bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Gatifloxacin 0.5% eye drops; placebo eye drops
Intervention description: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily; Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Intervention MeSH terms: Gatifloxacin; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 859.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      The study will determine the safety and efficacy of gatifloxacin eye drops in patients with
      bacterial conjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically diagnosed with bacterial conjunctivitis

        Exclusion Criteria:

          -  Signs and/or symptoms of conjunctivitis for more than 96 hours

          -  Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis

          -  Clinical diagnosis of chlamydia in either eye
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Placebo; Methotrexate
Intervention description: Administered by intravenous infusion, 8 mg/kg every 4 weeks.; Placebo to tocilizumab administered by intravenous infusion every 4 weeks.; Administered orally or parenterally, 7.5-25 mg weekly.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness,
      and markers of atherogenic risk in patients with moderate to severe active rheumatoid
      arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab
      8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg
      weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus
      methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age

          -  rheumatoid arthritis (RA) of >6 months duration

          -  able to receive outpatient treatment

          -  on methotrexate for at least 12 weeks before entering study, at a stable dose of
             7.5-25 mg/week for the last 8 weeks

          -  oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) permitted, if
             at a stable dose for 4 weeks before study start

        Exclusion Criteria

          -  major surgery (including joint surgery) within 8 weeks prior to screening, or planned
             surgery within 6 months after entering study

          -  history of, or current inflammatory joint disease or rheumatic autoimmune disease
             other than RA

          -  inadequate response to anti-tumor necrosis factor (TNF) agent during the 6 months
             prior to baseline, or inadequate response to >2 anti-TNF agents

          -  initiation of treatment with lipid lowering agents within 12 weeks prior to baseline
A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Intervention: Amifostine; CyberKnife stereotactic radiosurgery
Intervention description: Amifostine and CyberKnife stereotactic radiosurgery; CyberKnife stereotactic radiosurgery
Intervention MeSH terms: Amifostine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tic douloureux

Summary:

      Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that
      significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has
      been shown to provide pain relief in majority of patients treated. However, a common side
      effect of radiosurgery is facial numbness. Our goal is to maximize pain control while
      minimizing side effects. To this end, the purpose of this study is to evaluate whether adding
      a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.
    

Eligibility criteria:

        Inclusion Criteria:

        All patients age 18 years and older with typical trigeminal neuralgia, as determined by
        diagnostic criteria set by the International Headache Society, who are:

          -  Intolerant of or refractory to medical management; AND

          -  Not candidates for or refusing a surgical micro-vascular decompression.

        Exclusion Criteria:

          -  Patients who present with pre-existing BNI grade III or IV facial numbness.

          -  Patients who have previously been treated with MVD.

          -  Patients who have previously had an ablative treatment, including prior SRS.

          -  Pediatric patients (age <18), pregnant women, and patients who are unable to give
             informed consent will be excluded.
Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: Inhaled nitric oxide; Sham inhaled nitric oxide
Intervention description: Inhaled nitric oxide, 40 parts per million, for six hours.; Sham inhaled nitric oxide administration, 0 parts per million, for six hours.
Intervention MeSH terms: Nitric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: Sepsis; Severe sepsis; Septic shock

Summary:

      The purpose of this study is to determine whether inhaled nitric oxide is an effective
      treatment for microcirculatory dysfunction and acute organ system failure in the early stage
      of sepsis therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed or suspected infection (acute)

             PLUS:

          2. One or both of the following criteria for potential tissue hypoperfusion:

        (2a) systolic blood pressure <90 mmHg despite 30cc/kg intravenous crystalloid challenge, OR
        (2b) serum lactate >4 mmol/L.

        Exclusion Criteria:

          1. age < 14 years

          2. pregnancy

          3. "Do Not Resuscitate" status (prior to enrollment)

          4. active clinically significant bleeding of any etiology

          5. status-post cardiac arrest

          6. need for immediate surgery

          7. inability to place a sublingual videomicroscopy probe under the tongue (e.g. inability
             to open the mouth or patient requirement of a high-flow face mask for supplemental
             oxygen [although videomicroscopy can be performed in patients with an endotracheal
             tube or nasal cannula])

          8. >24 hours elapsed since first documented evidence of meeting criteria for potential
             tissue hypoperfusion (2a or 2b above).

