bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Prednisolone Acetate 1%; Prednisolone Acetate 0.12%; Loteprednol Etabonate 0.2%; Placebo
Intervention description: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.; One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.; One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.; One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Intervention MeSH terms: Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Lubricant Eye Drops; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Allergic conjunctivitis

Summary:

      To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to
      prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic
      suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of
      allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID)
      dosing and 1 week of four times daily (QID) dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age & either sex, any race

          -  Willing and able to follow all instructions

          -  Positive history of ocular allergies

          -  Reproducible positive ocular allergic reaction induced by conjunctival allergen
             challenge

        Exclusion Criteria:

          -  Have planned surgery during trial period

          -  Female currently pregnant, planning a pregnancy or lactating

          -  Use of disallowed medications

          -  Have ocular infections, or ocular conditions that could affect study parameters

          -  Have moderate to severe dry eye

          -  Have used an investigational drug or device within 30 days of start of study

          -  Female that is currently pregnant, planning a pregnancy or lactating
Prunes for Gastrointestinal Function After Gynecologic Surgery
Condition: Constipation
MeSH terms: Constipation
Intervention: Prunes; Docusate Sodium
Intervention description: 12 oz of prunes daily; Oral docusate sodium twice daily
Intervention MeSH terms: Bismuth subsalicylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized control trial that randomizes patients post-operatively
      into standard care versus standard care plus prunes. Patients in the control arm will take
      100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm
      will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary
      objective is to determine the time to first bowel movement after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female patients seen in the Gynecology or Urogynecology clinics at LAC+USC Medical
             Center who are planned for surgery requiring at least 24 hour stay

          2. Age 18 or greater

          3. Able to give informed consent

          4. No contraindications to docusate or prune consumption

        Exclusion Criteria:

          1. Unable to give informed consent

          2. Unwilling to follow protocol

          3. Active malignancy

          4. Emergency surgery

          5. Diabetes mellitus

          6. Inflammatory bowel disease, gastroparesis, or other bowel disorder

          7. History of bowel resection or presence of colostomy

          8. Dependence on regular laxative use prior to surgery

          9. Baseline frequency of bowel movements less than weekly

         10. Intraoperative enterotomy or any bowel surgery performed at the time of surgery

         11. Patient unable to initiate oral intake on post op day 1 for any reason

         12. Allergy to docusate or prunes
Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: Efinaconazole
Intervention description: Solution
Intervention MeSH terms: Efinaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the
      treatment of pediatric subjects with mild to severe onychomycosis of the toenails.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female subjects of any race, 6 to 16 years of age (inclusive). PK Subset: Male
             or female subjects of any race, 12 to 16 years of age (inclusive).

          -  Verbal and written informed consent/assent obtained from the subject and/or their
             parent or legal guardian.

          -  Good general health, as assessed by the investigator, based on the subject's medical
             history, physical examination, and safety laboratory tests.

          -  Target great toenail for all subjects, and both great toenails for subjects in the PK
             subset, must have evidence of toenail growth, per subject's report that monthly
             clipping is needed.

          -  Subjects and their parents/legal guardians are willing to comply with study
             instructions and return to the investigational center for all required visits (a visit
             schedule with the length of each visit will be provided to ensure that the subject can
             meet the requirements and have adequate transportation).

        Key Exclusion Criteria:

          -  Females who are pregnant, nursing an infant, or planning a pregnancy during the study
             period.

          -  History of immunosuppression and/or clinical signs indicative of possible
             immunosuppression, as determined by the investigator, or known human immunodeficiency
             virus infection.

          -  History of diabetes that is uncontrolled as determined by the investigator (diabetes
             that is controlled by diet or medication does not exclude a subject).

          -  Presence of any toenail infection other than or in addition to dermatophytes, such as
             Scytalidium as determined by the investigator (candidal onychomycosis infection,
             concurrent with a positive dermatophyte culture, is acceptable).
Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A
Condition: Haemophilia A
MeSH terms: Hemophilia A
Intervention: Optivate 500IU
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Healthy volunteers: No
Keywords: Haemophilia A

Summary:

      Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma
      inhibitor levels for at least 100 Exposure Days (EDs) for each subject.

      Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and
      adverse events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent or, if less than 18 years of age written assent (where
             possible) and their parent/guardian's written informed consent.

          -  Severe haemophilia A (< 1%# FVIII:C).

          -  Previously Treated Patients (PTPs) with > 150 exposure days on prior Factor VIII
             therapy (of which at least the last 50 EDs or 2 years treatment can be confirmed by
             way of subject records).

          -  Immunocompetent with CD4 count > 200 / µl.

          -  HIV negative or a viral load < 200 particles / µl.

               -  subjects suffering from severe haemophilia A (<2%) may be enrolled, but only
                  after approval by BPL. Subjects with a Factor VIII of <2% may not constitute more
                  than 50% of the total patient population. A separate statistical evaluation will
                  be conducted for the <1% and <2% populations.

        Exclusion Criteria:

          -  • History of inhibitor development to FVIII or a positive result on the Nijmegen
             Bethesda at screening (quantitative result of > 0.6 BU) prior to the administration of
             Optivate®.

               -  Known or suspected hypersensitivity to the investigational medicinal product or
                  its excipients.

               -  Clinically significant liver disease, renal disease, or coagulopathy other than
                  haemophilia A.

               -  History of unreliability or non cooperation (including not being able to complete
                  the study diary).

               -  Participating in, or have taken part in another trial within the last 30 days.
Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Condition: Anterior Cervical Discectomy and Fusion (ACDF)
Intervention: Remifentanil; Ketamine; Dexmedetomidine
Intervention description: Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.; Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.; dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.
Intervention MeSH terms: Dexmedetomidine; Ketamine; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will help the investigators learn more about the best way to give anesthesia for
      these kinds of surgery. The investigators will be using 2 different groups of medications
      that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does
      not. The investigators wish to test whether a narcotic free anesthetic will result in an
      overall safer surgery, better patient recovery, and satisfaction. The investigators think
      also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover
      faster after surgery , and consume less pain medicines in the postoperative period.
    

Eligibility criteria:

        Inclusion Criteria

          -  Men and women 18- to 80-years old

          -  ASA 1, 2, 3

          -  1 or 2 levels ACDF

        Exclusion Criteria

          -  ASA 4

          -  Seizure disorders

          -  Chronic narcotic use

          -  Opiate abuse

          -  Major cardiac comorbidity, or significantly elevated blood pressure

          -  Known hypersensitivity to fentanyl analogs, ketamine, or propofol injectable
             emulsions.

          -  Known allergy to eggs, egg products, soybeans, or soy products
Knee Injection RCT
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Ketorolac Tromethamine Injection; Methylprednisolone Acetate Injection; Hylan G-F 20
Intervention description: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine; One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine; One knee injection of Hylan G-F 20 (Synvisc-One)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Ketorolac; Ketorolac Tromethamine; Prednisolone hemisuccinate; Prednisolone phosphate; Hylan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Knee; Injection; Ketorolac

Summary:

      Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of
      knee osteoarthritis (OA) compared to steroids and viscosupplementation.

      Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective
      study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in
      the nonsurgical management of symptomatic OA compared to injections with corticosteroids and
      viscosupplements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic
             evidence of joint space narrowing and 2) are interested in knee injections for pain
             relief.

        Exclusion Criteria:

          -  Prior injections into the same knee within the past 6 months,

          -  Pregnant and/or lactating women,

          -  Inflammatory joint disease including rheumatoid or psoriatic arthritis,

          -  Concurrent use of anti-rheumatic drugs,

          -  Allergy or hypersensitivity to the study medications,

          -  Patients on an active pain management contract,

          -  Patients with insurance that requires pre-certification for any of the study drugs,

