bioihbjkbjnl/mcl2 huggingface dataset:
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida
Condition: Candidiasis; Fungemia
MeSH terms: Infections; Candidiasis; Fungemia
Intervention: Active anidulafungin; Active Caspofungin
Intervention description: Subjects in this arm will receive active anidulafungin and placebo caspofungin; Subjects in this arm will receive active caspofungin and placebo anidulafungin
Intervention MeSH terms: Caspofungin; Anidulafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection

Summary:

      The purpose of this study is to gather information on the use of anidulafungin for the
      treatment of serious Candida infection. It is expected that anidulafungin will be at least as
      safe and as effective as the comparator drug, caspofungin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a
             culture specimen obtained from a normally sterile site accompanied by signs and
             symptoms of infection.

          -  Male or female ≥ 16 years of age.

          -  Expected hospitalization for at least fourteen (14) days.

        Exclusion Criteria:

          -  Pregnancy or breast feeding or planning to become pregnant during the study.

          -  Recent treatment with one of the study drugs over the last 30 days.

          -  Allergy to either study drug or to this class of drugs.

          -  Significant liver dysfunction.

          -  Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of
             the central nervous system.
IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: Ropivacaine injection
Intervention description: Total dose not to exceed 3 mg/kg of ropivacaine.
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral
      nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing
      arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor
      canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block
      involved with sciatic nerve block. The lack of motor block is important to facilitate
      postoperative ambulation and physical therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients less than 21 years of age

          -  American Society of Anesthesiologists physical status I and II

          -  Undergoing elective anterior cruciate ligament reconstruction

        Exclusion Criteria:

          -  They are unable or unwilling to take part in the study

          -  History of allergy to any of the medications administered for the nerve block

          -  Contraindication to peripheral nerve block

          -  Patients who are unable to understand instructions or questions related to the study
             or the families required language interpretation

          -  Patients who consume opioid medications for more than three days per week for more
             than a month prior to surgery
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 619.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      The purpose of this study is to measure the effectiveness and safety of TD 4208, an
      investigational drug being developed to treat people with moderate to very severe COPD,
      compared to placebo, a treatment without activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older

        Exclusion Criteria:

          -  Females who are pregnant, lactating, breast-feeding or planning to become pregnant
             during the study
Radial Artery Versus Saphenous Vein Patency (RSVP) Study
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Intervention: Coronary artery bypass graft (CABG) surgery
Intervention description: Patients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Coronary artery bypass; Coronary arteries; Atherosclerosis; Angiography; Blood flow

Summary:

      The purpose of this study is to determine whether the radial artery (artery in the arm) or
      saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass
      surgery, have a greater patency rate (degree of opening)at 5 years after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  on waiting list for clinically-indicated myocardial revascularization surgery

          -  aged 40-70 years

          -  significant stenosis (≥70%) in the circumflex territory as identified on preoperative
             angiograms

          -  negative Allen's test (defined as the return of palmar circulation within 5 seconds of
             releasing ulnar artery compression)

          -  willing to give written informed consent

        Exclusion Criteria:

          -  poor left ventricular (LV) function (LV ejection fraction <25%)

          -  severe diffuse peripheral vascular disease or bilateral varicose venous disease

          -  inability to comply with the angiographic follow-up at 3 months or/and 5 years
Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD
Condition: COPD
Intervention: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
Intervention description: GFF MDI administered as 2 inhalations BID
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is an open-label, multi-center study to evaluate the accuracy, reliability and
      functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI)
      dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment
      Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Give their signed written informed consent to participate.

          -  Are at least 40 years of age and no older than 80 at Visit 1.

          -  A female of non-child bearing potential or child bearing potential, has a negative
             serum pregnancy test, and agrees to approved contraceptive methods.

          -  COPD Diagnosis: Subjects with an established clinical history of COPD as defined by
             the American Thoracic Society(ATS)/European Respiratory Society (ERS).

          -  Current or former smokers with a history of at least 10 pack-years of cigarette
             smoking.

