bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Erenumab
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Erenumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The purpose of this study is to measure the gastrointestinal emptying time using the wireless
      motility capsule (WMC) technology (FDA approved SmartPill™) in adult participants with
      migraine who are taking a monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP)
      antagonist called galcanezumab or erenumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine, with or without aura, as determined by the study
             investigator and in consideration of International Headache Society International
             Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)

          -  Have a frequency of less than 15 monthly headache days of which up to 14 can be
             migraine headache days.

          -  Participants can be on no more than 1 other migraine preventive treatment (except for
             tricyclic antidepressants and verapamil which are not allowed) as long as: that
             participant has had a stable dose of the oral migraine preventive treatment for a
             minimum of 2 months or participants have received onabotulinumtoxinA for a minimum of
             2 cycles prior to screening

        Exclusion Criteria:

          -  Participants with a history of gastric bezoars, swallowing disorders, severe dysphagia
             to food or pills, suspected or known strictures, fistulas, or physiological/mechanical
             GI obstruction

          -  History of any abdominal surgery within the past 3 months or GI surgery with the
             exception of cholecystectomy, appendectomy, or Nissen fundoplication

          -  History of irritable bowel syndrome (IBS), chronic constipation, Crohn's disease,
             celiac disease, ulcerative colitis, or diverticulitis

          -  Participants with type 1 or type 2 diabetes

          -  Participants with cardiac pacemakers or other implanted or portable electromechanical
             device

          -  Participants with a body mass index of ≥40 kilograms per square meter (kg/m²)

          -  Women who are pregnant or nursing

          -  Participants currently on mAb CGRP antagonists or have received a mAb CGRP antagonist
             within the past 6 months prior to visit 1

          -  Participants who have received an oral CGRP antagonist (gepant) in the last 14 days
             prior to Visit 1
Mupirocin-Iodophor ICU Decolonization Swap Out Trial
Condition: Staphylococcus Aureus
Intervention: Arm 1. Routine Care (Mupirocin/CHG); Arm 2. Iodophor/CHG Decolonization
Intervention description: The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.; The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
Intervention MeSH terms: Mupirocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-inferiority cluster randomized controlled trial
Masking: None (Open Label)
Enrollment: 353323.0
Sex: All
Healthy volunteers: No
Keywords: MRSA; healthcare-associated infections; mupirocin; iodophor; resistance

Summary:

      The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the
      non-inferiority of two decolonization regimens:

      Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the
      context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with
      iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that
      enrolled "subjects" represents 137 individual HCA Hospitals (representing ~235 ICUs) that
      have been randomized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria includes all U.S. HCA hospitals with an adult ICU;

          -  Note: Unit of randomization is the hospital, but the participants are hospital adult
             ICUs

          -  All patients within adult ICUs are included, including rare patients <18 years and
             >=12 years.

        Exclusion Criteria:

          -  Exclusion criteria includes ICUs with an average length of stay of less than 2 days;

          -  HCA hospitals that are not able to transfer or merge data into the centralized data
             warehouse for the baseline and intervention periods of the study are also excluded.
Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing
Condition: Acetaminophen Toxicity
Intervention: First Treatment Period; Washout; Second Treatment Period
Intervention description: (duration: 14 days) Subjects will be randomized to receive either of the 2 interventions (4 grams of solid acetaminophen formulation for two weeks vs. 4 grams of solid acetaminophen formulation + 70 mg/kg/day of liquid propylene glycol); (duration: 14 days) At the end of the First intervention period all participants will enter a washout period.; (duration: 14 days) At the end of the washout period, participants will receive the alternative intervention.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Eligible subjects will then be randomized at a 1:1 ratio to receive either acetaminophen (APAP) or APAP + propylene glycol for 2 weeks (Treatment Period 1). At the end of the Treatment Period 1 subjects will enter the Wash-Out period for 2 weeks. Study subjects will then receive the alternative treatment for 2 weeks (Treatment Period 2). Overall, the maximum duration of treatment is approximately 6 weeks.
RESPONDERS: Subjects whose transaminase levels rise to 3 times normal or greater during either of the Treatment Periods will be deemed responders and the intervention will cease.
If subjects are in the Treatment Period 1, they will enter the washout period and continue to return daily to ensure that liver function tests decline. After the 2 week washout-period, responders will cross over to Treatment Period 2.
If subjects are in the Treatment Period 2 phase, they will continue to return to the CRC and have their transaminases checked until they return to normal.
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acetaminophen; Propylene glycol

Summary:

      A purpose of this protocol is to is to compare the metabolites of the toxic bioactivating
      pathway after acetaminophen alone or acetaminophen followed by Propylene Glycol (PG) and to
      determine if it prevents the formation of the toxic metabolites of acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers ages 20-40

          -  Patients not taking any chronic medications

        Exclusion Criteria:

          -  Any history of liver disease

          -  Frequent alcohol use (2 or more drinks more than 4 times per week)

          -  Pregnant women

          -  Chronic medical condition requiring daily pharmacotherapy or the use of any daily
             prescription medications.