          -  Inability to make own decisions regarding the informed consent,

          -  Inability to read and/or understand English,

          -  Patients who are unable to return for follow-up or be reached by phone.
Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries
Condition: Postpartum Sepsis; Postpartum Endometritis; Postpartum Fever
MeSH terms: Sepsis; Puerperal Infection; Endometritis
Intervention: Azithromycin; Azithromycin and amoxicillin; Placebo
Intervention description: Azithromycin tablet; azithromycin and amoxicillin; Placebo tablet
Intervention MeSH terms: Amoxicillin; Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 756.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon,
      Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or
      prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of
      azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal
      infectious outcomes and perinatal outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal
             delivery with

               1. Prolonged membrane rupture (≥8 hours) or

               2. Prolonged labor (≥18 hours).

        Exclusion Criteria:

          -  Clinical chorioamnionitis or any other active bacterial infection (e.g.
             pyelonephritis, pneumonia, abscess) at time of randomization: because standard
             antibiotic therapy for these conditions may confound trial intervention.

          -  Allergy to azithromycin or amoxicillin

          -  Plan for cesarean delivery prior to enrollment

          -  Fetal demise or major congenital anomaly: Major congenital anomalies may confound
             assessment of neonatal outcomes and every attempt will be made up front to exclude
             them from randomization. However, some unrecognized fetal anomalies may inevitably be
             randomized. These will not be excluded post-randomization from the primary (maternal
             outcome) analysis; they will be taken into consideration in the secondary analyses of
             neonatal outcomes.
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Ranibizumab; Aflibercept
Intervention description: 0.5 mg intravitreal injection; 2 mg intravitreal injection
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: The reading center was masked for treatment assignment in order to ensure unbiased evaluation of the primary, secondary and exploratory objectives that were determined by SDOCT, autofluorescence imaging, and microperimetry and multifocal ERG (where available).
When communicating with the reading center study centers had to be vigilant not to unblind the reading center to the treatment.
Site staff performing the assessments of BCVA, contrast sensitivity (where possible), VFQ25 and IReST (reading speed) were also masked to the identity of the treatment.
The central laboratory used for analysis of all specimens collected for biomarker assessment were blinded to the identity of the treatment.
Enrollment: 712.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: wet age-related macular degeneration (AMD); ranibizumab; aflibercept; Best Corrected Visual Acuity (BCVA); Spectral Domain Optical Coherence Tomography (SD-OCT)

Summary:

      The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg
      aflibercept bimonthly intravitreal injections on retinal thickness stability.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Visual impairment predominantly due to neovascular AMD Active

          -  Newly diagnosed, untreated, angiographically documented choroidal neovascularization
             (CNV) lesion

        Key Exclusion Criteria:

          -  Stroke or myocardial infarction less than 3 Months prior to study entry

          -  Active injection or inflammation of either eye at the time of study entry

          -  Any type of systemic disease (or received treatment for it), including any medical
             condition (controlled or uncontrolled) that were to be expected to progress, recur, or
             change to an extent which could bias the assessment of the clinical status of the
             patient to a significant degree or put the patient at special risk
Comparison of Two Application Techniques for LET Gel
Condition: Lacerations; Pain, Procedural; LET
MeSH terms: Pain, Procedural; Lacerations
Intervention: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Intervention description: Topical anesthetic
Intervention MeSH terms: Lidocaine; Epinephrine; Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded randomized study; patients are randomized to one of two groups
Masking: Double (Care Provider, Outcomes Assessor)
Masking description: Investigator and nurse applied intervention and masked the intervention from the care provider. Separate nurse not caring for the patient, blinded to the intervention, brought in to obtain pain score (outcome)
Enrollment: 48.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Comparison of anesthetic efficacy of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine
      (0.5%) topical gel (LET) applied three times for 10 minutes each time vs. once for 30 minutes
      prior to suturing simple lacerations in children aged 7-17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Simple <= 3cm lacerations requiring suturing (as decided by clinician care providers)

          -  Plan to suture with simple interrupted sutures

        Exclusion Criteria:

          -  Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears,
             or occurring over joints

          -  Patients whose primary language was neither English nor Spanish

          -  Developmentally delayed or disabled patient such that they were unable to give a pain
             score

          -  Patients requiring procedural sedation or anxiolysis with oral or intranasal midazolam