bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Condition: Intraocular Lens Replacement
Intervention: OMS302; Placebo
Intervention description: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced salt solution (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.; Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cataract; lens replacement

Summary:

      The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug)
      for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens
      Replacement (ILR) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Competent and willing to voluntarily provide informed consent

          -  18 years of age or older

          -  In good general health needing to undergo cataract extraction or lens extraction with
             lens replacement surgery in one eye, under topical anesthesia

        Exclusion Criteria:

          -  No allergies to the medications and/or the active ingredients of any of the study
             medications

          -  No medications with the same activities of the active ingredients in OMS302 for
             defined time intervals prior to and after surgery

          -  No other significant eye injuries, eye conditions or general medical conditions likely
             to interfere with the evaluation of the study medication
The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study)
Condition: Dysfunctional Voiding; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Phenazopyridine; no Phenazopyridine
Intervention description: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 92.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a
      retropubic midurethral sling operation.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Any female subjects scheduled to undergo Mid-Urethral Sling (MUS) through the UMass
        urogynecology service for incontinence.

        Exclusion Criteria:

          1. Planned concurrent prolapse or other procedure besides cystoscopy

          2. Using intermittent self catheterization preoperatively

          3. Undergoing spinal anesthesia for the procedure

          4. Known allergy to phenazopyridine (AKA Pyridium)

          5. Renal insufficiency

          6. Any condition or situation that in the attending physician's opinion would
             contra-indicate the use of phenazopyridine

          7. Subjects not competent to give consent

          8. Prisoners

          9. Non-English speaking patients

         10. Age <18

         11. Pregnant patients

         12. Contraindications to the use of IV methylene blue including

               1. Patients with known hypersensitivity reactions

               2. Severe renal insufficiency

               3. Patients with G6PD deficiency
Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Condition: ADHD; Substance Abuse
MeSH terms: Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate (OROS-MPH); Methylphenidate (OROS-MPH) - Placebo
Intervention description: Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.; Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of osmotic-release methylphenidate
      (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual for Mental Disorders, 4th Edition (DSM-IV)
             diagnostic criteria for ADHD

          -  Meet DSM-IV diagnostic criteria for at least one non-nicotine substance use disorder

          -  Has a DSM-IV ADHD Symptom Checklist score ≥ 22 derived from the adolescent-completed
             checklist

        Exclusion Criteria:

          -  Serious medical illness

          -  History of tic disorder

          -  Pregnant or breastfeeding

          -  Meet DSM-IV criteria for current or life-time psychotic disorder

          -  Meet DSM-IV criteria for current or life-time bipolar disorder

          -  Requires/or prescribed other concurrent psychotropic medication

          -  Taking any medications that may produce interactions with OROS-MPH

          -  Opiate dependence

          -  Methamphetamine abuse or dependence

          -  Suicidal risk

          -  Enrolled in an inpatient, residential, day treatment, or outpatient substance abuse
             program within 28 days prior to signing consent
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex 25 mg; Proellex 50 mg
Intervention description: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle; Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Uterine Fibroids

Summary:

      The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four
      months each) will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Speak, read and understand English or Spanish;

          -  Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation
             therapy (previous myomectomy is acceptable) for any cause and no surgical
             interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial
             embolization) are planned or anticipated during the study;

          -  One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;

          -  Menstrual cycle lasting from 24 to 36 days;

          -  History of excessive menstrual bleeding;

          -  Negative urine pregnancy test at screening.

        Additional inclusion criteria may apply.

        Exclusion Criteria:

          -  Six months or more (immediately prior to Screening Visit) without a menstrual period;

          -  Prior hysterectomy;

          -  Prior bilateral oophorectomy;

          -  Pregnant or lactating females or women who are attempting or expecting to become
             pregnant at any time during the study;

          -  Documented endometriosis, active pelvic inflammatory disease (PID), platelet
             dysfunction, or Von Willebrand's Disease;

          -  Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade
             including atypical squamous cells of undetermined significance (ASCUS) associated with
             Human Papilloma Virus (HPV);

          -  Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or
             any other organ system;

          -  Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or
             Chlamydia or previous history of auto-immune disease or positive serum antinuclear
             antibodies.

        Additional exclusion criteria may apply.
2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
Condition: Surgical Site Infections; Post Operative Complication
MeSH terms: Infections; Surgical Wound Infection; Postoperative Complications
Intervention: 2% chlorhexidine gluconate cloths
Intervention description: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: skin flora

Summary:

      Surgical site infection (SSI) following spinal surgery is a frequent complication and results
      in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a
      frequent complication that has been reported to occur in 0.7-12.0% of patients and result in
      higher postoperative morbidity, mortality and health care costs. Vanderbilt University
      Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision
      surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of
      risk factors is thus important in the development of strategies to prevent these potentially
      devastating infections. This study proposes a randomized, controlled trial of neuro-spine
      patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op
      surgical site infections in spine patients.

      Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect
      (decrease rates) of SSI compared to patients who receive routine standard of care (soap and
      water pre-op, day of surgery and daily post-operative).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors:

          -  Diabetic OR

          -  BMI>30 OR

          -  ASA>2 OR

          -  pre-operatively hospitalized OR

          -  >60 years old OR

          -  chronic steroids/immunosuppressive medications OR

          -  prior history of SSI

        Exclusion Criteria:

          -  Unable to consent

          -  Non English speaking

          -  Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate
             cloths

          -  Current infection or history of spine infections

          -  Patients with tumors or intradural spinal pathology.
Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Condition: Leukaemia, Lymphocytic, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: chlorambucil, tablets; ofatumumab (GSK1841157) infusion
Intervention description: 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles; iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
Intervention MeSH terms: Ofatumumab; Chlorambucil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 447.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Safety; Untreated; Efficacy; Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia (CLL), untreated; Ofatumumab; Oncology

Summary:

      The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to
      chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed CLL diagnosis and active CLL requiring treatment

          -  considered inappropriate for fludarabine-based therapy

          -  not been treated for CLL before

          -  fully active at a minimum or fully capable of selfcare and up and about more than 50%
             of waking hours

          -  age 18yrs or older

          -  signed written informed consent

        Exclusion Criteria:

          -  prior CLL therapy

          -  abnormal/inadequate blood values, liver, and kidney function

          -  certain heart problems, active or chronic infections, serious significant diseases,
             active autoimmune hemolytic anemia (AIHA) requiring treatment, other current cancer or
             within last 5 years

          -  CLL transformation

          -  CLL central nervous system involvement

          -  current participation in other clinical study

          -  inability to comply with the protocol activities

          -  lactating or pregnant women or female patients of child-bearing potential (or male
             patients with such partners) not willing to use adequate contraception
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Condition: Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Gadobutrol (Gadavist, Gadovist, BAY86-4875); ProHance
Intervention description: Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw); Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw); ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 165.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: MRI; Brain Metastasis; Gadolinium; Imaging; Diagnostic Agent

Summary:

      This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance,
      which has already been approved as a pharmaceutical product of similar indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients at least 20 years of age

          -  Patients with diagnosed primary cancer

          -  Patients with metastatic lesions by CT/MRI

        Exclusion Criteria:

          -  Patients who have contraindication to the MRI examinations

          -  Patients who have severe renal disorder

          -  Patients in extremely serious general condition
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BMS-188667; Mycophenolate mofetil; Prednisone; Placebo matching with BMS-188667
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 695.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when
      used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)
    

Eligibility criteria:

        For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching
        Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on
        clinical trial participation.

        Note: Subjects > 16 are eligible for enrollment at selected centers

        Inclusion Criteria:

          -  Potential subjects must have active lupus nephritis

          -  Biopsy within 12 months prior to screening visit indicating active Class 3 or 4
             proliferative lupus glomerulonephritis (lupus effecting your kidney)

          -  Urine protein creatinine ratio (UPCR) ≥ 1 at Screening

          -  Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)

          -  There must also be evidence of active disease within 3 months of Screening, based on
             at least one of the following:

               -  Worsening of lupus nephritis OR

               -  UPCR ≥ 3 at Screening OR

               -  Active urine sediment OR

               -  Biopsy within 3 months prior to screening visit indicating active Class 3 or
                  Class 4 active proliferative lupus glomerulonephritis

        Inclusion Criteria for the Long-Term Extension Period:

          -  Signed Written Informed Consent

          -  Subjects who achieve a complete or partial renal response after completing 2 years of
             double-blind treatment

        Exclusion Criteria:

          -  Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis

          -  Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,
             hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
             cerebral disease, or other concomitant medical conditions that, in the opinion of the
             Investigator, might place the subject at unacceptable risk for participation in this
             study

          -  Significant active Central nervous system (CNS) lupus with the exception of fatigue or
             mild stable cognitive

          -  Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too
             significant and irreversible
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: atomoxetine hydrochloride; Placebo
Intervention description: Oral 40-100 mg/day; Oral delivery of matching placebo
Intervention MeSH terms: Atomoxetine 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: 2017.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: ADHD; Adult; long term; maintenance of response; Attention Deficit Hyperactivity Disorder

Summary:

      LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with
      Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label
      conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study.
      Those patients that meet the response criteria will continue the blind phase of the study up
      to a year. During that period, patients that respond to atomoxetine will be randomized to
      continue the treatment with atomoxetine or with placebo (neither the patients nor
      investigators know if patients receive atomoxetine or placebo).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults

          -  Male or female

          -  Must meet Attention-Deficit/Hyperactivity Disorder (ADHD) according to Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™)
             criteria

        Exclusion Criteria:

          -  Comorbidity with major psychiatric disorder

          -  Clinically significant depression or anxiety

          -  Patients with significant medical conditions

          -  Current alcohol/drugs abuse/dependence

          -  Concomitant excluded medications
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: olodaterol; tiotropium; placebo
Intervention description: fixed dose combination; fixed dose combination
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 809.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the efficacy and safety of 12 weeks once daily
      treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler)
      compared with tiotropium and placebo in patients with COPD.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis chronic obstructive pulmonary disease

          -  Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal
             and post FEV1/ FVC < 70%

          -  Male or female patients, 40 years of age or more

          -  Smoking history more than 10 pack years

        Exclusion criteria:

          -  Significant diseases other than COPD

          -  History of asthma

          -  COPD exacerbation in previous 3 months

          -  Completion of pulmonary rehabilitation program within previous 6 weeks or current
             participation in pulmonary rehabilitation program.

          -  Pregnant or nursing women

          -  Patients unable to comply with pulmonary medication restrictions