bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773; hydrochlorothiazide; torasemide; BI 10773; torasemide; BI 10773; hydrochlorothiazide
Intervention description: multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses
Intervention MeSH terms: Empagliflozin; Hydrochlorothiazide; Torsemide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to investigate the effect of BI 10773,
      hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore
      the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be
      assessed.
    

Eligibility criteria:

        Inclusion criteria:

        1. male and female patients of type 2 diabetes
A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Comparator: Placebo 5mg (run in); Donepezil 5 - 10 mg; Comparator: Placebo 5-10 mg; Donepezil 10 mg
Intervention description: Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.; Donepezil 1 capsule (5 mg) orally, once daily for 14 days.
Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).; Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days.
Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).; Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).
Intervention MeSH terms: Donepezil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This study will evaluate the performance of the CogState computerized neuropsychological
      battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's
      Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with
      mild-to-moderate Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is ambulatory, male or female and 55 years of age or older

          -  Participant has reliable informant/caregiver who can communicate effectively with the
             study site and personnel

        Exclusion Criteria:

          -  Participant has a history within the last 6 months or current evidence of a psychotic
             disorder or an active major depressive disorder or participant has any history of
             schizophrenia

          -  Participant has a history of multiple and/or serious allergies to drugs or food or a
             history of an allergic reaction to more than 3 drug classes
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
Condition: Neoplasms
Intervention: BIBW 2992; BIBF 1120
Intervention description: EGFR inhibitor; VEGF inhibitor
Intervention MeSH terms: Nintedanib; Afatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the
      combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide
      dosing recommendation for subsequent phase II trials in patients with metastatic cancer.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with confirmed histological or cytological diagnosis of advanced solid
             tumours and for whom no proven therapy exists or who are not amenable to established
             treatments.

          2. Age 18 years or older.

          3. Life expectancy of at least three months.

          4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.

          5. Patients previously treated and with asymptomatic brain metastases are eligible

          6. Patients must have recovered from recent surgery.

        Exclusion criteria:

          1. Active infectious disease

          2. Recent surgery within the last 4 weeks prior visit 1.

          3. Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take
             oral medication

          4. History of haemorrhagic or thrombotic events

          5. Significant cardiovascular diseases within

          6. Current peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE)
             grade 1 except due to trauma

          7. Untreated or symptomatic brain metastases or leptomeningeal disease.

          8. Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2
             (HER2) inhibiting drug or antiangiogenic drug.

          9. Therapeutic anticoagulation.

         10. Female patients of childbearing potential.

         11. Known pre-existing interstitial lung disease
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
Condition: Healthy
Intervention: Placebo to BI 416970; BI 416970
Intervention description: single rising doses; single rising doses
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics
      (PK) of single rising doses of BI 416970. A further objective is to assess the influence of
      CYP2C9 phenotype on the PK of BI 416970.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy males according to the investigator's assessment, based on a complete medical
             history including a physical examination, vital signs (Blood Pressure, Pulse Rate),
             12-lead electrocardiogram, and clinical laboratory

          -  Age 18 to 50 years (incl.)

          -  Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and local legislation

          -  Known genotype of CYP2C9 isoenzyme

        Exclusion criteria:

          -  Any finding in the medical examination (including Blood Pressure, Pulse Rate or
             Electrocardiogram) is deviating from normal and judged as clinically relevant by the
             investigator

          -  Repeated measurement of systolic blood pressure outside of ranges 90-140 mmHg,
             diastolic blood pressure outside of ranges 50-90 mmHg, or pulse rate outside the range
             of 50 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
             medication

          -  Diseases of the central nervous system (such as epilepsy), other peripheral
             neurological disorders or psychiatric disorders
Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study
Condition: Urinary Tract Infection
MeSH terms: Urinary Tract Infections
Intervention: E. coli 83972 coated urinary catheter
Intervention description: E. coli 83972 coated urinary catheter
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: urinary tract infection; urinary catheter; Escherichia coli; biofilm