          9. inability to obtain written informed consent
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
Condition: Heart Failure; Respiratory Insufficiency; Stroke Acute; Infectious Diseases; Rheumatic Diseases
MeSH terms: Communicable Diseases; Infections; Rheumatic Diseases; Respiratory Insufficiency; Heart Failure; Collagen Diseases
Intervention: Rivaroxaban, 10 mg; Rivaroxaban, 7.5 mg; Placebo
Intervention description: Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.; Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from >=30 to less than (<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.; All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 12024.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Heart Failure; Respiratory Insufficiency; Stroke Acute; Infectious Diseases; Rheumatic Diseases; Medically ill Patient; Rivaroxaban; Thromboembolism; Prophylactic Anti-Coagulation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with
      placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related
      death post-hospital discharge in high-risk, medically ill patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The duration of the index hospitalization must have been at least 3 and no more than
             10 consecutive days

          -  Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE
             Risk Score of: greater than or equal 4, or 3 with D-dimer > 2* upper limit of normal
             (ULN), or 2 with D-dimer > 2*ULN

        Key Exclusion Criteria:

          -  Any serious bleeding within 3 months prior to randomization or occurring during index
             hospitalization

          -  Serious trauma (including head trauma) within 4 weeks before randomization

          -  History of hemorrhagic stroke at any time in the past

          -  Any medical condition that requires chronic use of any parenteral or oral
             anticoagulation
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe/simvastatin 10/40; atorvastatin 40 mg; atorvastatin 20 mg
Intervention description: ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.; atorvastatin 40 mg tablet once daily for 6 weeks; All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40
      mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent
      reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared
      between the two treatment groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are either statin naive or on approved lipid lowering therapy for 6
             weeks prior to study initiation

          -  Participant meets Adult Treatment Panel (ATP) III High Risk criteria

        Exclusion Criteria:

          -  Females who are pregnant or breastfeeding

          -  Participant consumes more than 14 alcoholic beverages per week

          -  Participant has been treated with an investigational drug within the last 30 days

          -  Participant has congestive heart failure (New York Heart Association [NYHA] Type III
             or IV)

          -  Participant has had gastric bypass

          -  Participant is newly diagnosed with type 1 or 2 diabetes

          -  Participant is Human Immunodeficiency Virus (HIV) positive

          -  Participant has a history of drug or alcohol abuse within the last 5 years
Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat hydrochloride; Placebo
Intervention description: Oral capsule QOD; Oral capsule QOD
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Sponsor and Assessor were also blinded
Enrollment: 67.0
Sex: All
Minimum age: 16 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; AT1001; Migalastat; Pharmacokinetics; Substrate; Galafold

Summary:

      The primary objective of this study was to compare the effect of migalastat (123 milligrams
      [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) versus
      placebo on kidney globotriaosylceramide (GL-3).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 16 and 74 diagnosed with Fabry disease.

          -  Confirmed mutant form of α-galactosidase A shown to be responsive to migalastat in
             vitro.

          -  Participant has never been treated with enzyme replacement therapy (ERT) or has not
             received ERT for 6 consecutive months or longer before the screening visit for the
             study.

          -  Urine GL-3 ≥4 times the upper limit of normal at screening.

          -  Participants taking angiotensin converting enzyme inhibitors or angiotensin receptor
             blockers must be on a stable dose for a minimum of 4 weeks before the baseline visit.

          -  Females who can become pregnant and all males agree to be sexually abstinent or use
             medically accepted methods of birth control during the study and for 30 days after
             study completion.

          -  Participant is willing and able to provide written informed consent and assent, if
             applicable.

        Exclusion Criteria:

          -  Participant has undergone or is scheduled to undergo kidney transplantation, or is
             currently on dialysis.

          -  Estimated glomerular filtration rate <30 milliliters per minute per 1.73 meters
             squared (chronic kidney disease Stage 4 or 5) based on the Modification of Diet in
             Renal Disease equation at screening.

          -  Pregnant or breast-feeding.

          -  History of allergy or sensitivity to study medication (including excipients) or other
             iminosugars (for example, miglustat, miglitol).

          -  Participant is treated or has been treated with any investigational drug within 30
             days of study start.

