bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
Condition: Healthy Adult Male
Intervention: OPC-34712
Intervention MeSH terms: Brexpiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The ratios of the geometric means of the ODT formulation to those of the reference
      formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of
      brexpiprazole (OPC-34712)).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of providing written informed consent prior to initiation of any trial-related
             procedures, and able, in the opinion of the investigator, to comply with all
             requirements of the trial

        Exclusion Criteria:

          -  Clinically significant abnormality at the time of screening (eg, significant deviation
             from reference ranges) or in medical history that, in the opinion of investigator or
             sponsor may place the subject at risk or interfere with outcome variables, including
             drug absorption, distribution, metabolism, and excretion

          -  History of serious mental disorder

          -  History of drug or alcohol abuse within 2 years prior to screening

          -  History of any significant drug allergy

          -  Use of an investigational drug within 120 days prior to the first dosing of trial drug

          -  Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to
             screening

          -  Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange
             products, starfruit, or starfruit products within 72 hours prior to dosing

          -  Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or
             St. John's Wort within 14 days prior to the first dosing of trial drug, or of
             antibiotics within 30 days prior to the first dosing of trial drug

          -  History of major surgery of the digestive tract (excluding appendectomy)

          -  Any subject who, in the opinion of the investigator, should not participate in the
             trial
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: RO5185426
Intervention description: Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, non-randomized study will assess the mass balance, metabolism, routes and
      rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032)
      in previously treated or untreated patients with metastatic melanoma. Patients will receive
      continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be
      administered. Anticipated time on study treatment is until disease progression occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Histologically confirmed metastatic melanoma, surgically incurable and unresectable
             Stage IIIc or IV (AJCC)

          -  Prior treatment for metastatic melanoma allowed; >/= 28 days must be elapsed since
             previous systemic treatment prior to first administration of study drug

          -  Positive BRAF V600E mutation result (by Roche CoDx test)

          -  ECOG performance status 0-1

          -  Adequate hematologic, renal and liver function

          -  Body Mass Index (BMI) 18 to 32 kg/m2 inclusive

        Exclusion Criteria:

          -  Active CNS lesions

          -  History of or known spinal cord compression, or carcinomatous meningitis

          -  Anticipated or ongoing administration of any anticancer therapies other than those
             administered in this study

          -  Refractory nausea or vomiting, or other medical conditions that are capable of
             altering the absorption, metabolism or elimination of the study drug

          -  Known clinically significant active infection

          -  Known HIV positivity or AIDS-related illness, active HBV, or active HCV

          -  Previous malignancy within the past 5 years, except for basal or squamous cell
             carcinoma of the skin, melanoma in situ, and carcinoma in situ of the cervix

          -  Clinically significant cardiovascular disease or incident within the 6 months prior to
             study drug administration

          -  Patients who have had at least one dose of study drug (RO5185426 or comparator) in a
             clinical trial that includes RO5185426
Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing
Condition: Skin Graft
Intervention: Autologous Platelet Rich Plasma; Keratinocyte suspension; Standard dressings
Intervention description: Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.; Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.; Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Skin graft donor site healing; skin; wound; platelet concentrate; keratinocytes; burns

Summary:

      This prospective randomized trial evaluated the impact of autologous keratinocytes suspended
      in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that
      the treatment would speed and improve wound healing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skin graft donor sites total surface < 15% BSA

          -  Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area

        Exclusion Criteria:

          -  Patients treated with immunosuppressors

          -  Patients treated with corticoids

          -  Patients suffering from terminal renal insufficiency

          -  Patients suffering from severe peripheral arteriopathy
Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Enantyum® oral solution; Keral® tablet
Intervention description: One dose of 25 mg DKP oral solution; One dose of 25 mg DKP tablet
Intervention MeSH terms: Dexketoprofen trometamol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexketoprofen; Bioavailability; Comparative; Pharmacokinetic

Summary:

      The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an
      Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In
      addition, this study intends to evaluate the safety and tolerability of Test and Reference
      formulations.
    

Eligibility criteria:

        Inclusion Criteria:

        - Healthy male and female subjects between 18 to 50 years old, with a Body Mass Index (BMI)
        between 18 Kg/m2 and 28 Kg/m2-

        Exclusion Criteria:

          -  History of previous allergy idiosyncrasy / sensitivity to DKP.TRIS or other NSAIDs
             (aspirin, ibuprofen etc).

          -  Any condition which might interfere with the absorption, distribution, metabolism or
             excretion of the drugs.

          -  Surgery within previous 6 months, or blood loss > 400 mL within previous 3 months.

          -  Subject with positive human immunodeficiency virus (HIV), hepatitis B surface antigen
             (Hep B) and hepatitis C virus antibody (Hep C) results.

          -  History of clinically significant alcohol, medicine or drug abuse.
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)
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B
Intervention: TAF
Intervention description: 25 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Severe Hepatic Impairment

Summary:

      The primary objective of this study is to evaluate the single-dose pharmacokinetics of
      tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal
      hepatic function and in participants with severe hepatic impairment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Screening laboratory parameters within defined thresholds

          -  Creatinine clearance must be ≥ 60 mL/min

        Key Exclusion Criteria:

          -  Females who are pregnant or nursing or males who have a pregnant partner

          -  Infection with hepatitis B virus (HBV) or HIV

          -  History of clinically significant illness (including psychiatric or cardiac) or any
             other medical disorder that may interfere with participant treatment and/or adherence
             to the protocol

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide
Condition: Healthy Volunteers
Intervention: Ritlecitinib; Tolbutamide
Intervention description: Ritlecitinib 200 mg provided as four 50 mg oral capsules; Tolbutamide 500 mg provided as one 500 mg oral tablet
Intervention MeSH terms: Tolbutamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics (PK)

Summary:

      This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the
      effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and/or female participants who are healthy as determined by medical evaluation
             including medical history, full physical examination (including BP and pulse rate
             measurements), clinical laboratory tests, and 12-lead ECG.