Summary:

      This study is a prospective pilot clinical trial investigating the use of urinary catheters
      coated with benign E. coli in geriatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients followed at the MEDVAMC

          -  Require an indwelling bladder catheter (either transurethral or suprapubic)

          -  Have a history of at least 1 UTI in the past will be eligible for enrollment

          -  Have pre-existing bladder colonization

        Exclusion Criteria:

          -  obstructive urolithiasis

          -  percutaneous nephrostomy catheters

          -  supravesicular urinary diversion

          -  vesicoureteral reflux

          -  active malignancy

          -  uncontrolled diabetes mellitus

          -  AIDS

          -  requirement for immunosuppressive medication, expected survival < 6 months, creatinine
             clearance > 2.0 mg/dL, or current antibiotic therapy

          -  Latex allergy

          -  Allergic to 2 or more classes of drugs to which the urinary isolate is susceptible

          -  Prostate cancer on hormonal therapy with or without any surgery or radiation therapy
             anticipated within the next 6 months

          -  Prisoners

          -  Significant known mental illness or emotional disorder related to organic or inorganic
             causes

          -  subjects who are not capable of giving informed consent will not be included unless
             the subject's designated decision-maker is readily available
CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos
Condition: Caregiver Burnout
MeSH terms: Dementia; Caregiver Burden
Intervention: CuidaTXT
Intervention description: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: This intervention, CuidaTXT [Spanish for self-care and texting], will be available in English and Spanish, incorporate two-way messaging and will tailor text messages to the preferences of Latino caregivers. CuidaTXT will be multicomponent and based on the Stress Process Framework as supported by evidence. The intervention will incorporate social support and coping components including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dementia; Caregiver; mHealth; Stress; Latino; Disparities

Summary:

      Latino families with dementia experience substantial disparities in access to caregiver
      support compared to their non-Latino white peers, putting them at an increased risk for
      negative emotional, physical and financial outcomes. This R21 will address this research gap
      by 1) Developing a culturally and linguistically appropriate text message intervention for
      caregiver support among Latino family caregivers of individuals with dementia and 2) Testing
      the feasibility and acceptability of CuidaTXT, a multicomponent text message caregiver
      support intervention culturally and linguistically tailored for the Latino community.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Spanish and English-speaking individuals

          -  Over the age of 18

          -  Identify as Latino

          -  Report providing hands-on care for a relative who has been given a clinical or
             research dementia diagnosis

          -  Care recipient has an AD-8 screening score greater than or equal to 2, indicating
             cognitive impairment

          -  Self-report being able to read and write

          -  Self-report owning a cell phone with a flat fee and use it at least weekly for texting

        Exclusion Criteria:

        -
A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance
Condition: Healthy Volunteer
Intervention: Tamiflu (oseltamivir); Tamiflu (oseltamivir)
Intervention description: Single dose of Tamiflu in volunteers on dialysis; Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min
Intervention MeSH terms: Oseltamivir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety
      of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine
      clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.
    

Eligibility criteria:

        Inclusion Criteria:

        General

          -  Adult volunteers, aged 19 to 90 years

          -  Medically stable with no hospitalization for a significant disease in the 3 months
             before study start

        Volunteers on dialysis

          -  A documented and well-established dialysis therapy

        Volunteers with reduced creatinine clearance

          -  Creatinine clearance from 10 to 30 mL/min

          -  Stable renal function

        Exclusion Criteria:

          -  Clinically significant and unstable disease (e.g., cardiac, hepatic, pulmonary)

          -  Medical history of concurrent medical condition that would compromise participation in
             the study

          -  Hypotensive episodes or symptoms of fainting, dizziness or lightheadedness in the 4
             weeks before screening