          -  FEV1/FVC ratio of <0.70.

          -  Post-bronchodilator FEV1 must be ≥ 30% and <80% predicted normal value calculated
             using the Third National Health and Nutrition Examination Survey (NHANES III)
             reference equations, and must also be greater than or equal to 750 mL.

          -  Subject is willing and, in the opinion of the Investigator, able to adjust current
             COPD therapy as required by the protocol.

        Exclusion Criteria:

          -  Pregnancy, nursing females or subjects trying to conceive.

          -  Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic,
             pulmonary, hematological, psychiatric, or other medical illness that would interfere
             with participation in this study.

          -  Current primary diagnosis of asthma.

          -  History of ECG abnormalities.

          -  Poorly controlled or worsening COPD prior to Screening or during the Screening Period.

          -  Clinically significant bladder neck obstruction or urinary retention.

          -  Male subjects with a trans-urethral resection of prostate (TURP) or full resection of
             the prostate within 6 months prior to Screening.

          -  Cancer that has not been in complete remission for at least five years.

          -  Inadequately treated glaucoma.

          -  History of allergic reaction or hypersensitivity to any component of the formulations
             used in this study.
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Rosuvastatin; Placebo
Intervention description: oral; oral
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Heterozygous Familial Hypercholesterolemia

Summary:

      The primary objective of this study is to determine the efficacy of once-daily rosuvastatin
      in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day
      0) to the end of the 12-week double-blind treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17
             years) with heterozygous familial hypercholesterolemia (HeFH)

        Exclusion Criteria:

          -  Certain medical conditions and lab test results

          -  History of a reaction to rosuvastatin or other statin drugs

          -  Use of specified disallowed medications
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
Condition: Retinal Vein Occlusion; Macular Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion
Intervention: Ozurdex; Ozurdex
Intervention description: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies; 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BRVO; CRVO; Macular Edema; Anti-VEGF; Ozurdex

Summary:

      To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular
      function and recalcitrant macular edema associated with retinal vein occlusion following
      treatment with 2 or more prior intravitreal anti-VEGF drug injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion
             (BRVO)

          -  Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last
             45 days.

          -  Age 18 years or older

          -  ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of
             20/25 to 20/800

          -  Central foveal thickness >275 microns or presence of cystic edema on OCT studies.

          -  For sexually active women of childbearing potential, agreement to the use of an
             appropriate form of contraception (or abstinence) for the duration of the study.

          -  Ability to provide written informed consent • Capable of complying with study protocol

        Exclusion Criteria:

          -  History of steroid-related glaucoma (steroid response) requiring more than one topical
             glaucoma medication.

          -  Intraocular injection of steroid medication within prior 4 months

          -  Evidence of significant retinal ischemia on fluorescein angiography in the opinion of
             the treating physician.

          -  Previous laser photocoagulation within 4 months of study

          -  Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy)
             that would limit visual acuity in the opinion of the treating physician

          -  Patients who are pregnant.

          -  Unwilling or unable to follow or comply with all study related procedures.
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Alendronate
Intervention description: Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.
Intervention MeSH terms: Alendronate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Even though this is an open-label study, participants and Investigators who will be participating in this study (BA058-05-005) will remain blinded to the prior treatment assignment in Study BA058-05-003 (NCT02653417) until all participants completed the first 6 months of BA058-05-005 for prespecified data analysis. Complete data analysis for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Enrollment: 1139.0
Sex: Female
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: BA058; Abaloparatide-SC; abaloparatide; ACTIVExtend; osteoporosis; fracture; bone loss

Summary:

      The purpose of this study is to provide 24 months of standard of care data on participants
      previously enrolled in Study BA058-05-003 (NCT02653417).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or
             placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).

          2. The participant was no more than 40 days from End-of-Treatment (Month 18) in Study
             BA058-05-003 (NCT02653417).

        Exclusion Criteria:

          1. Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.

