bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Gait After Dysport Treatment
Condition: Equinovarus; Acquired
MeSH terms: Clubfoot
Intervention: Dysport
Intervention description: Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors.
Intervention MeSH terms: abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This pilot study will aim to understand the potential benefit of the assessment of walking
      using video slow motion for muscle selection and the development of an image catalogue guide
      of the potential results of injection of abobotulinumtoxinA by comparing foot postures before
      and after injection. The objective is to evaluate the use of video assessment to improve
      muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary
      outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of
      walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale
      (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with
      equinovarus foot deformity who are able to ambulate will be included in the study. Dysport
      1000 to 1500 units will be used to be distributed on the basis of clinical indication to
      ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors.
      The duration of subjects' participation is 4-6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide signed and dated informed consent form

          -  Willing to comply with all study procedures and be available for the duration of the
             study

          -  Male or female, aged ≥ 18

          -  Equinovarus foot deformity appropriate for botulinum toxin treatment (naïve or
             non-naïve)

          -  Modified Ashworth Scale between 1 to 3

          -  Women of reproductive potential must use effective contraception for the duration of
             the study

        Exclusion Criteria:

          -  Inability to walk without leg brace

          -  Previous surgical intervention to affected/ankle/foot

          -  Uncontrolled seizures

          -  Pregnancy or lactation

          -  Known allergic reactions to Dysport

          -  Treatment with another investigational drug or other intervention in the past 4 months

          -  Modified Ashworth Scale 4

          -  Anything that would place the individual at increased risk or preclude the
             individual's full compliance with or completion of the study

          -  Lower motor neuron disorder

          -  < Four months post botulinum toxin or serial casting
Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study
Condition: Glaucoma; Drugs; Normal Tension Glaucoma; Primary Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma
Intervention: Timolol Maleate; Brimonidine Tartrate
Intervention description: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.; Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
Intervention MeSH terms: Timolol; Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study evaluates the possible acute changes in peripapillary blood flow after
      instillation of antiglaucoma medications in patients with primary open angle glaucoma (POAG),
      normal tension glaucoma (NTG), or ocular hypertension (OHTN) using Optical Coherence
      Tomography (OCT) angiography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ocular hypertension, primary open angle glaucoma, or normal tension
             glaucoma in the study eye(s)

          -  Age 18-90

          -  Best corrected visual acuity of 20/60 or better

        Exclusion Criteria:

          -  Current use of either brimonidine or timolol

          -  Other disease, ophthalmic or systemic, that is likely to significantly affect the OCT
             test in the study eye(s) including:

               -  More than moderate grade cataract that significantly reducing OCTA scan signal
                  level

               -  Macular degeneration other than mild drusen or pigmentary changes

               -  Diabetic retinopathy other than mild background non proliferative retinopathy

               -  Prior or current macular edema

               -  Prior laser treatment to the retina

               -  Prior retinal detachment

               -  Prior central serous retinopathy

               -  Prior retinal vein or artery occlusion

               -  Prior inflammatory retinopathy or choroidopathy

               -  Keratoconus or other corneal ectasia

               -  Corneal scarring in central 4 mm

               -  Prior penetrating keratoplasty

               -  Ischemic optic neuropathy

               -  Dementia beyond early/mild memory loss

               -  History of cerebrovascular accident

               -  History of severe carotid stenosis

               -  History of previous ocular surgery other than non-complicated cataract extraction
A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
Condition: Subdural Hematoma
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Intervention: Tranexamic Acid
Intervention description: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a single center single arm study of 50 patients to 1) determine the safety of
      tranexamic acid in the chronic subdural hematoma population following surgical drainage of
      chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the
      rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be
      compared to historical controls. This study intends to be a prerequisite to a large
      nationally funded randomized control trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients undergoing intervention for chronic subdural hematoma (cSDH) including
             drainage

          -  cSDH will be defined as hematoma on CT imaging that is predominantly iso- to hypodense
             to brain

          -  18-85 years of age

        Exclusion Criteria:

          -  cSDH not requiring surgical drainage

          -  patients undergoing bedside twist drill craniostomy

          -  medically unstable for surgery

          -  patients requiring long-term anticoagulation (unable to stay off for less than 30
             days)

          -  patients not expected to survive to the completion of followup

          -  patients comatose prior to the initiation of treatment

          -  history of thromboembolic problem including stroke, myocardial infarction, deep vein
             thrombosis and/or pulmonary embolism

          -  pregnant

          -  minor

          -  allergy/sensitivity to tranexamic acid

          -  irreversible coagulopathy

          -  known clotting disorder

          -  bilateral hematomas with both requiring drainage

          -  incarcerated

          -  any patient not judged suitable for the study by the investigators

          -  women who are taking combination hormonal contraception
Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Condition: Pain
Intervention: Paracervical block technique with lidocaine
Intervention description: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 332.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain during first-trimester surgical abortion

Summary:

      The purpose of this study is to determine the level of pain women experience with a surgical
      abortion and the effect that varying paracervical block techniques might have on that pain.
      These different techniques involve wait time following the injection as well as the number of
      sites injected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 years or older

          -  voluntarily requesting pregnancy termination

          -  ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age

          -  generally healthy

          -  English or Spanish speaking

          -  able or willing to sign an informed consent and agree to terms of the study

        Exclusion Criteria:

          -  gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this
             gestational age at the study sites)

          -  incomplete abortion

          -  failed medical abortion

          -  required or requested IV sedation (prior to randomization)

          -  patient who declines Ibuprofen, Lorazepam or PCB

          -  medical contraindication or allergy to any of the study medications

          -  chronic use of narcotic pain medication or heroin

          -  significant physical or mental health condition

          -  adnexal mass or tenderness on pelvic exam consistent with inflammatory disease

          -  known hepatic disease

          -  women who, in the opinion of the investigator, are not suitable for the study protocol
Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Copaxone®
Intervention description: Subcutaneous Injections
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 861.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare patient medication satisfaction as measured
      by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three
      time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women at least 18 years of age or older.

          2. Patients must have a confirmed and documented RRMS diagnosis

          3. Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit.

          4. Patients must be in a stable neurological condition, relapse-free and free of any
             corticosteroid treatment 30 days prior to randomization.

          5. Women of child-bearing potential must have a negative urine pregnancy test at
             screening visit and must practice an acceptable method of birth

          6. Patients must be able to sign and date a written informed consent prior to entering
             the study.

          7. Patients must be willing and able to comply with the protocol requirements for the
             duration of the study.

        Exclusion Criteria

          1. Patient had any contraindication to Copaxone therapy.

          2. Previous use of Copaxone 40 mg/mL three times per week.

          3. Patients with progressive forms of MS.

          4. Patients with neuromyelitis optica.

          5. Use of experimental or investigational drugs, and/or participation in drug clinical
             studies within the 6 months prior to screening.

          6. Patients who have been treated with; immunosuppressive medications, immunoglobulins
             and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or
             mitoxantrone at any time

          7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid
             treatment within 6 months prior to screening visit.

          8. Pregnancy or breastfeeding.

          9. Clinically significant or unstable medical or surgical condition that would preclude
             safe and complete study participation

         10. Employees of the clinical study site or any other individuals involved with the
             conduct of the study, or immediate family members of such individuals

               -  other criteria may apply, please contact the investigator for more information
Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen
Condition: Tonsillectomy; Adenoidectomy
Intervention: Acetaminophen
Intervention description: already included in arm/group descriptions
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical
      patients. The drug is available in an over the counter, inexpensive oral form as well as a
      considerably more expensive intravenous form. This study will compare opioid requirements and
      acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus
      intravenous routes given pre operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for
             obstructive sleep apnea with or without additional minor procedures such as sleep
             endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or
             ear exam. ( Minor additional procedures that are frequently combined with
             tonsillectomy and adenoidectomy but are not commonly considered to have pain that is
             significantly greater than the tonsillectomy and adenoidectomy).

