bioihbjkbjnl/mcl2 huggingface dataset:
Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)
Condition: Blister
MeSH terms: Blister
Intervention: Paper tape
Intervention description: Paper tape assigned to each participant's randomly selected foot.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Blisters are a very common complaint in both the general population and also the athlete.
      This study's aim is to determine whether applying paper tape (an inexpensive and common
      component of most foot care kits) to the foot of endurance runners prevents the frequency and
      severity of friction blisters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All runners who are enrolled in an RTP 4 deserts event,

          -  All runners who are 18-75 years old, and

          -  All runners who speak English. The study will be enrolling only those who speak
             English, so they can fully understand and have knowledgeable consent to the study
             enrollment protocols.

        Exclusion Criteria:

          -  Any blisters, broken blisters, or hot spots present on either foot at the time of
             initial taping as determined by visual foot inspection by a enrolling study physician.

          -  The runner has a pre-existing blistering condition.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept
Intervention MeSH terms: Etanercept
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
Healthy volunteers: No
Keywords: Etanercept; Enbrel; DCE-MRI; RA

Summary:

      The purpose of this study is to assess whether DCE-MRI can detect changes of active disease
      in rheumatoid arthritis (RA) patients after 4, 8 and 12 weeks of etanercept.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fulfillment of the 1987 American College of Rheumatology (ACR) criteria for RA with a
             disease duration > 6 months

          -  Presence of active disease (defined as both tender and swollen joints) in at least one
             wrist

          -  Sub-optimal response to methotrexate (MTX) defined by the presence of the following
             criteria (based on 68/66 joint count): 8 or more swollen joints AND 8 or more tender
             joints (with involvement of the wrist, fingers and at least one region outside the
             hands) at screening

          -  Must be receiving MTX at a stable dose > 15 mg/week at least 12 weeks prior to
             baseline

          -  a lower dose is acceptable if otherwise not tolerated (toxicity documentation
             required).

        Exclusion Criteria:

          -  Patients who are currently receiving disease modifying anti-rheumatic drug (DMARD)
             therapy (other than MTX, hydroxychloroquine or sulfasalazine) including tumor necrosis
             factor (TNF) antagonists (etanercept, infliximab, and adalimumab), abatacept,
             rituximab, leflunomide, cyclosporine, and gold (oral and intramuscular injection)
             within 8 weeks or 5.5 half-lives, whichever is longer, of screening

          -  Co-existing condition requiring medications that alter vascular flow (e.g., nitrates,
             calcium channel blockers, ergot containing drugs) [Potential effects of
             antihypertensive and migraine medications will be discussed with the Sponsor]

          -  Comorbid autoimmune disorders including systemic lupus erythematosus

          -  Unable to undergo an MRI examination (e.g., presence of a pacemaker, defibrillator, or
             other implanted device such as anterior interbody cages, aneurysm clip or pedicle
             screws

          -  allergic to contrast agent

          -  tattoos [in area of examination if contains metallic pigment])

          -  or will likely require sedation for the procedure
Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: D6-25-hydroxyvitamin D3
Intervention description: Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
Intervention MeSH terms: Hydroxycholecalciferols; Calcifediol
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic kidney disease; vitamin d catabolism

Summary:

      The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3
      supplementation using a gold standard pharmacokinetic approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF
             (NCT03104855)

          -  Age ≥ 18 years

          -  Self-reported race Caucasian, African American, or African

        Exclusion Criteria:

          -  Primary hyperparathyroidism

          -  Gastric bypass

          -  Tuberculosis or sarcoidosis

          -  Current pregnancy

          -  Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic
             encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)

          -  History of kidney transplantation (unless failed transplant now treated with
             hemodialysis)

          -  Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce
             CYP24A1 within 4 weeks (wash-out allowed)

          -  Serum calcium > 10.1 mg/dL

          -  Hemoglobin < 10 g/dL
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
Condition: Healthy Volunteers
Intervention: Nitisinone, capsule; Nitisinone, suspension
Intervention MeSH terms: Nitisinone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Orfadin; Nitisinone; Bioequivalence; Bioavailability

Summary:

      The study is primarily being performed in order to demonstrate bioequivalence between the
      Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also
      contain a comparison of the bioavailability of the suspension given with food and on an empty
      stomach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male volunteers

          -  Age: 18-55 years, inclusive

          -  BMI: 18,5-30,0 kg/m2, inclusive

        Exclusion Criteria:

          -  heavy smokers

          -  Consumption of more than 4 cups of coffee per day.

