bioihbjkbjnl/mcl2 huggingface dataset:
Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Intervention: Artificial tears
Intervention description: At random, subjects will receive isotonic artificial tear or a control (normal saline).
Intervention MeSH terms: Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dry eye; artificial tears; tear osmolarity; residence time

Summary:

      Background:

      Osmolarity is defined as the concentration of particles dissolved in a solution. Normal tears
      contain various dissolved particles including proteins, salts and other electrolytes. The
      investigators plan to investigate how osmolarity of the tear film changes over time after
      instillation of artificial tears containing hyaluronate. This is one kind of artificial tear
      that is used to treat dry eye.

      Dry eye and tear osmolarity:

      Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and
      ineffective. There has been a resurgence of interest and research in dry eye in the past 5
      years, and tear osmolarity has emerged as perhaps, one of the most effective ways to evaluate
      tear quality and dry eye status. Dry eye is usually treated with artificial tears, and many
      formulations are available. The investigators will test an isotonic solution that contains
      hyaluronate. Hyaluronate binds water and should help to maintain water on the eye.

      Objective:

      We plan to study the time course of possible changes in tear film osmolarity following
      instillation of an isotonic artificial tear containing hyaluronate. The investigators will
      use the TearLab, a new clinical instrument that has been developed to quickly and easily
      measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity
      over time can help doctors determine efficacy and dosing schedules. The investigators will
      test the isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline
      solution.

      Hypothesis:

      The investigators should be able to measure a decrease in tear osmolarity over time following
      instillation due to the water-binding effect of hyaluronate artificial tears relative to a
      control (normal saline solution).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age Normal vision in both eyes (20/30 best corrected) Preference
             for patient with dry eye symptoms

        Exclusion Criteria:

          -  No ocular disease other than dry eye Currently taking no ocular or systemic
             medications that might affect results
Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section
Condition: Contraception
Intervention: Copper IUD ( ParaGard Intrauterine Contraceptive Device)
Intervention description: Intraoperative placement of copper IUD at time of C-section
Intervention MeSH terms: Copper; Contraceptive Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Postpartum contraception; Copper IUD

Summary:

      This is a pilot study of up to 10 women, which will test the hypothesis that the placement of
      copper IUDs through the uterine incision at the time of uncomplicated elective C-section is
      technically feasible and acceptable to women seeking long-term contraception.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant woman

          -  Requires elective C-section

          -  Desires long-term contraception

        Exclusion Criteria:

          -  Contraindications to copper IUD
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: ziprasidone
Intervention description: Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
Intervention MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder

Summary:

      The primary objective of this study is to evaluate change in weight as a result of switching
      from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder
      who have failed to achieve a satisfactory clinical response to quetiapine due to lack of
      efficacy or poor tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, between 18 and 55 years of age, at the time of consent.

          -  Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or
             schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of
             Mental Disorders - Fourth Edition)

          -  Subjects must have normal vital signs, physical examination, ECG, and laboratory
             findings except for minor deviations determined and documented to be clinically
             insignificant by the investigator or a sub-investigator who is a medical doctor.

        Exclusion Criteria:

          -  Subjects who are unable to provide informed consent

          -  Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual
             of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or
             schizoaffective disorder, including psychoactive substance abuse or dependence within
             one year of study entry

          -  Females who are pregnant, breast feeding, or lactating at screening.
Overactive Bladder Innovative Therapy Trial (OrBIT)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Urgent PC Neuromodulation System; Tolterodine
Intervention description: The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Intervention MeSH terms: Tolterodine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OAB symptoms of urgency, frequency, and urge incontinence

Summary:

      The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug
      therapy for the treatment of symptoms of overactive bladder (OAB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years of age

          -  Experiences OAB with a voiding frequency of at least 8 times per day

          -  Is ambulatory and able to use a toilet independently and without difficulty

        Exclusion Criteria:

          -  On OAB pharmacotherapy within the previous month

          -  Primary complaint is stress urinary incontinence

          -  Has pacemaker or implantable defibrillator

          -  Has history of heart problems

          -  Has nerve damage or neuropathy

          -  Has gastric or urinary retention

          -  Has uncontrolled narrow-angle glaucoma

          -  Has known sensitivity to drug ingredients

          -  Is pregnant or planning to become pregnant during the trial
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Condition: Cataract
MeSH terms: Cataract
Intervention: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Intervention MeSH terms: Moxifloxacin; Dexamethasone; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aqueous Humor; Moxifloxacin; Vigadexa

Summary:

      The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing
      with a combination drug Vigadexa preoperatively in cataract patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requires cataract surgery;

          -  Acceptable health status (medical history, physical, laboratory and ophthalmologic
             exams);

          -  Able to follow instructions and willing to attend all study visits;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Any known or suspected allergies/hypersensitivity to any of the investigational test
             product components;

          -  History of invasive intraocular surgery in the eye to be operated, within 4 months
             before enrollment;

          -  Use of medications, as specified in protocol;

          -  Severe dry eye syndrome;

          -  Use of contact lenses two days before surgery until the last visit;

          -  External eye disease, infection or inflammation of the eyes or eyelids;

          -  Excessive bleeding tendency;

          -  No vision in the eye not included in the study;

          -  Pregnant or breastfeeding;

          -  Other protocol-defined exclusion criteria may apply.
Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
Condition: Thermal Burns
MeSH terms: Burns
Intervention: Lidocaine; Placebo
Intervention description: Lidocaine infusion runs for a total of 24 hours; Normal saline runs for a total of 24 hours
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain management; Narcotic consumption; Skin graft

Summary:

      Thermal injury results in one of the most intense and prolonged forms of pain the body can
      experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and
      their use in the perioperative period has been the mainstay of treatment; although medication
      requirements in burn patients are often underestimated. More medication may not be the
      answer, as relatively large doses of short acting opioids in the operative theater are
      associated with greater postoperative opioid consumption and higher pain scores. Furthermore,
      extensive use of opioids has resulted in the development of by hyperalgesia and allodynia.
      Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic,
      and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used
      for perioperative pain management in a variety of surgical procedures. The design of this
      study will examine if lidocaine will reduce the pain scores and narcotic utilization in
      patients undergoing surgical procedures for burn injuries. The intervention group will
      receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The
      control group will get an equal volume of saline. The investigators will compare pain scores,
      opioid use, and narcotic equivalents based on body weight and burn surface area (BSA)
      grafted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Burn patient ≥ 18 years of age

          -  Burn patient scheduled to go to OR for excision and/or grafting procedure

        Exclusion Criteria:

          -  Burn patient < 18 years of age

          -  Intubated patient on sedation drip

          -  Prolonged hypotension defined as Systolic Blood Pressure (SBP) < 90 mm/Hg for greater
             than 30 minutes in the pre-op area

          -  Severe underlying cardiovascular disease (documented ejection fraction < 40%)

          -  Documented conduction block, bradycardia or active congestive heart failure

          -  Documented active gastritis or ulcers

          -  Previous steroid medication history if documented adrenal insufficiency

          -  Patient with documented liver disease

          -  Patient with epilepsy or known seizure disorder

          -  Pregnant Women
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis (Diagnosis); Allergic Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis
MeSH terms: Sinusitis; Rhinitis, Allergic
Intervention: Mometasone Furoate Nasal Irrigation; Mometasone Nasal Spray
Intervention description: Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.; Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mometasone irrigation, mometasone spray, chronic rhinosinusitis

Summary:

      Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant
      disease burden. The recommended medical management of CRS includes large-volume, low-pressure
      saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the
      efficacy and safety of INCS are well-established for the long-term management of CRS,
      penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The
      aim of this study is to evaluate the effectiveness of mometasone furoate large-volume,
      low-pressure nasal irrigation for surgery-naive CRS patients.
    

Eligibility criteria:

        Inclusion Criteria:

        12-weeks or longer of two or more of the following signs and symptom consistent with CRS:

          -  mucopurulent drainage(anterior, posterior, or both)

          -  nasal obstruction (congestion)

          -  facial pain-pressure-fullness

          -  and decreased sense of smell

        AND inflammation documented by one or more of the following findings:

          -  purulent mucus or edema in the middle meatus or ethmoid region

          -  radiographic imaging showing inflammation of the paranasal sinuses.