          -  Participant is currently treated or has ever been treated with migalastat.
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Condition: Prostate Cancer; Male Erectile Disorder; Stage I Prostate Cancer; Stage II Prostate Cancer
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Intervention: sildenafil citrate; alprostadil; robotic-assisted laparoscopic surgery; quality-of-life assessment; questionnaire administration
Intervention description: Given orally; Given intraurethrally; Undergo prostatectomy; Ancillary studies; Ancillary studies
Intervention MeSH terms: Sildenafil Citrate; Alprostadil
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone
      prostatectomy for prostate cancer to recover from erectile dysfunction.

      PURPOSE: This randomized clinical trial is studying giving sildenafil together with
      alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical
      prostatectomy for nonmetastatic prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  All patients undergoing BNS-RAP for prostate cancer will be asked to participate

          -  Ability to achieve erections sufficient for intercourse prior to surgery and an
             SHIMS-5 score of >= 22

          -  Must maintain follow up care at COH for visits 1, 3, 6, 9, 12, and 18 months post
             surgery

          -  Participants willing to participate on study for a minimum of 18 months

          -  Consented participant on the Prostate database study (protocol 00149)

          -  Patients must have a clinical stage of < T3

          -  Gleason score < 8 on post-operative pathological sample prior to randomization

        Exclusion Criteria

          -  Metastatic disease

          -  Coronary artery disease on nitrate therapy (including oral sublingual nitrates)

          -  Unable to maintain follow up visits at COH at 1, 3, 6, 9, 12, and 18 months
             post-operatively

          -  Pathology diagnosis >= pT3

          -  Prior hormonal treatment use for prostate cancer or low serum testosterone

          -  Allergy to prostaglandin PGE1, Lidocaine, or Viagra

          -  Gleason score >= 8 on post-operative pathological sample prior to randomization

          -  Concomitant use of cytochrome P450 3AY inhibitors (cimetidine, erythromycin,
             ketoconazole, or protease inhibitors)

          -  SHIMS-5 score =< 21
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Depression
Intervention: Pregabalin; placebo
Intervention description: Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose; placebo capsules twice a day for 14 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregabalin; Lyrica; depression

Summary:

      The intent of this study is to identify and treat fibromyalgia subjects with comorbid
      depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI
      (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine
      whether pregabalin demonstrates improvement relative to placebo in improving pain associated
      with fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women of any race or ethnicity who are at least 18 years of age.

          -  Adult women and men with a diagnosis of fibromyalgia and stable depression (major
             depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have
             been taking an antidepressant (SSRI or SNRI) primarily for their depression for at
             least 3 months.

        Exclusion Criteria:

          -  Have failed pregabalin treatment due to lack of improvement of symptoms at doses of
             greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin
             ingredient, or participated in a pregabalin clinical trial. If the subject has taken
             pregabalin and discontinued for reason other than lack of improvement or intolerance,
             then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is
             not permitted.

          -  Patients with severe or unstable depression are not eligible.

          -  Patients with other types of pain or conditions that may make it difficult to evaluate
             fibromyalgia symptoms are not eligible

          -  Any subject considered at risk of suicide or self harm based on investigator judgment
             and/or the details of a risk assessment
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 628.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in
      combination with insulin glargine or insulin degludec, is safe and effective in participants
      with type 2 diabetes (T2D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have T2D based on the disease diagnostic criteria World Health
             Organization (WHO) classification.

          -  Participants must have been treated for at least 90 days prior to screening with
             either basal insulin + at least 1 prandial injection of bolus insulin or premixed
             analog/human insulin regimens at least twice daily.

          -  Participants must be treated no more than 3 oral anti-hyperglycemic medications
             (OAMs).

          -  Participants must have a HbA1c ≥7.0% and ≤11.0%.

          -  Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared
             (kg/m2).

        Exclusion Criteria:

          -  Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or
             latent autoimmune diabetes in adults.

          -  Participants must not have had any episode of severe hypoglycemia within the 6 months
             prior to screening.

          -  Participants must not have had 1 or more episodes of diabetic ketoacidosis or
             hyperglycemic hyperosmolar state within the 6 months prior to screening.

          -  Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1)
             receptor agonist, or pramlintide within 90 days prior to screening.