bioihbjkbjnl/mcl2 huggingface dataset:
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
Condition: Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis; Neoplasms
Intervention: DS-8201a; Ritonavir; Itraconazole
Intervention description: DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution; Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration; Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration
Intervention MeSH terms: Ritonavir; Itraconazole; Trastuzumab deruxtecan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Unresectable or metastatic solid malignant tumors; Solid malignant tumors; Oncology; HER2; Antibody drug conjugate; ADC

Summary:

      HER2-positive cancer is a cancer that tests positive for a protein called human epidermal
      growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study
      will test an experimental drug called DS-8201a that has not been approved by the health
      authorities yet.

      DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test
      positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a pathologically documented unresectable or metastatic solid malignant tumor, with
             HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization
             (ISH) +], Next Generation Sequencing, or other analysis techniques as appropriate]
             that is refractory to or intolerable with at least one prior systemic chemotherapy
             regimen, or for which no standard treatment is available

          -  Has a left ventricular ejection fraction (LVEF) ≥ 50%

          -  Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

        Exclusion Criteria:

          -  Has a contraindication for receiving ritonavir or itraconazole according to the
             prescribing information

          -  Has a medical history of myocardial infarction within 6 months before enrollment or
             symptomatic congestive heart failure
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
Condition: Colitis, Ulcerative; Crohn Disease
MeSH terms: Crohn Disease; Colitis, Ulcerative
Intervention: Vedolizumab
Intervention description: Vedolizumab intravenous infusion.
Intervention MeSH terms: Vedolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the PK of vedolizumab following a single intravenous
      infusion in healthy adult Chinese participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. The participant 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.

        Exclusion Criteria:

          1. Has one or more positive response on the progressive multifocal leukoencephalopathy
             (PML) subjective symptoms checklist at Screening or before dosing on Day 1.

          2. Has had a surgical procedure requiring general anesthesia within 30 days before the
             initial Screening Visit or is planning to undergo a surgery that requires general
             anesthesia during the study period (through Final Visit/Day 127).

          3. For participants who are negative for hepatitis B surface antigen (HBsAg) but are
             positive for either surface antibodies and/or core antibodies, hepatitis B virus
             Deoxyribonucleic Acid (DNA) polymerase chain reaction will be performed and any result
             that meets or exceeds detection sensitivity will be excluded.

          4. Has poor peripheral venous access.

          5. Has a QT interval with Fridericia correction method (QTcF) greater than (>) 430
             millisecond (ms) (males) or >450 ms (females) or PR outside the range 120 to 220 ms,
             confirmed with 1 repeat testing within a maximum of 5 minutes, at the Screening Visit
             or Check-in (Day -1).
Study of Testosterone and rHGH in FSHD
Condition: Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Intervention: Testosterone Enanthate; Somatropin
Intervention description: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.; Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and tolerability of combination
      therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients
      with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A genetically confirmed diagnosis of FSHD (or clinical symptoms suggestive of FSHD
             with a first degree relative with genetically confirmed FSHD)

          -  Hematocrit of ≤ 50%

          -  Prostate-specific antigen ≤ 4.0 ng/ml (or ≤ 3.0 ng/ml if the participant has a
             first-degree relative with prostate cancer)

          -  Fasting blood glucose <126 mg/dl

          -  Able to walk continuously for six minutes (cane, walker, orthoses allowed)

          -  Able to independently administer intramuscular and subcutaneous injections (or have a
             family member who is capable and willing to administer these injections)

        Exclusion Criteria:

          -  Diabetes

          -  Obesity (BMI>35 kg/m2)

          -  Cardiovascular disease (heart failure, coronary artery disease, uncontrolled
             hypertension, untreated hypercholesterolemia)

          -  Untreated thyroid disease

          -  Deep vein thrombosis

          -  Untreated severe sleep apnea

          -  Past pituitary disease

          -  Significant musculoskeletal injury and/or pain that affects walking

          -  A systolic blood pressure over 160 or a diastolic pressure over 100

          -  Plans to dramatically change exercise habits

          -  Liver disease

          -  Renal disease

          -  Cancer (other than basal cell skin cancer)

          -  Plans to conceive

          -  Heavy alcohol use (greater than 50g/day)

          -  Current testosterone or HGH use

          -  Current use of medications that interfere with the growth hormone or gonadal endocrine
             axis.
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Intervention: NST-4016 600mg; Placebo oral capsule; Moxifloxacin 400mg; NST-4016 2000mg
Intervention description: Likely maximum therapeutic dose of NST-4016; Placebo for comparison with moxifloxacin and potential NST-4016 effects; Active comparator with known effect on QT interval; Supratherapeutic dose of NST-4016
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo
      and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and
      supratherapeutic doses of icosabutate in healthy male and female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Males or females, of any race, between 18 and 55 years of age, inclusive, at
             Screening.

