bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Risedronate; ibandronate [Bonviva/Boniva]
Intervention description: 35mg po weekly for 12 weeks; 150mg po monthly for 3 months
Intervention MeSH terms: Risedronic Acid; Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 356.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This 2 arm crossover study will evaluate patient reported preference for either once monthly
      Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal
      osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12
      weeks; they will then cross over to receive the alternative treatment for a further 12
      weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample
      size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ambulatory women with post-menopausal osteoporosis;

          -  patients who are bisphosphonate-naive, or who have previously received oral daily or
             i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

        Exclusion Criteria:

          -  malignant disease diagnosed within previous 10 years (except for successfully resected
             basal cell cancer;) breast cancer within previous 20 years;

          -  inability to stand or sit upright for at least 60 minutes;

          -  disease/disorder/treatment with drugs known to influence bone metabolism.
Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
Condition: Rheumatoid Arthritis; Plaque Psoriasis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Psoriasis
Intervention: Etanercept via Autoinjector A; Etanercept via Autoinjector B
Intervention description: Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.; Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis
      (PsO) patients who self inject etanercept for one of two experimental autoinjectors.
    

Eligibility criteria:

        Inclusion Criteria: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate
        to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the
        opinion of the investigator in addition to the caring physician's intent to initiate
        treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or
        prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous
        biologics for RA. - Willing to self-inject per investigator judgement at screening and
        capable of self-injection using the autoinjector A or B as documented at baseline by the
        investigator. - Able to read and write in English. -

        Exclusion Criteria: Latex allergy. - Subject has an active infection (including chronic or
        localized infections) for which anti-infectives were indicated within 4 weeks prior to
        first dose of etanercept. - Subject had prosthetic joint infection within 5 years of
        screening or native joint infection within 1 year of screening.

          -  Other criteria may apply.
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Condition: Chronic Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Intervention: Allopurinol; Placebo
Intervention description: lactose placebo pill
Intervention MeSH terms: Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: allopurinol

Summary:

      Subjects will undergo a placebo and allopurinol phase to better understand the effects of the
      reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  self-identified as Asian/European ancestry

          -  generally healthy with approved lab values for CBC,HFP,RFP, and uric acid

          -  Subjects with the ABCG2 genotype, homozygous, heterozygous or homozygous for the major
             allele of rs2231142 will be recruited

        Exclusion Criteria:

          -  vascular disease

          -  renal impairment

          -  medications/supplements that affect uric acid levels

          -  pregnant or lactating women

          -  prior history of allergic reaction to allopurinol or testing positive for HLA-B*5801
             allele

          -  risk of urinary or gastric retention or narrow-angle glaucoma

          -  impaired hepatic function

          -  evidence of anemia

          -  evidence or diagnosis of congestive heart failure

          -  smokers

          -  subjects with a mutation other than rs2231142 in the ABCG2 genotype

          -  subjects taking hormonal contraceptives or other hormonal medications

          -  evidence of recreational drug use as determined by questionnaire
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Naproxen Sodium (Aleve, BAY117031); Ibuprofen (Advil); Placebo
Intervention description: 220 mg x 2 tablets, oral, single dose; 200 mg x 2 tablets, oral, single dose; Matching placebo, 2 tablets, oral, single dose
Intervention MeSH terms: Ibuprofen; Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Postsurgical pain

Summary:

      To compare the duration of analgesic efficacy as determined by the time to rescue medication
      of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen
      400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to
      severe post-impaction surgery dental pain.

      To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440
      mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

      To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440
      mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male or female volunteers 16-40 years of age;

          -  Body mass index 18.0 to 30.0 kg/m^2 inclusive;

          -  Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony
             impacted third molars. Up to two maxillary third molars may be removed regardless of
             impaction level. Supernumerary teeth present may also be removed at the discretion of
             the oral surgeon;

          -  Mandibular molars must demonstrate modified Demirjian root classification stage D, E,
             F, G or H;

        Exclusion Criteria:

          -  History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal
             anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local
             anesthetics, rescue medication or components of the investigational products;

          -  Evidence or history of clinically significant (in the judgment of the investigator)
             hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
             psychiatric, neurologic diseases, or malignancies within the last 5 years;

          -  Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
Hypothyroidism Treated With Calcitonin
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Intervention: Calcitonin
Intervention description: calcitonin nasal spray
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 88 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Some people with hypothyroidism have persistent symptoms despite adequate treatment with
      thyroid hormones. We are testing whether giving calcitonin to such people will improve their
      quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal TSH on levothyroxine therapy

        Exclusion Criteria:

          1. pregnant or 6 months post partum

          2. Current or previous thyroid cancer

          3. Congenital hypothyroidism

          4. any tobacco use

          5. prescribed proton pump inhibitors

          6. prescribed steroids

          7. taking armour thyroid, naturethroid, or any dessicated thyroid hormone

          8. Unstable medical conditions (CKD, Cirrhosis etc)

          9. pituitary disease
A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: travoprost 0.004% and brinzolamide 1%; fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle
Intervention description: Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.); group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
Intervention MeSH terms: Timolol; Travoprost; Dorzolamide; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 46.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Double blind, crossover randomized, multicentric study to compare efficacy and tolerability
      of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed
      combination in patients with glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension

          -  Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM

          -  Stable visual field in last 6 months

          -  6 weeks wash out from previous topical medications

        Exclusion Criteria:

          -  Age
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: amlodipine, hydralazine, terazosin or hydrochlorothiazide
Intervention description: In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Hydralazine; Terazosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; Hypertension

Summary:

      The purpose of this study is to study the effect of blocking the renin angiotensin system on
      urinary free light chain excretion as compared to urine microalbumin creatinine ratio in
      subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a
      biomarker of earlier detection of kidney function impairment in subjects with diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes

          -  Hypertension

          -  Estimated glomerular filtration rate (eGFR) > 30 ml/min

          -  Use of Ace Inh and ARB for control of blood pressure who are willing to be placed on
             alternate drug(s) in the washout period for blood pressure control

        Exclusion Criteria:

          -  Pregnancy

          -  Patients with chronic kidney disease stage with eGFR < 30 ml/min (CKD stage IV and V)

          -  Nephrotic range proteinuria (urinary protein > 3.5 gm/day)

          -  History or renal transplantation

          -  History of multiple myeloma

          -  Known history of hypersensitivity reaction or intolerability to Ace Inh or ARB.
Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Omeprazole 20 mg
Intervention description: Capsules, orally; Tablets, orally
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Frequent Heartburn; Omeprazole; Omeprazole, sodium bicarbonate drug combination; Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Proton Pump Inhibitors

Summary:

      This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination
      product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent
      heartburn.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of reproductive potential must demonstrate a negative urine pregnancy test and
             agree to use an acceptable method of birth control

          -  Suffer from frequent heartburn

          -  Refrain from taking non-study medicine or treatment for heartburn for the duration of
             the study

          -  Be free of any clinically significant disease that requires a physician's care

          -  Read and understand English

        Exclusion Criteria:

          -  Any significant medical condition which is a contraindication to the use of omeprazole
             or sodium bicarbonate

          -  Known hypersensitivity to the study drugs or any components

          -  Experiencing any of the following: trouble or pain with swallowing food, vomiting with
             blood, bloody or black stools

          -  Participation in another investigational study within 4 weeks prior to the screening
             visit.
A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease
Condition: Pompe Disease
MeSH terms: Glycogen Storage Disease Type II
Intervention: Alglucosidase alfa
Intervention description: 4000 L alglucosidase alfa administered by IV infusion at the same dose and dose regimen used for the patient's routine treatment prior to the study for 52 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the efficacy and safety of treatment with 4000
      litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.
    

Eligibility criteria:

        Inclusion Criteria:

        A participant might meet all of the following criteria to be eligible for this study.

          1. The participant and/or their parent/legal guardian was willing and able to provide
             signed informed consent.

          2. The participant might be at least 1 year of age at the time of informed consent.

          3. The participant had a diagnosis of Pompe disease and might have received treatment
             with 160 L alglucosidase alfa prior to screening.

          4. The participant, if female and of childbearing potential, might have a negative
             pregnancy test (urine beta-human chorionic gonadotropin) at baseline. Note: all female
             participants of childbearing potential and sexually mature males might agree to use a
             medically accepted method of contraception throughout the study.

        Exclusion Criteria:

        A participant who met any of the following criteria were to be excluded from this study.

          1. The participant had within the past 3 months received or was currently receiving any
             investigational product other than 160 L alglucosidase alfa or was currently
             participating in another clinical treatment study.

          2. The participant, in the opinion of the Investigator, was clinically unstable and would
             not be expected to survive to completion of the 52-week treatment period.

          3. The participant and/or their parent/legal guardian, in the opinion of the
             Investigator, was unable to adhere to the requirements of the study.
Double-Blind Placebo-Controlled CIN Trial
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Intervention: Iopamidol 300 (Contrast); Placebo (Normal Saline)
Intervention description: Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan; Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CT, iodinated contrast, contrast-induced AKI, kidney injury

Summary:

      This double-blinded placebo-controlled study will examine the incidence and significance of
      contrast-induced acute kidney injury following IV iodine-based contrast material
      administration in subjects with stage IIIB or stage IV chronic kidney disease.

      Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to
      evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive
      either weight-based low-osmolality iodinated contrast material or saline. The primary outcome
      measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inpatients scheduled for CT scan of abdomen and/or pelvis

          -  Had surgery in the last 4 weeks

          -  Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each
             other, with most recent within 5 days of CT)

          -  Suspected infection or fluid collection in abdomen and/or pelvis

        Exclusion Criteria:

          -  Pregnant

          -  Severe Allergy (anaphylaxis) to contrast

          -  Dialysis in last 7 days

          -  Received intravascular iodinated contrast in last 48 hours

          -  CT of abdomen and pelvis in last 7 days shows no fluid collection

          -  Prisoners

          -  CT ordered for an indication that requires (eg, CT angiogram) or contraindicates (eg,
             renal stone CT) the administration of intravascular contrast
Sympathetic Nervous System Modulation in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Metoprolol Succinate
Intervention description: Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.
Intervention MeSH terms: Metoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension; sympathetic nervous system

Summary:

      This is a study of patients with high blood pressure who are already treated with an
      angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair
      blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor
      blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic
      nervous system, thereby further improving left ventricular filling and blood pressure
      control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor
             or angiotensin receptor blocker

        Exclusion Criteria:

          -  Known valvular heart disease of more than mild severity

          -  Known coronary artery disease defined by an angiographic coronary artery stenosis
             greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial
             infarction, or previous coronary revascularization

          -  Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than
             50%

          -  Atrial fibrillation

          -  Current treatment with a β-adrenergic blocking drug or a calcium channel blocker

          -  Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake

          -  Participation in another research study within the prior 30 days

          -  A life-limiting disease process that is likely to preclude completion of study
             participation

          -  Pregnancy or breast feeding

          -  Inability or unwillingness to provide informed consent

          -  Baseline resting heart rate less than 65 beats per minute

          -  Diabetes

          -  Iodine allergy

          -  Unwilling to sign informed consent.