          2. Participants who experienced a treatment-related serious adverse event (SAE) during
             Study BA058-05-003 (NCT02653417).
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Interferon-alfa; SU011248
Intervention description: 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity; 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Intervention MeSH terms: Interferons; Interferon-alpha; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 750.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test whether SU011248 has activity and is safe compared to
      interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed renal cell carcinoma of clear cell histology with metastases

          -  Evidence of measurable disease by radiographic technique

          -  Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

        Exclusion Criteria:

          -  Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC

          -  History of or known brain metastases

          -  Serious acute or chronic illness or recent history of significant cardiac abnormality
Self Selection Trial of Naproxen Sodium
Condition: Pain
Intervention: Naproxen sodium ER (BAYH6689); Advil
Intervention description: Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain; Commercially available Advil; oral caplet upon incidence of pain
Intervention MeSH terms: Naproxen
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 253.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Self Selection Tria

Summary:

      A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their
      own use based on expected duration of pain greater than 12 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 12 years of age

          -  Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the
             past month

          -  Able to read and understand English

          -  Provide written informed consent (subjects 12-17 years of age provide written assent
             and/or parent or legal guardian provide written consent)

          -  Provide contact information

        Exclusion Criteria:

          -  Have participated in a trial involving OTC analgesics in the last 6 months

          -  They or someone else in the household work for a market research company, an
             advertising agency, a public relations firm, a pharmaceutical company, as a healthcare
             professional, or as part of a health care practice (eliminated for reasons of
             confidentiality or increased awareness of drugs and their labels)

          -  Have a history of known allergies to Nonsteroidal Antiinflammatory Drugs (NSAIDs)
             (i.e., naproxen, ibuprofen, acetaminophen, aspirin, etc.)

          -  Have a history of heart surgery in the last 60 days or plans for heart surgery in the
             next 60 days

          -  Female subjects who have a positive urine pregnancy test or who are breastfeeding.
S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000
Condition: Cataract; Macular Degeneration
MeSH terms: Cataract; Macular Degeneration
Intervention: selenium; vitamin E; vitamin E placebo; selenium placebo
Intervention description: 200 mcg daily for 7-12 years; 400 IU daily by mouth for 7-12 years; daily for 7-12 years; daily for 7-12 years
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13475.0
Sex: Male
Minimum age: 50 Years
Maximum age: 120 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cataract; advanced macular degeneration

Summary:

      RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent
      cataracts or age-related macular degeneration in men receiving these drugs as part of a
      clinical trial for the prevention of prostate cancer.

      PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work
      in preventing cataract and age-related macular degeneration in men enrolled on SELECT
      (SWOG-S0000).
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT)
             SWOG-S0000

          -  Diagnosis of 1 of the following:

               -  Age-related macular degeneration (AMD) at baseline or at follow-up

               -  Cataract or a cataract extraction at follow-up (Closed for accrual as of
                  10/01/29)

                    -  Participants with a prior diagnosis of cataract at baseline followed by
                       another cataract event (cataract diagnosis or a cataract extraction) at
                       follow-up are not eligible

                    -  Participants with a prior diagnosis of cataract at baseline followed by a
                       diagnosis of AMD at follow-up are eligible

        PATIENT CHARACTERISTICS:

          -  See Disease Characteristics

        PRIOR CONCURRENT THERAPY:

          -  Not applicable
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
Condition: Pneumococcal Conjugate Vaccine
MeSH terms: Anemia, Sickle Cell
Intervention: 13-valent Pneumoccocal Conjugate Vaccine
Intervention description: 2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety, tolerability and immunogenicity of 13-valent
      pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been
      vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of
      antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease
      after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18
      years of age. They will be given the vaccination twice, each vaccination separated by
      approximately 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject between the ages of >=6 to <18 years.

          -  Diagnosis of SCD

          -  23vPS vaccination at least 6 months prior to enrollment.

        Exclusion Criteria:

          -  Previous vaccination with pneumococcal conjugate vaccine.

          -  Previous reaction to any vaccine or vaccine-related component or contraindication to
             vaccination with pneumococcal conjugate vaccine.