          -  2. Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening

          -  3. In good health

        Exclusion Criteria:

          -  1. An uninterpretable or abnormal ECG at Screening and/or Check in

          -  2. History of risk factors for Torsades de Pointes

          -  3. sustained supine systolic blood pressure >140 mmHg or <90 mmHg

          -  4. Unstable cardiovascular disease, including recent myocardial infarction or cardiac
             arrhythmia.

          -  5. Female subjects who are pregnant (or planning to become pregnant within 90 days
             after the final dose administration) or are currently lactating

          -  6. Subjects who, in the opinion of the Investigator (or designee), should not
             participate in this study
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 Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: TAK-906; Esomeprazole
Intervention description: TAK-906 capsules.; Esomeprazole capsules.
Intervention MeSH terms: Esomeprazole
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: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI)
      esomeprazole on the single-dose PK of orally administered TAK-906.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Continuous non-smoker who has not used nicotine containing products for at least 3
             months prior to the first dosing and throughout the study, based on screening urine
             cotinine test.

          2. Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to
             (<=) 30 kilogram per square meter (kg/m^2) at Screening.

        Exclusion Criteria:

          1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          2. QT interval corrected using Fridericia's formula (QTcF) interval is greater than (>)
             450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance
             by the Investigator or designee at screening.

          3. Donation of blood or significant blood loss (example, approximately 500 milliliter
             [mL]) within 56 days prior to the first dosing.

          4. Plasma donation within 7 days prior to the first dosing.

          5. Participation in another clinical study within 30 days or 5 half-lives prior to the
             first dosing. The 30 day window or 5 half-lives will be derived from the date of the
             last blood collection or dosing, whichever is later, in the previous study to Day 1 of
             Study Period 1 of the current 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
Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Drug: OP0201 20mg; Drug: Placebo 0mg
Intervention description: OP0201; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with
      Acute Otitis Media.
    

Eligibility criteria:

        Inclusion Criteria includes but is not limited to:

          1. AOM diagnosis with moderate to severe bulging of the TM and recent (< 48 hours [h])
             onset of ear pain.

          2. Moderate to severe ear pain in the affected ear(s), defined as a score of ≥ 5 (on a
             scale of 0 10) on the NRS 11 as evaluated by the subject at Screening.

          3. Generally good health (other than AOM) as determined by evaluation of medical history
             and physical examination at Screening.

          4. Negative urine pregnancy test at Screening for all female subjects of childbearing
             potential.

          5. Able to read and sign written informed consent prior to study participation.

        Exclusion Criteria includes but is not limited to:

          1. Presence of a perforated TM at Screening or had a perforated TM within 6 months (mo)
             prior to Screening as determined by medical history

          2. Subjects with tympanostomy tubes

          3. Acute or chronic otitis externa

          4. Chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks
             or longer

          5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg,
             cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

          6. Clinically relevant blockage of 1 or both nasal passages, as determined by the
             investigator's medical judgment

          7. Permanent hearing loss irrespective of otitis media

          8. Subjects with medical conditions that may affect interpretation of the safety or
             efficacy of study drug as determined by the investigator's medical judgment

          9. Subjects with craniofacial abnormalities (eg, cleft palate, Down's Syndrome)

         10. Subjects with erythema of the TM without other evidence of otitis media

         11. Seborrheic dermatitis involving the affected external ear canal or pinna

         12. Use of medications with known vasoconstrictive properties (eg, decongestants [Afrin®,
             Sudafed®]) currently or within 2 h prior to Screening

         13. Use of oral analgesics < 2 h prior to Screening or Baseline (oral analgesics > 2 h are
             permitted as long as ear pain criteria are met per Inclusion Criteria)
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Condition: Healthy Volunteers
Intervention: RO7017773; Itraconazole
Intervention description: Single doses of RO7017773; Multiple doses of Itraconazole
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the effect of multiple oral doses of itraconazole
      on the pharmacokinetics of RO7017773 in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria

          -  Healthy (absence of evidence of any active or chronic disease following a detailed
             medical and surgical history, a complete physical examination including vital signs,
             12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the
             Investigator.

          -  Male and women of non-childbearing potential (WONCBP)

        Exclusion Criteria

          -  History of convulsions (other than benign febrile convulsions of childhood) including
             epilepsy, or personal history of significant cerebral trauma or central nervous system
             (CNS) infections (e.g., meningitis)

          -  History of clinically significant hypersensitivity or allergic reactions

          -  Abnormal blood pressure

          -  Abnormal pulse rate

          -  History or presence of clinically significant ECG abnormalities before study drug
             administration or cardiovascular disease

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities

          -  Positive test for drugs of abuse or alcohol

          -  Evidence of human immunodeficiency virus (HIV) infection

          -  Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result
             at screening or within 3 months prior to starting study treatment

          -  Participants who regularly smoke more than 5 cigarettes daily or the equivalent and
             are unable or unwilling not to smoke during the in-house period