bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Condition: Gastric Acid; Human Experimentation
Intervention: Omeprazole/sodium bicarbonate; omeprazole magnesium; sodium bicarbonate
Intervention description: Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.; Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.; Sodium bicarbonate. Single dose.
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to
      compare effects on stomach acid; 30 participants will continue treatment for 7 days and will
      have repeat evaluations at Day 7. The other 30 participants will receive a single
      administration of sodium bicarbonate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal subjects who are 18-65 years of age.

          -  Non-childbearing potential females or those using birth control.

        Exclusion Criteria:

          -  History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump
             inhibitors

          -  History of significant gastrointestinal disease

          -  Any significant medical illness

          -  Gastrointestinal disorder or surgery leading to impaired drug absorption

          -  Currently using gastrointestinal medications
Corticosteroids for Children With Febrile Urinary Tract Infections
Condition: Acute Urinary Tract Infection; Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Placebo; Dexamethasone
Intervention description: Twice daily for 3 days; 0.15 mg/kg/dose twice daily for 3 days
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 546.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Renal scarring; Dexamethasone; Child; Corticosteroids; Pediatric; Urinary tract infection; Escherichia Coli Urinary Tract Infection

Summary:

      In this study the investigators will determine whether corticosteroids given at the time of
      urinary tract infection help prevent permanent damage to the kidneys.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 2 months to 6 years

          -  Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged
             specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged
             specimen or ≥1+ leukocyte esterase (LE) on dipstick

          -  Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the
             body either at home or at doctor's office within 24 hours of diagnosis

        Exclusion Criteria:

          -  Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;

          -  Planned admission to intensive care unit;

          -  Known bacteremia;

          -  Previous protocol defined UTI;

          -  Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral
             valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic
             bladder, pelvic or fused kidney);

          -  Congenital/acquired immunodeficiency;

          -  Bag urine collection

          -  Chronic diseases that could potentially interfere with response to therapy, such as
             chronic gastrointestinal conditions (i.e. malabsorption, inflammatory bowel disease),
             liver/kidney failure;

          -  Allergy to dexamethasone

          -  Antibiotic use within 7 days of enrollment (except if given in the last 48 hours)

          -  Systemic use of corticosteroids or other immunomodulating agents within 14 days of
             enrollment

          -  History of Kawasaki disease

          -  Sickle cell disease (not trait)
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
Condition: Chronic Renal Insufficiency; Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Proteinuria
Intervention: Vitamin D; Placebo
Intervention description: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months; Patients randomized to this arm will receive one placebo pill once weekly.
Intervention MeSH terms: Vitamin D
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; CKD; proteinuria

Summary:

      A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney
      Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney
      damage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 years

          -  Ability to provide informed consent

          -  Chronic kidney disease stage 3 and 4

          -  On ACE inhibitor or ARB for albuminuria if tolerated

          -  Assessed during eligibility screen:

          -  Albuminuria >30 mg/g creatinine

          -  25(OH) vitamin D level >12.5 and <75 nmol/L

        Exclusion Criteria:

          -  On vitamin D in past 4 weeks

          -  Plans to relocate out of New York City in the next 6 months

          -  25 (OH) Vitamin D level <12.5 nmol/L

          -  HIV infection

          -  History of hypercalcemia or kidney stones

          -  Serum phosphate >5.5 mg/dl in past 3 months

          -  Serum calcium >10.0 mg/dl in past 3 months

          -  SBP >160 DBP >100 at screening visit

          -  Transplanted organ

          -  Cancer

          -  Polycystic kidney disease

          -  Rapidly deteriorating kidney function with the expectation for initiation of dialysis
             in less than 6 months
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Condition: Primary Immune Deficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Immune Globulin Subcutaneous (Human) (SCIG)
Intervention description: IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID

Summary:

      The objective of this study is to assess the efficacy, safety, tolerability, and
      pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary
      immunodeficiency (PID). In addition, the study will assess the health-related quality of life
      and pharmacoeconomic aspects related to treatment with IgPro20.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy

          -  Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for
             at least 3 doses prior to signing of informed consent

          -  Written informed consent

        Exclusion Criteria:

          -  Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin
             replacement therapy

          -  Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia,
             osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time
             of screening

          -  Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic
             leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma

          -  Allergic or other severe reactions to immunoglobulins or other blood products recorded
             in the past 3 months or at the time of screening

          -  Pregnancy or nursing mother

          -  A positive result at screening on any of the following viral markers: human
             immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus

          -  Participation in a study with other investigational product during this study and
             within 3 months prior to screening