        Exclusion Criteria:

          -  Patients who meet University of California Davis Children's Hospital (UCDCH) criteria
             for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively,
             exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep
             study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%,
             cardiac disease, difficult intubation.

          -  Patients with a known allergy to acetaminophen

          -  Patients with known hepatic insufficiency or severe hepatic disease

          -  Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Patients who are malnourished (ie lower levels of glutathione)

          -  Patients with severe renal impairment as defined by calculated creatinine clearance
             <20 ml/min (per modified Schwarz equation)

          -  Patients who are pregnant
At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: bamlanivimab
Intervention description: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab by a registered nurse. This infusion will last approximately 1 hour followed by 1 hour of observation.
Intervention MeSH terms: Bamlanivimab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID19; bamlanivimab; UnitedHealth

Summary:

      This is an open-label, pragmatic, single-dose study using matched controls in participants
      with mild to moderate COVID-19. Participants will track for developing symptoms while at home
      and upon reporting of symptoms will test for COVID-19. If positive for COVID-19, a one-time
      at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion. Participants
      will then track for 28 days to assess for any additional medical care needed or if
      hospitalization was required.
    

Eligibility criteria:

        Inclusion Criteria:

          -  UnitedHealthcare member

          -  confirmed COVID-19 positive

          -  located in an area where Bamlanivimab (LY3819253) is available for infusion

        Exclusion Criteria:

          -  current (from first symptom report) hospitalization for COVID-19

          -  prior administration of Bamlanivimab or other COVID-19 therapies

          -  previous COVID-19 diagnosis

          -  prior receipt of a COVID-19 vaccine

          -  not authorized for patient use per the EUA
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Intervention: Nebulized magnesium sulfate
Intervention description: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Versus
15 mg albuterol in 22 ml of normal saline via nebulizer over one hour
Intervention MeSH terms: Magnesium Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Magnesium sulfate; Childhood asthma; Emergency department

Summary:

      The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as
      a vehicle for albuterol in children with moderate to severe asthma exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age ≥ seven years

          -  Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist
             medication

          -  Able to complete bedside spirometry

          -  FEV1 < 70% predicted

        Exclusion Criteria:

          -  Known allergy to magnesium sulfate

          -  Known contra-indication to albuterol

          -  Respiratory distress occurring as a result of bedside spirometry

          -  History of neuromuscular disease, cardiac disease, renal disease, or underlying
             chronic lung disease

          -  Pregnancy

          -  Use of oral steroid medication within 72 hours of presentation

          -  Radiographic evidence of pneumonia at presentation

          -  Intubation during the current encounter prior to study enrollment

          -  Administration of intravenous magnesium sulfate prior to study enrollment

          -  Prior participation in this study
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?
Condition: Knee Osteoarthritis; Knee Rheumatism
MeSH terms: Rheumatic Diseases
Intervention: Obturator nerve regional block; Adductor canal regional block; Saline
Intervention description: Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.; Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.; Saline as placebo comparator
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: adductor canal regional block; obturator nerve regional block; total knee arthroplasty; knee replacement surgery; Knee rheumatoid arthritis

Summary:

      One common anesthetic that is performed for total knee replacement surgery is spinal
      anesthesia with an adductor canal regional block, which involves injecting numbing medication
      in the thigh region for pain control after surgery. The aim of this study is to determine
      whether the addition of another regional block called obturator nerve block, which involves
      injecting numbing medication in the upper thigh region, will improve pain control after
      surgery while not sacrificing mobility after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo total knee arthroplasty

          -  Planned use of regional anesthesia for procedure

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  Patients on immunosuppressive therapy

          -  Patients with history of diabetes

          -  Patients with lower limb neuropathy

          -  Patients with history of chronic opioid use for > 3 months, including but not limited
             to, fentanyl, morphine, oxycodone, methadone

          -  Patients with known allergy or intolerance to any drug used in the study

          -  Patients with history of alcohol or drug abuse

          -  Patients with history of intolerance of nonsteroidal anti-inflammatory drugs

          -  Patients with hepatic or renal insufficiency

          -  ASA score of 4 or greater