          -  Uncontrolled hypotension or hypertension

          -  Infection with hepatitis B, hepatitis C or human immunodeficiency virus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Co-administration of Saxagliptin and Metformin IR, Fasted; Saxagliptin/Metformin, Fasting; Co-administration of Saxagliptin and Metformin IR, Fed; Saxagliptin/Metformin, Fed
Intervention description: Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions; Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions; Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions; Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate
      release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg
      metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ages 19 to 45 inclusive

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, physical examination, electrocardiograms (ECGs), and clinical
             laboratory determinations

          -  Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

        Exclusion Criteria:

          -  Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable
             barrier methods (condoms and spermicides) to avoid pregnancy for the entire study
             period and for up to 8 weeks after the last dose of investigational product

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months) gastrointestinal disease

          -  Any major surgery within 4 weeks of study drug administration

          -  History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds

          -  History of allergy or intolerance to metformin or other similar acting agents

          -  Prior exposure to saxagliptin

          -  Prior exposure to metformin within 3 months of study drug administration.

          -  Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Condition: Dizziness
MeSH terms: Dizziness
Intervention: balance prosthesis
Intervention description: vibrotactile stimulation
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
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Chronic imbalance; vestibular disorders; balance prosthesis

Summary:

      The goal of this project is to provide individuals that have a balance deficit with a device
      that will give them signals that they can feel (vibrations) in order to help them maintain a
      correct sense of balance and perception of place in the environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory patients who have had chronic imbalance for at least one year, and have
             reached a functional performance plateau with respect to their balance adaptation.

        Exclusion Criteria:

          -  Neurological disorders other than chronic balance disorders, as determined by medical
             history and neurological screening procedure.

          -  Any medical condition as determined by the health questionnaire that would interfere
             with performance on the postural stability evaluation tests.

          -  Peripheral neuropathies of the lower extremities.

          -  Subjects who are unwilling or unable to adhere to all study requirements, including
             completion of the training period, evaluation tests, and return to clinic for a
             follow-up visit.
Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Condition: Healthy
Intervention: PRO-156
Intervention description: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Intervention MeSH terms: Ketorolac
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution
      PRO-156 over the ocular surface of ophthalmologically healthy volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female.

          -  Age between 18 and 40 years old at screening visit.

          -  Signed informed consent

        Exclusion Criteria:

          -  Patient with one blind eye.

          -  Any ocular or systemic condition.

          -  Visual acuity of 20/100 in any eye.

          -  Use of ocular or systemic medication.

          -  Contraindications or sensitivity to any component of the study treatment.

          -  Contact lens users.

          -  Ocular surgery within the past 3 months..

          -  Pregnant, nursing or childbearing potential women who were not using effective
             contraception.

          -  Participation in any studies of investigational drugs within 90 days previous to the
             inclusion.
A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: Comparator: V212; Comparator: Placebo
Intervention description: 0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart; Placebo; 4-dose regimen administered ~30 days apart.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 290.0
Sex: All
Minimum age: 50 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes Zoster (Shingles)

Summary:

      The purpose of this study was to assess the safety and tolerability of gamma-irradiated
      varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C
      (Part 2) and to determine if they were immunogenic when administered to healthy individuals,
      as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent
      assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and
      gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune
      response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine
      would elicit an acceptable VZV-specific immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 50 to 59 years of age

          -  No fever on vaccination days

          -  Must have had chickenpox or lived in an area where the chickenpox virus is prevalent
             for 30 or more years

          -  Females of child-bearing potential must use acceptable forms of birth control

        Exclusion Criteria:

          -  Prior history of shingles

          -  Prior receipt of any chickenpox or shingles vaccine

          -  Pregnant or breastfeeding

          -  Received or expect to receive a live virus vaccine (such as measles, mumps, rubella)
             from 4 weeks before the first visit through the last visit

          -  Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia)
             from 7 days before the first visit through the last visit

          -  Received immunoglobulin or blood products

          -  Receiving treatment that may weaken the immune system

          -  Have an immune system disorder