          -  History of drug and/or alcohol abuse.

          -  Positive drug screen or alcohol breath test.

          -  Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human
             immunodeficiency virus (HIV) 1-2 antibodies.

          -  Enrollment in another concurrent clinical study

          -  Intake of an investigational medicinal product within three months prior to inclusion
             in this study.

          -  Donation of more than 50 mL of blood within 60 days prior to drug administration

          -  Donation of more than 1,5 liters of blood in the 10 months prior to first drug
             administration.
Bioavailability of Apixaban Crushed Tablet
Condition: Thrombosis
MeSH terms: Thrombosis
Intervention: Apixaban
Intervention MeSH terms: Apixaban
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether the bioavailability of apixaban crushed
      tablets suspended in water or mixed with applesauce is similar to the bioavailability of
      apixaban whole tablets administered orally.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Healthy participants as determined by no clinically significant deviation from normal
             in findings of medical history, physical examination, electrocardiograms, vital signs,
             and clinical laboratory tests.

          -  Women of childbearing potential allowed. Must be following highly effective methods of
             contraception

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  History of significant head injury within the last 2 years, including individuals with
             base of skull fractures

          -  Any major surgery within 4 weeks of study drug administration or anticipated within 2
             weeks after completion of the study

          -  Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study
             drug

          -  History of Gilbert's Syndrome

          -  Inability to tolerate oral medication

          -  Inability to be venipunctured and/or tolerate venous access

          -  Use of tobacco- or nicotine-containing products (including, but not limited to,
             cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or
             nicotine gum) within 6 months prior to study drug administration

          -  Any laboratory test results outside of the range of normal, confirmed by repeat
             results of:

               -  Platelet count <150,000 cells/µL

               -  Activated partial thromboplastin time >upper limit of normal (ULN)

               -  International normalized ratio >ULN

               -  Alanine aminotransferase >ULN

               -  Aspartate aminotransferase >ULN

               -  Total bilirubin >ULN

               -  Serum creatinine ≥1.5 mg/dL

               -  Hemoglobin <lower limit of normal (LLN)

               -  Hematocrit <LLN
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants
Condition: Neoplasm, Advanced or Metastatic
Intervention: TAK-117; Lansoprazole; TAK-117
Intervention description: TAK-117 capsules; Lansoprazole capsules; TAK-117 tablets
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Serabelisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
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 evaluate the relative bioavailability of a new tablet
      formulation of TAK-117 (new clinical trial material [NTM]) compared to the TAK-117 Process B
      capsules (current clinical trial material [CTM]) (Part 1), to assess the effects of food on
      the oral bioavailability and pharmacokinetics (PK) of TAK-117 (Part 2), and to assess the
      effects of gastric pH-modifying agent on the PK of TAK-117 in healthy participants (Part 3).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is aged 18 to 45 years inclusive, at the time of consent.

          2. Is healthy adult male or female.

          3. Weighs greater than or equal to (>=) 45 kilogram (kg) (female) or >=55 kg (male), and
             body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2),
             inclusive, at screening.

          4. Suitable venous access for the study-required blood sampling, including PK sampling.

          5. Has provided the voluntary written consent.

        Exclusion Criteria:

          1. Any clinically significant abnormality at screening or medical history of cardiac,
             hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic,
             dermatologic, hematologic, neurologic, or psychiatric disease.

          2. Manifestations of malabsorption due to prior GI surgery, GI disease, or for an unknown
             other reason that may alter the PK of TAK-117 or lansoprazole.

          3. Creatinine clearance less than or equal to (<=) 90 milliliter per minute (mL/min)
             based either on Cockroft-Gault estimate or based on a 12- or 24-hour urine collection
             during screening.

          4. Known intolerance to TAK-117 or lansoprazole, or any of the excipients of either drug.

          5. A positive test result for human immunodeficiency virus (HIV), hepatitis A antibody
             (HAVAb), hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody Anti-HBc
             (IgM), or hepatitis C antibody (HCVAb) tests at screening, or serological reactions
             for syphilis during screening.