        Exclusion Criteria:

          -  inability to speak or understand English

          -  nasal polyps

          -  history of nasal or sinus surgery

          -  comorbid mucociliary conditions

          -  dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma
             and chronic obstructive pulmonary disease

          -  history of oral or systematic antibiotic use in the past 2 weeks

          -  history of allergy to MF or other topical steroids

          -  pregnant or breastfeeding

          -  participants with a baseline SNOT-22 score of 9 or less will be excluded due to
             inability to achieve a minimally clinically improved difference pre- and
             post-intervention.
To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)
Condition: Urea Cycle Disorders
MeSH terms: Urea Cycle Disorders, Inborn
Intervention: HPN-100
Intervention description: Participants received individualized doses of HPN-100 orally, three times daily (TID) with meals. The initial dose was the same dose administered at the end of the HPN-100-005SE, HPN-100-007, or HPN-100-012SE studies. Dose adjustments (including frequency adjustments) were permitted as judged clinically appropriate by the investigator based on assessment of ammonia-scavenging needs (e.g., severity of the UCD defect, dietary protein intake, and urinary phenylacetylglutamine [PAGN] excretion). The maximum recommended dose of HPN-100 in participants weighing less than 20 kg was 0.53 mL/kg/day (equivalent to 600 mg/kg/day of NaPBA), and was 11.48 mL/m²/day in heavier subjects (equivalent to 13g/m²/day of NaPBA). The maximum HPN-100 dose recommended per protocol was 17.4 mL/day, which is equivalent to 20 g/day of NaPBA.
Intervention MeSH terms: 4-phenylbutyric acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Urea Cycle Disorders; GT4P; HPN-100; Sodium Phenylbutyrate (NaPBA); Glyceryl tri-(4-phenylbutyrate); Phenylbutyrate; Hyperion; BUPHENYL; hyperammonemia

Summary:

      This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate)
      in participants with a urea cycle disorder (UCD) who completed the safety extensions of
      HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or
      HPN-100-012 (NCT01347073; HPN-100-012SE). The initial studies were 1- to 2-week crossover
      studies, and their associated safety extensions were 12-month, open-label studies. All
      participants who completed the initial studies were eligible to enroll in the associated
      safety extension studies, and new participants were also permitted to enroll directly into
      the safety extension studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects who completed Studies HPN-100-005SE, HPN-100-007, or
             HPN-100-012SE

          -  Signed informed consent by participant and/or participant's legally authorized
             representative

          -  Negative pregnancy test for all females of childbearing potential

        Exclusion Criteria:

          -  Any clinical or laboratory abnormality or medical condition that, at the discretion of
             the investigator, may have put the participant at increased risk when participating

          -  Known hypersensitivity to PAA (phenylacetate) or PBA (phenylbutyrate).

          -  Liver transplant, including hepatocellular transplant

          -  Pregnant, breastfeeding or lactating females
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: CSL Limited Influenza Vaccine; Placebo
Intervention description: A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.; Placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 7500.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza
      Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a
      population defined as being not at risk of severe complications following influenza
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination

          -  Non pregnant/ non lactating females

        Exclusion Criteria:

          -  Hypersensitivity to influenza vaccine or allergy to any components of the Study
             Vaccines

          -  Vaccination against influenza in the previous 6 months

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality

          -  Known history of Guillain-Barré Syndrome;

          -  Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.

          -  History of neurological disorders or seizures

          -  Confirmed or suspected immunosuppressive condition or a previously diagnosed
             immunodeficiency disorder

          -  Current or recent immunosuppressive or immunomodulative therapy, including systemic
             corticosteroids

          -  Administration of immunoglobulins and/or any blood products;

          -  Participation in a clinical trial or use of an investigational compound;

          -  Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28
             days (for live vaccines) prior;

          -  Participants indicated to receive an influenza vaccine on an annual basis according to
             the local public health recommendations.