          -  Unable to provide informed consent
Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction
Condition: Ureteral Obstruction
MeSH terms: Ureteral Obstruction
Intervention: Tamsulosin; Tolterodine ER
Intervention description: 0.4 mg by mouth once per day.; 4 mg by mouth once a day.
Intervention MeSH terms: Tamsulosin; Tolterodine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tolterodine; Tamsulosin; Ureteral Obstruction

Summary:

      The purpose of this study is to determine whether combination therapy with Tolterodine ER and
      Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent
      symptoms. The second purpose is to determine if people have less stent discomfort if they
      take these medications starting 2 weeks before the stent is placed

      The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will provide
      added benefits in reducing stent symptoms in patients who have had unilateral placement of a
      ureteral stent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with unilateral ureteral stent placement for urolithiasis

        Exclusion Criteria:

          1. Pre-existing lower urinary tract symptoms

          2. Active urinary tract infection

          3. Contraindication to anticholinergic medication

               1. Prior hypersensitivity or allergy to tolterodine

               2. Patients with severe hepatic impairment (Child-Pugh Class C)

               3. Patients with uncontrolled close (narrow) angle glaucoma

               4. Patients with urinary retention

          4. Current anticholinergic use

          5. Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)

          6. Women who are pregnant or nursing

          7. Under 18 years of age

          8. Prior hypersensitivity or allergy to tolterodine

          9. Patients with severe hepatic impairment (Child-Pugh Class C)

         10. Patients with uncontrolled close (narrow) angle glaucoma

         11. Patients with urinary retention

         12. Unable to provide informed consent
Pain Expectations in Subjects With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Modafinil; Gabapentin; Placebo
Intervention MeSH terms: Gabapentin; Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Osteoarthritis; Knee pain; Hip pain; Total Knee Replacement Surgery

Summary:

      The purpose of this research study is to test whether or not researchers can alter or change
      expectations on pain. The researchers will test whether there is an effect on the size of the
      pupil and responses to thermal heat temperatures in subjects with osteoarthritis of the knee
      or hip or healthy subjects for comparison.

      One of 3 possible treatment groups will be administered to qualifying subjects: (1)
      gabapentin, a medication that is commonly used to treat nerve pain, (2) modafinil, a
      medication that is commonly used to treat people with narcolepsy (a disorder that causes
      people to fall asleep) and (3) a placebo, which is an inactive substance, like a sugar pill,
      that is not thought to have any effect on your disease or condition
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the knee or hip

          -  Adult (ages 18-80)

          -  Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with
             normal activity)

          -  American Society of Anesthesiologists physical status 1-3

          -  Healthy subjects without pain

        Exclusion Criteria:

          -  Pregnancy;

          -  Currently taking gabapentin

          -  Currently taking a narcotic prescription medication that is > 50 mg morphine
             equivalents/day

          -  Advanced or unstable cardiac, pulmonary, renal or hepatic dysfunction

          -  History of previous eye surgery

          -  Psychotic disorder or a recent psychiatric hospitalization
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
Condition: REM Sleep Behavior Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; REM Sleep Behavior Disorder; Mental Disorders
Intervention: Sodium Oxybate; Placebo
Intervention description: Sodium Oxybate will be titrated up weekly by 1.5g nightly dose increments from an initial 4.5g total nightly dose (which could be given in two unequal doses if needed, or one single dose no greater than 4.5g) to an optimal individual dose based on clinical response on RBD symptoms and tolerance, to a maximum nightly dose of 9g ("flexible dose" period lasting up to 8 weeks). The optimal dose will then be continued for at least 4 weeks ("stable dose").; Placebo will be similar in appearance, smell and flavor to the subjects, so that the investigators and participants will be unable to distinguish it from sodium oxybate.
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: sodium oxybate

Summary:

      This study is the first clinical trial using sodium oxybate for the treatment of REM sleep
      behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of
      narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has
      shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal,
      2016; Moghadam, 2017).
    