          6. Has Lactose intolerance (only for Part 2).
Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers
Condition: Healthy
Intervention: BI 10773 25 mg; Warfarin 25 mg; BI 10773 25 mg; Warfarin
Intervention description: 25 mg BI 10773 qd for 5 days; 25 mg Warfarin single dose; 25 mg BI 10773 qd for 12 days; 25 mg warfarin single dose with and without 50 mg BI 10773
Intervention MeSH terms: Empagliflozin; Warfarin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to investigate the bioavailability of BI 10773 and of
      warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of
      warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the
      pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral
      administration of BI 10773.
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male subjects
Drug-Drug Interaction Study of Colchicine and Azithromycin
Condition: Pharmacokinetics
Intervention: Colchicine; Azithromycin; Colchicine
Intervention description: A single dose of 0.6 mg colchicine administered alone at 7:30 am on Day 1; Two 250 mg azithromycin tablets administered at 7:30 am on Day 15, then one 250 mg tablet administered daily at 7:30 am on Days 16 to 19.; A single dose of 0.6 mg colchicine administered with azithromycin at 7:30 am on Day 19.
Intervention MeSH terms: Azithromycin; Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: blood levels over time;; colchicine;; azithromycin;; healthy

Summary:

      Azithromycin is a possible weak to moderate inhibitor of CYP3A4, one of the enzymes
      responsible for the metabolism of colchicine. This study will evaluate the effect of multiple
      doses of azithromycin on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A
      secondary objective is to evaluate the safety and tolerability of this regimen in healthy
      volunteers. All study subjects will be monitored for adverse events throughout the study
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (postmenopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood 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, gall bladder or
             biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic,
             dermatologic, neurological, 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
Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo); timolol ophthalmic solution 0.5%; AGN-207281 vehicle ophthalmic solution (Placebo)
Intervention description: One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.; One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days; One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3
      doses of AGN-207281 based on an ongoing review of data during the study period compared with
      timolol ophthalmic solution or placebo in patients with ocular hypertension or primary
      open-angle glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or primary open-angle glaucoma in each eye

          -  Requires IOP-lowering therapy in both eyes

          -  Visual acuity score of 20/100 or better in each eye

        Exclusion Criteria:

          -  Experienced significant weight change (over 10 pounds) within 60 days

          -  History of alcohol or drug addiction

          -  History of migraines or frequent headaches

          -  Anticipated wearing of contact lenses during the study

          -  Required chronic use of ocular medications during study

          -  Eye surgery within 6 months

          -  Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months

          -  Use of oral, intramuscular, intravenous corticosteroids within 21 days

          -  Use of ophthalmic corticosteroids within 2 months
A Study of Galcanezumab in Healthy Participants.
Condition: Healthy
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate how much galcanezumab gets into the body after
      it is given as an injection just under the skin by two different devices. This study will
      measure how much galcanezumab reaches the blood stream and will test how it affects
      calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may
      occur will be collected. The study will last about 20 weeks for each participant. Screening
      is required within 45 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy as determined by medical history and physical examination

          -  Have a body mass index (BMI) between 19.0 and 35.0 kilogram per meter square (kg/m²)

          -  Have clinical laboratory test results within normal reference range for the
             investigative site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator

        Exclusion Criteria:

          -  Have previously completed or withdrawn from this study or any other study
             investigating galcanezumab, and have previously received galcanezumab

          -  Have allergies to either humanized monoclonal antibodies, diphenhydramine,
             epinephrine, or methylprednisolone

          -  Intend to use over-the-counter or prescription medication within 7 days prior to
             dosing and during the study (especially systemic glucocorticoids, immunomodulatory
             drugs, drugs with propensity for dermal reactions, drugs with known hepatic toxicity,
             etc). Stable doses of hormone replacement therapy (HRT) are allowed for inclusion at
             the discretion of the investigator

          -  Have had lymphoma, leukemia, or any malignancy within the past 5 years except for
             basal cell or squamous epithelial carcinomas of the skin that have been resected with
             no evidence of metastatic disease for 3 years
Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Condition: Pharmacokinetics
Intervention: Sufentanil NanoTab (SUF NT) 15 mcg; Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Intervention description: Period 1: One dose of SUF NT 15 mcg administered sublingually; Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day
Intervention MeSH terms: Ketoconazole; Sufentanil; Dsuvia
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Area under curve, time to maximum concentration

Summary:

      Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following
      sublingual administration of sufentanil NanoTab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non smoking

          -  Ages 18 to 45 year, inclusive

          -  BMI between 18 and 30

        Exclusion Criteria:

          -  subjects taking any prescription or OTC medications or vitamins or supplements

          -  pregnant females

          -  subjects with pulmonary disease or sleep apnea