          -  Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to
             screening), or planning to donate blood during the study
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Condition: Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases
Intervention: PTK 0796; linezolid; moxifloxacin
Intervention description: PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg; For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution; moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution
Intervention MeSH terms: Moxifloxacin; Linezolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CSSI; Abscess; Wound; Cellulitis; Complicated Skin and Skin Structure Infections (cSSSI)

Summary:

      A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of
      complicated skin and skin structure infections (cSSSI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, ages 18 years or older

          -  Is expected to require ≥4 days of IV antibiotic therapy

          -  Has an acute complicated skin and skin structure infection with findings of systemic
             inflammatory response

          -  Female patients must not be pregnant at the time of enrollment and must agree to a
             reliable method of birth control during the study and for 30 days following the last
             dose of study drug

        Exclusion Criteria:

          -  Has received an investigational drug within past 1 month

          -  Has been previously enrolled in this protocol

          -  Has received >24 hr of a potentially effective systemic antibiotic immediately prior
             to study drug

          -  Is nursing
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Condition: Gastric Acid; Human Experimentation
Intervention: Omeprazole/sodium bicarbonate; omeprazole magnesium (20 mg equivalent)
Intervention description: Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.; Single dose of omeprazole magnesium per day for either 1 or 7 days.
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to
      compare effects on stomach acid; 30 participants will continue treatment for 7 days and will
      have repeat evaluations at Day 7.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal subjects who are 18-65 years of age.

          -  Non-childbearing potential females or those using birth control.

        Exclusion Criteria:

          -  History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump
             inhibitors

          -  History of significant gastrointestinal disease

          -  Any significant medical illness

          -  Gastrointestinal disorder or surgery leading to impaired drug absorption

          -  Currently using gastrointestinal medications
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX™ (concomitant); Comparator: Influenza Vaccine; ZOSTAVAX™ (Nonconcomitant)
Intervention description: a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4; a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1; Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 763.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention of Herpes Zoster

Summary:

      The purpose of this study is to determine whether the investigational zoster vaccine has a
      comparable immune response (the body's ability to protect against disease) and safety profile
      when given concomitantly with another vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 50 years of age or older

        Exclusion Criteria:

          -  Prior history of Herpes Zoster (shingles)

          -  Prior receipt of varicella or zoster vaccine

          -  Immunosuppressed
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin (MK0431); Placebo/Glipizide 5 mg; Metformin; Pioglitazone
Intervention description: Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104; Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104); Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104); Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus

Summary:

      The purpose of this study is to determine the safety and efficacy of an investigational drug
      in patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes mellitus
A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction
Condition: Acute Coronary Syndromes
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Infarction
Intervention: Placebo; Prasugrel
Intervention description: Administered once orally; Administered orally
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4033.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndromes; Heart Disease; Percutaneous Coronary Intervention; P2Y12; NSTEMI

Summary:

      The purpose of this trial is to investigate the potential benefits/risks regarding
      pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants
      with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention
      (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have acute coronary syndrome consisting of non-ST-segment elevation with elevated
             troponin

          -  Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24
             hours from time of planned randomization, but no more than 48 hours from randomization

          -  Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein
             IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels

          -  May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to
             prasugrel

          -  Must be enrolled at a cardiac catheterization laboratory hospital or at a
             hospital/ambulance service affiliated with a cardiac catheterization laboratory
             hospital

        Exclusion Criteria:

          -  Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry
             or randomization

          -  Have cardiogenic shock

          -  Have refractory ventricular arrhythmias

          -  Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)

          -  Have had cardiac arrest within 1 week of entry or randomization into the study
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta
Intervention description: 120, 200 or 360 micrograms iv every 4 weeks (starting dose)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of once-monthly
      administration of intravenous Mircera for the maintenance of hemoglobin levels in
      hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous
      injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time
      on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >= 18 years of age;

          -  chronic renal anemia;

          -  continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;

          -  regular long-term hemodialysis therapy with the same mode of dialysis for previous 3
             months.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension requiring hospitalization or interruption of epoetin
             treatment in previous 6 months;

          -  significant acute or chronic bleeding.
Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: TA-650 3 mg/kg; TA-650 6 mg/kg; TA-650 10 mg/kg
Intervention description: 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.; 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.; 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 327.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA; Infliximab; TA-650; Remicade

Summary:

      The purpose of this study is to assess the efficacy, safety and pharmacokinetics of
      maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with
      methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis
      (RA) showing an insufficient response to MTX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with active RA in spite of stable dose of MTX

        Exclusion Criteria:

          -  Having received infliximab in the past

          -  Having a history of serious infection which caused hospitalization within 6 months
             before the registration

          -  Having an active tuberculosis

          -  Having a complication or a history of malignancy within 5 years before the
             registration