Eligibility criteria:

        Inclusion Criteria:

          -  40-85 years old

          -  With or without Parkinson's disease

          -  Experiencing RBD episodes on average at least 2x/week or 8x/month

          -  Able to report RBD episodes themselves or via a partner witness

        Exclusion Criteria:

          -  History of falls during ambulation in the last 6 months despite adequate neurologic
             treatment

          -  Requirement of an ambulatory device at home

          -  Inadequately treated symptomatic orthostatic hypotension

          -  BMI > 35

          -  Untreated or uncontrolled OSA (4%AHI>15)

          -  Cognitive impairment resulting in inability to comply with treatment instructions

          -  Pregnancy
Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Liposome Bupivacaine; Bupivacaine HCl
Intervention description: Administered via local tissue infiltration around the knee joint; Administered via CFNB
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing
      total knee replacement (TKR). However the resulting motor blockade can lead to decreased
      quadriceps muscle strength and delayed functional recovery.The purpose of this study is to
      compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control
      and functional recovery
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA Status I-III

          -  Scheduled to undergo primary unilateral total knee arthroplasty

        Exclusion Criteria:

          -  Patients who are pregnant or nursing

          -  Alcohol or narcotic dependence within the last 2 years

          -  Condition requiring regular use of analgesia that may confound post surgical
             assessments as determined by principle investigator

          -  BMI > 40kg/m2

          -  Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or
             pathological conditions potentially aggravated by epinephrine

          -  Allergies to amide-type local anesthetics

          -  Any disease condition or lab result that could complicate a patients postoperative
             recovery

          -  History of hypotension

          -  Abnormal liver, renal or cardiac function

          -  Other physical, mental or medical conditions that, in the opinion of the investigator,
             make study participation inadvisable.
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
Condition: Vitreomacular Traction; Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: Ocriplasmin 0.125 mg in a 0.1 mL volume
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: 18 Years
Healthy volunteers: No
Keywords: VMT; sVMA; vitrectomy; ocriplasmin

Summary:

      The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin
      (JETREA™®) over a 6-month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of VMT/sVMA, with evidence of focal VMT visible on Spectral Domain - Optical
             Coherence Tomography (SD-OCT).

          -  Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed
             consent form.

          -  Willing and able to attend all study visits.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential if pregnant, test positive on a urine pregnancy test,
             intend to become pregnant during the study period, breastfeeding, or not in agreement
             to use adequate birth control methods to prevent pregnancy throughout the study.

          -  Hypersensitivity to ocriplasmin or any of the JETREA™® excipients.

          -  Active or suspected intraocular or periocular infection in either eye.

          -  Participation in any interventional clinical trial within 30 days prior to baseline.

          -  Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.

          -  Broad VMT/VMA > 1500 microns at baseline in the study eye.

          -  History of vitrectomy in the study eye.

          -  History of laser photocoagulation to the macula in the study eye.

          -  Any relevant concomitant ocular condition in the study eye that, in the opinion of the
             Investigator, could be expected to worsen or require surgical intervention during the
             study period.

          -  Macular hole of > 400 microns diameter in the study eye.

          -  High myopia in the study eye.

          -  Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study
             eye that, in the Investigator's opinion, suggests lens/zonular instability.

          -  Aphakia in the study eye.

          -  History of retinal detachment in the study eye.

          -  Recent ocular surgery or ocular injection in the study eye within the past 90 days
             (including laser therapy).

          -  Proliferative diabetic retinopathy or ischemic retinopathies in the study eye.

          -  Retinal vein occlusions in the study eye.

          -  Exudative age-related macular degeneration (AMD) in the study eye.

          -  Vitreous hemorrhage in the study eye.

          -  Other protocol-specified exclusion criteria may apply.
Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: tacrolimus ointment
Intervention description: tacrolimus ointment to be applied twice daily to affected areas during duration of study
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: atopic dermatitis; eczema

Summary:

      The purpose of this research study is to better understand how the study drug works when
      people use it to treat atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects age 2-15.

          2. Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face
             and genital areas can be included in the body surface area determination and treatment
             area.

          3. The ability and willingness to follow all study procedures, attend all scheduled
             visits, and successfully complete the study.

          4. The ability to understand and sign a written informed consent/assent form, which must
             be obtained prior to treatment.

        Exclusion Criteria:

          1. Known allergy to tacrolimus or to any component of the formulations.

          2. The use of systemic therapy for atopic dermatitis within the past 4 weeks.

          3. Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or
             retinoids) within the past 2 weeks.

          4. Use of any investigational therapy within the past 4 weeks.

          5. Pregnant females, females who are breast feeding, or females of childbearing potential
             who are not practicing an acceptable method of birth control (abstinence, birth
             control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the
             investigator. Acceptable contraception must be used during the entire study. A
             pregnancy test will be performed on females of childbearing potential at baseline and
             at week 4.

          6. Any other condition which, in the judgment of the investigator, would put the subject
             at unacceptable risk for participation in the study.