      and single and multiple dose part with elderly healthy subjects (Part 2), to assess the
      safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and
      multiple ascending dose administration to healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Japanese elderly and young males and females (of non-childbearing potential)

          -  Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more
             than 100 kg

        Exclusion Criteria:

          -  Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or
             retinal diseases or disorders

          -  Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.

          -  Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other
             nicotine products.

          -  Neurological disease, including seizures, recent memory impairment, or clinically
             significant head injury.