          -  BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

          -  Past/present clinically significant hematological, renal, endocrine, pulmonary, GI,
             CV, hepatic, psychiatric, neurological, dermatological or allergic disease (including
             drug allergies).

          -  Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

          -  Infection with hepatitis B or C viruses.

          -  Participants with any of the following acute or chronic infections or infection
             history: any infection requiring treatment within 2 weeks prior to the start of study
             participation; any infection requiring hospitalization or parenteral antimicrobial
             therapy within 60 days of the first dose of investigational product; any infection
             judged to be an opportunistic infection or clinically significant within the past 6
             months of the first dose of investigational product; known active or history of
             recurrent bacterial, viral, fungal, mycobacterial or other infections; history of
             recurrent localized dermatomal herpes zoster, or history of disseminated (single
             episode) herpes simplex or disseminated herpes zoster.

          -  History of any lymphoproliferative disorder such as EBV related lymphoproliferative
             disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of
             current lymphatic or lymphoid disease.

          -  Known presence or a history of malignancy other than a successfully treated or excised
             non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
             situ.
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.
Condition: Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypertension
Intervention: Riociguat (Adempas, BAY63-2521) 1.0 mg; Riociguat (Adempas, BAY63-2521) 2.5 mg
Intervention description: 1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).; 2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).
Intervention MeSH terms: Riociguat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease; COPD; Pulmonary hypertension

Summary:

      This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic
      effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to
      chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pulmonary hypertension due to COPD, undergoing routine invasive
             measurement of hemodynamic parameters.

          -  Catheters for measurement of hemodynamic parameters (PAP [pulmonary artery pressure],
             PCWP [pulmonary capillary wedge pressure], CO [cardiac output], SBP [systolic blood
             pressure]) must be in place independent of the trial.

        Exclusion Criteria:

          -  Acute exacerbation of COPD,

          -  Pre-existing lung disease other than COPD,

          -  Acute or severe chronic left heart failure,

          -  Severe coronary artery disease,

          -  Uncontrolled arterial hypertension;

          -  Severe left ventricular hypertrophy,

          -  Congenital or acquired valvular or myocardial disease,

          -  Systolic blood pressure < 100 mmHg,

          -  Heart rate < 55 bpm or >105 bpm,

          -  PaO2 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) < 50 mmHg,

          -  PaCO2 (arterial partial pressure of carbon dioxide) > 55 mmHg,

          -  Severe hepatic insufficiency,

          -  Severe renal insufficiency.
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
Condition: Lymphoma, T-Cell, Cutaneous
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: placebo for SHAPE (SHP-141); SHAPE (SHP-141) 0.1% BID; SHAPE (SHP-141) 0.5% BID; SHAPE (SHP-141) 1.0% BID
Intervention description: topical gelled solution; topical gelled solution; topical gelled solution; topical gelled solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; Cutaneous T-Cell Lymphoma

Summary:

      The purpose of this study is to investigate the safety and tolerability of topical SHP141
      applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell
      Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients
      with Stage IA, IB, or IIA CTCL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically confirmed CTCL; a documented verifiable biopsy report is required.

          -  Documented clinical Stage IA, IB, or IIA CTCL.

          -  Skin lesion involvement of at least 3% of BSA accessible for topical application of
             study drug and biopsy.

          -  ECOG performance status of 0-2.

        Exclusion Criteria:

          -  CTCL with histologic evidence of folliculotropic variant or large cell transformed
             CTCL.

          -  Severe pruritus requiring systemic or topical treatment.

          -  Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and
             has been designated as Stage IA-IIA disease).

          -  Coexistent second malignancy or history of prior solid organ malignancy within
             previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ
             carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been
             treated curatively, or prostate cancer that has been treated curatively).

          -  Any prior history of a hematologic malignancy (other than CTCL).

          -  History of or current major renal, hepatic, gastrointestinal, pulmonary,
             cardiovascular, genito-urinary or hematological disease, CNS disorders, infectious
             disease or coagulation disorders as determined by the Investigator.

          -  Evidence of active Hepatitis B or C or HIV.

          -  Circulating atypical cells >5%
A Study of Dulaglutide in Healthy Participants
Condition: Healthy
Intervention: Dulaglutide (Reference); Dulaglutide (Test)
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide; Immunoglobulin Fc Fragments
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate a new formulation of dulaglutide (study drug)
      administered under the skin as one injection using a single dose pen compared to three
      injections using a pre filled syringe.

      This study will evaluate how much of the study drug enters the body and how long it takes the
      body to get rid of it. Information about any side effects that may occur will also be
      collected.

      The study will last about 84 days, including screening and will require overnight stays in
      the clinical research unit (CRU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy as determined by medical history and physical examination at time of
             screening

          -  Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared
             (kg/m²) inclusive

        Exclusion Criteria:

          -  Have known allergies to dulaglutide, glucagon-like peptide-1 (GLP-1) related
             compounds, or any components of the formulation

          -  Have family history of medullary thyroid cancer (MTC) or a genetic condition that
             predisposes to MTC

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis) or gastrointestinal disorder (e.g., relevant esophageal
             reflux or gall bladder disease) or any gastrointestinal disease which impacts gastric
             emptying (e.g., gastric bypass surgery, pyloric stenosis, with the exception of
             appendectomy) or could be aggravated by GLP-1 analogs